Gyno-Pevaryl 1 Vaginal Pessary


Gyno-Pevaryl 1 vaginal pessary

Econazole nitrate

Gyno-Pevaryl is a registered trademark

Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again If you have any further questions, ask your doctor or pharmacist This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours If you get side effects and they become serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist In this leaflet 1. What Gyno-Pevaryl 1 is and what it is used for 2. Before you use Gyno-Pevaryl 1 3. How to use Gyno-Pevaryl 1 4. Possible side effects 5. How to store Gyno-Pevaryl 1 6. Further information What Gyno-Pevaryl 1 is and what it is used for

The name of your medicine is Gyno-Pevaryl 1 vaginal pessary. It is called ‘Gyno-Pevaryl 1’ in this leaflet.

Gyno-Pevaryl 1 is a solid, bullet-shaped pessary (vaginal suppository). When inserted into the vagina it releases a medicine called econazole. This belongs to a group of medicines called ‘antifungals’.

Gyno-Pevaryl 1 is used for infections of the vagina and the skin around the vagina. The infections are caused by fungi and yeasts such as thrush (Candida).

Before you use Gyno-Pevaryl 1 Do not use Gyno-Pevaryl 1 if: You are allergic to anything in Gyno-Pevaryl 1 (listed in section 6 below) You are allergic to any other medicine used to treat thrush or other fungal infections You are under 16 years old

Do not use this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Gyno-Pevaryl 1.

Take special care with Gyno-Pevaryl 1

Check with your doctor or pharmacist before using this medicine if:

You are using a ‘barrier’ method of contraception. This includes condoms or diaphragms. This is because Gyno-Pevaryl 1 can damage the rubber and stop them working properly. Talk to your doctor about using another type of contraception while you are using this medicine Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription or herbal medicines.

In particular tell your doctor if you are taking:

Medicines to thin the blood (anticoagulants) such as warfarin or acenocoumarol Pregnancy and breast-feeding

Please tell your doctor before using Gyno-Pevaryl 1 if you are pregnant, think you may be pregnant or might become pregnant.

You may still be able to use Gyno-Pevaryl 1 if your doctor thinks you need to.

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Driving and using machines

This medicine is not likely to affect you being able to drive or use any tools or machines.

How to use Gyno-Pevaryl 1

Always use this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Using the pessary Use the pessary just before going to bed. This helps it to stay in place Do not swallow the pessary Inserting the pessary with the applicator Remove the pessary from the plastic packet using the easy open tab Pull the plunger of the applicator out until it sticks Gently push the pessary into the cup. Do not force it because it might stick Lie down with your knees bent and spread apart. Insert the applicator high into your vagina, pessary first Push the plunger to release the pessary Remove the applicator and dispose of it safely in your household waste If you swallow Gyno-Pevaryl 1

If the pessary is eaten or swallowed talk to a doctor or go to the nearest hospital casualty department straight away.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Gyno-Pevaryl 1 can cause side effects, although not everybody gets them.

Stop using Gyno-Pevaryl 1 and tell your doctor straight away if you notice the following. You may need urgent medical treatment. Sudden swelling of the face or throat. Hives (also known as nettle rash or urticaria), severe irritation, reddening or blistering of your skin. These may be signs of a severe allergic reaction (affects less than 1 in 10,000 people) Other side effects: Itchy and red skin around or inside the vagina. This is much milder than an allergic reaction. Tell your doctor or pharmacist if this feeling lasts for more than a few minutes or gets worse (rash, burning or swelling)

If you get side effects and they become serious or if you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Gyno-Pevaryl 1

Keep out of the reach and sight of children. Store in the original container. Do not store above 30°C. Keep away from heat and sunlight.

Do not use Gyno-Pevaryl 1: After the expiry date which is stated on the label. The expiry date refers to the last day of that month If the plastic packet is broken or missing If the pessary is not light beige in colour

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

Further information

The active substance in Gyno-Pevaryl 1 is econazole nitrate. The pessary contains 150mg econazole nitrate.

The other ingredients are polygel, colloidal silicon dioxide, Witepsol H 19, Wecobee FS, stearyl heptanoate.

What Gyno-Pevaryl 1 looks like and contents of the pack

Gyno-Pevaryl 1 comes in a plastic strip containing one pessary. It is bullet-shaped and light beige in colour.

The product licence is held by: JANSSEN-CILAG LTD 50-100 Holmers Farm Way High Wycombe Bucks HP12 4EG UK Gyno-Pevaryl 1 is made by: Janssen Pharmaceutica NV Turnhoutseweg 30 B-2340 Beerse Belgium

OR

McGregor Cory Ltd Middleton Close Banbury Oxfordshire OX16 8RS UK

For information in large print, tape, CD or Braille, telephone 0800 7318450.

This leaflet was last approved in August 2008.


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Gyno-Daktarin 20mg / g Cream


1. Name Of The Medicinal Product

Gyno-Daktarin 20mg/g cream

2. Qualitative And Quantitative Composition

Miconazole nitrate 2% w/w.

(Each gram of cream contains 20mg miconazole nitrate)

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Vaginal cream.

The cream is white and homogeneous.

4. Clinical Particulars 4.1 Therapeutic Indications

For the treatment of mycotic vulvovaginitis and superinfections due to gram-positive bacteria.

4.2 Posology And Method Of Administration

Gyno-Daktarin cream is for vaginal administration.

Recommended dosage

Administer the contents of one applicator (about 5g of cream) once daily deeply into vagina for 10 – 14 days or twice daily for 7 days. For vulvitis the cream should be applied topically twice daily. Continue the course of treatment even after pruritus and leukorrhoea have disappeared or menstruation begins.

4.3 Contraindications

Gyno-Daktarin cream is contraindicated in individuals with a known hypersensitivity to miconazole or another ingredient of the cream.

4.4 Special Warnings And Precautions For Use

Should local sensitisation or an allergic reaction occur, treatment should be discontinued.

Appropriate therapy is indicated when the sexual partner is also infected.

Gyno-Daktarin cream does not stain skin or clothes.

The concurrent use of latex condoms or diaphragms with vaginal anti-infective preparations may decrease the effectiveness of latex contraceptive agents. Therefore Gyno-Daktarin cream should not be used concurrently with a latex condom or latex diaphragm.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Miconazole administered systemically is known to inhibit CYP3A4/2C9. Due to the limited systemic availability after vaginal application, clinically relevant interactions occur very rarely. In patients on oral anticoagulants, such as warfarin, caution should be exercised and anticoagulant effect should be monitored. The effects and side effects of other drugs metabolized by CYP2C9 (e.g.,oral hypoglycemics and phenytoin) and also CYP3A4 (e.g., HMG-CoA reductase inhibitors such as simvastatin and lovastatin and calcium channel blockers such as dihydropyridines and verapamil), when co-administered with miconazole, can be increased and caution should be exercised.

Contact should be avoided between certain latex products such as contraceptive diaphragms or condoms and Gyno-Daktarin cream since the constituents of the cream may damage the latex. (see section 4.4).

4.6 Pregnancy And Lactation

Pregnancy

Although intravaginal absorption is limited, Gyno-Daktarin cream should only be used in the first trimester of pregnancy only if, in the judgement of the physician, the potential benefits outweigh the possible risks.

Lactation

It is not known whether miconazole nitrate is excreted in human milk. Caution should be exercised when using Gyno-Daktarin cream during lactation.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

The safety of GYNO-DAKTARIN was evaluated in a total of 537 women with microbiologically confirmed candidiasis and symptoms (e.g., vulvovaginal itching, burning/irritation), or signs of vulvar erythema, edema, excoriation, or vaginal erythema or edema who participated in 2 single-blind clinical trials. Subjects were treated with miconazole intravaginally, randomly assigned to either a single 1,200 mg capsule, or a 7-day application of 2% vaginal cream. Adverse Drug Reactions (ADRs) reported by

In the table, the frequencies are provided according to the following convention:

Very common

Common

Uncommon

Rare

Very rare <1/10,000, including isolated reports

Table 1. Adverse Drug Reactions Reported by Gyno-Daktarin-treated Subjects in 2 Single Blind Clinical Trials

 

Body System/Organ Class

Frequency Category

Undesirable effects

 

Skin and subcutaneous tissue disorders

 

 

Common

Rash

Uncommon

Rash pruritic, urticaria

Reproductive System and Breast Disorders

 

 

Very common

Genital pruritus female, vaginal burning sensation, vulvovaginal discomfort

 

Common

Dysmenorrhoea

 

A range of additional reactions were reported during the clinical trials, such as: vaginal discharge, vaginal haemorrhage, vaginal pain, headache, dysuria, urinary tract infection, abdominal pain, rosacea, swelling face and nausea. However due to the design of these studies, a definitive causal relationship could not be established.

Table 2.Adverse Drug Reactions Identified During Postmarketing Experience with Gyno-Daktarin by Frequency Category Estimated from Spontaneous Reporting Rates

 

Immune System Disorders

 

Not known

Hypersensitivity including Anaphylactic and Anaphylactoid reactions, Angioedema

Skin and Subcutaneous Tissue Disorders

 

Not known

Pruritis

Reproductive System and Breast Disorders

 

Not known

Vaginal irritation, pelvic cramps

4.9 Overdose

Symptoms

In case of accidental ingestion, no problems are expected.

Treatment

In the event of accidental ingestion of large quantities, an appropriate method of gastric emptying may be used if considered appropriate.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic classification:

(Anti-infectives and antiseptics, excl. combinations with corticosteroids, imidazole derivatives)

ATC code: G01A F04

Miconazole combines a potent antifungal activity against common dermatophytes and yeasts with an antibacterial activity against certain gram-positive bacilli and cocci.

Miconazole inhibits the biosynsthesis of ergosterol in fungi and changes the composition of other lipid components in the membrane, resulting in fungal cell necrosis.

In general, miconazole exerts a very rapid effect on pruritus, a symptom that frequently accompanies dermatophyte and yeast infections.

5.2 Pharmacokinetic Properties

Absorption: Miconazole persists in the vagina for up to 72 hours after a single dose. Systemic absorption of miconazole after intravaginal administration is limited, with a bioavailability of 1 to 2% following intravaginal administration of a 1200 mg dose. Plasma concentrations of miconazole are measurable within 2 hours of administration in some subjects, with maximal levels seen 12 to 24 hours after administration. Plasma concentrations decline slowly thereafter and were still measurable in most subjects 96 hours post-dose. A second dose administered 48 hours later resulted in a plasma profile similar to that of the first dose.

Distribution: Absorbed miconazole is bound to plasma proteins (88.2%) and red blood cells (10.6%).

Metabolism and Excretion: The small amount of miconazole that is absorbed is eliminated predominantly in faeces as both unchanged drug and metabolites over a four-day post-administration period. Smaller amounts of unchanged drug and metabolites also appear in urine. The mean apparent elimination half-life is 57 hours.

5.3 Preclinical Safety Data

No relevant information additional to that contained elsewhere in the Summary of Product Characteristics.

6. Pharmaceutical Particulars 6.1 List Of Excipients

PEG-6, PEG-32 and glycol stearate

Oleoyl macroglycerides

Liquid paraffin

Benzoic acid (E210)

Butylated hydroxyanisole (E320)

Purified water

6.2 Incompatibilities

None known.

6.3 Shelf Life

24 months.

6.4 Special Precautions For Storage

Do not store above 25?C.

6.5 Nature And Contents Of Container

Tube containing 15 g, 40 g or 78 g of cream.

The aluminium tube inner is lined with heat polymerised epoxy-phenol resin with a white polypropylene cap.

The cream is supplied with disposable cardboard vaginal applicators.

*Not all pack sizes are marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

UK

8. Marketing Authorisation Number(S)

PL 0242/0015

9. Date Of First Authorisation/Renewal Of The Authorisation

12 December 2008

10. Date Of Revision Of The Text

23rd July 09


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Progesterone Insert


Pronunciation: proe-JES-ter-one
Generic Name: Progesterone
Brand Name: Endometrin
Progesterone Insert is used for:

Supporting embryo implants and early pregnancy in certain women. It is also used as part of an assisted reproductive technology (ART) treatment program. It may also be used for other conditions as determined by your doctor.

Progesterone Insert is a hormone. It works by changing the lining of the uterus.

Do NOT use Progesterone Insert if: you are allergic to any ingredient in Progesterone Insert you have vaginal bleeding of an unknown cause, you have had a recent miscarriage, or the embryo is implanted outside the uterus (ectopic pregnancy) you know or suspect that you have breast cancer you have bleeding in the brain or severe blood vessel problems you have a history of bleeding or blood clotting problems (eg, blood clots in the legs, lungs, or eyes), heart attack, stroke, or liver disease you are using other vaginal products (eg, vaginal antifungal creams)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Progesterone Insert:

Some medical conditions may interact with Progesterone Insert. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have a history of heart or blood vessel problems, depression or other mental/mood problems, or cancer

Some MEDICINES MAY INTERACT with Progesterone Insert. Tell your health care provider if you are taking any other medicines, especially any of the following:

Carbamazepine or rifampin because they may decrease Progesterone Insert's effectiveness Other vaginal products (eg, vaginal antifungal creams) because they may alter Progesterone Insert's actions

This may not be a complete list of all interactions that may occur. Ask your health care provider if Progesterone Insert may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Progesterone Insert:

Use Progesterone Insert as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Progesterone Insert. Talk to your pharmacist if you have questions about this information. Wash your hands before and after using Progesterone Insert. Unwrap the applicator and place one insert in the space provided at the end of the applicator. You may use Progesterone Insert while standing, sitting, or when lying on your back with your knees bent. Gently place the thin end of the applicator well into the vagina. Push the plunger to release the insert, then remove the applicator and throw it away in the trash. If you miss a dose of Progesterone Insert, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Progesterone Insert.

Important safety information: Progesterone Insert may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Progesterone Insert with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Do not use Progesterone Insert at the same time as other vaginal therapy without checking with your doctor. Progesterone Insert may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away. Progesterone Insert should not be used in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: Progesterone Insert is used to support early pregnancy. Progesterone Insert is found in breast milk. If you are or will be breast-feeding while you use Progesterone Insert, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Progesterone Insert:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Bloating; breast tenderness; constipation; cramping; drowsiness; fluid retention; headache; nausea; stomach pain; tiredness; vaginal burning or irritation; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (eg, rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal vaginal bleeding; calf or leg pain, swelling, or tenderness; change in emotions, mood, or behavior; chest pain; coughing up blood; fainting; one-sided weakness; pain in the groin; partial or complete loss of vision; stomach pain, swelling, or tenderness; sudden, severe headache, vomiting, dizziness, or fainting; sudden shortness of breath; swelling of hands, ankles, or feet; unusual vaginal itching, discharge, or odor; visual or speech disturbances; weakness or numbness in an arm or leg; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Progesterone side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Progesterone Insert:

Store Progesterone Insert at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat and light. Do not remove from the sealed foiled pouch until just before use. Keep Progesterone Insert out of the reach of children and away from pets.

General information: If you have any questions about Progesterone Insert, please talk with your doctor, pharmacist, or other health care provider. Progesterone Insert is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Progesterone Insert. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Progesterone resources Progesterone Side Effects (in more detail) Progesterone Use in Pregnancy & Breastfeeding Progesterone Drug Interactions Progesterone Support Group 15 Reviews for Progesterone - Add your own review/rating Compare Progesterone with other medications Amenorrhea Endometrial Hyperplasia, Prophylaxis Perimenopausal Symptoms Premature Labor Progesterone Insufficiency Seizures Uterine Bleeding
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antifungal, azole Vaginal


Class Name: antifungal, azole (Vaginal route)

Commonly used brand name(s)

In the U.S.

3 Day Vaginal Cream Femizol-M Gynazole-1 Gyne-Lotrimin Monistat 1 Mycelex-3 Mycelex-7 Terazol 3 Terazol 7 Tioconazole 1 Vagistat-1 Zazole

In Canada

Canesten 2 Canesten 3 Canesten 6 Day Canesten Combi-Pak 1 Day Canesten Combi-Pak 3 Day Canesten External Cream Clotrimaderm Gyne Cure Gyno-Trosyd Miconazole 3 Day Ovule Treatment Miconazole Nitrate Monistat 1 Combination Pack Vaginal Ovule

Available Dosage Forms:

Ointment Kit Cream Suppository Tablet Tampon Uses For This Medicine

Vaginal azoles are used to treat yeast (fungus) infections of the vagina.

For first-time users, make sure your doctor has checked and confirmed that you have a vaginal yeast infection before you use the vaginal azole antifungal medicines that do not require a prescription. Vaginal yeast infections can reoccur over time and, when the same symptoms occur again, self-treating with these medicines is recommended. However, you should see your doctor if the symptoms occur again within 2 months.

Vaginal antifungal azoles are available both over-the-counter (OTC) and with your doctor's prescription.

Before Using This Medicine Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on these medicines have been done only in adult patients, and there is no specific information comparing use of vaginal azoles in children with use in other age groups. It is recommended that these medicines not be used in children up to 12 years of age.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of vaginal azoles in the elderly with use in other age groups, they are not expected to cause different side effects or problems in older people than they do in younger adults.

Pregnancy

Studies have not been done in humans for use of all azole antifungals during the first trimester of pregnancy. These medicines are safe and effective when used for at least 7 days during the second and third trimesters of pregnancy. However, check with your doctor before using this medicine during the first trimester of pregnancy. Also, use of 1- and 3-day treatments may not be effective during pregnancy.

Breast Feeding

It is not known whether vaginal azoles pass into the breast milk. However, these medicines have not been shown to cause problems in nursing babies.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of This Medicine

Vaginal azoles usually come with patient directions. Read them carefully before using this medicine.

Use this medicine at bedtime, unless otherwise directed by your doctor. The vaginal tampon form of miconazole should be left in the vagina overnight and removed the next morning.

This medicine is usually inserted into the vagina with an applicator. However, if you are pregnant, check with your doctor before using the applicator.

Some of the vaginal suppositories or tablets come packaged with a small tube of cream. This cream can be applied outside of the vagina in the genital area to treat itching. The packages are called combination, dual, or twin packs.

To help clear up your infection completely, it is very important that you keep using this medicine for the full time of treatment , even if your symptoms begin to clear up after a few days. If you stop using this medicine too soon, your symptoms may return. Do not miss any doses. Also, do not stop using this medicine if your menstrual period starts during the time of treatment.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For butoconazole For yeast infection: For vaginal cream dosage form: Adults and teenagers— Women who are not pregnant: 100 milligrams (mg) (one full applicator) of 2% cream inserted into the vagina at bedtime for three nights in a row. Pregnant women, after the third month: 100 mg (one full applicator) of 2% cream inserted into the vagina at bedtime for six nights in a row. Children up to 12 years of age—Use and dose must be determined by your doctor. For vaginal suppository dosage form: Adults and teenagers— Women who are not pregnant: 100 mg (one suppository) inserted into the vagina at bedtime for three nights in a row. Children up to 12 years of age—Use and dose must be determined by your doctor. For clotrimazole For yeast infection: For vaginal cream dosage form: Adults and teenagers—The dose depends on the strength of the cream. 1% cream: 50 milligrams (mg) (one full applicator) inserted into the vagina at bedtime for six to fourteen nights in a row. 2% cream: 100 mg (one full applicator) inserted into the vagina at bedtime for three nights in a row. 10% cream: 500 mg (one full applicator) inserted into the vagina at bedtime for one night only. Children up to 12 years of age—Use and dose must be determined by your doctor. For vaginal tablet dosage form: Adults and teenagers—The dose depends on the strength of the vaginal tablet. Women who are not pregnant: 100-mg tablet: Insert one tablet into the vagina at bedtime for six or seven nights in a row. 200-mg tablet: Insert one tablet into the vagina at bedtime for three nights in a row. 500-mg tablet: Insert one tablet into the vagina at bedtime for one night only. Pregnant women: 100 mg (one vaginal tablet) inserted into the vagina at bedtime for seven nights in a row. Children up to 12 years of age—Use and dose must be determined by your doctor. For econazole For yeast infection: For vaginal suppository dosage form: Adults and teenagers—150 milligrams (mg) (one vaginal suppository) inserted into the vagina at bedtime for three nights in a row. Children up to 12 years of age—Use and dose must be determined by your doctor. For miconazole For yeast infection: For vaginal cream dosage form: Adults and teenagers—20 milligrams (one full applicator) inserted into the vagina at bedtime for seven nights in a row. Treatment may be repeated if needed. Children up to 12 years of age—Use and dose must be determined by your doctor. For vaginal suppository dosage form: Adults and teenagers—The dose depends on the strength of the suppository. 100-milligram (mg) suppository: Insert one vaginal suppository into the vagina at bedtime for seven nights in a row. Treatment may be repeated if needed. 200-mg suppository or 400-mg suppository: Insert one vaginal suppository into the vagina at bedtime for three nights in a row. Treatment may be repeated if needed. 1200-mg suppository: Insert one vaginal suppository into the vagina at bedtime for one night. Children up to 12 years of age—Use and dose must be determined by your doctor. For tampon dosage form: Adults and teenagers—100 mg (one tampon) inserted into the vagina at bedtime and then removed the next morning. This is repeated every night for five nights in a row. Children up to 12 years of age—Use and dose must be determined by your doctor. For terconazole For yeast infection: For vaginal cream dosage form: Adults and teenagers—The dose depends on the strength of the cream. 0.4% cream: 20 milligrams (mg) (one full applicator) inserted into the vagina at bedtime for seven nights in a row. 0.8% cream: 40 mg (one full applicator) inserted into the vagina at bedtime for three nights in a row. Children up to 12 years of age—Use and dose must be determined by your doctor. For vaginal suppository dosage form: Adults and teenagers—80 mg (one vaginal suppository) inserted into the vagina at bedtime for three nights in a row. Children up to 12 years of age—Use and dose must be determined by your doctor. For tioconazole For yeast infection: For vaginal ointment dosage form: Adults and teenagers—300 milligrams (mg) (one full applicator) of 6.5% ointment inserted into the vagina at bedtime for one night only. Children up to 12 years of age—Use and dose must be determined by your doctor. For vaginal suppository dosage form: Adults and teenagers—300 mg (one vaginal suppository) inserted into the vagina at bedtime for one night only. Children up to 12 years of age—Use and dose must be determined by your doctor. Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Keep the vaginal cream, ointment, and suppository forms of this medicine from freezing.

Precautions While Using This Medicine

If your symptoms do not improve within 3 days or have not disappeared in 7 days, or if they become worse, check with your doctor. The 1- or 3-day treatments may take up to 7 days to completely clear up your infection. However, not all vaginal infections are caused by yeast. If symptoms occur again within 2 months, check with your doctor.

Vaginal medicines usually will come out of the vagina during treatment. To keep the medicine from getting on your clothing, wear a minipad or sanitary napkin. The use of nonmedicated tampons (like those used for menstrual periods) is not recommended since they may soak up the medicine.

To help clear up your infection completely and to help make sure it does not return, good health habits are also required.

Wear cotton panties (or panties or pantyhose with cotton crotches) instead of synthetic (for example, nylon or rayon) panties. Wear only clean panties.

If you have any questions about this, check with your health care professional.

Vaginal yeast infections are not usually spread by having sex and your sex partner does not need to be treated. However, if the sex partner has symptoms of local itching or skin irritation of the penis, he may benefit by being treated also.

If you use latex or rubber birth control devices (condoms, diaphragms, or cervical caps), you should wait 3 days after treatment with azole antifungal agents before using them again. Many brands of vaginal azoles contain oils in the product that can weaken these devices. This increases the chances of a condom breaking during sexual intercourse. The rubber in cervical caps or diaphragms may break down faster and wear out sooner. Check with your health care professional to make sure the vaginal azole product you are using can be used with latex rubber birth control devices.

Check with your doctor before douching to obtain advice about whether you may douche and, if allowed, the proper method.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Less common Vaginal burning, itching, discharge, or other irritation not present before use of this medicine Rare Skin rash or hives

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common or rare Abdominal or stomach cramps or pain burning or irritation of penis of sexual partner headache

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Healthcare (Micromedex) products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Healthcare does not assume any responsibility or risk for your use of the Thomson Healthcare products.


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Gelato Chlorhexidine Rinse


Generic Name: chlorhexidine gluconate
Dosage Form: oral rinse
Gelato Chlorhexidine Distilled Water, Glycerin, Polysorbate 20, Poloxamer 407, Sodium Saccharin, Mint Flavor, FD and C Blue #1

The effect of Chlohexidrine Gluconate Oral Rinse on periodontitis has not been determined. An increase in supragingival calculus was not noted in clinical testing in chlohexidine gluconate oral rinse users compared with control users. It is not known if Chlorhexidine Gluconate oral rinse use results in an increase in subgingival calculus. Calculus deposits should be removed by a dental prophylaxis at intervals not greater than six months. Hypersensitivity and generalized allergic reactions have occured. read CONTRAINDICATIONS indicated on the insert inside the box.

To open, press down while turning cap. To seal, turn until cap clicks and is tight. Fill dosage cup to the fill like (150ml). Swish in your mouth undiluted for 30 seconds, the spit out. Use after breakfast and before bedtime. Or, use as prescribed by your dentist.

Chlorhexidine Gluconate Oral Rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. For patients having coexisting gingivitis and periodontitis, read PRECAUTIONS indicated on the insert inside the box.

Store at controlled room temperature 68-77F (20-25C). Protect from freezing.

0.12% Chlorhexidine Gluconate

Antigingivitis


GELATO CHLOROHEXIDINE 
chlorhexidine gluconate  rinse Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68400-500 Route of Administration DENTAL, TOPICAL, ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE) CHLORHEXIDINE GLUCONATE 56.76 mL  in 473 mL Inactive Ingredients Ingredient Name Strength Water   Glycerin   FD&C BLUE NO. 1   SACCHARIN SODIUM   POLYSORBATE 20   POLOXAMER 407   Product Characteristics Color      Score      Shape Size Flavor MINT Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 68400-500-16 473 mL In 1 BOTTLE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/31/2010
Labeler - Deepak Products, inc. (124886743) Establishment Name Address ID/FEI Operations Deepak Products, inc. 124886743 manufacture Revised: 04/2011Deepak Products, inc.
More Gelato Chlorhexidine Rinse resources Gelato Chlorhexidine Rinse Side Effects (in more detail) Gelato Chlorhexidine Rinse Use in Pregnancy & Breastfeeding Gelato Chlorhexidine Rinse Support Group 1 Review for Gelato Chlorhexidine - Add your own review/rating Compare Gelato Chlorhexidine Rinse with other medications Gingivitis Mucositis Periodontitis
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Radian B Muscle Lotion


1. Name Of The Medicinal Product

Radian B Liniment/Radian B Muscle Lotion/Radian B Sport Muscle Lotion/ Radian B Winter Sport Muscle Lotion/ Cura Heat Pain Relief Lotion

2. Qualitative And Quantitative Composition

Menthol

1.4

%w/v

Camphor

0.6

%w/v

Aspirin

1.2

%w/v

Equivalent to ammonium salicylate

1.0

%w/v

Methyl Salicylate

0.6

%w/v

Equivalent to salicylic acid

(as Methyl and Ethyl Esters)

0.54

%w/v

3. Pharmaceutical Form

Liniment for topical application to human beings.

4. Clinical Particulars 4.1 Therapeutic Indications

For symptomatic relief of muscular aches and pains, including fibrositis, sciatica, lumbago, sprained ligaments, bruises, muscle stiffness, strains, tennis elbow, golf shoulder.

4.2 Posology And Method Of Administration

Posology: For external application.

For Adults and Children Over 12 Years:

Apply the lotion on the affected part once or twice, leaving 10-15 minutes between applications. Smooth in or massage if preferred. If necessary, repeat application up to three times daily, reducing to morning and evening when acute symptoms subside.

When convenient, use after a warm bath.

Children Under 12: Not recommended for children under 12.

Elderly: The adult dose is appropriate.

4.3 Contraindications

Not to be used on children under 12 years old. Do not apply to skin abrasions. Do not apply to irritated skin. Not to be used by persons who are sensitive to any of the ingredients. If irritation develops, use of the product should be discontinued. Pregnancy and lactation.

4.4 Special Warnings And Precautions For Use

Keep away from eyes and other sensitive areas. If symptoms persist, consult a doctor. Flammable: Do not use near naked flame. Should not be placed on or used near polished or painted surfaces.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

There have been reports that topical salicylates may potentiate the anticoagulant effects of warfarin.

4.6 Pregnancy And Lactation

Use of the product during pregnancy and lactation is not recommended.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

If used on tender skin do not cover immediately after application. If an adverse reaction occurs, discontinue use immediately. Known side effects of menthol - contact dermatitis or eczema, hypersensitivity reactions characterised by urticaria, flushing and headache.

4.9 Overdose

When used externally as directed, overdose is unlikely.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Radian B is manufactured using the following active ingredients; Menthol, camphor, aspirin and methyl salicylate. The finished product contains menthol, camphor, ammonium salicylate and a mixture of methyl and ethyl esters of salicylic acid. The product provides salicylate ions which have analgesic properties. Methyl and ethyl salicylate are readily absorbed through the skin and have counter-irritant properties. Menthol relieves itching, dilates the vessels causing a sensation of coldness followed by an analgesic effect. Camphor acts as a rubefacient and mild analgesic and is employed as a counter-irritant.

5.2 Pharmacokinetic Properties

The active ingredients are well-documented pharmacopoeial ingredients. The extent of percutaneous absorption in human volunteers of (14C) acetyl salicylic acid from Radian B was studied and estimated by measurement of blood and urinary concentrations of radioactivity. Significant absorption through the skin was indicated by the excretion of almost 10% of the applied radioactivity in the urine within 5 days with approximately 5.5% in the first 24 hours.

5.3 Preclinical Safety Data

None

6. Pharmaceutical Particulars 6.1 List Of Excipients

Industrial Methylated Spirit 95

Glycerol

Citronella oil

Ammonia '880'

Water (purified)

6.2 Incompatibilities

None known

6.3 Shelf Life

60 months

6.4 Special Precautions For Storage

Store below 25°C

6.5 Nature And Contents Of Container

Ribbed oval glass bottle with polypropylene insert and plastic cap. Polythene bottle and plastic cap. Pack sizes 50 and 100ml.

White HDPE bottle with red urea cap and wad. Pack sizes: 30, 125 and 250ml oval bottles and 500 and 2000ml round bottles.

Boston round silver HDPE bottle and silver polypropylene cap without wad. Pack size 500ml.

Silver HDPE bottle with silver coloured, black urea cap and wad and LDPE insert. Pack sizes: 125 and 250ml oval bottle.

Silver HDPE bottle with LDPE plug insert and warm red coloured, spigot seal polypropylene cap. Pack sizes: 125, 250ml and 500ml oval bottle.

White polypropylene bottle with an angled neck containing an applicator, consisting of polypropylene plug, ring and spring, encasing a red polyurethane foam, with a red polypropylene cap. Pack size 80ml.

6.6 Special Precautions For Disposal And Other Handling

No special precautions necessary

7. Marketing Authorisation Holder

Thornton & Ross Limited

Linthwaite

Huddersfield

West Yorkshire

HD7 5QH

United Kingdom

8. Marketing Authorisation Number(S)

PL 00240/0359

9. Date Of First Authorisation/Renewal Of The Authorisation

30 April 2002

10. Date Of Revision Of The Text

04/03/2008


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anesthetic, local Rectal


Class Name: anesthetic, local (Rectal route)

Commonly used brand name(s)

In the U.S.

AnaMantle HC Proctofoam-NS

In Canada

Tronothane

Available Dosage Forms:

Suppository Foam Uses For This Medicine

Rectal anesthetics are used to relieve the pain and itching of hemorrhoids (piles) and other problems in the rectal area. However, if you have hemorrhoids that bleed, especially after a bowel movement, check with your doctor before using this medicine. Bleeding may mean that you have a condition that needs other treatment.

These medicines are available without a prescription; however, your doctor may have special instructions on the proper use and dose for your medical problem.

Before Using This Medicine Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Children may be especially sensitive to the effects of local anesthetics. This may increase the chance of side effects during treatment.

Geriatric

Elderly people are especially sensitive to the effects of local anesthetics. This may increase the chance of side effects during treatment.

Pregnancy

Rectal anesthetics have not been reported to cause birth defects or other problems in humans.

Breast Feeding

Rectal anesthetics have not been reported to cause problems in nursing babies.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

Infection at or near place of treatment or Large sores, broken skin, or severe injury at or near place of treatment—The chance of unwanted effects may be increased. Proper Use of This Medicine

For safe and effective use of this medicine:

Rectal anesthetics usually come with patient directions. Read them carefully before using the medicine, even if it was prescribed by your doctor. Check with your pharmacist if you have any questions about how to use the product. Follow your doctor's instructions if this medicine was prescribed. Follow the manufacturer's package directions if you are treating yourself. Do not use more of this medicine, do not use it more often, and do not use it for a longer time than directed. To do so may increase the chance of absorption into the body and the chance of unwanted effects.

This medicine should be used only for conditions being treated by your doctor or for problems listed on the package label. Do not use it for other problems without first checking with your doctor. This medicine should not be used if certain kinds of infections are present.

For applying a rectal anesthetic to the area around the rectum:

First, clean the area, using mild soap and water or a cleansing wipe. Rinse the area carefully and dry it gently with a soft towel or toilet paper. Apply a small amount of medicine to the sore area, using a piece of gauze, a tissue, or a "finger cot."

For inserting a rectal cream or ointment inside the rectum:

Use only products that come packaged in pre-filled applicators or that come packaged with a special inserter called a rectal tube. If you are using a product that has an inserter (rectal tube) packaged separately from the tube of cream or ointment: Remove the cap from the tube of cream or ointment. Attach the inserter to the top of the tube. Squeeze the tube until a little cream or ointment comes out on the inserter. Then spread the cream or ointment over the inserter. Place the inserter into your rectum and squeeze the tube until a small amount of medicine comes out. Then remove the inserter from your body. Remove the inserter from the tube and replace the cap. Then wash the applicator carefully. If you are using the product that comes in pre-filled applicators: Follow the manufacturer's directions for using the applicator and inserting the medicine. Each applicator is meant to be used only once. Throw the applicator away after using it.

For inserting the rectal aerosol foam (e.g., Proctofoam/nonsteroid) into the rectum:

Do not insert the container itself into your rectum. Use the applicator provided. To fill the container—First, shake the container hard for several seconds. Then, holding the container upright, insert it into the applicator. Press the cap of the container until the foam reaches the fill line of the applicator. Remove the applicator from the container. To use the medicine—Place a small amount of foam on the tip of the applicator. Insert the applicator into your rectum, then push the plunger as far as possible. Remove the applicator. Then take it apart and wash it carefully. Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For benzocaine For pain and itching of hemorrhoids or other problems in the rectal area: For rectal ointment dosage form: Adults—Apply a small amount of ointment to the area around the rectum up to six times a day. Children—Use and dose must be determined by the doctor. For dibucaine For pain and itching of hemorrhoids or other problems in the rectal area: For rectal ointment dosage form: Adults—Insert a small amount of ointment into the rectum three or four times a day, in the morning, in the evening, and after bowel movements. Or, apply a small amount of ointment to the area around the rectum three or four times a day. Children—Use and dose must be determined by the doctor. For pramoxine For pain and itching of hemorrhoids or other problems in the rectal area: For rectal cream dosage form: Adults—Apply a small amount to the area around the rectum up to five times a day, in the morning, in the evening, and after bowel movements. Children—Use and dose must be determined by the doctor. For rectal ointment dosage form: Adults—Insert a small amount of ointment into the rectum up to five times a day, in the morning, in the evening, and after bowel movements. Or, apply a small amount to the area around the rectum up to five times a day, in the morning, in the evening, and after bowel movements. For the rectal aerosol foam dosage form: Adults—Insert 1 applicatorful into the rectum two or three times a day. Or, apply a small amount to the area around the rectum two or three times a day. Children—Use and dose must be determined by the doctor. For tetracaine and for tetracaine and menthol For pain and itching of hemorrhoids or other problems in the rectal area: For the rectal cream or rectal ointment dosage form: Adults—Insert a small amount into the rectum up to six times a day. Or, apply a small amount to the area around the rectum up to six times a day. Children—Use and dose must be determined by the doctor. Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using This Medicine

Check with your doctor:

If your condition does not improve after you have been using this medicine regularly for 7 days, or if it becomes worse. If any bleeding from the rectum occurs. If you notice any rash, redness, or irritation that was not present before you started using this medicine.

False test results may occur if benzocaine or tetracaine is present in your body when a certain laboratory test is done. This test uses a medicine called bentiromide (e.g., Chymex) to show how well your pancreas is working. You should not use any products containing benzocaine or tetracaine for about 72 hours (3 days) before this test is done.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Stop taking this medicine and get emergency help immediately if any of the following effects occur:

Signs and symptoms of too much medicine being absorbed by the body Blurred or double vision confusion convulsions (seizures) dizziness or lightheadedness drowsiness feeling hot, cold, or numb increased sweating ringing or buzzing in ears shivering or trembling slow or irregular heartbeat unusual anxiety, excitement, nervousness, or restlessness unusual paleness

Check with your doctor as soon as possible if any of the following side effects occur:

Less common Burning, stinging, swelling, or tenderness not present before treatment skin rash, redness, itching, or hives at or near place of application

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Healthcare (Micromedex) products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Healthcare does not assume any responsibility or risk for your use of the Thomson Healthcare products.


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Terconazole Suppositories


Pronunciation: ter-KON-a-zole
Generic Name: Terconazole
Brand Name: Terazol 3
Terconazole Suppositories are used for:

Treating vaginal yeast infections in women.

Terconazole Suppositories are an antifungal agent. It works by weakening the fungal cell membrane and killing sensitive fungi that cause yeast infections.

Do NOT use Terconazole Suppositories if: you are allergic to any ingredient in Terconazole Suppositories

Contact your doctor or health care provider right away if any of these apply to you.

Before using Terconazole Suppositories:

Some medical conditions may interact with Terconazole Suppositories. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have a history of liver disease

Some MEDICINES MAY INTERACT with Terconazole Suppositories. However, no specific interactions with Terconazole Suppositories are known at this time

Ask your health care provider if Terconazole Suppositories may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Terconazole Suppositories:

Use Terconazole Suppositories as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Terconazole Suppositories. Talk to your pharmacist if you have questions about this information. Terconazole Suppositories are for vaginal use only. Filling the applicator - Break off suppository from the plastic strip. Pull the plastic completely apart at the notched end. Place the flat end of the suppository into the open end of the applicator as shown. Using the applicator - Lie on your back with your knees drawn up toward your chest. Holding the applicator by the ribbed end of the barrel, gently insert it into the vagina as far as it will comfortably go. Press the plunger to release the suppository into the vagina. Remove the applicator from the vagina. Cleaning the applicator - After each use, you should thoroughly clean the applicator by following this procedure: Pull the plunger out of the barrel. Wash both pieces with lukewarm, soapy water, and dry them thoroughly. Put the applicator back together by gently pushing the plunger into the barrel as far as it will go. To insert without the applicator - Lie on your back with your knees drawn up toward your chest. Place the suppository on the tip of your finger. Insert the suppository gently. Terconazole Suppositories works best if it is used at the same time each day. To clear up your infection completely, use Terconazole Suppositories for the full course of treatment. Keep using it even if you feel better in a few days. If you miss a dose of Terconazole Suppositories, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Terconazole Suppositories.

Important safety information: You can use the medication even if you are having your menstrual period. However, you should not use tampons because they may absorb the medication. Instead, use external pads or napkins until you have finished your medication. You may also wish to wear a sanitary napkin if the vaginal medicine leaks. Dry the genital area thoroughly after showering, bathing, or swimming. Change out of a wet bathing suit or damp exercise clothes as soon as possible. A dry environment is less likely to encourage the growth of yeast. Terconazole Suppositories may decrease the effectiveness of condoms and diaphragms. If your infection clears up and occurs again in a few weeks, see your doctor. Be sure to use Terconazole Suppositories for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The fungus could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future. Use Terconazole Suppositories with caution in the ELDERLY; they may be more sensitive to its effects. Terconazole Suppositories should not be used in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Terconazole Suppositories while you are pregnant. It is not known if Terconazole Suppositories are found in breast milk. Do not breast-feed while taking Terconazole Suppositories. Possible side effects of Terconazole Suppositories:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Body pain; burning or itching of the vagina; headache.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chills; flu-like symptoms (headache; tiredness; muscle aches; fever); vaginal sensitivity or irritation.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Terconazole side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Terconazole Suppositories:

Store Terconazole Suppositories at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Terconazole Suppositories out of the reach of children and away from pets.

General information: If you have any questions about Terconazole Suppositories, please talk with your doctor, pharmacist, or other health care provider. Terconazole Suppositories are to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Terconazole Suppositories. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Terconazole resources Terconazole Side Effects (in more detail) Terconazole Use in Pregnancy & Breastfeeding Terconazole Support Group 6 Reviews for Terconazole - Add your own review/rating Compare Terconazole with other medications Vaginal Yeast Infection
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Terazol 3 Suppositories


Pronunciation: ter-KON-a-zole
Generic Name: Terconazole
Brand Name: Terazol 3
Terazol 3 Suppositories are used for:

Treating vaginal yeast infections in women.

Terazol 3 Suppositories are an antifungal agent. It works by weakening the fungal cell membrane and killing sensitive fungi that cause yeast infections.

Do NOT use Terazol 3 Suppositories if: you are allergic to any ingredient in Terazol 3 Suppositories

Contact your doctor or health care provider right away if any of these apply to you.

Before using Terazol 3 Suppositories:

Some medical conditions may interact with Terazol 3 Suppositories. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have a history of liver disease

Some MEDICINES MAY INTERACT with Terazol 3 Suppositories. However, no specific interactions with Terazol 3 Suppositories are known at this time

Ask your health care provider if Terazol 3 Suppositories may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Terazol 3 Suppositories:

Use Terazol 3 Suppositories as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Terazol 3 Suppositories. Talk to your pharmacist if you have questions about this information. Terazol 3 Suppositories are for vaginal use only. Filling the applicator - Break off suppository from the plastic strip. Pull the plastic completely apart at the notched end. Place the flat end of the suppository into the open end of the applicator as shown. Using the applicator - Lie on your back with your knees drawn up toward your chest. Holding the applicator by the ribbed end of the barrel, gently insert it into the vagina as far as it will comfortably go. Press the plunger to release the suppository into the vagina. Remove the applicator from the vagina. Cleaning the applicator - After each use, you should thoroughly clean the applicator by following this procedure: Pull the plunger out of the barrel. Wash both pieces with lukewarm, soapy water, and dry them thoroughly. Put the applicator back together by gently pushing the plunger into the barrel as far as it will go. To insert without the applicator - Lie on your back with your knees drawn up toward your chest. Place the suppository on the tip of your finger. Insert the suppository gently. Terazol 3 Suppositories works best if it is used at the same time each day. To clear up your infection completely, use Terazol 3 Suppositories for the full course of treatment. Keep using it even if you feel better in a few days. If you miss a dose of Terazol 3 Suppositories, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Terazol 3 Suppositories.

Important safety information: You can use the medication even if you are having your menstrual period. However, you should not use tampons because they may absorb the medication. Instead, use external pads or napkins until you have finished your medication. You may also wish to wear a sanitary napkin if the vaginal medicine leaks. Dry the genital area thoroughly after showering, bathing, or swimming. Change out of a wet bathing suit or damp exercise clothes as soon as possible. A dry environment is less likely to encourage the growth of yeast. Terazol 3 Suppositories may decrease the effectiveness of condoms and diaphragms. If your infection clears up and occurs again in a few weeks, see your doctor. Be sure to use Terazol 3 Suppositories for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The fungus could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future. Use Terazol 3 Suppositories with caution in the ELDERLY; they may be more sensitive to its effects. Terazol 3 Suppositories should not be used in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Terazol 3 Suppositories while you are pregnant. It is not known if Terazol 3 Suppositories are found in breast milk. Do not breast-feed while taking Terazol 3 Suppositories. Possible side effects of Terazol 3 Suppositories:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Body pain; burning or itching of the vagina; headache.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chills; flu-like symptoms (headache; tiredness; muscle aches; fever); vaginal sensitivity or irritation.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Terazol 3 side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Terazol 3 Suppositories:

Store Terazol 3 Suppositories at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Terazol 3 Suppositories out of the reach of children and away from pets.

General information: If you have any questions about Terazol 3 Suppositories, please talk with your doctor, pharmacist, or other health care provider. Terazol 3 Suppositories are to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Terazol 3 Suppositories. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Terazol 3 resources Terazol 3 Side Effects (in more detail) Terazol 3 Use in Pregnancy & Breastfeeding Terazol 3 Support Group 0 Reviews for Terazol 3 - Add your own review/rating Compare Terazol 3 with other medications Vaginal Yeast Infection
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Minims Pilocarpine 4%


Generic Name: pilocarpine (Ophthalmic route)

pye-loe-KAR-peen

Commonly used brand name(s)

In the U.S.

Isopto Carpine Ocu-Carpine Ocusert Pilo Pilocar Pilopine-HS

In Canada

Minims Pilocarpine 2% Minims Pilocarpine 4%

Available Dosage Forms:

Device Suspension Solution Gel/Jelly

Therapeutic Class: Direct Acting Miotic

Pharmacologic Class: Cholinergic

Uses For Minims Pilocarpine 4%

Pilocarpine is used to treat glaucoma and other eye conditions.

This medicine is available only with your doctor's prescription.

Before Using Minims Pilocarpine 4%

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Although there is no specific information comparing use of this medicine in children with use in other age groups, pilocarpine is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. Although there is no specific information comparing use of pilocarpine in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Asthma or Eye disease or problems (other)—Pilocarpine may make the condition worse Proper Use of pilocarpine

This section provides information on the proper use of a number of products that contain pilocarpine. It may not be specific to Minims Pilocarpine 4%. Please read with care.

To use the eye drop form of pilocarpine:

First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 1 or 2 minutes to allow the medicine to be absorbed by the eye. Immediately after using the eye drops, wash your hands to remove any medicine that may be on them. To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

To use the eye gel form of pilocarpine:

First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Squeeze a thin strip of gel into this space. A 1?-cm (approximately ?-inch) strip of gel is usually enough, unless you have been told by your doctor to use a different amount. Let go of the eyelid and gently close the eyes. Keep the eyes closed for 1 or 2 minutes to allow the medicine to be absorbed by the eye. Immediately after using the eye gel, wash your hands to remove any medicine that may be on them. To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). After using the eye gel, wipe the tip of the gel tube with a clean tissue and keep the tube tightly closed.

To use the eye insert form of pilocarpine:

This medicine usually comes with patient directions. Read them carefully before using this medicine. If you think this medicine unit may be damaged, do not use it. If you have any questions about this, check with your health care professional. If the unit seems to be releasing too much medicine into your eye, remove it and replace with a new unit. If you have any questions about this, check with your doctor.

Use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of too much medicine being absorbed into the body and the chance of side effects.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For eye drop dosage form: For chronic glaucoma: Adults and children—One drop one to four times a day. For acute angle-closure glaucoma: Adults and children—One drop every five to ten minutes for three to six doses. Then one drop every one to three hours until eye pressure is reduced. For eye gel dosage form: For glaucoma: Adults and teenagers—Use once a day at bedtime. Children—Use and dose must be determined by your doctor. For eye insert dosage form: For glaucoma: Adults and children—Insert one ocular system every seven days. Infants—Use and dose must be determined by your doctor. Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Store the eye system form of this medicine in the refrigerator. Keep from freezing. Store the 3.5-gram size (of the gel form) at room temperature.

Precautions While Using Minims Pilocarpine 4%

Your doctor should check your eye pressure at regular visits.

For patients using the eye drop or gel form of this medicine:

For a short time after you use this medicine, your vision may be blurred or there may be a change in your near or far vision, especially at night. Make sure your vision is clear before you drive, use machines, or do anything else that could be dangerous if you are not able to see well.

For patients using the eye insert form of this medicine:

For the first several hours after you insert this unit in the eye, your vision may be blurred or there may be a change in your near or far vision, especially at night. Therefore, insert this unit in the eye at bedtime, unless otherwise directed by your doctor. If this unit is inserted in the eye at any other time of the day, make sure your vision is clear before you drive, use machines, or do anything else that could be dangerous if you are not able to see well. Minims Pilocarpine 4% Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Symptoms of too much medicine being absorbed into the body Increased sweating muscle tremors nausea, vomiting, or diarrhea troubled breathing or wheezing watering of mouth Less common or rare Eye pain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Blurred vision or change in near or far vision decrease in night vision Less common Eye irritation headache or browache

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Minims Pilocarpine 4% resources Minims Pilocarpine 4% Use in Pregnancy & Breastfeeding Minims Pilocarpine 4% Drug Interactions Minims Pilocarpine 4% Support Group 0 Reviews for Minims Pilocarpine 4% - Add your own review/rating Compare Minims Pilocarpine 4% with other medications Glaucoma Intraocular Hypertension
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spermicide Vaginal


Class Name: spermicide (Vaginal route)

Commonly used brand name(s)

In the U.S.

Advantage-S Conceptrol Crinone Delfen Foam Emko Encare Endometrin First-Progesterone VGS Gynol II Prochieve Today Sponge Vagi-Gard Douche Non-Staining

Available Dosage Forms:

Gel/Jelly Sponge Suppository Foam Liquid Film Cream Uses For This Medicine

Vaginal spermicides are a type of contraceptive (birth control). These products are inserted into the vagina before any genital contact occurs or sexual intercourse begins. They work by damaging and killing sperm in the vagina. Therefore, the sperm are not able to travel from the vagina into the uterus and fallopian tubes, where fertilization takes place.

Vaginal spermicides, when used alone, are much less effective in preventing pregnancy than birth control pills, an intrauterine device (IUD), or spermicides used together with another form of birth control, such as cervical caps, condoms, or diaphragms. Studies have shown that when spermicides are used alone, pregnancy usually occurs in 21 of each 100 women during the first year of spermicide use. The number of pregnancies is reduced when spermicides are used with another method, especially the condom. Discuss with your doctor what your options are for birth control and the risks and benefits of each method.

The most effective way to protect yourself against HIV (AIDS) and other sexually transmitted diseases (STDs) is by abstinence (not having sexual intercourse) or by having only one partner who you can be sure is not already infected or is not going to get an STD. However, if either of these methods is not likely or possible, using latex (rubber) condoms with a spermicide is the best way of protecting yourself.

The use of a spermicide is recommended even when you are using nonbarrier methods of birth control, such as birth control pills (the pill) or intrauterine devices (IUDs), since these do not offer any protection from STDs.

Vaginal spermicides are available without a prescription.

Before Using This Medicine Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

These products have been used by teenagers and have not been shown to cause different side effects or problems than they do in adults. However, some younger users may need extra counseling and information on the importance of using spermicides exactly as they are supposed to be used so they will work properly.

Pregnancy

Many studies have shown that the use of vaginal spermicides does not increase the risk of birth defects or miscarriage.

Breast Feeding

It is not known if vaginal spermicides pass into breast milk in humans. However, their use has not been reported to cause problems in nursing babies.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

Allergies, irritations, or infections of the genitals—Using vaginal spermicides may cause moderate to severe irritation in these conditions. Also, benzalkonium suppositories may be less effective in women with vaginal infections. Conditions or medical problems where it is important that pregnancy does not occur—Vaginal spermicides, when used alone, are much less effective than birth control pills, an intrauterine device (IUD), or spermicides used together with another form of birth control, such as cervical caps, condoms, or diaphragms. Discuss with your doctor what your options are for birth control and the risks and benefits of each method. Recent childbirth or abortion or Toxic shock syndrome, history of—Cervical caps or diaphragms should not be used in these cases because there is an increased chance of developing toxic shock syndrome. Sores on the genitals (sex organs) or Irritation of the vagina or rectum—Do not use this medicine if you or your sex partner have HIV or AIDS. This medicine can irritate the vagina and rectum, which may increase the risk of getting HIV or AIDS. Discuss this with your doctor if you have any questions.

If you develop any medical problem or begin using any new medicine (prescription or nonprescription) while you are using this medicine, you may want to check with your doctor.

Proper Use of This Medicine

Make sure you carefully read and follow the directions that come with each spermicide product. Each product may have different directions for using the product. The directions tell you how much to use, how long you must wait before having intercourse, and how long you must leave it in the vagina after intercourse.

Spermicide products are for vaginal use only and are not for rectal (anal) use.

Vaginal douching is not needed or advised after using these medicines. When using a spermicide, douching within 6 to 8 hours after the last sexual intercourse (even with just water) may stop the spermicide from working properly. Also, washing or rinsing the vaginal or rectal area may wash the spermicide away before it has had time to work properly.

Cervical caps and diaphragms are not recommended for use during your menstrual period because of an increased chance of developing toxic shock syndrome. Your doctor may advise you to use condoms with a spermicide instead during your menstrual periods when protection is needed.

For proper use of spermicide when used alone:

Follow directions carefully to make sure the spermicide is properly placed in the vagina. The spermicide should be inserted deep into the vagina and directly on the cervix (opening to the uterus). Use the correct amount, according to the product directions. Use another dose for each act of intercourse. After you have applied or inserted the spermicide, wait the correct amount of time before having intercourse so that the spermicide can begin to work. If you do not have intercourse within half an hour, read the product directions to see if you need to apply more spermicide.

For proper use of spermicide with cervical caps, condoms, or diaphragms:

Make sure the directions for the spermicide you choose state that it is safe for use with latex cervical caps, condoms, or diaphragms. If the directions do not say the spermicide is safe to use with latex products, the spermicide may cause cervical caps, condoms, or diaphragms to weaken and leak or cause condoms to break during intercourse. If there is a leak or break during intercourse, it may be a good idea for the female partner to immediately place more spermicide in the vagina. If you need an extra lubricant, make sure it is a water-based product safe for use with cervical caps, condoms, or diaphragms. Spermicides, especially gels and jellies, provide some lubrication during sexual intercourse. Oil-based products such as hand, face, or body cream; petroleum jelly; cooking oils or shortenings; or baby oil should not be used because they weaken the latex rubber. (Even some products that easily rinse away with water are oil-based and should not be used.) Use of oil-based products increases the chances of the condom breaking during sexual intercourse. These products can also cause the rubber in cervical caps or diaphragms to break down faster and wear out sooner.

For patients using spermicides with a cervical cap:

To be most effective at preventing pregnancy, the cervical cap must always be used with a spermicide. Both must be used every time you have sexual intercourse. Before inserting the cervical cap, inspect it for holes, tears, or cracks. If there are holes or defects, the cervical cap will not work effectively, even with a spermicide. It must be replaced. Before you put the cervical cap over the cervix (opening to the uterus), a spermicide cream, foam, gel, or jelly should be put into the cup of the cervical cap. Follow the manufacturer's directions on how long before sexual intercourse you may apply the spermicide. Fill the cervical cap one-third full with spermicide. To insert the cervical cap, squeeze the rim between your thumb and forefinger so that it is narrow enough to fit into the vagina. While in a comfortable position, push the cervical cap as deeply into the vagina as it will go. Release the rim and press it into place around the cervix with your finger. The rim should be round again and be directly on the cervix. The cervical cap is held onto the cervix by suction. Some doctors may recommend that you put more spermicide into the vagina each time you repeat sexual intercourse using a cervical cap. You should also check to make sure the cervical cap is in the proper position on the cervix before and after each time you have intercourse. You may wear the cervical cap for up to 48 hours (2 days). Do not remove the cervical cap if it has been less than 8 hours since the last time you had sexual intercourse To remove the cervical cap, use 1 or 2 fingers to push the rim away from the cervix. This will break the suction seal with the cervix. Then gently pull the cervical cap out of the vagina. Call your doctor if you have trouble removing the cervical cap.

For patients using spermicides with condoms

Condoms do not have to be used with spermicides, but the spermicide may provide a back-up birth control method in case the condom breaks or leaks. Spread some spermicide on the outside of the condom, after it is unrolled over the penis. It is even more important that the female partner also use a spermicide inside the vagina. Each time you repeat intercourse, a new condom must be used. Condoms should never be reused. Spermicide should also be applied to the outside of the new condom. The female partner must also put more spermicide in the vagina each time she has intercourse.

For patients using spermicides with a diaphragm:

To be most effective at preventing pregnancy, diaphragms must always be used with a spermicide. Some women may choose to insert a diaphragm every night to avoid the chance of having unprotected sexual intercourse and an unplanned pregnancy. Inspect the diaphragm for holes by holding it up to a light. If there are holes or defects, the diaphragm will not work effectively, even with a spermicide. It must be replaced. Before you put the diaphragm over the cervix (opening to the uterus), a spermicide cream, foam, gel, or jelly should be put into the cup of the diaphragm. Follow the manufacturer's directions on how much spermicide to use and how long before sexual intercourse you may apply the spermicide. Also, spread some spermicide all around the rim of the diaphragm that will be touching the cervix. Some doctors also advise spreading more spermicide on the outside of the cup of the diaphragm. To insert the diaphragm, squeeze the rim between your thumb and forefinger so that it is narrow enough to fit into the vagina. While in a comfortable position, push the diaphragm as deeply into the vagina as it will go and release the rim. Some women use a special applicator that makes it easier to insert the diaphragm. The diaphragm rim should be round again and be directly on the cervix. Each time you repeat sexual intercourse, you should put more spermicide into the vagina. Do not remove the diaphragm if it has been less than 6 or 8 hours (depending upon which brand of spermicide you use) since the last sexual intercourse. For the diaphragm to be most effective at preventing pregnancy, it must remain in the vagina for at least 6 or 8 hours (depending upon which brand of spermicide you use) after sexual intercourse. Be careful not to move the diaphragm out of place while you are applying more spermicide. Do not wear the diaphragm for more than 24 hours, since doing so increases the risk of getting toxic shock syndrome or a urinary tract (bladder) infection. To remove the diaphragm, hook one finger over the rim nearest the front. Pull the diaphragm downward and out of the vagina. Call your doctor if you have trouble removing the diaphragm. Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For benzalkonium chloride For preventing pregnancy: For vaginal dosage form (suppositories): Adults and teenagers— For use alone—One suppository inserted into the vagina at least ten minutes, but not longer than four hours, before each time you have sexual intercourse. It may help to wet the suppository before inserting it into the vagina. For use with a diaphragm—After the diaphragm with spermicide has been placed into the vagina, insert one suppository at least ten minutes, but not longer than four hours, before each time you have sexual intercourse. It may help to wet the suppository before inserting it into the vagina. Also, insert another suppository before sexual intercourse if six hours have passed since you inserted the diaphragm. For nonoxynol 9 For preventing pregnancy: For vaginal dosage form (cream): Adults and teenagers— For use alone—One applicatorful of a 5% cream inserted into the vagina just before each time you have sexual intercourse. For use with a diaphragm—One applicatorful of a 2 or 5% cream inserted into the cup of the diaphragm. Spread more spermicide along the rim of the diaphragm. Insert the diaphragm into the vagina just before, but not longer than six hours before, sexual intercourse. Also, insert one applicatorful just before each time you have intercourse or if six hours have passed since you inserted the diaphragm. For vaginal dosage form (film): Adults and teenagers—One film inserted into the vagina from five to fifteen minutes (but not longer than one and one-half hours) before each time you have sexual intercourse. For vaginal dosage form (foam): Adults and teenagers— For use alone—One applicatorful inserted into the vagina just before, but not longer than one hour before, each time you have sexual intercourse. For use with a diaphragm—One applicatorful inserted into either the vagina or into the cup of the diaphragm, depending on the product. Spread more spermicide along the rim of the diaphragm. Insert the diaphragm into the vagina just before, but not longer than one hour before, sexual intercourse. Also, insert another applicatorful into the vagina just before, but not longer than one hour before, each time you have sexual intercourse. For vaginal dosage form (gel): Adults and teenagers— For use alone—One applicatorful of a 3.5, 4, or 5% gel inserted into the vagina before each time you have sexual intercourse. The 3.5% gel may be used up to twenty-four hours before each act of intercourse. The 4% gel may be used up to one hour before each act of intercourse. The 5% gel must used just before intercourse. For use with a diaphragm—One or two teaspoonfuls (depending on the product) or the contents of one packet of gel is placed into the cup of the diaphragm. Spread more spermicide along the rim of the diaphragm. Insert the diaphragm into the vagina just before, or up to six hours before, sexual intercourse. Also, insert another applicatorful or the contents of one packet into the vagina before each time you have sexual intercourse or if six hours have passed since you inserted the diaphragm. For vaginal dosage form (jelly): Adults and teenagers— For use alone—One applicatorful of 2.2 or 3% jelly inserted into the vagina just before each time you have sexual intercourse. The contraceptive effect of the 2.2 or 3% jelly will last one hour. For use with a diaphragm—One applicatorful or two teaspoonfuls of jelly (depending on the product) placed into the cup of the diaphragm. Spread more spermicide along the rim of the diaphragm. Insert the diaphragm into the vagina just before, but not longer than six hours before, sexual intercourse. Also, insert another applicatorful before each time you have sexual intercourse or if six hours have passed since you inserted the diaphragm. For vaginal dosage form (suppositories): Adults and teenagers— For use alone—One suppository inserted into the vagina from ten to fifteen minutes (depending on the product) before, but not longer than one hour before, each time you have sexual intercourse. For use with a diaphragm—After the diaphragm with spermicide has been placed into the vagina, insert one suppository into the vagina from ten to fifteen minutes (depending on the product) before, but not longer than one hour before, sexual intercourse. Also, insert another suppository before each time you have sexual intercourse or if six hours have passed since you have inserted the diaphragm. For octoxynol 9 For preventing pregnancy: For vaginal dosage form (cream): Adults and teenagers— For use with a diaphragm—Two teaspoonfuls placed into the cup of the diaphragm. Spread more spermicide along the rim of the diaphragm. Insert the diaphragm into the vagina just before, but not longer than six hours before, sexual intercourse. Also, insert one applicatorful of the vaginal cream just before each time you have sexual intercourse or if six hours have passed since you inserted the diaphragm. For vaginal dosage form (jelly): Adults and teenagers— For use with a diaphragm—One applicatorful placed into the cup of the diaphragm. Spread more spermicide along the rim of the diaphragm. Insert the diaphragm into the vagina just before, but not longer than six hours before, sexual intercourse. Also, insert another applicatorful just before each time you have sexual intercourse or if six hours have passed since you inserted the diaphragm. Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using This Medicine

Do not use this medicine if you or your sex partner have HIV or AIDS. This medicine can irritate the vagina and rectum, which may increase the risk of getting HIV or AIDS. Discuss this with your doctor if you have any questions.

This medicine will not protect you from getting HIV or AIDS, or other sexually transmitted diseases (STDs). If this is a concern for you, discuss this with your doctor.

If you have a rash or burning, itching, or other irritation of the genitals, discontinue use of the spermicide and contact your doctor. .

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

RareSigns of toxic shock syndrome—for cervical caps or diaphragms Chills confusion dizziness fever lightheadedness muscle aches sunburn-like skin rash that is followed by peeling of the skin unusual redness of the inside of the nose, mouth, throat, vagina, or eyelids

Check with your doctor as soon as possible if any of the following side effects occur:

RareFor females and males Skin rash, redness, irritation, or itching that does not go away within a short period of time For females only Cloudy or bloody urine increased frequency of urination pain in the bladder or lower abdomen thick, white, or curd-like vaginal discharge—with use of cervical caps or diaphragms only vaginal irritation, redness, rash, dryness, or whitish discharge

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common Vaginal discharge (temporary)—with use of creams, foams, and suppositories vaginal dryness or odor

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Healthcare (Micromedex) products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Healthcare does not assume any responsibility or risk for your use of the Thomson Healthcare products.


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pilocarpine Ophthalmic


pye-loe-KAR-peen

Commonly used brand name(s)

In the U.S.

Isopto Carpine Ocu-Carpine Ocusert Pilo Pilocar Pilopine-HS

In Canada

Minims Pilocarpine 2% Minims Pilocarpine 4%

Available Dosage Forms:

Device Suspension Solution Gel/Jelly

Therapeutic Class: Direct Acting Miotic

Pharmacologic Class: Cholinergic

Uses For pilocarpine

Pilocarpine is used to treat glaucoma and other eye conditions.

pilocarpine is available only with your doctor's prescription.

Before Using pilocarpine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For pilocarpine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to pilocarpine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Although there is no specific information comparing use of pilocarpine in children with use in other age groups, pilocarpine is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. Although there is no specific information comparing use of pilocarpine in the elderly with use in other age groups, pilocarpine is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of pilocarpine. Make sure you tell your doctor if you have any other medical problems, especially:

Asthma or Eye disease or problems (other)—Pilocarpine may make the condition worse Proper Use of pilocarpine

To use the eye drop form of pilocarpine:

First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 1 or 2 minutes to allow the medicine to be absorbed by the eye. Immediately after using the eye drops, wash your hands to remove any medicine that may be on them. To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

To use the eye gel form of pilocarpine:

First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Squeeze a thin strip of gel into this space. A 1?-cm (approximately ?-inch) strip of gel is usually enough, unless you have been told by your doctor to use a different amount. Let go of the eyelid and gently close the eyes. Keep the eyes closed for 1 or 2 minutes to allow the medicine to be absorbed by the eye. Immediately after using the eye gel, wash your hands to remove any medicine that may be on them. To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). After using the eye gel, wipe the tip of the gel tube with a clean tissue and keep the tube tightly closed.

To use the eye insert form of pilocarpine:

pilocarpine usually comes with patient directions. Read them carefully before using pilocarpine. If you think pilocarpine unit may be damaged, do not use it. If you have any questions about this, check with your health care professional. If the unit seems to be releasing too much medicine into your eye, remove it and replace with a new unit. If you have any questions about this, check with your doctor.

Use pilocarpine only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of too much medicine being absorbed into the body and the chance of side effects.

Dosing

The dose of pilocarpine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of pilocarpine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For eye drop dosage form: For chronic glaucoma: Adults and children—One drop one to four times a day. For acute angle-closure glaucoma: Adults and children—One drop every five to ten minutes for three to six doses. Then one drop every one to three hours until eye pressure is reduced. For eye gel dosage form: For glaucoma: Adults and teenagers—Use once a day at bedtime. Children—Use and dose must be determined by your doctor. For eye insert dosage form: For glaucoma: Adults and children—Insert one ocular system every seven days. Infants—Use and dose must be determined by your doctor. Missed Dose

If you miss a dose of pilocarpine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Store the eye system form of pilocarpine in the refrigerator. Keep from freezing. Store the 3.5-gram size (of the gel form) at room temperature.

Precautions While Using pilocarpine

Your doctor should check your eye pressure at regular visits.

For patients using the eye drop or gel form of pilocarpine:

For a short time after you use pilocarpine, your vision may be blurred or there may be a change in your near or far vision, especially at night. Make sure your vision is clear before you drive, use machines, or do anything else that could be dangerous if you are not able to see well.

For patients using the eye insert form of pilocarpine:

For the first several hours after you insert this unit in the eye, your vision may be blurred or there may be a change in your near or far vision, especially at night. Therefore, insert this unit in the eye at bedtime, unless otherwise directed by your doctor. If this unit is inserted in the eye at any other time of the day, make sure your vision is clear before you drive, use machines, or do anything else that could be dangerous if you are not able to see well. pilocarpine Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Symptoms of too much medicine being absorbed into the body Increased sweating muscle tremors nausea, vomiting, or diarrhea troubled breathing or wheezing watering of mouth Less common or rare Eye pain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Blurred vision or change in near or far vision decrease in night vision Less common Eye irritation headache or browache

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More pilocarpine Ophthalmic resources Pilocarpine Ophthalmic Use in Pregnancy & Breastfeeding Pilocarpine Ophthalmic Drug Interactions Pilocarpine Ophthalmic Support Group 0 Reviews for Pilocarpine Ophthalmic - Add your own review/rating pilocarpine ophthalmic Concise Consumer Information (Cerner Multum) Isopto Carpine Drops MedFacts Consumer Leaflet (Wolters Kluwer) Pilocarpine Monograph (AHFS DI) Compare pilocarpine Ophthalmic with other medications Glaucoma Intraocular Hypertension
read more


Pilopine-HS


Generic Name: pilocarpine (Ophthalmic route)

pye-loe-KAR-peen

Commonly used brand name(s)

In the U.S.

Isopto Carpine Ocu-Carpine Ocusert Pilo Pilocar Pilopine-HS

In Canada

Minims Pilocarpine 2% Minims Pilocarpine 4%

Available Dosage Forms:

Device Suspension Solution Gel/Jelly

Therapeutic Class: Direct Acting Miotic

Pharmacologic Class: Cholinergic

Uses For Pilopine-HS

Pilocarpine is used to treat glaucoma and other eye conditions.

This medicine is available only with your doctor's prescription.

Before Using Pilopine-HS

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Although there is no specific information comparing use of this medicine in children with use in other age groups, pilocarpine is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. Although there is no specific information comparing use of pilocarpine in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Asthma or Eye disease or problems (other)—Pilocarpine may make the condition worse Proper Use of pilocarpine

This section provides information on the proper use of a number of products that contain pilocarpine. It may not be specific to Pilopine-HS. Please read with care.

To use the eye drop form of pilocarpine:

First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 1 or 2 minutes to allow the medicine to be absorbed by the eye. Immediately after using the eye drops, wash your hands to remove any medicine that may be on them. To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

To use the eye gel form of pilocarpine:

First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Squeeze a thin strip of gel into this space. A 1?-cm (approximately ?-inch) strip of gel is usually enough, unless you have been told by your doctor to use a different amount. Let go of the eyelid and gently close the eyes. Keep the eyes closed for 1 or 2 minutes to allow the medicine to be absorbed by the eye. Immediately after using the eye gel, wash your hands to remove any medicine that may be on them. To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). After using the eye gel, wipe the tip of the gel tube with a clean tissue and keep the tube tightly closed.

To use the eye insert form of pilocarpine:

This medicine usually comes with patient directions. Read them carefully before using this medicine. If you think this medicine unit may be damaged, do not use it. If you have any questions about this, check with your health care professional. If the unit seems to be releasing too much medicine into your eye, remove it and replace with a new unit. If you have any questions about this, check with your doctor.

Use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of too much medicine being absorbed into the body and the chance of side effects.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For eye drop dosage form: For chronic glaucoma: Adults and children—One drop one to four times a day. For acute angle-closure glaucoma: Adults and children—One drop every five to ten minutes for three to six doses. Then one drop every one to three hours until eye pressure is reduced. For eye gel dosage form: For glaucoma: Adults and teenagers—Use once a day at bedtime. Children—Use and dose must be determined by your doctor. For eye insert dosage form: For glaucoma: Adults and children—Insert one ocular system every seven days. Infants—Use and dose must be determined by your doctor. Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Store the eye system form of this medicine in the refrigerator. Keep from freezing. Store the 3.5-gram size (of the gel form) at room temperature.

Precautions While Using Pilopine-HS

Your doctor should check your eye pressure at regular visits.

For patients using the eye drop or gel form of this medicine:

For a short time after you use this medicine, your vision may be blurred or there may be a change in your near or far vision, especially at night. Make sure your vision is clear before you drive, use machines, or do anything else that could be dangerous if you are not able to see well.

For patients using the eye insert form of this medicine:

For the first several hours after you insert this unit in the eye, your vision may be blurred or there may be a change in your near or far vision, especially at night. Therefore, insert this unit in the eye at bedtime, unless otherwise directed by your doctor. If this unit is inserted in the eye at any other time of the day, make sure your vision is clear before you drive, use machines, or do anything else that could be dangerous if you are not able to see well. Pilopine-HS Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Symptoms of too much medicine being absorbed into the body Increased sweating muscle tremors nausea, vomiting, or diarrhea troubled breathing or wheezing watering of mouth Less common or rare Eye pain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Blurred vision or change in near or far vision decrease in night vision Less common Eye irritation headache or browache

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Pilopine-HS side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Pilopine-HS resources Pilopine-HS Side Effects (in more detail) Pilopine-HS Use in Pregnancy & Breastfeeding Pilopine-HS Drug Interactions Pilopine-HS Support Group 0 Reviews for Pilopine-HS - Add your own review/rating Pilopine-HS Concise Consumer Information (Cerner Multum) Isopto Carpine Drops MedFacts Consumer Leaflet (Wolters Kluwer) Pilocarpine Monograph (AHFS DI) Compare Pilopine-HS with other medications Glaucoma Intraocular Hypertension
read more


Lacrisert


hydroxypropyl cellulose
Dosage Form: ophthalmic insert

STERILE OPHTHALMIC INSERT

Lacrisert Description

Lacrisert1 (hydroxypropyl cellulose ophthalmic insert) is a sterile, translucent, rod-shaped, water soluble, ophthalmic insert made of hydroxypropyl cellulose, for administration into the inferior cul-de-sac of the eye.

The chemical name for hydroxypropyl cellulose is cellulose, 2-hydroxypropyl ether. It is an ether of cellulose in which hydroxypropyl groups (-CH2CHOHCH3) are attached to the hydroxyls present in the anhydroglucose rings of cellulose by ether linkages. A representative structure of the monomer is:

The molecular weight is typically 1 ? 106.

Hydroxypropyl cellulose is an off-white, odorless, tasteless powder. It is soluble in water below 38°C, and in many polar organic solvents such as ethanol, propylene glycol, dioxane, methanol, isopropyl alcohol (95%), dimethyl sulfoxide, and dimethyl formamide.

Each Lacrisert is 5 mg of hydroxypropyl cellulose. Lacrisert contains no preservatives or other ingredients. It is about 1.27 mm in diameter by about 3.5 mm long.

Lacrisert is supplied in packages of 60 units, together with illustrated instructions and a special applicator for removing Lacrisert from the unit dose blister and inserting it into the eye. A spare applicator is included in each package.

1 Registered trademark of ATON PHARMA, INC.
COPYRIGHT © ATON PHARMA, INC., 2007
All rights reserved Lacrisert - Clinical Pharmacology Pharmacodynamics

Lacrisert acts to stabilize and thicken the precorneal tear film and prolong the tear film breakup time which is usually accelerated in patients with dry eye states. Lacrisert also acts to lubricate and protect the eye.

Lacrisert usually reduces the signs and symptoms resulting from moderate to severe dry eye syndromes, such as conjunctival hyperemia, corneal and conjunctival staining with rose bengal, exudation, itching, burning, foreign body sensation, smarting, photophobia, dryness and blurred or cloudy vision. Progressive visual deterioration which occurs in some patients may be retarded, halted, or sometimes reversed.

In a multicenter crossover study the 5 mg Lacrisert administered once a day during the waking hours was compared to artificial tears used four or more times daily. There was a prolongation of tear film breakup time and a decrease in foreign body sensation associated with dry eye syndrome in patients during treatment with inserts as compared to artificial tears; these findings were statistically significantly different between the treatment groups. Improvement, as measured by amelioration of symptoms, by slit lamp examination and by rose bengal staining of the cornea and conjunctiva, was greater in most patients with moderate to severe symptoms during treatment with Lacrisert. Patient comfort was usually better with Lacrisert than with artificial tears solution, and most patients preferred Lacrisert.

In most patients treated with Lacrisert for over one year, improvement was observed as evidenced by amelioration of symptoms generally associated with keratoconjunctivitis sicca such as burning, tearing, foreign body sensation, itching, photophobia and blurred or cloudy vision.

During studies in healthy volunteers, a thickened precorneal tear film was usually observed through the slit-lamp while Lacrisert was present in the conjunctival sac.

Pharmacokinetics and Metabolism

Hydroxypropyl cellulose is a physiologically inert substance. In a study of rats fed hydroxypropyl cellulose or unmodified cellulose at levels up to 5% of their diet, it was found that the two were biologically equivalent in that neither was metabolized.

Studies conducted in rats fed 14C-labeled hydroxypropyl cellulose demonstrated that when orally administered, hydroxypropyl cellulose is not absorbed from the gastrointestinal tract and is quantitatively excreted in the feces.

Dissolution studies in rabbits showed that hydroxypropyl cellulose inserts became softer within 1 hour after they were placed in the conjunctival sac. Most of the inserts dissolved completely in 14 to 18 hours; with a single exception, all had disappeared by 24 hours after insertion. Similar dissolution of the inserts was observed during prolonged administration (up to 54 weeks).

Indications and Usage for Lacrisert

Lacrisert is indicated in patients with moderate to severe dry eye syndromes, including keratoconjunctivitis sicca. Lacrisert is indicated especially in patients who remain symptomatic after an adequate trial of therapy with artificial tear solutions.

Lacrisert is also indicated for patients with:
Exposure keratitis
Decreased corneal sensitivity
Recurrent corneal erosions

Contraindications

Lacrisert is contraindicated in patients who are hypersensitive to hydroxypropyl cellulose.

Warnings

Instructions for inserting and removing Lacrisert should be carefully followed.

Precautions General

If improperly placed, Lacrisert may result in corneal abrasion (see DOSAGE AND ADMINISTRATION). Information for Patients

Patients should be advised to follow the instructions for using Lacrisert which accompany the package.

Because this product may produce transient blurring of vision, patients should be instructed to exercise caution when operating hazardous machinery or driving a motor vehicle.

Drug Interactions

Application of hydroxypropyl cellulose ophthalmic inserts to the eyes of unanesthetized rabbits immediately prior to or two hours before instilling pilocarpine, proparacaine HCl (0.5%), or phenylephrine (5%) did not markedly alter the magnitude and/or duration of the miotic, local corneal anesthetic, or mydriatic activity, respectively, of these agents. Under various treatment schedules, the anti-inflammatory effect of ocularly instilled dexamethasone (0.1%) in unanesthetized rabbits with primary uveitis was not affected by the presence of hydroxypropyl cellulose inserts.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Feeding of hydroxypropyl cellulose to rats at levels up to 5% of their diet produced no gross or histopathologic changes or other deleterious effects.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Adverse Reactions

The following adverse reactions have been reported in patients treated with Lacrisert, but were in most instances mild and transient:
Transient blurring of vision (See PRECAUTIONS)
Ocular discomfort or irritation
Matting or stickiness of eyelashes
Photophobia
Hypersensitivity
Edema of the eyelids
Hyperemia

Lacrisert Dosage and Administration

One Lacrisert ophthalmic insert in each eye once daily is usually sufficient to relieve the symptoms associated with moderate to severe dry eye syndromes. Individual patients may require more flexibility in the use of Lacrisert; some patients may require twice daily use for optimal results.

Clinical experience with Lacrisert indicates that in some patients several weeks may be required before satisfactory improvement of symptoms is achieved.

Lacrisert is inserted into the inferior cul-de-sac of the eye beneath the base of the tarsus, not in apposition to the cornea, nor beneath the eyelid at the level of the tarsal plate. If not properly positioned, it will be expelled into the interpalpebral fissure, and may cause symptoms of a foreign body. Illustrated instructions are included in each package. While in the licensed practitioner's office, the patient should read the instructions, then practice insertion and removal of Lacrisert until proficiency is achieved.

NOTE: Occasionally Lacrisert is inadvertently expelled from the eye, especially in patients with shallow conjunctival fornices. The patient should be cautioned against rubbing the eye(s) containing Lacrisert, especially upon awakening, so as not to dislodge or expel the insert. If required, another Lacrisert ophthalmic insert may be inserted. If experience indicates that transient blurred vision develops in an individual patient, the patient may want to remove Lacrisert a few hours after insertion to avoid this. Another Lacrisert ophthalmic insert maybe inserted if needed.

If Lacrisert causes worsening of symptoms, the patient should be instructed to inspect the conjunctival sac to make certain Lacrisert is in the proper location, deep in the inferior cul-de-sac of the eye beneath the base of the tarsus. If these symptoms persist, Lacrisert should be removed and the patient should contact the practitioner.

How is Lacrisert Supplied

Lacrisert, a sterile, translucent, rod-shaped, water-soluble, ophthalmic insert made of hydroxypropyl cellulose, 5 mg, is supplied as follows:

NDC 25010-805-68 in packages containing 60 unit doses (each wrapped in an aluminum blister), two reusable applicators, and a plastic storage container to store the applicators after use.

Storage

Store below 30°C (86°F).

Distributed by:
ATON PHARMA, INC.
Lawrenceville, NJ 08648, USA

Manufactured by:
Merck and Co., Inc.
West Point, PA 19486 USA

Issued June 2007

Printed in USA

INSTRUCTIONS FOR USING Lacrisert® (HYDROXYPROPYL CELLULOSE OPHTHALMIC INSERT)

Note: Your licensed practitioner or a trained associate can demonstrate the proper use of Lacrisert2. Please read and follow these instructionscarefully for your subsequent use.

Clinical experience with Lacrisert indicates that in some patients several weeks may be required before satisfactory improvement of symptoms is achieved.

Two applicators (one spare) are supplied with each package.

Before opening the package of Lacrisert, wash your hands thoroughly with soap and water.

STEP 1: On a flat surface, open blister pocket slowly and smoothly by peeling back label area. Each blister pocket contains one Lacrisert ophthalmic insert.

STEP 2: Open applicator package with label side up. Avoid touching grooved tip of the applicator. Pick up applicator by the wide end and rinse the tip thoroughly under hot running tap water. Gently shake off excess water.

STEP 3: Hold applicator with tip facing down and with forefinger on top to guide and apply gentle pressure. Lightly press the grooved tip of the applicator onto the Lacrisert ophthalmic insert and it will adhere to the applicator.

It is important to follow STEPS 4 and 5 carefully or you might experience difficulty in keeping Lacrisert (hydroxypropyl cellulose ophthalmic insert) in your eye.

STEP 4: Look into a mirror. Starting with the right eye, turn your head to the right so that the colored part of the eye is close to your nose. Use your free hand to grasp the lower lid between the thumb and index finger. Pull the lid away from the eyeball and create a pocket between the white part of the eyeball and the lid.

STEP 5: Place the tip of the applicator containing Lacrisert into the pocket. Avoid touching the colored part of the eye.

Remove the applicator. It is important, after removing the applicator, to look down, then release the lower eyelid. Lacrisert (hydroxypropyl cellulose ophthalmic insert) should remain deep in the lower pocket recess of the eye and not near the edge of the lower eyelid.

Repeat procedure with left eye, turning head to the left so that the colored part of the eye is close to your nose.

Rinse the applicator thoroughly under hot running tap water after use. Gently shake off visible water droplets and promptly return it to the storage container. Note that the storage container provides space for a strip of two Lacrisert ophthalmic inserts next to the applicator storage compartment.

IMPORTANT

If Lacrisert causes worsening of symptoms, or if new symptoms develop, it should be removed and your prescriber contacted.

Should the removal of the Lacrisert ophthalmic insert be necessary, follow these instructions.

Locate Lacrisert by pulling the lid away from the eyeball while looking for Lacrisert in a mirror. Then close the eyelids. When located, move Lacrisert upward with your fingers through the closed eyelids. Keep the lids against the eyeball and Lacrisert should slip over the lid margin so that you can remove it with a clean facial tissue without touching the colored part of the eye.

CAUTION: Because this product may produce transient blurring of vision, you should exercise caution when operating hazardous machinery or driving a motor vehicle.

Store below 30°C (86°F).

Issued May 2007

ATON PHARMA, INC.
LAWRENCEVILLE, NJ 08648, USA

2 Registered trademark of ATON PHARMA, INC.
Lacrisert 
hydroxypropyl cellulose  pellet Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 25010-805 Route of Administration OPHTHALMIC DEA Schedule      INGREDIENTS Name (Active Moiety) Type Strength hydroxypropyl cellulose (hydroxypropyl cellulose) Active 5 MILLIGRAM  In 1 PELLET Product Characteristics Color white (translucent) Score no score Shape OVAL (rod-shaped) Size 4mm Flavor Imprint Code Contains          Coating false Symbol false Packaging # NDC Package Description Multilevel Packaging 1 25010-805-68 12 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 5 PELLET In 1 BLISTER PACK This package is contained within the CARTON (25010-805-68)
Revised: 03/2008Aton Pharma, Inc. More Lacrisert resources Lacrisert Side Effects (in more detail) Lacrisert Use in Pregnancy & Breastfeeding Lacrisert Support Group 0 Reviews for Lacrisert - Add your own review/rating Lacrisert Concise Consumer Information (Cerner Multum) Lacrisert Advanced Consumer (Micromedex) - Includes Dosage Information Lacrisert Insert MedFacts Consumer Leaflet (Wolters Kluwer) FreshKote Drops MedFacts Consumer Leaflet (Wolters Kluwer) Genteal Advanced Consumer (Micromedex) - Includes Dosage Information Lacri-Lube S.O.P. Ointment MedFacts Consumer Leaflet (Wolters Kluwer) Murine Tears Drops MedFacts Consumer Leaflet (Wolters Kluwer) Murocel Eye Drops MedFacts Consumer Leaflet (Wolters Kluwer) Refresh Redness Relief Drops MedFacts Consumer Leaflet (Wolters Kluwer) Refresh liquigel Compare Lacrisert with other medications Eye Dryness/Redness
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Boots Clotrimazole 500mg Vaginal Tablet


Boots Clotrimazole 500 mg Vaginal Tablet

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription to treat thrush. However, you still need to use it carefully to get the best results from it.

Keep this leaflet, you may need to read it again Ask your pharmacist if you need more information or advice You must contact a pharmacist or doctor if your symptoms worsen or do not go away after 3 days What this medicine is for

This medicine contains Clotrimazole which belongs to a group of medicines called antifungals, which act to treat infections caused by fungi. It can be used to treat thrush (vaginal candidiasis). Thrush is a common infection caused by a yeast (or fungus), which may live harmlessly in the vagina without you even noticing it. However, in certain circumstances, it may develop into an infection in the vagina and symptoms may spread to the surrounding area. These symptoms may include one or more of the following:

Itching of the vagina and surrounding area (the vulva) Redness and swelling of the tissues of the vagina and vulva Soreness of the vagina and vulva A white non-smelling discharge from the vagina

Thrush may be aggravated by sexual intercourse, but it is not a sexually transmitted disease. Sometimes however, thrush can be passed to your partner through sexual intercourse.

If your partner has penile thrush he may have one or more of the following symptoms:

Soreness and redness of the penis Tightness of the foreskin An abnormal penile discharge Before you use this medicine

This medicine can be used by women between the ages of 16 and 60 years. However, some people should not use this medicine or should seek the advice of their pharmacist or doctor first.

Do not use: If you are allergic to any of the ingredients If you are pregnant, unless your doctor tells you to – if your doctor tells you to use the pessary do not use the applicator to insert it Talk to your pharmacist or doctor: If this is the first time you have had these symptoms If you are under 16 years, or 61 years or older If you have had thrush more than twice in the last 6 months If you or your partner have been exposed to a sexually transmitted disease If you have lower stomach pain, or pain or a burning sensation on passing urine If you have abnormal or irregular vaginal bleeding, or a blood-stained discharge If you have sores, ulcers or blisters on your vulva or vagina Other important information

The ingredients in the pessary may affect the latex used in contraceptives such as condoms and diaphragms. This may reduce the effectiveness of the contraceptives. You should therefore use other methods of contraception for at least 5 days after using the pessary.

You can help the treatment to work if you follow these simple self-help tips:

Although the infected area will itch, do not scratch as this will damage the surface of the skin and cause the infection to spread further Keep the affected areas of skin clean Pay particular attention to drying the skin but avoid excessive rubbing

To help prevent thrush from coming back once you have treated it, follow these simple steps:

Wash daily Wear cotton underwear and loose fitting clothing Try to avoid wearing tights, nylon underwear and tight fitting clothing After going to the toilet, wipe yourself from the front to the back, as a thrush infection may be transferred from the bowel Try to avoid washing with perfumed soaps or using vaginal deodorants Do not rub hard with sponges or flannels and avoid hot baths with strong perfumed oils Change your sanitary protection regularly If you take other medicines

Before you use this medicine, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time. If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.

How to use this medicine

The carton contains a single pessary held inside a foil blister pack and an applicator for insertion of the pessary into the vagina. Check the foil is not broken before use. If it is, do not use the pessary.

Women aged 16 to 60 years: Insert the pessary into the vagina at night using the applicator provided.

If you are pregnant do not use the applicator. Wash and dry your hands, and insert the pessary with your fingers.

Directions for inserting the pessary Remove the applicator from the packaging Pull out the plunger until it stops Remove the pessary from the blister pack and place the pessary firmly into the applicator To fit the pessary into the applicator, squeeze the applicator lightly on either side. The pessary fits tightly into the applicator and needs to be pushed into the holder about 1 cm Carefully put the applicator as deep as is comfortable into the vagina (this is easiest when laying on your back with your knees bent up) Holding the applicator in place, slowly press the plunger until it stops so that the pessary is deposited into the vagina. Remove the applicator Dispose of the applicator in a safe place, out of the reach of children The applicator cannot be flushed down the toilet Wash your hands thoroughly after use

For use in the vagina only.

Do not use the pessary at the same time as you are having a period. Wait until your period has finished.

Do not use for children under 16 years, or if you are an adult of 61 years or older, unless your doctor tells you to.

Do not use more than one pessary.

After you use the pessary the symptoms of thrush (itching, burning, discharge) should go away within 3 days.

If symptoms worsen or do not go away after 3 days talk to your doctor.

If anyone accidentally swallows the pessary: Talk to a doctor straight away or go to your nearest hospital casualty department. Take your medicine and this leaflet with you.

Possible side effects

Most people will not have problems, but some may get some.

If you get these side effects see a doctor:

Allergic reaction (e.g. skin rash, red or itchy skin)

These other effects are less serious.

If they bother you talk to a pharmacist:

Mild burning or irritation straight after inserting the pessary

The side effects of this medicine can be very similar to the symptoms that you are treating.

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

How to store this medicine

Do not store above 25°C.

Protect from moisture.

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.

Use by the date on the end flap of the carton.

What is in this medicine

This vaginal tablet contains Clotrimazole 500 mg, which is the active ingredient.

As well as the active ingredient, the vaginal tablet also contains lactose, adipic acid, pregelatinised maize starch, sodium hydrogen carbonate, microcrystalline cellulose, magnesium stearate, maize starch, stearic acid, colloidal silicon dioxide, polysorbate 80.

The pack contains 1 vaginal tablet with an applicator.

Who makes this medicine

Manufactured for

The Boots Company PLC Nottingham NG2 3AA

Marketing Authorisation Holder and Manufacturer:

Tillomed Laboratories Ltd 3 Howard Road Eaton Socon St Neots Cambridgeshire PE19 3ET

Leaflet prepared February 2008

If you would like any further information about this medicine, please contact

The Boots Company PLC Nottingham NG2 3AA

3379eMC


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Prepidil


Generic Name: dinoprostone (Vaginal route)

dye-noe-PROST-one

Vaginal route(Suppository)

Dinoprostone should be used with strict adherence to recommended dosages, and should be used by medically trained personnel in a hospital which can provide immediate intensive care and acute surgical facilities .

Commonly used brand name(s)

In the U.S.

Cervidil Prepidil Prostin E2

Available Dosage Forms:

Tampon Suppository Gel/Jelly Insert, Extended Release

Therapeutic Class: Uterine Stimulant

Pharmacologic Class: Prostaglandin

Uses For Prepidil

Dinoprostone works by causing the cervix to thin and dilate (open) and the uterus to contract (cramp) the way it does during labor.

Dinoprostone may also be used for other purposes as determined by your doctor.

Dinoprostone is to be administered only by or under the immediate care of your doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, dinoprostone is used in certain patients with the following medical condition:

Unusual increase in bleeding of the uterus after delivery (postpartum hemorrhage) Before Using Prepidil

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Anemia (or history of)—Dinoprostone, when used in doses that stimulate the uterus to contract, may result in loss of blood in some patients that may require a blood transfusion Asthma (or history of, including childhood asthma) or Lung disease—Dinoprostone may cause narrowing of the blood vessels in the lungs or narrowing of the lung passages, especially when it is used in doses that stimulate the uterus to contract Epilepsy (or history of)—Rarely, seizures have occurred with dinoprostone when it is used in doses that stimulate the uterus to contract Glaucoma—Rarely, the pressure within the eye has increased and constriction of the pupils has occurred during the use of medicines like dinoprostone; this may also be a problem with dinoprostone when it is used in doses that stimulate the uterus to contract Heart or blood vessel disease (or history of) or High blood pressure (or history of) or Low blood pressure (history of)—Dinoprostone may cause changes in heart function or blood pressure changes; two patients with a history of heart disease had heart attacks when dinoprostone was used in doses that stimulated the uterus to contract Kidney disease (or history of) or Liver disease (or history of)—The body may not remove dinoprostone from the blood stream at the usual rate, which may make the dinoprostone work longer or cause an increased chance of side effects, especially when dinoprostone is used in doses that stimulate the uterus to contract Problems during delivery, history of or Surgery of uterus (history of) or Unusual vaginal bleeding—There is an increased risk of problems occurring with dinoprostone when it is used in doses that stimulate the uterus to contract Proper Use of dinoprostone

This section provides information on the proper use of a number of products that contain dinoprostone. It may not be specific to Prepidil. Please read with care.

After dinoprostone is given, you will need to lie down for 10 minutes to 2 hours so that the medicine can be absorbed. The length of time you must remain lying down will depend on what form of the medicine you are using.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For cervical dosage form (gel): To thin and widen the opening of the cervix just before labor: Adults and teenagers—Your doctor will insert 0.5 milligram (mg) (one application) of dinoprostone into the canal of your cervix. You should remain lying on your back for at least ten to thirty minutes after it has been applied. For vaginal dosage form (gel): To cause the uterus to contract for labor: Adults and teenagers—Your doctor will insert 1 milligram (mg) (one applicatorful) of dinoprostone into your vagina. You should remain lying on your back for at least thirty minutes after it has been applied. You may need another dose of 1 to 2 mg six hours after the first dose. For vaginal dosage form (suppositories): To cause the uterus to contract to abort a pregnancy: Adults and teenagers—Your doctor will insert 20 milligrams (mg) (one suppository) into your vagina every three to five hours as needed. You should remain lying on your back for at least ten minutes after it has been inserted. For vaginal dosage form (system): To thin and widen the opening of the cervix just before labor: Adults and teenagers—Your doctor will insert 10 milligrams (mg) (one system) into your vagina. You should remain lying on your back for at least two hours after it has been inserted. Prepidil Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common or rare Fast or slow heartbeat hives increased pain of the uterus pale, cool, blotchy skin on arms or legs pressing or painful feeling in chest shortness of breath swelling of face, inside the nose, and eyelids tightness in chest trouble in breathing weak or absent pulse in arms or legs wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Abdominal or stomach cramps diarrhea fever nausea vomiting Less common or rare Chills or shivering constipation flushing headache swelling of the genital area (vulva) tender or mildly bloated abdomen or stomach

This procedure may still result in some effects, which occur after the procedure is completed, that need medical attention. Check with your doctor if any of the following side effects occur:

Chills or shivering (continuing) fever (continuing) foul-smelling vaginal discharge pain in lower abdomen unusual increase in bleeding of the uterus

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Prepidil side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Prepidil resources Prepidil Side Effects (in more detail) Prepidil Use in Pregnancy & Breastfeeding Prepidil Drug Interactions Prepidil Support Group 0 Reviews for Prepidil - Add your own review/rating Prepidil Prescribing Information (FDA) Prepidil Concise Consumer Information (Cerner Multum) Prepidil Gel MedFacts Consumer Leaflet (Wolters Kluwer) Cervidil Prescribing Information (FDA) Cervidil Inserts MedFacts Consumer Leaflet (Wolters Kluwer) Prostin E2 Prescribing Information (FDA) Compare Prepidil with other medications Abortion Labor Induction Trophoblastic Disease
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Amino-Cerv Cream


Pronunciation: uh-MEE-no AS-ids/SO-dee-uhm PRO-pee-oh-nate/you-REE-ah
Generic Name: Amino Acids/Sodium Propionate/Urea Cervical
Brand Name: Amino-Cerv
Amino-Cerv Cream is used for:

Treating inflammation or injury of the cervix. It is usually used after childbirth or certain medical procedures. It may also be used to treat other conditions as determined by your doctor.

Amino-Cerv Cream is an amino acid, antifungal, and urea combination. The amino acids help wounds to heal. They also help to increase cell growth. Sodium propionate kills sensitive fungi. Urea helps to break down dead tissue. It also increases new tissue growth.

Do NOT use Amino-Cerv Cream if: you are allergic to any ingredient in Amino-Cerv Cream

Contact your doctor or health care provider right away if any of these apply to you.

Before using Amino-Cerv Cream:

Some medical conditions may interact with Amino-Cerv Cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparations, or dietary supplement if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Amino-Cerv Cream. Because little, if any, of Amino-Cerv Cream is absorbed into the blood, the risk of it interacting with another medicine is low.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Amino-Cerv Cream may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Amino-Cerv Cream:

Use Amino-Cerv Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Amino-Cerv Cream. Talk to your pharmacist if you have questions about this information. Use Amino-Cerv Cream before going to bed unless directed otherwise by your doctor. If you are wearing a pessary, remove it before you use Amino-Cerv Cream. Do not tape over the pinhole on the top of the bulb on the applicator. To use Amino-Cerv Cream, attach the applicator to the tube. Squeeze the tube from the bottom until the medicine reaches the correct dose mark on the applicator. Detach the applicator from the tube. Insert it 3 4 inch into the vagina. Do NOT insert it all the way into the vagina. Squeeze the bulb firmly once. This will deposit the cream into the vagina. Do not release the bulb until you have removed the applicator from the vagina. Clean the applicator right away. Hold it under water and flush it (squeeze the bulb) several times. Wipe the threads of the tube and the inside of the cap. Recap the tube tightly. Do not use other feminine sprays or vaginal or cervical medicines. They may interact with Amino-Cerv Cream. If you miss a dose of Amino-Cerv Cream, use it as soon as possible. If you do not remember until the next day, skip the missed dose. Go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Amino-Cerv Cream.

Important safety information: Amino-Cerv Cream is for vaginal use only. Do not get it in your eyes, nose, or mouth. If you get it in your eyes, rinse at once with cool water. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Amino-Cerv Cream while you are pregnant. It is unknown if Amino-Cerv Cream is found in breast milk. If you are or will be breast-feeding while you use Amino-Cerv Cream, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Amino-Cerv Cream:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Amino-Cerv Cream. Seek medical attention right away if any of these SEVERE side effects occur:

Seek medical attention right away if any of these SEVERE side effects occur: Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Amino-Cerv side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Amino-Cerv Cream:

Store Amino-Cerv Cream at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Amino-Cerv Cream out of the reach of children and away from pets.

General information: If you have any questions about Amino-Cerv Cream, please talk with your doctor, pharmacist, or other health care provider. Amino-Cerv Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Amino-Cerv Cream. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Amino-Cerv resources Amino-Cerv Side Effects (in more detail) Amino-Cerv Use in Pregnancy & Breastfeeding Amino-Cerv Support Group 0 Reviews for Amino-Cerv - Add your own review/rating Compare Amino-Cerv with other medications Cervicitis
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estrogen Vaginal


Commonly used brand name(s)

In the U.S.

Estrace Estring Femring Ortho Dienestrol Premarin Vagifem

In Canada

Estragyn Neo-Estrone Oestrilin

Available Dosage Forms:

Tablet Cream Insert, Extended Release Suppository Uses For estrogen

Estrogens are hormones produced by the body. Among other things, estrogens help develop and maintain female organs.

When your body is in short supply of this hormone, replacing it can ease the uncomfortable changes that occur in the vagina, vulva (female genitals), and urethra (part of the urinary system). Conditions that are treated with vaginal estrogens include a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), and inflammation of the urethra (atrophic urethritis).

Estrogens work partly by increasing a normal clear discharge from the vagina and making the vulva and urethra healthy. Using or applying an estrogen relieves or lessens:

Dryness and soreness in the vagina Itching, redness, or soreness of the vulva Feeling an urge to urinate more often then is needed or experiencing pain while urinating Pain during sexual intercourse

When used vaginally or on the skin, most estrogens are absorbed into the bloodstream and cause some, but not all, of the same effects as when they are taken by mouth. Estrogens used vaginally at very low doses for treating local problems of the genitals and urinary system will not protect against osteoporosis or stop the hot flushes caused by menopause.

Estrogens for vaginal use are available only with your doctor's prescription.

Before Using estrogen Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Estrogen vaginal cream is not indicated in children. Studies have not been conducted.

Geriatric

Elderly women greater than 65 years of age may have an increased risk of certain side effects during treatment, especially stroke, invasive breast cancer, and memory problems.

Pregnancy

Estrogens should not be used during pregnancy, since an estrogen called diethylstilbestrol (DES) that is no longer taken for hormone replacement has caused serious birth defects in humans and animals.

Breast Feeding

Use of estrogen is not recommended in nursing mothers. Estrogens pass into the breast milk and may decrease the amount and quality of breast milk. Caution should be exercised in mothers who are using estrogen and breast-feeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

Asthma or Epilepsy or Heart problems or Kidney problems or Migraine headaches—Estrogens may worsen these conditions. Blood clotting problems—Although worsening of a blood clotting condition is unlikely, some doctors do not prescribe vaginal estrogens for patients with blood clotting problems or a history of these problems. Breast cancer (active, suspected, or past history)—Estrogens should not be used. Certain cancers, including cancers of the breast, bone, or uterus (active or suspected)—Estrogens may interfere with the treatment of breast or bone cancer or worsen cancer of the uterus when these conditions are present. Cholestatic jaundice (flow of bile from the liver is blocked), past history—Caution should be used when this condition is present. Diabetes mellitus (sugar diabetes)—Estrogens may alter your body's response to sugar in your diet. Endometriosis or Fibroid tumors of the uterus—Estrogens may worsen endometriosis or increase the size of fibroid tumors. Gallbladder problems (gallstones)—Estrogens may increase your chance of getting a gallbladder attack. Heart attack or Stroke (active or past history)—Estrogens should not be used. Hepatic hemangioma (noncancerous tumors of the liver)—Estrogens may worsen this medical problem. High blood pressure—Estrogens may worsen this medical problem. Hypercalcemia (too much calcium in your blood)—Estrogens may worsen this medical problem. Hypertriglyceridemia (too much triglycerides in your blood)—Estrogens may increase your chance of getting pancreatitis or other side effects. Hypocalcemia (too little calcium in your blood)—Your doctor should treat the low calcium in your blood before starting estrogen therapy. Irritation or infection of the vagina—Usually estrogens decrease infections or irritation of the vagina, but sometimes these conditions may become worse. Liver disease or Liver problems—Estrogens should not be used. Lupus erythematosus, systemic (SLE or lupus)—Estrogens may worsen this medical problem. Physical problems within the vagina, such as narrow vagina, vaginal stenosis, or vaginal prolapse—Estradiol vaginal insert or ring may be more likely to slip out of place or cause problems, such as irritation of the vagina. Porphyria—Estrogens may worsen this medical problem. Thyroid problems (underactive thyroid)—Estrogens may alter your body's response to your thyroid medication. Your doctor may alter the amount of thyroid replacement that you take while on estrogen therapy. Vision changes, sudden onset including Bulging eyes or Double vision or Migraine headache or Vision loss, partial or complete—Estrogens may cause these problems. Tell your doctor if you have had any of these problems. Unusual genital or vaginal bleeding of unknown causes—Use of estrogens may delay diagnosis or worsen the condition. The reason for the bleeding should be determined before estrogens are used. Proper Use of estrogen

Vaginal estrogen products usually come with patient directions. Read them carefully before using estrogen.

Wash your hands before and after using the medicine. Also, keep the medicine out of your eyes. If estrogen does get into your eyes, wash them out immediately, but carefully, with large amounts of tap water. If your eyes still burn or are painful, check with your doctor.

Use estrogen only as directed. Do not use more of it and do not use it for a longer time than your doctor ordered. It can take up to 4 months to see the full effect of the estrogens. Your doctor may reconsider continuing your estrogen treatment or may lower your dose several times within the first one or two months, and every 3 to 6 months after that. Sometimes a switch to oral estrogens may be required for added benefits or for higher doses. When using the estradiol vaginal insert or ring, you will need to replace it every 3 months or remove it after 3 months.

For vaginal creams or suppositories:

Vaginal creams and some vaginal suppositories are inserted with a plastic applicator. Directions for using the applicator are supplied with your medicine. If you do not see your dose marked on the applicator, ask your health care professional for more information. To fill the applicator for cream dosage forms: Screw the applicator onto the tube. Squeeze the medicine into the applicator slowly until it is measured properly. Remove the applicator from the tube. Replace the cap on the tube. To fill the applicator for suppository dosage form: Place the suppository into the applicator. To place the dose using the applicator for cream and suppository dosage forms: Relax while lying on your back with your knees bent or stand with one foot on a chair. Hold the full applicator in one hand. Slide the applicator slowly into the vagina. Stop before it becomes uncomfortable. Slowly press the plunger until it stops. Withdraw the applicator. The medicine will be left behind in the vagina. To care for the applicator for cream and suppository dosage forms: Clean the applicator after use by pulling the plunger out of the applicator and washing both parts completely in warm, soapy water. Do not use hot or boiling water. Rinse well. After drying the applicator, replace the plunger.

For vaginal insert or ring dosage form:

To place the vaginal insert: Relax while lying on your back with your knees bent or stand with one foot on a chair. Pinch or press the sides of the vaginal insert together, between your forefinger and middle finger. With one hand, part the folds of skin around your vagina. Slide the vaginal insert slowly into the upper third of your vagina. Stop before it becomes uncomfortable. The exact location is not too important but it should be comfortable. If it seems uncomfortable, then carefully push the vaginal insert higher into the vagina. To remove the vaginal insert: Stand with one foot on a chair. Slide one finger into the vagina and hook it around the closest part of the vaginal insert. Slowly pull the vaginal insert out. Dispose of the vaginal insert by wrapping it up and throwing it into the trash. Do not flush it down the toilet. Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For conjugated estrogens For vaginal dosage form (cream): For treating inflammation of the vagina (atrophic vaginitis): Adults—At first, 0.5 gram (g) of conjugated estrogens inserted into the vagina once a day or as directed by your doctor to achieve the lowest dose possible. Usually your doctor will want you to use estrogen for only three weeks of each month (three weeks on and one week off). Your doctor may increase your dose as needed. However, the dose is usually not more than 2 grams per day. For treating a genital skin condition (vulvar atrophy): Adults—0.5 gram (g) of conjugated estrogens inserted into the vagina two times per week. Usually your doctor will want you to use estrogen for only three weeks of each month (three weeks on and one week off). For estradiol For vaginal dosage form (cream): For treating a genital skin condition (vulvar atrophy) and inflammation of the vagina (atrophic vaginitis): Adults—200 to 400 micrograms (mcg) of estradiol (two to four grams of cream) inserted into the vagina once a day for one to two weeks, decreasing the dose by one half over two and four weeks. After four weeks, your doctor will probably ask you to use the medicine less often, such as 100 mcg (one gram of cream) one to three times a week and for only three weeks of each month (three weeks on and one week off). For vaginal dosage form (insert or ring): For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis) in postmenopausal women, and inflammation of the urethra (urethritis) in postmenopausal women: Adults—One insert containing 2 to 24.8 milligrams (mg) of estradiol inserted into the vagina every three months. The insert will slowly release estradiol at a rate of 7.5 to 100 micrograms (mcg) every twenty-four hours with continuous use. For estrone For vaginal dosage form (cream): For treating a genital skin condition (vulvar atrophy) and inflammation of the vagina (atrophic vaginitis) in postmenopausal women: Adults—2 to 4 milligrams (mg) of estrone (two to four grams of cream) inserted into the vagina once a day or as directed by your doctor. For vaginal dosage form (suppository): For treating a genital skin condition (vulvar atrophy) and inflammation of the vagina (atrophic vaginitis) in postmenopausal women: Adults—250 to 500 micrograms (mcg) inserted into the vagina once a day or as directed by your doctor. Missed Dose

If you miss a dose of estrogen, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

When using the suppository or cream several times a week: If you miss a dose of estrogen and remember it within 1 or 2 days of the missed dose, use the missed dose as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

When using the cream or suppositories more than several times a week: If you miss a dose of estrogen, use it as soon as possible if remembered within 12 hours of the missed dose. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using estrogen

It is very important that your doctor check your progress at regular visits to make sure estrogen does not cause unwanted effects. Plan on going to see your doctor every year, but some doctors require visits more often.

It is not yet known whether the use of vaginal estrogens increases the risk of breast cancer in women. It is very important that you check your breasts on a regular basis for any unusual lumps or discharge. Report any problems to your doctor. You should also have a mammogram (x-ray picture of the breasts) done if your doctor recommends it.

It is important that you have a regular pelvic exam (pap smear). Your doctor will tell you how often this exam should be done.

Talk to your doctor if you have high blood pressure, high cholesterol (fats in the blood), or diabetes, use tobacco, or are overweight. You may have a higher risk for getting heart disease.

Although the chance is low, use of estrogen may increase your chance of getting cancer of the ovary or uterus (womb). Regular visits to your health professional can help identify these serious side effects early.

If you think that you may be pregnant, stop using the medicine immediately and check with your doctor.

Tell the doctor in charge that you are using estrogen before having any laboratory test, because some test results may be affected.

For vaginal creams or suppositories:

Avoid using latex condoms, diaphragms, or cervical caps for up to 72 hours after using estrogen vaginal creams. Certain estrogen products may contain oils in the creams that can weaken latex (rubber) products and cause condoms to break or leak, or cervical caps or diaphragms to wear out sooner. Check with your health care professional to make sure the vaginal estrogen product you are using can be used with latex devices. estrogen is often used at bedtime to increase effectiveness through better absorption. Vaginal creams or suppositories will melt and leak out of the vagina. A minipad or sanitary napkin will protect your clothing. Do not use tampons (like those used for menstrual periods) since they may soak up the medicine and make the medicine less effective. Avoid exposing your male sexual partner to your vaginal estrogen cream or suppository by not having sexual intercourse right after using these medicines. Your male partner might absorb the medicine through his penis if it comes in contact with the medicine.

For estradiol vaginal inserts or rings:

Contact your doctor if you have problems removing your vaginal insert. It is not necessary to remove the vaginal insert for sexual intercourse unless you prefer to remove it. If you do take it out, or if it accidentally slips or comes out of the vagina, you can replace the vaginal insert in the vagina after washing it with lukewarm water. Never use hot or boiling water. If it slips down, gently push it upwards and back into place. Replace the vaginal insert every 3 months. Talk to your doctor on a regular basis about how long to use the vaginal insert. estrogen Side Effects

The risk of any serious adverse effect is unlikely for most women using low doses of estrogens vaginally. Even women with special risks have used vaginal estrogens without problems.

Check with your doctor immediately if any of the following side effects occur:

Less common Breast pain enlarged breasts itching of the vagina or genitals headache nausea stinging or redness of the genital area thick, white vaginal discharge without odor or with a mild odor Rare Feeling of vaginal pressure (with estradiol vaginal insert or ring) unusual or unexpected uterine bleeding or spotting vaginal burning or pain (with estradiol vaginal insert or ring) Incidence not known Diarrhea dizziness fast heartbeat feeling faint fever hives hoarseness itching joint pain, stiffness, or swelling muscle pain rash shortness of breath skin redness swelling of eyelids, face, lips, hands, or feet tightness in the chest trouble with breathing or swallowing vomiting wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common Abdominal or back pain clear vaginal discharge (usually means the medicine is working) Incidence not known Acne enlargement of penis or testes growth of pubic hair rapid increase in height swelling of the breasts or breast soreness in males

Also, many women who are using estrogens with a progestin (another female hormone) will start having monthly vaginal bleeding that is similar to menstrual periods. This effect will continue for as long as the medicine is taken. However, monthly bleeding will not occur in women who have had the uterus removed by surgery (hysterectomy).

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


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Teruflex Blood Bag System


Generic Name: anticoagulant citrate phosphate dextrose (cpd) and as-5 red cell preservative
TERUFLEX® BLOOD BAG SYSTEM WITH BLOOD SAMPLING ARM® CPD/OPTISOL® SOLUTION Issued 8/96
TERUFLEX® BLOOD BAG SYSTEM With Blood Sampling Arm® CPD/OPTISOL® SOLUTION
Read these instructions carefully before use.
INSTRUCTIONS FOR BLOOD COLLECTION: Use aseptic technique
Materials Needed:
VENOJECT® ll Tube Holder (code P-1316R)
VENOJECT® ll Multi-Sample Luer Adapter (code MN *2000)
VENOJECT® ll Plastic Blood Collection Tubes (or equivalent glass or plastic evacuated blood collection tube)
1. Confirm that all numbered tubing of each blood bag unit contains segment numbers.
2. Make a loose knot in donor tubing below "Y" unless alternate methods are used to seal tubing.
3. Clamp donor tubing.
4. Suspend primary bag as far as possible below the donor's arm.
5. Apply blood pressure cuff or tourniquet to donor's arm. Disinfect site of phlebotomy. If blood pressure cuff is used, inflate cuff to approximately 60 mmHg.
6. Remove needle protector and perform phlebotomy. Remove clamp to permit blood flow into primary bag.
CAUTION Do not touch needle after removing the needle protector.
7. Appropriately secure donor tubing to donor's arm.
8. MIX BLOOD WITH ANTICOAGULANT AT SEVERAL INTERVALS DURING COLLECTION.
9. Collect labeled volume of blood (+/–10%).
10. Tighten knot firmly after collection. Clamp between knot and "Y". Sever donor tubing between the knot and clamp. Alternate methods may be used to seal tubing.
CAUTION Do not use the dielectric tube sealer while the needle is connected to the donor's body.
Anytime before Step #13 below, sever donor tubing between the two seals.
Collect blood samples as follows:
a) Connect VENOJECT II Multi-Sample Luer Adapter to VENOJECT II Tube Holder (Fig. 1).
b) Remove covers and connect multi-sample luer adapter to female luer at end of donor sampling tubing (Fig. 2).
c) Snap CLIKTIP in donor sampling tubing to open blood pathway.
Insert Fig. 1 here
Insert Fig. 2 here
d) Insert blood collection tube (VENOJECT II or equivalent) firmly into VENOJECT II Tube Holder : when full, remove sample tube from holder. Repeat to collect additional samples.
11. Reapply clamp to donor tubing between phlebotomy needle and "Y"; release pressure on donor's arm and remove needle.
CAUTION Discard tubing/phlebotomy needle unit according to institutional procedures.
12. Immediately after collection, invert bag several times to assure blood and anticoagulant are well mixed.
13. Strip blood from the donor tubing into bag, mix well, and allow tubing to refill. Seal on or near X marks on donor tubing to provide numbered aliquots of anticoagulated blood for testing.
14. The time of addition of OPTISOL Solution may vary depending on the processing option selected. Add the solution under one of the following conditions.
a) After removal of plasma from freshly collected blood.
b) Within 8 hours of blood collection if components are prepared.
c) Within 72 hours of collection if blood is refrigerated immediately following collection.
15. Centrifuge the unit to separate red cells from plasma.
16. Snap CLlKTIP (inline closure device) of primary collection bag and transfer plasma into satellite bag. Clamp transfer tubing of satellite bag.
17. Snap CLlKTIP of OPTlSOL Solution bag and drain contents into primary bag containing red blood cells. Seal tubing of primary bag in two places, and cut between seals and separate from satellite bag(s).
NOTE: For TERUFLEX double bags, seal OPTISOL Solution bag tubing in two places and cut between seals. Discard OPTISOL Solution container.
18. Invert the red cell- OPTISOL mixture several times to insure the final AS-5 red cell product is well suspended.
19. Store AS-5 Red Blood Cells between 1-6°C.
20. Infuse AS-5 Red Blood Cells within 42 days of collection.
For further processing, use standard component processing techniques.
To open blister package, peel cover film back four fifths of its length.
After opening, unused bags may be stored for 30 days by returning cover film to original position and sealing with tape to prevent possible loss of moisture.
Insert Fig. 3 here
CAUTIONS
•THE PACKET OF AGELESS CONTAINED IN THIS PACKAGE ABSORBS OXYGEN AND GENERATES HEAT ON REMOVAL AND SHOULD BE HANDLED WITH CARE.
• DISPOSE WITH PACKET IN TRAY.
• DO NOT DISPOSE WITH WASTES CONTAINING VOLATILE OR FLAMMABLE MATERIALS.
• DISCARD AGELESS PACKET WITHOUT OPENING.
TERUMO® TERUMO CORPORATION 44-1, 2-CHOME, HATAGAYA, SHIBUYA-KU, TOKYO, JAPAN
®: Registered Trademark
N-BB-OP-A(SP) 3


Tray/Case Label

TERUFLEX® BLOOD BAG SYSTEM with
BLOOD SAMPLING ARM®
CPD WITH OPTISOL® RED CELL PRESERVATIVE SOLUTION
FOR COLLECTION OF 500mL OF BLOOD
Each unit consists of a collection bag containing 70mL of Anticoagulant
CPD solution, with a satellite bag containing 111mL of OPTlSOL Red
Cell Preservative Solution.
Each 70mL Anticoagulant CPD solution USP contains 1.79g Dextrose
(monohydrate) USP, 1.84g Sodium Citrate (dihydrate) USP, 209mg Citric
Acid (anhydrous) USP, 156mg Monobasic Sodium Phosphate
(monohydrate) USP.
Each 111mL OPTISOL Red Cell Preservative Solution contains 974mg
Sodium Chloride USP, 1.00g Dextrose (monohydrate) USP, 583mg
Mannitol USP, 33.3mg Adenine USP.
STERILE, NON-PYROGENIC FLUID PATH.
DO NOT USE UNLESS ANTICOAGULANT IS CLEAR.
CODE
LOT No.
EXPIRY
UNITS
DONOR NEEDLE 16G x 1 1/2? (1.60 x 38mm)
Rx ONLY
RECOMMENDED STORAGE: Room Temperature (15-30°C/59-86°F).
Avoid excessive heat. Protect from freezing.
After opening, unused bags may be stored for 30 days by returning cover film to original
position and sealing with tape to prevent possible loss of moisture.
See Instructions For Blood Collection.
Manufactured by : TERUMO CORPORATION Tokyo, Japan
® : Registered Trademark
Blood Sampling Arm is a trademark of TERUMO CORPORATION.
Rev. 01/03
B-4-H6-A4 2
Place Label here



Teruflex Blood Bag System WITH BLOOD SAMPLING ARM ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) AND OPTISOL (AS-5) RED CELL PRESERVATIVE 
anticoagulant citrate phosphate dextrose (cpd) and as-5 red cell preservative  kit Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 53877-009 Packaging # NDC Package Description Multilevel Packaging 1 53877-009-41 24 BAG In 1 CASE contains a BAG 1 1 KIT In 1 BAG This package is contained within the CASE (53877-009-41) QUANTITY OF PARTS Part # Package Quantity Total Product Quantity Part 1 1 BAG   70 mL Part 2 1 BAG   111 mL Part 1 of 2 ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD)  
anticoagulant citrate phosphate dextrose (cpd)  solution Product Information       Route of Administration INTRAVENOUS DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Trisodium Citrate Dihydrate (Citric Acid) Trisodium Citrate Dihydrate 26.3 g  in 1000 mL Sodium Phosphate, Monobasic (Phosphoric Acid) Sodium Phosphate, Monobasic 2.22 g  in 1000 mL Dextrose Monohydrate (Dextrose) Dextrose Monohydrate 25.5 g  in 1000 mL Anhydrous Citric Acid (Citric Acid) Anhydrous Citric Acid 2.99 g  in 1000 mL Inactive Ingredients Ingredient Name Strength Water   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 70 mL In 1 BAG None Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA880217 05/05/2010
Part 2 of 2 OPTISOL RED CELL PRESERVATIVE  
as-5 red cell preservative  solution Product Information       Route of Administration INTRAVENOUS DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Chloride (SODIUM CATION) Sodium Chloride 877 mg  in 100 mL Dextrose Monohydrate (Dextrose) Dextrose Monohydrate 900 mg  in 100 mL Mannitol (Mannitol) Mannitol 525 mg  in 100 mL Adenine (Adenine) Adenine 30 mg  in 100 mL Inactive Ingredients Ingredient Name Strength Water   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 111 mL In 1 BAG None Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA880217 05/05/2010
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA880217 05/05/2010
Labeler - Terumo Corporation (690543319) Establishment Name Address ID/FEI Operations Terumo Corp. - Fujinomiya Factory 695214015 manufacture Revised: 06/2011Terumo Corporation

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Femring


Generic Name: estrogen (Vaginal route)

Commonly used brand name(s)

In the U.S.

Estrace Estring Femring Ortho Dienestrol Premarin Vagifem

In Canada

Estragyn Neo-Estrone Oestrilin

Available Dosage Forms:

Tablet Cream Insert, Extended Release Suppository Uses For Femring

Estrogens are hormones produced by the body. Among other things, estrogens help develop and maintain female organs.

When your body is in short supply of this hormone, replacing it can ease the uncomfortable changes that occur in the vagina, vulva (female genitals), and urethra (part of the urinary system). Conditions that are treated with vaginal estrogens include a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), and inflammation of the urethra (atrophic urethritis).

Estrogens work partly by increasing a normal clear discharge from the vagina and making the vulva and urethra healthy. Using or applying an estrogen relieves or lessens:

Dryness and soreness in the vagina Itching, redness, or soreness of the vulva Feeling an urge to urinate more often then is needed or experiencing pain while urinating Pain during sexual intercourse

When used vaginally or on the skin, most estrogens are absorbed into the bloodstream and cause some, but not all, of the same effects as when they are taken by mouth. Estrogens used vaginally at very low doses for treating local problems of the genitals and urinary system will not protect against osteoporosis or stop the hot flushes caused by menopause.

Estrogens for vaginal use are available only with your doctor's prescription.

Before Using Femring Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Estrogen vaginal cream is not indicated in children. Studies have not been conducted.

Geriatric

Elderly women greater than 65 years of age may have an increased risk of certain side effects during treatment, especially stroke, invasive breast cancer, and memory problems.

Pregnancy

Estrogens should not be used during pregnancy, since an estrogen called diethylstilbestrol (DES) that is no longer taken for hormone replacement has caused serious birth defects in humans and animals.

Breast Feeding

Use of this medicine is not recommended in nursing mothers. Estrogens pass into the breast milk and may decrease the amount and quality of breast milk. Caution should be exercised in mothers who are using estrogen and breast-feeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

Asthma or Epilepsy or Heart problems or Kidney problems or Migraine headaches—Estrogens may worsen these conditions. Blood clotting problems—Although worsening of a blood clotting condition is unlikely, some doctors do not prescribe vaginal estrogens for patients with blood clotting problems or a history of these problems. Breast cancer (active, suspected, or past history)—Estrogens should not be used. Certain cancers, including cancers of the breast, bone, or uterus (active or suspected)—Estrogens may interfere with the treatment of breast or bone cancer or worsen cancer of the uterus when these conditions are present. Cholestatic jaundice (flow of bile from the liver is blocked), past history—Caution should be used when this condition is present. Diabetes mellitus (sugar diabetes)—Estrogens may alter your body's response to sugar in your diet. Endometriosis or Fibroid tumors of the uterus—Estrogens may worsen endometriosis or increase the size of fibroid tumors. Gallbladder problems (gallstones)—Estrogens may increase your chance of getting a gallbladder attack. Heart attack or Stroke (active or past history)—Estrogens should not be used. Hepatic hemangioma (noncancerous tumors of the liver)—Estrogens may worsen this medical problem. High blood pressure—Estrogens may worsen this medical problem. Hypercalcemia (too much calcium in your blood)—Estrogens may worsen this medical problem. Hypertriglyceridemia (too much triglycerides in your blood)—Estrogens may increase your chance of getting pancreatitis or other side effects. Hypocalcemia (too little calcium in your blood)—Your doctor should treat the low calcium in your blood before starting estrogen therapy. Irritation or infection of the vagina—Usually estrogens decrease infections or irritation of the vagina, but sometimes these conditions may become worse. Liver disease or Liver problems—Estrogens should not be used. Lupus erythematosus, systemic (SLE or lupus)—Estrogens may worsen this medical problem. Physical problems within the vagina, such as narrow vagina, vaginal stenosis, or vaginal prolapse—Estradiol vaginal insert or ring may be more likely to slip out of place or cause problems, such as irritation of the vagina. Porphyria—Estrogens may worsen this medical problem. Thyroid problems (underactive thyroid)—Estrogens may alter your body's response to your thyroid medication. Your doctor may alter the amount of thyroid replacement that you take while on estrogen therapy. Vision changes, sudden onset including Bulging eyes or Double vision or Migraine headache or Vision loss, partial or complete—Estrogens may cause these problems. Tell your doctor if you have had any of these problems. Unusual genital or vaginal bleeding of unknown causes—Use of estrogens may delay diagnosis or worsen the condition. The reason for the bleeding should be determined before estrogens are used. Proper Use of estrogen

This section provides information on the proper use of a number of products that contain estrogen. It may not be specific to Femring. Please read with care.

Vaginal estrogen products usually come with patient directions. Read them carefully before using this medicine.

Wash your hands before and after using the medicine. Also, keep the medicine out of your eyes. If this medicine does get into your eyes, wash them out immediately, but carefully, with large amounts of tap water. If your eyes still burn or are painful, check with your doctor.

Use this medicine only as directed. Do not use more of it and do not use it for a longer time than your doctor ordered. It can take up to 4 months to see the full effect of the estrogens. Your doctor may reconsider continuing your estrogen treatment or may lower your dose several times within the first one or two months, and every 3 to 6 months after that. Sometimes a switch to oral estrogens may be required for added benefits or for higher doses. When using the estradiol vaginal insert or ring, you will need to replace it every 3 months or remove it after 3 months.

For vaginal creams or suppositories:

Vaginal creams and some vaginal suppositories are inserted with a plastic applicator. Directions for using the applicator are supplied with your medicine. If you do not see your dose marked on the applicator, ask your health care professional for more information. To fill the applicator for cream dosage forms: Screw the applicator onto the tube. Squeeze the medicine into the applicator slowly until it is measured properly. Remove the applicator from the tube. Replace the cap on the tube. To fill the applicator for suppository dosage form: Place the suppository into the applicator. To place the dose using the applicator for cream and suppository dosage forms: Relax while lying on your back with your knees bent or stand with one foot on a chair. Hold the full applicator in one hand. Slide the applicator slowly into the vagina. Stop before it becomes uncomfortable. Slowly press the plunger until it stops. Withdraw the applicator. The medicine will be left behind in the vagina. To care for the applicator for cream and suppository dosage forms: Clean the applicator after use by pulling the plunger out of the applicator and washing both parts completely in warm, soapy water. Do not use hot or boiling water. Rinse well. After drying the applicator, replace the plunger.

For vaginal insert or ring dosage form:

To place the vaginal insert: Relax while lying on your back with your knees bent or stand with one foot on a chair. Pinch or press the sides of the vaginal insert together, between your forefinger and middle finger. With one hand, part the folds of skin around your vagina. Slide the vaginal insert slowly into the upper third of your vagina. Stop before it becomes uncomfortable. The exact location is not too important but it should be comfortable. If it seems uncomfortable, then carefully push the vaginal insert higher into the vagina. To remove the vaginal insert: Stand with one foot on a chair. Slide one finger into the vagina and hook it around the closest part of the vaginal insert. Slowly pull the vaginal insert out. Dispose of the vaginal insert by wrapping it up and throwing it into the trash. Do not flush it down the toilet. Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For conjugated estrogens For vaginal dosage form (cream): For treating inflammation of the vagina (atrophic vaginitis): Adults—At first, 0.5 gram (g) of conjugated estrogens inserted into the vagina once a day or as directed by your doctor to achieve the lowest dose possible. Usually your doctor will want you to use this medicine for only three weeks of each month (three weeks on and one week off). Your doctor may increase your dose as needed. However, the dose is usually not more than 2 grams per day. For treating a genital skin condition (vulvar atrophy): Adults—0.5 gram (g) of conjugated estrogens inserted into the vagina two times per week. Usually your doctor will want you to use this medicine for only three weeks of each month (three weeks on and one week off). For estradiol For vaginal dosage form (cream): For treating a genital skin condition (vulvar atrophy) and inflammation of the vagina (atrophic vaginitis): Adults—200 to 400 micrograms (mcg) of estradiol (two to four grams of cream) inserted into the vagina once a day for one to two weeks, decreasing the dose by one half over two and four weeks. After four weeks, your doctor will probably ask you to use the medicine less often, such as 100 mcg (one gram of cream) one to three times a week and for only three weeks of each month (three weeks on and one week off). For vaginal dosage form (insert or ring): For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis) in postmenopausal women, and inflammation of the urethra (urethritis) in postmenopausal women: Adults—One insert containing 2 to 24.8 milligrams (mg) of estradiol inserted into the vagina every three months. The insert will slowly release estradiol at a rate of 7.5 to 100 micrograms (mcg) every twenty-four hours with continuous use. For estrone For vaginal dosage form (cream): For treating a genital skin condition (vulvar atrophy) and inflammation of the vagina (atrophic vaginitis) in postmenopausal women: Adults—2 to 4 milligrams (mg) of estrone (two to four grams of cream) inserted into the vagina once a day or as directed by your doctor. For vaginal dosage form (suppository): For treating a genital skin condition (vulvar atrophy) and inflammation of the vagina (atrophic vaginitis) in postmenopausal women: Adults—250 to 500 micrograms (mcg) inserted into the vagina once a day or as directed by your doctor. Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

When using the suppository or cream several times a week: If you miss a dose of this medicine and remember it within 1 or 2 days of the missed dose, use the missed dose as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

When using the cream or suppositories more than several times a week: If you miss a dose of this medicine, use it as soon as possible if remembered within 12 hours of the missed dose. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Femring

It is very important that your doctor check your progress at regular visits to make sure this medicine does not cause unwanted effects. Plan on going to see your doctor every year, but some doctors require visits more often.

It is not yet known whether the use of vaginal estrogens increases the risk of breast cancer in women. It is very important that you check your breasts on a regular basis for any unusual lumps or discharge. Report any problems to your doctor. You should also have a mammogram (x-ray picture of the breasts) done if your doctor recommends it.

It is important that you have a regular pelvic exam (pap smear). Your doctor will tell you how often this exam should be done.

Talk to your doctor if you have high blood pressure, high cholesterol (fats in the blood), or diabetes, use tobacco, or are overweight. You may have a higher risk for getting heart disease.

Although the chance is low, use of estrogen may increase your chance of getting cancer of the ovary or uterus (womb). Regular visits to your health professional can help identify these serious side effects early.

If you think that you may be pregnant, stop using the medicine immediately and check with your doctor.

Tell the doctor in charge that you are using this medicine before having any laboratory test, because some test results may be affected.

For vaginal creams or suppositories:

Avoid using latex condoms, diaphragms, or cervical caps for up to 72 hours after using estrogen vaginal creams. Certain estrogen products may contain oils in the creams that can weaken latex (rubber) products and cause condoms to break or leak, or cervical caps or diaphragms to wear out sooner. Check with your health care professional to make sure the vaginal estrogen product you are using can be used with latex devices. This medicine is often used at bedtime to increase effectiveness through better absorption. Vaginal creams or suppositories will melt and leak out of the vagina. A minipad or sanitary napkin will protect your clothing. Do not use tampons (like those used for menstrual periods) since they may soak up the medicine and make the medicine less effective. Avoid exposing your male sexual partner to your vaginal estrogen cream or suppository by not having sexual intercourse right after using these medicines. Your male partner might absorb the medicine through his penis if it comes in contact with the medicine.

For estradiol vaginal inserts or rings:

Contact your doctor if you have problems removing your vaginal insert. It is not necessary to remove the vaginal insert for sexual intercourse unless you prefer to remove it. If you do take it out, or if it accidentally slips or comes out of the vagina, you can replace the vaginal insert in the vagina after washing it with lukewarm water. Never use hot or boiling water. If it slips down, gently push it upwards and back into place. Replace the vaginal insert every 3 months. Talk to your doctor on a regular basis about how long to use the vaginal insert. Femring Side Effects

The risk of any serious adverse effect is unlikely for most women using low doses of estrogens vaginally. Even women with special risks have used vaginal estrogens without problems.

Check with your doctor immediately if any of the following side effects occur:

Less common Breast pain enlarged breasts itching of the vagina or genitals headache nausea stinging or redness of the genital area thick, white vaginal discharge without odor or with a mild odor Rare Feeling of vaginal pressure (with estradiol vaginal insert or ring) unusual or unexpected uterine bleeding or spotting vaginal burning or pain (with estradiol vaginal insert or ring) Incidence not known Diarrhea dizziness fast heartbeat feeling faint fever hives hoarseness itching joint pain, stiffness, or swelling muscle pain rash shortness of breath skin redness swelling of eyelids, face, lips, hands, or feet tightness in the chest trouble with breathing or swallowing vomiting wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common Abdominal or back pain clear vaginal discharge (usually means the medicine is working) Incidence not known Acne enlargement of penis or testes growth of pubic hair rapid increase in height swelling of the breasts or breast soreness in males

Also, many women who are using estrogens with a progestin (another female hormone) will start having monthly vaginal bleeding that is similar to menstrual periods. This effect will continue for as long as the medicine is taken. However, monthly bleeding will not occur in women who have had the uterus removed by surgery (hysterectomy).

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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