URL Pharma, Inc.


Address URL Pharma, Inc.,
1100 Orthodox Street
Philadelphia, PA 19124Contact DetailsPhone: (800) 523-3684
Website: http://www.urlmutual.com/url_home_Landing.aspx
Careers: http://www.urlmutual.com/url_srv_Landing.aspx


More




Shionogi Pharma, Inc


Address Shionogi Pharma, Inc,
100 Campus Drive, Florham Park, NJ 07932Contact DetailsPhone: 973-966-6900
Website: http://www.shionogi-inc.com/
Careers: http://www.shionogi-inc.com/about-us...


More




NovaDel Pharma, Inc.


Address NovaDel Pharma, Inc.,
25 Minneakoning Road
Flemington, NJ 08822 Contact DetailsPhone: (908) 782-3431
Website: http://www.novadel.com/
Careers: http://www.novadel.com/about/careers.htm


More




Sodium Fluoride Chewable Tablets



Fluoride Chewable Tablets 1 mg

Active Ingredient: 1 mg of fluoride ion from 2.2 mg of sodium fluoride (NaF).

Inactive Ingredients: Lactose, Saccharine, Cherry Flavor, D&C Red #7 Calcium Lake, Magnesium Stearate.

DOSAGE AND ADMINISTRATION:

Dissolve in the mouth or chew before swallowing, preferably at bedtime after brushing teeth.

STORAGE:

Store at a Controlled Room Temperature 20?-25?C (68?-77?F)

743634

Manufactured for:
Libertas Pharma, Inc.
Lawrenceville, GA 30043
Iss. 03/11   172-12

Container Label

NDC 51862-172-12

Fluoride Chewable Tablets

1 mg

(From 2.2 mg of Sodium Fluoride)

Cherry Flavor       120 Tablets       Rx Only

Libertas
Pharma Inc.


FLUORIDE 
fluoride  tablet, chewable Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 51862-172 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 1 mg Inactive Ingredients Ingredient Name Strength CHERRY   LACTOSE   SACCHARIN   D&C RED NO. 7   MAGNESIUM STEARATE   Product Characteristics Color RED Score no score Shape ROUND Size 6mm Flavor CHERRY Imprint Code 172 Contains          Packaging # NDC Package Description Multilevel Packaging 1 51862-172-12 120 TABLET In 1 BOTTLE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 05/21/2011
Labeler - Libertas Pharma, Inc. (962128943) Revised: 05/2011Libertas Pharma, Inc.


More




Bayer Healthcare Pharmaceuticals


Address Bayer Healthcare Pharmaceuticals,
6 W. Belt
Wayne, NJ 07470-6806 Contact DetailsPhone: (888) 842-2937
Website: http://pharma.bayer.com/scripts/pages/en/index.php
Careers: http://www.mybayerjob.us/en/


More




Budenofalk 3mg Capsules


BUDENOFALK 3mg

Gastro-resistant Capsules

BUDESONIDE

Please read this leaflet carefully before you start to take your medicine.

It contains important information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist (chemist). Keep this leaflet until you have finished all of your medicine. You may want to read it again.

What is in your medicine?

Budenofalk 3mg comes in capsule form. Each gastro-resistant capsule contains 3mg of an active ingredient called budesonide.

The capsules also contain lactose monohydrate, sucrose, maize starch, triethyl citrate, talc, povidone and coating agents known as Eudragit.

The capsules are made of hard gelatin, purified water and sodium laurilsulfate. They are coloured with titanium dioxide (E171), red iron oxide (E172), black iron oxide (E172) and erythrosine (E127).

Each box of Budenofalk 3mg contains either 10, 50, 90, 100 or 120 pink capsules in blister strips.

Marketing Authorisation Holder and Manufacturer: Dr Falk Pharma GmbH D-79041 Freiburg Germany Distributed by: Dr Falk Pharma UK Ltd Unit K Bourne End Business Park Cores End Road Bourne End Bucks SL8 5AS UK What your medicine is used for

Your medicine contains a type of steroid which reduces inflammation. It may be used to treat Crohn’s disease, an inflammation which predominantly affects the last part of the small bowel and/or the first part of the large bowel but can affect other parts of the gastrointestinal tract.

Sometimes Crohn’s disease may include symptoms in the skin, eyes and joints. These symptoms are unlikely to respond to this medicine.

Budenofalk may also be used for the symptomatic relief of chronic diarrhoea due to collagenous colitis.

Before taking your medicine

You should not take this medicine if:

You are allergic to budesonide or any of the ingredients listed above. You have a serious liver disease.

If you are pregnant, trying to become pregnant or think you may be pregnant, you should avoid taking this drug unless advised by your doctor.

It is not known if budesonide passes into breast milk, therefore you should not breast feed while on treatment.

If you answer yes to any of the following questions, tell your doctor or pharmacist.

Do you have, or have you ever had, tuberculosis, high blood pressure, diabetes, brittle bones (osteoporosis), stomach ulcers, glaucoma, cataracts or liver problems? If you know or think you may have any sort of infection. Has anyone in your family ever had diabetes or glaucoma? Are you taking colestyramine, digoxin, water tablets, ketoconazole, ritonavir, itraconazole, clarithromycin, carbamazepine, rifampicin, cimetidine, oestrogens and oral contraceptives or antacids? Are you taking any other medication (including any medicines you have bought without a prescription) which your doctor does not know about?

Please try to avoid contact with people who have chicken pox, shingles or measles. This is particularly important if you do not think you have had this illness yourself. If you think you may have been exposed to any of these illnesses, tell your doctor as soon as possible. Please tell your doctor if you are about to go abroad and need a vaccination whilst you are taking this medicine.

The capsules contain lactose and sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product

How to take your medicine

It is important to take your medicine as directed by your doctor. The label will tell you how much to take and how often. If it does not or you are unsure, ask your doctor or pharmacist.

The usual dose is one capsule three times a day (morning, midday and evening). Take the capsules about 30 minutes before a meal. Swallow the capsules whole with a glass of water (avoid taking with grapefruit juice). Do not chew the capsules.

This medicine is not recommended for children.

It is important that you do not stop taking your medicine suddenly as it could make you ill. Keep taking your medicine until your doctor tells you to stop, even if you start to feel better. Your doctor will probably want to reduce your dose gradually, first from 3 to 2 capsules daily for one week, (one in the morning and one in the evening) and then only one capsule daily in the last week of treatment (taken in the morning).

Your doctor will not normally want you to take this medicine for more than 8 weeks.

If you go into hospital, or you visit a dentist or another doctor, tell them you are taking Budenofalk 3mg gastro-resistant capsules.

What to do if you forget to take your medicine

If you forget to take your capsules, take a dose as soon as you remember and then continue with the next dose as instructed on the label. Do not take more capsules in a day than you usually do.

What to do if you take too many capsules

If you accidentally take too many capsules, do not worry, but contact your doctor or local hospital casualty department as soon as possible. Take this medicine with you.

After taking your medicine

Like all medicines, Budenofalk 3mg gastro-resistant capsules may occasionally cause unwanted effects in some people. Most of these effects are not serious. This medicine contains a type of steroid, so you might experience unwanted effects typical of steroids. They may include:

Skin rashes, acne, itchy skin, development of marks and bleeding within the skin, delayed wound healing. Tiredness, muscle weakness or pain, brittle bones, wasting of bones and cartilage. Roundness of the face, weight gain, fluid retention including leg edema, increased risk of high blood sugar, diabetes mellitus, increased risk of infections, blood clots and high blood pressure. Heartburn, stomach complaints such as ulcers, pancreatitis and constipation. Cataract, glaucoma. Heavy or irregular periods and male hair growth patterns in women, growth retardation in children, impotence. Nervous system disorders including headaches, which may or may not be associated with blurred vision or vomiting and mood changes, such as depression, irritability or euphoria.

If you experience these or any other undesirable effects, then tell your doctor or pharmacist as soon as possible.

How to store your medicine Do not store above 25°C. Do not take this medicine after the expiry date printed on the carton or blister strip. If your doctor decides to stop treatment, return any left over capsules to the pharmacist. Only keep them if the doctor tells you to.

PL 08637/0002

PA 573/2/1

Keep this medicine in a safe place. Keep out of reach and sight of children.

REMEMBER: This medicine is for you. Never give it to anyone else. It may harm them, even if their problems seem to be the same as yours.

Leaflet revised: October 2006

Dr Falk Pharma UK Ltd Unit K Bourne End Business Park Cores End Road Bourne End Bucks SL8 5AS UK

‘Budenofalk’ is a registered trademark, the property of Dr Falk Pharma GmbH


More




Ethanolamine Oleate Injection BP (UCB Pharma Ltd)


1. Name Of The Medicinal Product

Ethanolamine Oleate Injection (monoethanolamine oleate). Solution for injection.

2. Qualitative And Quantitative Composition

Oleic acid 4.23% w/v

Ethanolamine 0.910% w/v

For excipients see 6.1.

3. Pharmaceutical Form

Solution for injection.

5 ml neutral glass ampoule containing a clear solution.

4. Clinical Particulars 4.1 Therapeutic Indications

The injection is recommended for use as a sclerosing agent in the treatment of small, uncomplicated varicose veins in the lower extremities.

4.2 Posology And Method Of Administration

Ethanolamine Oleate is administered by slow intravenous injection.

Adults Including The Elderly

The product is used only as a sclerosant and injected directly into the varicose vein. A dose of 2 to 5ml, divided between 3 or 4 sites, administered by slow injection into empty isolated segments of vein.

Children

The product is not recommended for use in children.

4.3 Contraindications

Inability to walk, acute phlebitis, oral contraceptive use, obese legs, known hypersensitivity to Ethanolamine Oleate or benzyl alcohol. Superficial thrombophlebitis and deep vein thrombosis in the region of the varicose veins. Marked arterial, cardiac or renal disease. Uncontrolled metabolic disorders such as diabetes mellitus. Patients with local or systemic infections.

4.4 Special Warnings And Precautions For Use

Care should be taken to ensure that the injection does not leak into perivenous tissue which could cause sloughing, ulceration and in severe cases, necrosis.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Safety during pregnancy has not been established. Use in pregnancy is not recommended.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Burning, cramping sensation, urticaria. Allergic reactions and anaphylaxis have been reported following use of sclerosing agents.

4.9 Overdose

Acute nephrotoxicity has been reported in two patients given 15-20ml of a solution containing 5% Ethanolamine with 2% Benzl Alcohol.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

ATC Code: C05B B 01; sclerosing agent for local injection.

Ethanolamine Oleate is an irritant. An injection of Ethanolamine Oleate into a vein irritates the intimal endothelium resulting in the formation of a thrombus. The thrombus occludes the vein and fibrous tissue develops resulting in a permanent obliteration of the vein.

5.2 Pharmacokinetic Properties

Ethanolamine Oleate is a locally acting agent. Absorption from the site of administration is not anticipated as its mode of action is to cause a permanent obstruction in the vein.

5.3 Preclinical Safety Data

None.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Benzyl alcohol

Water for Injection

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Do not store above 25°C. Keep the ampoule in the outer carton.

6.5 Nature And Contents Of Container

5 ml Neutral Glass (Type 1) Ampoules.

6.6 Special Precautions For Disposal And Other Handling

The product is used only as a sclerosant and injected directly into the varicose vein.

7. Marketing Authorisation Holder

UCB Pharma Limited

208 Bath Road

Slough

Berkshire

SL1 3WE

UK

8. Marketing Authorisation Number(S)

PL 0039/5671R

9. Date Of First Authorisation/Renewal Of The Authorisation

27 March 1987 / 26 May 1994 / 27 May 1999

10. Date Of Revision Of The Text

June 2005


More




Flurbiprofen Ophthalmic Solution



Dosage Form: ophthalmic solution
Flurbiprofen Sodium
Ophthalmic Solution, USP 0.03%

Sterile

DESCRIPTION

Flurbiprofen sodium ophthalmic solution, USP 0.03% is a sterile topical nonsteroidal anti-inflammatory product for ophthalmic use.

Chemical Name: Sodium (±)-2-(2-fluoro-4-biphenylyl)-propionate dihydrate.

Structural Formula:

Contains: Active: flurbiprofen sodium 0.03% (0.3mg/mL).

Preservative: thimerosal 0.005%. Inactives: citric acid; edetate disodium; polyvinyl alcohol 1.4%; potassium chloride; purified water; sodium chloride; and sodium citrate. May also contain hydrochloric acid and/or sodium hydroxide to adjust the pH. The pH of flurbiprofen sodium ophthalmic solution 0.03% is 6.0 to 7.0. It has an osmolality of 260 - 330 mOsm/kg.

CLINICAL PHARMACOLOGY

Flurbiprofen sodium is one of a series of phenylalkanoic acids that have shown analgesic, antipyretic, and anti-inflammatory activity in animal inflammatory diseases. Its mechanism of action is believed to be through inhibition of the cyclo-oxygenase enzyme that is essential in the biosynthesis of prostaglandins.

Prostaglandins have been shown in many animal models to be mediators of certain kinds of intraocular inflammation. In studies performed on animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humor barrier, vasodilatation, increased vascular permeability, leukocytosis, and increased intraocular pressure.

Prostaglandins also appear to play a role in the miotic response produced during ocular surgery by constricting the iris sphincter independently of cholinergic mechanisms. In clinical studies, flurbiprofen sodium ophthalmic solution 0.03% has been shown to inhibit the miosis induced during the course of cataract surgery. Results from clinical studies indicate that flurbiprofen sodium has no significant effect upon intraocular pressure.

INDICATIONS AND USAGE

Flurbiprofen sodium ophthalmic solution 0.03% is indicated for the inhibition of intraoperative miosis.

CONTRAINDICATIONS

Flurbiprofen sodium ophthalmic solution 0.03% is contraindicated in individuals who are hypersensitive to any components of the medication.

WARNINGS

With nonsteroidal anti-inflammatory drugs, there exists the potential for increased bleeding due to interference with thrombocyte aggregation. There have been reports that flurbiprofen sodium ophthalmic solution 0.03% may cause increased bleeding of ocular tissues including hyphemas in conjunction with ocular surgery.

There exists the potential for cross-sensitivity to acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.

PRECAUTIONS

General: Wound healing may be delayed with the use of flurbiprofen sodium ophthalmic solution 0.03%.

It is recommended that flurbiprofen sodium ophthalmic solution 0.03% be used with caution in surgical patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.

Drug interactions: Interaction of flurbiprofen sodium ophthalmic solution 0.03% with other topical ophthalmic medications has not been fully investigated.

Although clinical studies with acetylcholine chloride and animal studies with acetylcholine chloride or carbachol revealed no interference, and there is no known pharmacological basis for an interaction, there have been reports that acetylcholine chloride and carbachol have been ineffective when used in patients treated with flurbiprofen sodium ophthalmic solution 0.03%.

Carcinogenesis, Mutagenesis, Impairment of fertility: Long-term studies in mice and/or rats have shown no evidence of carcinogenicity with flurbiprofen. Long-term mutagenicity studies in animals have not been performed.

Pregnancy:

Pregnancy category C. Flurbiprofen has been shown to be embryocidal, delay parturition, prolong gestation, reduce weight, and/or slightly retard growth of fetuses when given to rats in daily oral doses of 0.4 mg/kg (approximately 333 times the human daily topical dose) and above.

Nursing mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from flurbiprofen sodium, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

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

Transient burning and stinging upon instillation and other minor symptoms of ocular irritation have been reported with the use of flurbiprofen sodium ophthalmic solution 0.03%. Other adverse reactions reported with the use of flurbiprofen sodium ophthalmic solution 0.03% include: fibrosis, miosis, and mydriasis.

Increased bleeding tendency of ocular tissues in conjunction with ocular surgery has also been reported.

OVERDOSAGE

Overdosage will not ordinarily cause acute problems. If accidentally ingested, drink fluids to dilute.

DOSAGE AND ADMINISTRATION

A total of four (4) drops of flurbiprofen sodium ophthalmic solution 0.03% should be administered by instilling one (1) drop approximately every 1/2 hour beginning 2 hours before surgery.

HOW SUPPLIED

Flurbiprofen sodium ophthalmic solution, USP is available for topical ophthalmic administration as a 0.03% sterile solution, and is supplied in a white opaque low density polyethylene bottle with a controlled dropper tip and a gray high impact polystyrene cap in the following size:

2.5 mL in 5 mL bottle - NDC 60758-910-03

Note: Store at 15°-25°C (59°-77°F).

Rx Only

Revised January 2004

© 2004 PACIFIC PHARMA
Irvine, CA 92612, U.S.A.

71587PY11P

PACIFIC

PHARMA®          NDC 60758-910-03

Rx Only

FLURBIPROFEN

SODIUM

Ophthalmic Solution, USP 0.03%

2.5 mL                     sterile

PACIFIC

PHARMA®

NDC 60758-910-03

FLURBIPROFEN

SODIUM

ophthalmic

solution, USP

0.03%

2.5 mL

Sterile

Rx only


FLURBIPROFEN SODIUM 
flurbiprofen sodium  solution/ drops Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 60758-910 Route of Administration OPHTHALMIC DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength flurbiprofen sodium (flurbiprofen) flurbiprofen sodium 0.3 mg  in 1 mL Inactive Ingredients Ingredient Name Strength thimerosal   citric acid monohydrate   edetate disodium   polyvinyl alcohol   potassium chloride   water   sodium chloride   sodium citrate   hydrochloric acid   sodium hydroxide   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 60758-910-03 1 BOTTLE In 1 CARTON contains a BOTTLE, DROPPER 1 2.5 mL In 1 BOTTLE, DROPPER This package is contained within the CARTON (60758-910-03)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA authorized generic NDA019404 05/29/1997
Labeler - Pacific Pharma, Inc. (877645267) Establishment Name Address ID/FEI Operations Allergan, Inc. 362898611 MANUFACTURE Revised: 06/2011Pacific Pharma, Inc. More Flurbiprofen Ophthalmic Solution resources Flurbiprofen Ophthalmic Solution Use in Pregnancy & Breastfeeding Flurbiprofen Ophthalmic Solution Drug Interactions Flurbiprofen Ophthalmic Solution Support Group 0 Reviews for Flurbiprofen Ophthalmic - Add your own review/rating Compare Flurbiprofen Ophthalmic Solution with other medications Inhibition of Intraoperative Miosis Postoperative Ocular Inflammation


More




MUCOGEL SUSPENSION (Chemidex Pharma Ltd)


1. Name Of The Medicinal Product

MUCOGEL SUSPENSION

2. Qualitative And Quantitative Composition

Each 5ml dose contains:

Aluminium Hydroxide Gel 220mg BP   Magnesium Hydroxide BP 195mg 3. Pharmaceutical Form

Antacid suspension for oral administration.

4. Clinical Particulars 4.1 Therapeutic Indications

Antacid therapy in gastric and duodenal ulcer, gastritis, heartburn, gastric hyperacidity. Treatment of indigestion. Relief of symptoms of heartburn and dyspepsia associated with gastric reflux in hiatus hernia, reflux oesophagitis and similar conditions.

4.2 Posology And Method Of Administration

Adults, elderly and children over 12 years of age:

10-20ml three times daily 20 minutes to one hour after meals, and at bedtime, or as required.

Children under 12 years of age:

Not recommended.

4.3 Contraindications

Should not be used in patients who are severely debilitated or suffering from kidney failure.

4.4 Special Warnings And Precautions For Use

None stated.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Antacids inhibit the absorption of tetracyclines and vitamins and should not be taken concomitantly.

4.6 Pregnancy And Lactation

For Mucogel Suspension no clinical data on exposed pregnancies are available.

Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.

Caution should be exercised when prescribing to pregnant women.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

Gastrointestinal side-effects are uncommon. This formulation minimises the problems of diarrhoea and constipation.

4.9 Overdose

Serious symptoms are unlikely to follow overdosage.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

The product contains two established antacids, magnesium and aluminium hydroxides with an acid neutralising capacity in excess of 25ml of 0.1N HC1 consumed, per gram of suspension.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Sorbitol Solution 70%

Mannitol

Hydrochloric Acid

Methyl P-Hydoxybenzoate

Propyl P-Hydroxybenzoate

Citric Acid

Simethicone Emulsion 30%

Saccharin Sodium

Hydrogen Peroxide 35% Solution

Peppermint Oil

Strong Sodium Hypochlorite Solution.

Purified Water

6.2 Incompatibilities

None stated.

6.3 Shelf Life

Unopened - 2 years

Opened - 28 days

6.4 Special Precautions For Storage

Do not freeze. Store below 25°C.

6.5 Nature And Contents Of Container

High-density polyethylene bottle with a polypropylene closure fitted with a tamper evident ring.

Pack sizes: 100ml, 300ml and 500ml

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

CHEMIDEX PHARMA LIMITED

CHEMIDEX HOUSE, EGHAM BUSINESS VILLAGE

CRABTREE ROAD

EGHAM

SURREY

TW20 8RB

UNITED KINGDOM

8. Marketing Authorisation Number(S)

PL 17736/0113

9. Date Of First Authorisation/Renewal Of The Authorisation

6th December 1997 / 15th January 1999

10. Date Of Revision Of The Text

11 DOSIMETRY (IF APPLICABLE)

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)


More




De-Noltab


De-Noltab 120 mg tablets

Tri-potassium di-citrato bismuthate

Read all of this leaflet carefully before you start taking 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What De-Noltab is and what it is used for 2. Before you take De-Noltab 3. How to take De-Noltab 4. Possible side effects 5. How to store De-Noltab 6. Further information What De-Noltab is and what it is used for

The active ingredient in De-Noltab belongs to the group of products that treat ulcers in the stomach or small intestine.

When De-Noltab tablets enter the stomach or intestine the tablet breaks up and coats the ulcer. It forms a protective barrier which protects the ulcer from the stomach acid, giving it time to heal. This protective layer stays in place during your meal but needs renewing before the next meal.

One of the factors causing peptic ulcers is a germ called Helicobacter pylori. For the ulcer to heal permanently the germ must be destroyed. De-Noltab helps clear up or reduce infections caused by this germ. Your doctor may give you De-Noltab in combination with other treatments to help destroy Helicobacter pylori.

Before you take De-Noltab Do not take De-Noltab if you have severe kidney problems. if you are allergic (hypersensitive) to tri-potassium di-citrato bismuthate or any of the other ingredients of De-Noltab (see list in section 6 ‘Further information’). Take special care with De-Noltab

Tell your doctor if you

have kidney problems. have been taking De-Noltab at high doses for a long time. This is not recommended because long term use could cause damage to the brain. Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

The combination of De-Noltab with:

other drugs that contain bismuth may cause damage to the brain a class of antibiotics called tetracyclines may affect the working of the antibiotic. Your doctor or pharmacist will be able to tell you if any of your medication belongs to this class of drugs. Taking De-Noltab with food and drink

Do not eat or drink anything, or take other medicines particularly antacids, half an hour before or after taking De-Noltab tablets. Milk, fruit, or fruit juice in particular can prevent the medicine from working properly.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Do not use De-Noltab during pregnancy or if you are breast feeding, unless clearly necessary.

Driving and using machines

It is unlikely that De-Noltab will affect your ability to drive or use machines.

Important information about some of the ingredients of De-Noltab

This medicine contains approximately 2 mmol (approximately 40 mg) potassium per tablet. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet (see section 6 for the list of ingredients).

How to take De-Noltab Instructions for proper use

Take a tablet with about half a glass of water.

Do not eat, drink, or use other medicines half an hour before or after taking a dose of De-Noltab.

Dosage

Always take De-Noltab exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose for adults and the elderly is one tablet to be taken four times a day on an empty stomach, half an hour before each of the three main meals and two hours after the last meal of the day

or

Two tablets twice daily, half an hour before breakfast and half an hour before the evening meal.

Duration of treatment

The maximum duration of one course of treatment is two months. Your doctor will not prescribe continuous treatment with De-Noltab, but it is possible that he/she may prescribe you one more course after completion of the first course.

If you take more De-Noltab than you should

Drink plenty of water and phone your doctor or a hospital casualty department immediately.

If you forget to take De-Noltab

Do not take a double dose to make up for a forgotten one. If you forget to take a dose, take the forgotten one before the next meal, provided this does not result in taking a double dose. If that should be the case, omit the forgotten dose.

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

De-Noltab Side Effects

Like all medicines, De-Noltab can cause side effects, although not everybody gets them.

Potentially life threatening allergic reaction may occur while you are taking De-Noltab. Signs of allergy include:

rash wheezing breathlessness swollen eyelids, face or lips and in extreme cases collapse

If you get any of these symptoms soon after taking De-Noltab, don’t take any more. Tell a doctor immediately and take the packaging and this leaflet with you. These are serious but very rare side effects (likely to affect less than 1 in 10,000 patients)

De-Noltab may cause the following:

Very common side effects (likely to affect more than 1 in 10 patients)

blackening of your stools (faeces). This is nothing to worry about and will disappear once you stop treatment

Uncommon side effects (likely to affect more than 1 in 1000 and less than 1 in 100 patients)

nausea, vomiting, constipation or diarrhoea rash and itching

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store De-Noltab

Do not store above 25 °C.

Keep out of the reach and sight of children.

Do not take De-Noltab after the expiry date which is stated on the carton and aluminium foil strip after EXP.

The expiry date refers to the last day of that month.

Further information What De-Noltab contains The active ingredient is tri-potassium di-citrato bismuthate, equivalent to 120 mg bismuth trioxide per tablet. The other ingredients are povidone (E1201), polacrillin potassium, macrogol, magnesium stearate (E572) and maize starch. The coating contains hypromellose (E468) and macrogol. What De-Noltab looks like and contents of the pack

De-Noltab tablets are creamy white, round, sugar coated tablets with marking of ‘gbr152’ on one side and company logo on the other side. They are available in packs of 112 tablets as a treatment course for one month.

Marketing Authorisation Holder Astellas Pharma Ltd. Lovett House Lovett Road Staines Middlesex TW18 3AZ UK Manufacturer Astellas Pharma Europe B.V. Elisabethhof 19 2353 EW Leiderdorp The Netherlands

This leaflet was last approved in May 2008

© 2000 Astellas Pharma Ltd.

123562


More




Haymine Tablets (Chemidex Pharma Ltd)


1. Name Of The Medicinal Product

HAYMINE TABLETS

2. Qualitative And Quantitative Composition

Each tablet contains:

Chlorphenamine maleate Ph.Eur. 10 mg

Ephedrine hydrochloride Ph.Eur. 15mg

3. Pharmaceutical Form

Sustained release tablet

4. Clinical Particulars 4.1 Therapeutic Indications

Relief of symptoms caused by allergic conditions such as hay fever, allergic rhinitis, perennial rhinitis, urticaria etc., which are responsive to antihistamine.

4.2 Posology And Method Of Administration

Adults, elderly and children over 12 years of age:

One or two tablets daily. One tablet should be taken in the morning on rising and a further tablet may be taken at night if required.

Children under 12 years of age:

Not recommended.

Method of administration - oral use.

4.3 Contraindications

Coronary thrombosis, hypertension, thyrotoxicosis and those on treatment with monoamine oxidase inhibitors.

4.4 Special Warnings And Precautions For Use

Tablets should be swallowed whole and not sucked or chewed. Do not exceed the stated dose. Asthmatics should consult their doctor before using this product. May cause drowsiness, if affected do not drive or operate machinery. Avoid alcoholic drink.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Alcoholic drinks and certain other central nervous system depressants can potentiate any sedative effect.

4.6 Pregnancy And Lactation

Contra-indicated.

4.7 Effects On Ability To Drive And Use Machines

Caution should be employed when driving or operating machinery.

4.8 Undesirable Effects

Although the combination of ephedrine with the anti-histamine chlorphenamine is intended to reduce side-effects, slight drowsiness may occur. Side effects of ephedrine are rare at the low dose employed in this preparation, however in particularly susceptible patients, effects such as giddiness, palpitations and muscular weakness may be experienced transiently.

4.9 Overdose

Treatment should include gastric lavage. In the event of convulsions sedate with intramuscular paraldehyde. Respiratory depression may necessitate mechanical ventilation. Symptomatic treatment of cardiovascular dysfunction should be given with careful patient monitoring. The physician should be aware that tablets in the intestine will continue to release the active ingredients for a period of hours.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Chlorphenamine is a potent H1-blocking drug. It antagonises the pharmacological actions of histamine released by antigen-antibody reaction in allergic diseases, thus providing symptomatic relief. Chlorphenamine alone is less effective when pollen counts are high, allergen exposure is prolonged and nasal congestion has become prominent.

Ephedrine has mild CNS stimulant properties which counteract any drowsiness produced by chlorphenamine. In addition it produces a decongestant action on nasal mucosal surfaces relieving mucosal congestion in conditions such as hay fever and allergic rhinitis.

5.2 Pharmacokinetic Properties

Chlorphenamine is readily absorbed after oral administration and may undergo enterohepatic re-circulation in man. It is eliminated with a t? of 12-15 hours.

Ephedrine is completely absorbed following oral administration and is eliminated with a t? of 3-6 hours.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Hydroxypropylmethylcellulose

Quinoline yellow

Hardened castor oil

Magnesium stearate

Nipastat

6.2 Incompatibilities

None known.

6.3 Shelf Life

4 years

6.4 Special Precautions For Storage

None

6.5 Nature And Contents Of Container

Strip packed in soft tempered aluminium foil laminated to polyethylene or blister packed in PVC/polyvinyl dichloride on hard tempered aluminium foil in 10's or 30's in cardboard cartons.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

CHEMIDEX PHARMA LIMITED

CHEMIDEX HOUSE, EGHAM BUSINESS VILLAGE

CRABTREE ROAD

EGHAM

SURREY

TW20 8RB

UNITED KINGDOM

8. Marketing Authorisation Number(S)

PL 17736/0117

9. Date Of First Authorisation/Renewal Of The Authorisation

9th March 1978 / 22 May 2003

10. Date Of Revision Of The Text

August 1997


More




Oily Phenol Injection BP (UCB Pharma Ltd)


1. Name Of The Medicinal Product

Oily Phenol Injection BP 5% w/v

2. Qualitative And Quantitative Composition

Phenol BP 5.00 % w/v

3. Pharmaceutical Form

Sterile solution intended for parenteral use

4. Clinical Particulars 4.1 Therapeutic Indications

Scleropathy of haemorrhoids

4.2 Posology And Method Of Administration

Injected into sub-mucosal layer at the base of the haemorrhoid

ADULTS

2-3 ml of oily phenol injection into the sub-mucosal layer at the base of the pile; Several injections may be given at different sites but not more than a total volume of 10 ml should be used at any one time.

CHILDREN

Use of this product is not advised

ELDERLY

No alternative dosage schedules have been suggested.

4.3 Contraindications

Oily Phenol Injection, BP is contraindicated in patients who are hypersensitive to phenol, nuts and in particular almond oil or any component of the product. It should not be used over large areas, since sufficient amounts may be absorbed to give rise to toxic symptoms. Oily Phenol Injection, BP is also contraindicated in neonates and children.

4.4 Special Warnings And Precautions For Use

For submucosal injection only. Not for intrathecal use. Complications of therapy can include local ulceration and sterile abscess formation. These complications may be serious following a misplaced injection (eg prostatic abscess). Care in choosing the correct site of injection is mandatory.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated

4.6 Pregnancy And Lactation

Safety in pregnancy has not been established. The effects on the foetus are unknown, therefore Oily Phenol is not recommended for use during pregnancy.

It is not known whether Oily Phenol is excreted in breast milk. Since safety in infants has not been established, Oily Phenol injection is not recommended for use whilst breast-feeding.

4.7 Effects On Ability To Drive And Use Machines

Effects of phenol oily injection are not likely to affect the patient's ability to drive and use machinery.

4.8 Undesirable Effects

General disorders and administration site conditions:

Pyrexia

Pain

Discomfort

Ulcer

Immune system disorders:

Hypersensitivity

Nervous system disorders:

Dizziness

Hepatobiliary disorders:

Hepatitis

Infections and infestations:

Abscess

Prostatic abscess

Necrotizing fasciitis

Retroperitoneal sepsis

Renal and urinary disorders:

Dysuria

Urinary incontinence

Reproductive system and breast disorders:

Impotence

4.9 Overdose

Symptoms:

The symptoms of overdosage after submucosal injection of Oily Phenol are not known, but are likely to be similar to symptoms observed after excessive exposure to phenol in other preparations. Absorption of phenol after application of dilute phenol solutions to extensive wounds has resulted in abdominal pains, dizziness, methaemoglobinaemia, haemoglobinurea, cyanosis, cardiac arrhythmias, ECG abnormalities, and may result in respiratory failure, circulatory failure, coma and death.

Treatment:

There is no specific antidote for acute phenol overdose. Treatment of overdose is symptomatic and supportive.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Oily phenol injection acts as an analgesic and thrombotic agent by numbimg the sensory nerve endings and precipitating proteins.

5.2 Pharmacokinetic Properties

Phenol is absorbed from the gastro-intestinal tract and through skin and mucous membranes. It is metabolised to phenylglucoronide and phenylsulphate and small amounts are oxidised to catechol and quinol which are mainly conjugated. The metabolites are excreted in the urine; on oxidation to quinones they may tint the urine green.

5.3 Preclinical Safety Data

No data available

6. Pharmaceutical Particulars 6.1 List Of Excipients

Almond oil

6.2 Incompatibilities

Incompatible with alkaline salts, acetanilide, phenazone, piperazine, quinine salts, phenacetin and iron salts. Phenol coagulates albumin and gelatinises collodion.

6.3 Shelf Life

3 years

6.4 Special Precautions For Storage

Store below 25 ° C

6.5 Nature And Contents Of Container

5 ml neutral glass (type 1) ampoules supplied in cartons of 10

6.6 Special Precautions For Disposal And Other Handling

None stated

7. Marketing Authorisation Holder

UCB Pharma Limited

208 Bath Road

Slough

Berkshire

SL1 3WE

UK

8. Marketing Authorisation Number(S)

PL 0039/5690R

9. Date Of First Authorisation/Renewal Of The Authorisation

20 March 1987 / 15 October 1997

10. Date Of Revision Of The Text

23rd September 2008


More




Oruvail IM Injection


Oruvail IM Injection

Ketoprofen

Please read this leaflet carefully BEFORE you have your Oruvail IM injection. This leaflet is a summary of the important information about your medicine.

Keep it in a safe place. You may want to refer to it again. If you have any questions or are not sure about anything to do with your treatment, ask your doctor or pharmacist for more information.

What Is In Oruvail Im Injection?

The active ingredient is ketoprofen, 100mg in 2ml of solution.

The solution also contains the following inactive ingredients: arginine, benzyl alcohol, water and E330.

Oruvail IM injection is available in packs of 10 ampoules each having 2 ml of injection solution.

Oruvail IM injection is one of a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDS).

The company responsible (also known as the marketing authorisation holder) for Oruvail is:

Aventis Pharma Ltd 50 Kings Hill Avenue Kings Avenue West Malling Kent ME19 4AH

The product is made by

Aventis Pharma Dagenham Essex RM10 7XS UK Why Have You Been Prescribed Oruvail?

Oruvail IM injection is normally used to treat painful flare ups of rheumatism, arthritis, pulled or strained muscles and tendons, gout, other painful conditions of the bone or muscle and pain and inflammation following orthopaedic surgery. If you need any further information on your condition, please ask your doctor.

Before Taking Your Medicine

Tell your doctor or nurse if any of the following apply:

If you have had an allergic reaction after taking Oruvail (or similar products) in the past If you are sensitive or allergic to any of the inactive ingredients If you are allergic to aspirin or any other non-steroidal anti-inflammatory drug If you suffer from any other allergies If you have or have had a stomach ulcer If you get indigestion or heartburn If you suffer from asthma If you have heart problems, previous stroke or think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker) If you have any kidney problems If you are pregnant, or planning a pregnancy If you are breast feeding If the patient is under 12 years of age If you are taking any other medicines. Some medicines may change the way Oruvail works e.g. aspirin or other non-steroidal anti-inflammatory drugs used to treat pain or inflammation, warfarin used to reduce clotting of the blood, sulphonamide antibiotics used to treat infection, phenytoin used to treat epilepsy, methotrexate used to treat cancer.

If you have to go to a doctor, dentist or hospital for any reason, tell them that you are having Oruvail injections.

Special Warnings

Oruvail should not affect your ability to drive or operate machinery.

However, Oruvail may occasionally cause drowsiness or dizziness in which case you should not drive or operate machinery.

How To Take Your Medicine

The usual adult dose is 1 to 2ml by injection into the muscle.

This may be repeated every 4 hours up to a maximum of 4ml in 24 hours. Treatment by injection is not normally continued for longer than 3 days. Elderly patients will normally be given the lowest effective dose.

Medicines such as Oruvail may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.

Oruvail is not recommended for children.

Treatment by injection will usually be followed by a course of Oruvail capsules taken by mouth.

Does Oruvail Have Side Effects?

As well as benefits, all medicines may occasionally have unwanted effects in some patients. These are called side effects.

Minor side effects of Oruvail, that are well known, are indigestion, nausea, constipation, diarrhoea, heartburn, abdominal discomfort, headache, dizziness, confusion, drowsiness, insomnia, mood change, pain or burning sensation at the site of injection. You do not need to worry about them unless they become troublesome - in which case, you should contact your doctor.

Some side effects may be more serious and you should tell your doctor immediately if you have any of the following:

Wheezing Tightness of the chest Faintness Skin rash Sensitivity to sunlight Swollen ankles Bad stomach pains Vomiting blood or dark coffee coloured granules Passing dark tarry bowel motions Bruising on your body Yellowing of the skin, aching limbs Reduced urine levels, low back pain

Do not be alarmed by this list of possible events.

Most people take Oruvail without any problems.

Medicines such as Oruvail may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.

All medicines may have unwanted effects which are not mentioned in the product leaflet. If you notice any other changes in your health whilst taking this medicine, tell your doctor immediately.

Expiry Date

You must not use medication after the expiry date.

This is given in two places:

on the carton on the ampoule

In both places it is given as ‘EXP’ followed by the month and year.

The injection should not be used after the end of that month.

Storage Of Oruvail

Your hospital pharmacist will normally keep the injection for you, in a safe place - out of reach of children and protected from light.

It should be kept below 30°C.

REMEMBER: These injections are for you. Only a doctor may prescribe them for you. Never give your medicines to other people. They may harm other people even if their symptoms appear the same as yours.

Oruvail is a trademark.

This leaflet was revised in May 2007.


More




Mephyton


phytonadione
Dosage Form: tablet
Tablets
Mephyton®
(PHYTONADIONE)
Vitamin K1 Mephyton Description

Phytonadione is a vitamin which is a clear, yellow to amber, viscous, and nearly odorless liquid. It is insoluble in water, soluble in chloroform and slightly soluble in ethanol. It has a molecular weight of 450.70.

Phytonadione is 2-methyl-3-phytyl-1, 4-naphthoquinone. Its empirical formula is C31H46O2 and its structural formula is:

Mephyton1 (Phytonadione) tablets containing 5 mg of phytonadione are yellow, compressed tablets, scored on one side. Inactive ingredients are acacia, calcium phosphate, colloidal silicon dioxide, lactose, magnesium stearate, starch, and talc.

1 Registered trademark of ATON PHARMA, INC.
COPYRIGHT © 2008 ATON PHARMA, INC.
All rights reserved Mephyton - Clinical Pharmacology

Mephyton tablets possess the same type and degree of activity as does naturally-occurring vitamin K, which is necessary for the production via the liver of active prothrombin (factor II), proconvertin (factor VII), plasma thromboplastin component (factor IX), and Stuart factor (factor X). The prothrombin test is sensitive to the levels of three of these four factors – II, VII, and X. Vitamin K is an essential cofactor for a microsomal enzyme that catalyzes the posttranslational carboxylation of multiple, specific, peptidebound glutamic acid residues in inactive hepatic precursors of factors II, VII, IX, and X. The resulting gammacarboxyglutamic acid residues convert the precursors into active coagulation factors that are subsequently secreted by liver cells into the blood.

Oral phytonadione is adequately absorbed from the gastrointestinal tract only if bile salts are present. After absorption, phytonadione is initially concentrated in the liver, but the concentration declines rapidly. Very little vitamin K accumulates in tissues. Little is known about the metabolic fate of vitamin K. Almost no free unmetabolized vitamin K appears in bile or urine.

In normal animals and humans, phytonadione is virtually devoid of pharmacodynamic activity. However, in animals and humans deficient in vitamin K, the pharmacological action of vitamin K is related to its normal physiological function; that is, to promote the hepatic biosynthesis of vitamin K-dependent clotting factors.

Mephyton tablets generally exert their effect within 6 to 10 hours.

Indications and Usage for Mephyton

Mephyton is indicated in the following coagulation disorders which are due to faulty formation of factors II,VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity.

Mephyton tablets are indicated in:

– anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives; – hypoprothrombinemia secondary to antibacterial therapy; – hypoprothrombinemia secondary to administration of salicylates; – hypoprothrombinemia secondary to obstructive jaundice or biliary fistulas but only if bile salts are administered concurrently, since otherwise the oral vitamin K will not be absorbed. Contraindications

Hypersensitivity to any component of this medication.

Warnings

An immediate coagulant effect should not be expected after administration of phytonadione.

Phytonadione will not counteract the anticoagulant action of heparin.

When vitamin K1 is used to correct excessive anticoagulant-induced hypoprothrombinemia, anticoagulant therapy still being indicated, the patient is again faced with the clotting hazards existing prior to starting the anticoagulant therapy.

Phytonadione is not a clotting agent, but overzealous therapy with vitamin K1 may restore conditions which originally permitted thromboembolic phenomena. Dosage should be kept as low as possible, and prothrombin time should be checked regularly as clinical conditions indicate.

Repeated large doses of vitamin K are not warranted in liver disease if the response to initial use of the vitamin is unsatisfactory. Failure to respond to vitamin K may indicate a congenital coagulation defect or that the condition being treated is unresponsive to vitamin K.

Precautions General

Vitamin K1 is fairly rapidly degraded by light; therefore, always protect Mephyton from light. Store Mephyton in closed original carton until contents have been used. (See also HOW SUPPLIED, Storage.)

Drug Interactions

Temporary resistance to prothrombin-depressing anticoagulants may result, especially when larger doses of phytonadione are used. If relatively large doses have been employed, it may be necessary when reinstituting anticoagulant therapy to use somewhat larger doses of the prothrombin-depressing anticoagulant, or to use one which acts on a different principle, such as heparin sodium.

Laboratory Tests

Prothrombin time should be checked regularly as clinical conditions indicate.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies of carcinogenicity or impairment of fertility have not been performed with Mephyton. Mephyton at concentrations up to 2000 mcg/plate with or without metabolic activation, was negative in the Ames microbial mutagen test.

Pregnancy Pregnancy Category C

Animal reproduction studies have not been conducted with Mephyton. It is also not known whether Mephyton can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Mephyton should be given to a pregnant woman only if clearly needed.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established with Mephyton. Hemolysis, jaundice, and hyperbilirubinemia in newborns, particularly in premature infants, have been reported with vitamin K.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Mephyton is administered to a nursing woman.

Geriatric Use

Clinical studies of Mephyton did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

Adverse Reactions

Severe hypersensitivity reactions, including anaphylactoid reactions and deaths have been reported following parenteral administration. The majority of these reported events occurred following intravenous administration.

Transient "flushing sensations" and "peculiar" sensations of taste have been observed with parenteral phytonadione, as well as rare instances of dizziness, rapid and weak pulse, profuse sweating, brief hypotension, dyspnea, and cyanosis.

Hyperbilirubinemia has been observed in the newborn following administration of parenteral phytonadione. This has occurred rarely and primarily with doses above those recommended.

Overdosage

The intravenous and oral LD50s in the mouse are approximately 1.17 g/kg and greater than 24.18 g/kg, respectively.

Mephyton Dosage and Administration Mephyton Summary of Dosage Guidelines (See circular text for details) Adults Initial Dosage Anticoagulant-Induced Prothrombin Deficiency
(caused by coumarin or indanedione derivatives) 2.5 mg-10 mg or up to 25 mg
(rarely 50 mg) Hypoprothrombinemia due to other causes
(Antibiotics; Salicylates or other drugs; Factors limiting absorption or synthesis) 2.5 mg-25 mg or more (rarely up to 50 mg) Anticoagulant-Induced Prothrombin Deficiency in Adults

To correct excessively prolonged prothrombin times caused by oral anticoagulant therapy – 2.5 to 10 mg or up to 25 mg initially is recommended. In rare instances 50 mg may be required, Frequency and amount of subsequent doses should be determined by prothrombin time response or clinical condition. (See WARNINGS.) If, in 12 to 48 hours after oral administration, the prothrombin time has not been shortened satisfactorily, the dose should be repeated.

Hypoprothrombinemia Due to Other Causes in Adults

If possible, discontinuation or reduction of the dosage of drugs interfering with coagulation mechanisms (such as salicylates, antibiotics) is suggested as an alternative to administering concurrent Mephyton. The severity of the coagulation disorder should determine whether the immediate administration of Mephyton is required in addition to discontinuation or reduction of interfering drugs.

A dosage of 2.5 to 25 mg or more (rarely up to 50 mg) is recommended, the amount and route of administration depending upon the severity of the condition and response obtained.

The oral route should be avoided when the clinical disorder would prevent proper absorption. Bile salts must be given with the tablets when the endogenous supply of bile to the gastrointestinal tract is deficient.

How is Mephyton Supplied

Tablets Mephyton, 5 mg vitamin K1, are yellow, round, scored, compressed tablets, coded ATON 405 on one side and Mephyton on the other. They are supplied as follows:

NDC 25010-405-15 bottles of 100.

Storage

Store in tightly closed original container at 25°C (77°F); excursions permitted to 15-30°C(59-86°F) [see USP Controlled Room Temperature]. Always protect Mephyton from light. Store in tightly closed original container and carton until contents have been used. (See PRECAUTIONS, General.)

Distributed by:
ATON PHARMA
Lawrenceville
NJ 08648
USA

Manufactured by:
Draxis Specialty Pharmaceuticals, Inc.
Kirkland, Quebec H9H 4J4

Issued January 2008

201290

PRINCIPAL DISPLAY PANEL - 5 mg Tablet Carton

ATON
PHARMA

NDC 25010-405-15

100 TABLETS

Mephyton®
(PHYTONADIONE)
Tablets

Each tablet contains:
5 mg Phytonadione

Rx only

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


Mephyton 
phytonadione  tablet Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 25010-405 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength phytonadione (phytonadione) phytonadione 5 mg Inactive Ingredients Ingredient Name Strength Acacia   Calcium phosphate   Silicon Dioxide   Lactose   Magnesium stearate   Starch, Corn   Talc   Product Characteristics Color YELLOW (pale yellow) Score 2 pieces Shape ROUND Size 6mm Flavor Imprint Code Aton;405;Mephyton Contains          Packaging # NDC Package Description Multilevel Packaging 1 25010-405-15 1 BOTTLE In 1 CARTON contains a BOTTLE 1 100 TABLET In 1 BOTTLE This package is contained within the CARTON (25010-405-15)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA010104 09/30/1955
Labeler - Aton Pharma, Inc. (795419675) Establishment Name Address ID/FEI Operations Draxis Pharma, Inc. (Produits Pharmaceutiques Specialises Draxis Inc.) 243604761 MANUFACTURE Revised: 12/2010Aton Pharma, Inc. More Mephyton resources Mephyton Side Effects (in more detail) Mephyton Dosage Mephyton Use in Pregnancy & Breastfeeding Drug Images Mephyton Drug Interactions Mephyton Support Group 0 Reviews for Mephyton - Add your own review/rating Mephyton Concise Consumer Information (Cerner Multum) Mephyton MedFacts Consumer Leaflet (Wolters Kluwer) Mephyton Advanced Consumer (Micromedex) - Includes Dosage Information Phytonadione Monograph (AHFS DI) Phytonadione MedFacts Consumer Leaflet (Wolters Kluwer) Aquamephyton Concise Consumer Information (Cerner Multum) Compare Mephyton with other medications Hypoprothrombinemia, Anticoagulant Induced Hypoprothrombinemia, Not Associated with Anticoagulant Therapy Hypoprothrombinemia, Prophylaxis Vitamin K Deficiency


More




Cardene 20mg and 30mg capsules


UK

Cardene 20 mg and 30 mg capsules

Nicardipine hydrochloride

Please read this leaflet carefully before you start to take your medicine.

If you have any questions or are not sure about anything, ask your doctor or pharmacist.

What is Cardene?

Cardene contains the active ingredient nicardipine hydrochloride which belongs to the class of drugs called calcium channel blockers. These cause relaxation of the smooth muscle of the blood vessels causing these vessels to widen or dilate.

Cardene capsules come in two strengths. Each capsule contains either 20 mg or 30 mg of nicardipine hydrochloride.

The 20 mg capsule is coloured blue and white. The 30 mg capsule is coloured blue and pale blue.

They also contain the additional ingredients: starch, magnesium stearate, gelatin, indigotine E132, titanium dioxide El71.

Both strengths of capsules are available in packs of 56.

The Product Licence holder is

Astellas Pharma Limited Lovett House Lovett Road Staines Middx TW18 3AZ UK

This medicine is made by

Farmasierra, S.A. Carretera de Ir?n Km. 26,200 San Sebasti?n de los Reyes 28700 Madrid Spain

The site where batch release takes place is

Astellas Pharma Europe BV Hogemaat 2 Meppel The Netherlands What is Cardene used for?

Your medicine is used for the treatment of mild to moderate high blood pressure (hypertension) and to help prevent attacks of chest pain diagnosed by your doctor as chronic stable angina. Chronic stable angina is a pattern of attacks of chest pain that are predictable and reproducible under certain conditions such as after exercise, stress or in cold weather. They are short in duration and can be relieved by rest or certain drugs.

When must Cardene not be used? If you are allergic to nicardipine or other dihydropyridines, or any of the ingredients Cardene contains. If you have had a recent heart attack (ie. within the last month), or a condition called advanced aortic stenosis which is narrowing of your aortic heart valve. If your chest pain is diagnosed by your doctor as unstable angina. For example, if the pattern of attacks of chest pain changes and occur without exertion, you should contact your doctor immediately. If you need immediate relief of chest pain in a sudden or acute angina attack. This situation should be treated with a different class of medicine. to try to prevent the occurrence of future heart attacks (if you have already had at least one heart attack). Cardene is not recommended for patients under the age of 18. When should you be extra careful when using/while taking Cardene?

Make sure your doctor knows if you:

have a heart, liver or kidney condition, or have had a stroke. are taking other medicines including those not prescribed by your doctor. This is extremely important, as using more than one medicine at the same time can strengthen or weaken the effect of either Cardene or other medicines. Examples of such effects have been reported for Cardene when also taking digoxin, cimetidine, cyclosporin and other blood pressure lowering drugs amongst other medicines. Rifampicin or grapefruit juice should not be taken with Cardene, since they could also interact and alter the effects of Cardene. are about to undergo an operation. You must tell the doctors in the hospital that you are taking Cardene. if you experience sudden dizziness, light-headedness or palpitations on treatment with Cardene, let your doctor know. Sometimes Cardene can cause too great a fall in blood pressure which, if not dealt with, could damage your heart or brain. May Cardene be used during pregnancy or while breast feeding? You should NOT take these capsules if you are pregnant. You must tell your doctor if you are pregnant, if you think you are pregnant or if you intend to become pregnant. You should NOT breast feed if you are taking these capsules. How should Cardene be taken? Always take your medicine exactly as your doctor tells you to and do not stop treatment unless he/she tells you to do so: The usual dose is 20-30 mg, every 8 hours. Your doctor may vary this according to your symptoms and blood pressure. The label will tell you how much to take and how often. If you are not sure, ask your doctor or pharmacist. Capsules should be swallowed with a glass of water, preferably at the same time each day. (NB. Do not use grapefruit juice). If you forget to take a dose, take another dose as soon as you remember provided there are at least 3 hours between doses. If this is not possible, do not take the missed dose. Do not take two doses together. Do not change the prescribed dose of your medicine yourself. If you think the effect of your medicine is too weak or too strong, talk to your doctor If you take too many capsules or someone else accidentally takes your medicine, contact your doctor, pharmacist or nearest hospital straight away. What are the possible unwanted effects of Cardene?

This medicine sometimes causes side-effects. These are usually mild and tend to pass with time, but if they trouble you consult your doctor.

Common side effects are:

Headache, ankle swelling (oedema), heat sensation, facial flushing, sensation of fast heart beats (palpitations), nausea, dizziness.

In some patients Cardene may cause an attack of angina (chest pain) shortly after first starting to take the capsules. If this happens to you, do not take any further doses and contact your doctor. In addition a few patients experience an increase in the severity or frequency of chest pain during treatment with Cardene. If this happens to you, you must inform your doctor as soon as possible.

Other less frequent side-effects include heart complaints, drowsiness, sleeplessness, ringing in the ears, pins and needles, psychological upset, itching, rashes, diffculty in passing urine or an increase in passing urine, shortness of breath, stomach upsets, and rarely, depression, increase in bruising and impotence.

If you are concerned about these or any other unwanted effects talk to your doctor.

How should Cardene be stored? Keep this medicine out of the reach and sight of children. Do not store above 25 °C. This medicine must not be used after the date (EXP) printed on the pack. Return any left over medicine to your pharmacist. Only keep it if your doctor tells you to. REMEMBER this medicine is for you. Only a doctor can prescribe it for you. Never give it to others. It may harm them even if their symptoms are the same as yours. Further information:

You can get more information on Cardene from your doctor or pharmacist.

Date of last review

July 2005

118143

14121/3


More




Dacarbazine 200 mg, powder for solution for injection (Hospira UK Ltd)


DACARBAZINE 200 mg POWDER FOR SOLUTION FOR INJECTION

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.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

In this leaflet: 1. What Dacarbazine Powder for Solution for Injection is and what it is used for 2. Before you use Dacarbazine Powder for Solution for Injection 3. How to use Dacarbazine Powder for Solution for Injection 4. Possible side effects 5. How to store Dacarbazine Powder for Solution for Injection 6. Further information What Dacarbazine Powder For Solution For Injection Is And What It Is Used For

Dacarbazine Powder for Solution for Injection is an anti-cancer medicine, in the form of a powder for solution for injection. Treatment with an anti-cancer medicine is sometimes called cancer chemotherapy.

Dacarbazine Powder for Solution for Injection may be used for the treatment of some types of cancer, for example: metastatic malignant melanoma (a type of skin cancer that has spread) and Hodgkin’s disease and some types of cancer in soft tissues.

Before You Use Dacarbazine Powder For Solution For Injection Do not use Dacarbazine Powder for Solution for Injection if you have shown signs of hypersensitivity (severe allergy) to dacarbazine on previous occasions if you have severe liver or kidney diseases in combination with yellow fever vaccine and some other types of vaccines (live attenuated) in combination with phenytoin (a medicine used to prevent convulsions). Taking/using other medicines

Special care should be taken if you are taking other medicinal products which could interact with Dacarbazine:

ciclosporin or tacrolimus (medicines used after having a transplant) fotemustine (a medicine used in cancer treatment) medicines which could damage your liver warfarin (a medicine used to thin the blood). Your doctor may need to do your blood test (INR) more often

Please tell your doctor if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.

Pregnancy and breast feeding

Do not use Dacarbazine:

if you are pregnant or trying to become pregnant if you are breast feeding Driving and using machines

Dacarbazine may influence the ability to drive or operate machinery because of nausea and vomiting or rare adverse reactions affecting the nervous system.

Important information about one of the ingredients of Dacarbazine Powder for Solution for Injection

This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium free’.

How To Use Dacarbazine Powder For Solution For Injection

This medicinal product is for intravenous use (injection into a vein).

Your treatment will usually be given to you in hospital.

You will be given Dacarbazine as an infusion (slow injection via a drip) into a vein or a slow intravenous injection(injection into a vein).

Tell your doctor or nurse at once if you notice any pain at the injection site during or shortly after treatment. Pain around the injection site could mean the needle has not been properly inserted into the vein.

The dose of dacarbazine will depend on the illness for which you are being treated. The dose is calculated according to your body surface area (expressed as mg/m2).

Depending on your illness, dosing is typically between 200 and 850 mg/m2 of dacarbazine.

As this medicine will be given to you whilst you are in hospital it is unlikely that you will be given too little or too much. However, tell your doctor or pharmacist if you have any concerns.

Possible Side Effects

Like all medicines Dacarbazine Powder for Solution for Injection can have side effects although not everybody gets them.

If any of the following happen, tell your doctor immediately: severe allergic reaction - you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth and throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint.

This is a very serious side effect. You may need urgent medical attention. This very serious side effect is rare.

If you experience any of the following tell your doctor as soon as possible:

Common (less than 1 in 10 patients but more than 1 in 100):

pallor (anaemia) loss of appetite nausea/vomiting

Uncommon (Less than 1 in 100 patients but more than 1 in 1000):

confusion fits (seizures) numbness of the skin or pins and needles sensation in the face (paraesthesia) headache blurred vision facial flushing hair loss (alopecia) transient rash an influenza (‘flu’) type syndrome of fever, muscle pain (myalgia) and generally feeling unwell (malaise) which may start approximately one week after treatment and may last for up to three weeks tiredness and weakness (lethargy)

Rare (less than 1 in 1000 patients but more than 1 in 10,000)

diarrhoea bruising increased sensitivity of the skin to sunlight (photosensitivity)

Very rare (less than 1 in 10,000)

redness of the skin/rash itching

Blood samples will be taken to check for changes in blood cells levels, which is a common side effect of Dacarbazine treatment. Blood and urine tests will be performed to check for changes in kidney function. Blood tests may be performed to check that your liver is working properly. Kidney and liver problems are uncommon.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

HOW TO STORE DACARBAZINE 200 mg POWDER FOR SOLUTION FOR INJECTION

Keep out of the reach and sight of children

The vials should be stored at 2 - 8°C with the vials kept in the outer carton (in order to protect from light).

This medicine should not be used after the expiry date printed on the vial label.

Further Information What Dacarbazine Powder for Solution for Injection contains

The medicine is presented in glass containers called vials containing 200 mg dacarbazine. Each pack contains 1 vial.

The active substance is dacarbazine The other ingredients are citric acid monohydrate, mannitol and sodium hydroxide What Dacarbazine Powder for Solution for Injection looks like and contents of the pack

The powder is a white or pale yellow solid.

The vial containing the powder is a glass container with a rubber stopper.

Each single-dose vial contains 200 mg of Dacarbazine. When reconstituted each ml of solution contains 10 mg of dacarbazine.

The 200 mg presentation of Dacarabazine is sold in packs containing 1 vial of powder

Marketing Authorisation Holder and Manufacturer

The Marketing authorisation holder and company responsible for batch release in the European Union is

Mayne Pharma Plc Queensway Royal Leamington Spa Warwickshire CV31 3RW UK

The Manufacturer is

Mayne Pharma Pty Ltd Lexia Place Mulgrave Victoria 3170 Australia

This leaflet was last approved in

08/2006


More




Boots Antifungal Cream


Boots Antifungal Cream

(Clotrimazole)

for fungal infections of the skin

20 g

Read all of this carton for full instructions.

What this medicine is for

An antifungal cream for the treatment of fungal skin infections including ringworm, athlete’s foot, fungal nappy rash, infections of the armpit, groin, toes and skin folds and thrush of the vulva or penis.

Before you use this medicine Do not use: If you are allergic to any of the ingredients If you are pregnant or breastfeeding, unless your doctor or midwife tells you to

Information about some of the ingredients: The ingredients in the cream 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 this medicine in the genital area. You may, for example, use a spermicide gel in addition to the condom or diaphragm. If you need more advice about this speak to your pharmacist.

Cetyl alcohol and stearyl alcohol in this medicine may cause skin reactions (e.g. contact dermatitis).

How to use this medicine

Check the tube seal is not broken before first use. If it is, do not use the cream.

Pierce tube seal with end of cap.

Adults and children: Apply to the affected area two or three times a day. Use the cream for at least 2 weeks. In some cases it may be necessary to continue to use the cream for more than 4 weeks.

If you are using the cream for a foot infection, make sure your feet, especially between the toes, are washed and thoroughly dried before applying the cream. Apply to the skin only.

Do not use more than the amount recommended above.

If symptoms do not go away talk to your doctor.

If anyone accidentally swallows some: Talk to a doctor straight away.

Possible side effects

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

If you get these side effects, stop using the cream and 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: Rarely, mild burning or irritation immediately after using the cream Pain

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

Keep all medicines out of the sight and reach of children.

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

Active ingredient

This topical cream contains Clotrimazole 1% w/w.

Also contains: purified water, 2-octyldodecanol, stearyl alcohol, cetyl alcohol, cetyl esters wax, sorbitan stearate, polysorbate 60, benzyl alcohol.

PL 10622/0004 [P]

Text prepared 8/08

Manufactured for The Boots Company PLC Nottingham NG2 3AA

by

Thornton & Ross Ltd Linthwaite Huddersfield West Yorkshire HD7 5QH Marketing Authorisation held by PLIVA Pharma Ltd Vision House Bedford Road Petersfield Hampshire GU32 2QB

If you need more advice ask your pharmacist.

1498cXPil


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


More




Primolut N


Due to regulatory changes, the content of the following Patient Information Leaflet may vary from the one found in your medicine pack. Please compare the 'Leaflet prepared/revised date' towards the end of the leaflet to establish if there have been any changes.
If you have any doubts or queries about your medication, please contact your doctor or pharmacist.

Primolut N

5 mg tablets

(norethisterone)

Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. You may need to read it again.

If you have more 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet 1. What Primolut N is and what it is used for 2. Before you take Primolut N 3. How you take Primolut N 4. Possible side effects 5. How to store Primolut N 6. Further information What Primolut N is and what it is used for

Primolut N contains norethisterone, which belongs to a group of medicines called progestogens, which are female hormones.

Primolut N can be used in several different circumstances:

to treat irregular, painful or heavy periods to treat endometriosis (where tissue from the lining of the womb is present in places where it is not normally found) to treat premenstrual syndrome (also known as premenstrual tension, PMS or PMT) to delay periods Before you take Primolut N Do not take Primolut N if you are: allergic to norethisterone or any of the other ingredients. The ingredients are listed in section 6 pregnant or if you think you might be pregnant

or if you have:

(or are recovering from) a liver disease and the blood tests show that your liver is not yet working normally certain types of jaundice (Dubin-Johnson or Rotor syndrome). (or have ever had) liver cancer. Blood Clots

Do not take Primolut N if you have blood clots in the legs, lungs, eyes or elsewhere, or have any medical condition which makes you more at risk of developing clots.

To reduce the risk of blood clots, treatment with Primolut N must be stopped:

six weeks before any planned major operation before any surgery to the legs before medical treatment for varicose veins if you are going to be immobilised for a long time (e.g. if you need bed-rest after an accident or operation, or if you have a plaster cast on a broken leg)

In addition, do not take Primolut N if you have had any of the following conditions when you were pregnant:

yellowing of the skin (idiopathic jaundice of pregnancy) itching of the whole body (pruritus of pregnancy) a rash known as herpes gestationis (also known as pemphigoid gestationis).

Tell your doctor if any of these apply to you and do not take Primolut N.

The doctor will take special care if: you have diabetes. Primolut N can produce changes in blood sugar levels. If you are diabetic, your doctor will check your blood sugar before starting treatment and regularly during treatment. you have an intolerance to some types of sugar (galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption).

Tell your doctor before you take Primolut N if any of these applies to you.

Other things you should know:

Once you have finished taking a course of Primolut N, you will usually have a menstrual bleed (period) 2-3 days after taking your last tablet. If you do not have a period, you must make sure that you are not pregnant before taking any more tablets.

The risk of blood clots occurring in the veins and arteries is slightly greater in women who take the combined oral contraceptive pill than in women who don’t. People do not always fully recover from such blood clots, which can cause strokes, heart attacks and bleeding into the brain (subarachnoid haemorrhage). In very rare cases these blood clots can be fatal. Although Primolut N is not an oral contraceptive, the risk of developing blood clots still exists. This risk may be higher if you:

have had blood clots before suffer from severe diabetes with changes to the blood vessels suffer from sickle-cell anaemia

On rare occasions, the use of hormones has been associated with some types of liver cancer. These may lead to bleeding in the abdomen. Tell your doctor if you feel pain in the upper abdomen that does not go away.

Pregnancy

Do not take Primolut N if you are pregnant. If you think you might be pregnant or are planning a family, tell your doctor before taking Primolut N.

Driving and using machines

Primolut N is unlikely to affect your ability to drive or use machines.

How you take Primolut N

Take the tablets as instructed by your doctor.

The number of tablets that you need to take and the number of days per month when you need to take them will depend on why the doctor has prescribed Primolut N. A common dosage would be 2-3 tablets each day. For some conditions Primolut N has to be taken every day, but this is not always the case.

If you are not sure about the number of tablets that you need to take, when they should be taken or how long you should take them for, you should ask your doctor or pharmacist.

Swallow the tablets whole with a drink of water.

If you take too many tablets

Taking too many tablets is unlikely to cause serious problems. If you take too many, contact your doctor who will tell you what do.

If you forget to take the tablets

If you forget a dose, wait until it is time to take the next prescribed dose. Do not take the missed dose. If you are worried, contact your doctor or pharmacist.

Primolut N Side Effects Reasons for stopping Primolut N immediately:

Stop taking Primolut N and speak to your doctor immediately if you experience any of the following:

migraine for the first time unusually bad headaches, occurring more often than before sudden changes to your eyesight, hearing or speech sudden changes to your senses of smell, taste or touch symptoms of blood clot formation or symptoms of inflammation of the veins combined with the formation of blood clots (thrombophlebitis): unusual pains in your leg(s) unusual swelling of your arms or legs sharp pains in your chest or sudden shortness of breath crushing pains or feelings of heaviness or tightness in your chest coughing for no apparent reason one side of your body suddenly becoming very weak or numb

Primolut N must also be stopped immediately if:

you become pregnant you develop jaundice or other liver problems you develop itching (pruritus) your doctor finds that your blood pressure is too high General side effects:

It is unusual for people to experience side effects when taking normal doses of Primolut N. Side effects that have been reported include:

feeling slightly sick (nausea) worsening of epilepsy worsening of migraine skin problems

At very high doses, changes in the way that the liver works have been reported.

Tell your doctor if any side effect gets serious, or if you experience any effects not listed in this leaflet. You should also tell your doctor if you notice any changes in your health or general sense of well-being while you are taking Primolut N.

How to store Primolut N

Keep this medicine out of the reach and sight of children.

Store in the original carton.

Do not use after the expiry date which is marked on both the outer container and on each blister strip of tablets.

Do not dispose of medicines in waste water or household rubbish. Any unused Primolut N tablets should be returned to a pharmacist (chemist) who will dispose of them properly. This helps the environment.

Further information What Primolut N contains

Each tablet contains 5 mg of the active ingredient, norethisterone. The other ingredients are lactose, maize starch and magnesium stearate (E572).

What’s in the pack

Each pack contains 30 tablets (3 foil blister packs containing 10 tablets each). Each white tablet has ‘AN’ embossed in a regular hexagon on one side.

Marketing authorisation holder: Bayer plc Bayer Schering Pharma Bayer House Strawberry Hill Newbury Berkshire RG14 1JA United Kingdom Manufacturers: Bayer Schering Pharma AG Berlin Germany

or

Schering GmBH & Co Produktions KG Weimar Germany This leaflet last revised:

May 2008

Product licence number:

PL 00010/0553


More




Aloxi


Generic Name: Palonosetron Hydrochloride
Class: 5-HT3 Receptor Antagonists
VA Class: GA700
Chemical Name: (3aS)-2,3,3a,4,5,6-Hexahydro-2-[(3S)-3-quinuclidinyl]-1H-benz[de]isoquinolin-1-one monohydrochloride
Molecular Formula: C19H24N2O•HCl
CAS Number: 135729-62-3

Introduction

Antiemetic; selective inhibitor of type 3 serotonergic (5-HT3) receptors.1 17

Uses for Aloxi Cancer Chemotherapy-induced Nausea and Vomiting

Prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.1

Prevention of acute nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy.1

Aloxi Dosage and Administration Administration IV Administration

Administer by direct IV injection.1

Do not mix with other drugs; flush tubing with 0.9% sodium chloride injection before and after administration.1

Rate of Administration

Inject over a period of 30 seconds.1

Dosage

Available as palonosetron hydrochloride; dosage expressed in terms of palonosetron.1

Adults Cancer Chemotherapy-induced Nausea and Vomiting IV

0.25 mg as a single dose administered approximately 30 minutes before administration of emetogenic chemotherapy.1

An additional dose within a 7-day period is not recommended; safety and efficacy of repeat doses (e.g., on consecutive or alternate days) not established.1

Prescribing Limits Adults Cancer Chemotherapy-induced Nausea and Vomiting IV

Maximum of one 0.25-mg dose within 7 days.1

Special Populations Hepatic Impairment

No dosage adjustments required.1

Renal Impairment

No dosage adjustments required.1

Geriatric Patients

No dosage adjustments required.1

Cautions for Aloxi Contraindications

Known hypersensitivity to palonosetron or any ingredient in the formulation.1

Warnings/Precautions Sensitivity Reactions

Sensitivity reactions may occur in patients with history of hypersensitivity to other 5-HT3 receptor antagonists.1

General Precautions Cardiovascular Effects

Prolongation of QT interval reported.1

Use with caution in patients who have or may develop prolongation of cardiac conduction intervals (particularly QTc), including those with congenital QT syndrome, those with uncorrected hypokalemia or hypomagnesemia, patients receiving diuretics that may induce electrolyte abnormalities, patients receiving antiarrhythmic agents or other drugs that alter cardiac conduction (e.g., prolong QT interval), and those receiving cumulative high-dose anthracycline therapy.1

Specific Populations Pregnancy

Category B.1

Lactation

Not known whether palonosetron is distributed into milk.1 Discontinue nursing or the drug.1

Pediatric Use

Safety and efficacy not established in children <18 years of age.1

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.1

Common Adverse Effects

Headache, constipation.1

Interactions for Aloxi

Approximately 50% metabolized, principally by CYP2D6 and to a lesser extent by CYP3A and CYP1A2;1 however, pharmacokinetics are not substantially different between poor and extensive CYP2D6 substrate metabolizers.1

Does not inhibit activity of isoenzymes 1A2, 2A6, 2B6, 2C9, 2D6, 2E1, or 3A4/5; effect on isoenzyme 2C19 activity undetermined.1 Does not induce activity of isoenzymes 1A2, 2D6, or 3A4/5.1

Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes

Clinically important pharmacokinetic interactions are unlikely.1

Drugs that Prolong QT Interval

Possible additive effect of QT-interval prolongation.1 Use concomitantly with caution.1

Specific Drugs

Palonosetron has been administered safely with analgesics, anticholinergic agents, antiemetics, antispasmodics, and corticosteroids in clinical studies.1

Drug

Interaction

Comments

Anthracyclines (e.g., doxorubicin)

Potential QTc interval prolongation with cumulative high-dose anthracycline therapy1

Antineoplastic activity of doxorubicin not inhibited in animal tumor models1

Use with caution1

Antiarrhythmics

Possible additive effect of QT-interval prolongation1

Use with caution1

Cisplatin

Antineoplastic activity not inhibited in animal tumor models1

Cyclophosphamide

Antineoplastic activity not inhibited in animal tumor models1

Cytarabine

Antineoplastic activity not inhibited in animal tumor models1

Diuretics

May induce electrolyte abnormalities and increase risk of QTc interval prolongation1

Use with caution1

Metoclopramide

Pharmacokinetic interaction unlikely1

Mitomycin

Antineoplastic activity not inhibited in animal tumor models1

Aloxi Pharmacokinetics Distribution Plasma Protein Binding

Approximately 62%.1

Elimination Metabolism

Approximately 50% metabolized (principally by CYP2D6 and to a lesser extent by CYP3A and CYP1A2) to 2 metabolites with <1% of the 5-HT3 receptor inhibitor activity of palonosetron.1 However, pharmacokinetics are not substantially different between poor and extensive CYP2D6 substrate metabolizers.1

Elimination Route

Eliminated principally in urine (80% in 144 hours, 40% as palonosetron).1

Half-life

Approximately 40 hours.1

Stability Storage Parenteral Injection

20–25°C (may be exposed to 15–30°C).1 Protect from light; do not freeze.1

ActionsActions

Antiemetic activity for acute nausea and vomiting appears to be mediated via inhibition of serotonin activity both centrally (in area postrema and chemoreceptor trigger zone) and peripherally (in GI tract).2 3 4 5 6 8 11 18 19 20

Alternative mechanisms to peripheral and CNS stimulation by serotonin appear to be responsible for delayed nausea and vomiting.2 3 5 6 7 8 9 10 11 12 13 14 15 16 Risk of delayed nausea and vomiting may be decreased by effective prevention of acute nausea and vomiting in the same chemotherapy cycle.13 20 Palonosetron’s potency and long plasma half-life may contribute to its efficacy in delayed nausea and vomiting.7 11 17 21

Advice to Patients

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 26

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, especially other drugs that may affect the QT interval (e.g., antiarrhythmic agents, diuretics, anthracyclines).1 26

Importance of informing clinician of any concomitant illnesses (e.g., cardiac conditions, electrolyte disturbances).26

Importance of informing patients of other important precautionary information.1 26 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Palonosetron Hydrochloride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injection, for IV use

0.05 mg (of palonosetron) per mL

Aloxi

MGI Pharma

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Aloxi 0.25MG/5ML Solution (EISAI): 5/$406.98 or 15/$1116.03

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions May 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. MGI Pharma. Aloxi (palonosetron hydrochloride) injection prescribing information. Bloomington, MN; 2006 Jan.

2. McKeage MJ. Comparative adverse effect profile of platinum drugs. Drug Saf. 1995; 13:228-44. [PubMed 8573296]

3. Cubeddu LX, Hoffmann IS. Participation of serotonin on early and delayed emesis induced by initial and subsequent cycles of cisplatinum-based chemotherapy: effects of antiemetics. J Clin Pharmacol. 1993; 33:691-7. [IDIS 319277] [PubMed 7691898]

4. Hesketh PJ, Gandara DR. Serotonin antagonists: a new class of antiemetic agents. J Natl Cancer Inst. 1991; 83:613-20. [PubMed 1850806]

5. Gralla RJ. Adverse effects of treatment: antiemetic therapy. In: DeVita VT Jr, Hellman S, Rosenberg SA, eds. Cancer: principles and practice of oncology. 4th ed. Philadelphia: J.B. Lippincott Company; 1993:2338-48.

6. Plosker GL, Goa KL. Granisetron: a review of its pharmacological properties and therapeutic use as an antiemetic. Drugs. 1991; 42:805-24. [PubMed 1723376]

7. Di Vall MV, Cersosimo RJ. Palonosetron. A novel 5-HT3 receptor antagonist for chemotherapy-associated nausea and vomiting. Formulary. 2003; 38:414-30.

8. Barger AM, Clark-Snow RA. Adverse effects of treatment. In: DeVita VT, Hellman S, Rosenberg SA, eds. Cancer: principles & practice of oncology. 6th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2001: 2869-80

9. De Mulder PHM, Seynaeve C, Vermorken JB et al. Ondansetron compared with high-dose metoclopramide in prophylaxis of acute and delayed cisplatin-induced nausea and vomiting: a multicenter, randomized, double-blind, crossover study. Ann Intern Med. 1990; 113:834-40. [IDIS 274419] [PubMed 2146911]

10. Gebbia V, Cannata G, Testa A et al. Ondansetron versus granisetron in the prevention of chemotherapy- induced nausea and vomiting. Results of a prospective randomized trial. Cancer. 1994; 74:1945-52. [IDIS 336138] [PubMed 8082100]

11. , Donnerer J, Beubler E. 5-HT3 receptor antgaonists in antiemetic therapy. In: Donnerer J (ed.): Antiemetic therapy. Basel:Karger; 2003: 22-32.

12. Kris MG, Pisters KM, Hinkley L. Delayed emesis following anticancer chemotherapy. Support Care Cancer. 1994; 2:297- 300. [PubMed 8000726]

13. Gregory RE, Ettinger DS. 5-HT3 receptor antagonists for the prevention of chemotherapy-induced nausea and vomiting. Drugs. 1998; 55: 173-89. [PubMed 9506240]

14. Merck. Emend (aprepitant) capsules prescribing information. Whitehouse Station, NJ; 2003 Mar.

15. Sorbera LA, Castaner J, Bayes M at al. Aprepitant and L758298. Drugs Fut. 2002; 27:211-22.

16. Merck. Emend (aprepitant) product information form for the American Hospital Formulary Service. 2003.

17. Eglen RM, Lee CH, Smith WL at al. Pharmacological characterization of RS 25259-17, a novel and selective 5-HT3 receptor antagonist, in vivo. Br J Pharmacol. 1995; 114:860-6 [PubMed 7773547]

18. Perez EA. Review of the preclinical pharmacology and comparative efficacy of 5-Hydroxytryptamine-3 receptor antagonists for chemotherapy-induced emesis. J Clin Oncol. 1995; 13:1036-43. [IDIS 344879] [PubMed 7707101]

19. Lindley C, Blower P. Oral serotonin type 3-recpetor antagonists for prevention of chemotherapy-induced emesis. Am J Health-Syst Pharm. 2000; 57:1685-97. [IDIS 452881] [PubMed 11006796]

20. Schnell FM. Chemotherapy-induced nausea and vomiting: the importance of acute antiemetic control. The Oncologist. 2003; 8:187-98. [PubMed 12697943]

21. MGI Pharma. Aloxi (palonosetron hydrochloride) injection. Overview. Bloomington, MN; [2003 Aug 28]. From MGI Pharma web site (http://www.mgipharma.com).

22. Wong EH, Clark R, Leung E et al. The interaction of RS-25259-197, a potent and selective antagonist, with 5-HT3 receptos. Br J Pharmacol. 1995; 114:851-9. [PubMed 7773546]

23. Clark RD, Miller AB, Berger J et al. 2 (Quinuclidin-3-yl) pyrido [4,3-b]indol-1-ones and isoquinolin-1-ones. Potent conformationally restricted 5-HT3 receptor antagonists. J Med Chem. 1993; 36:2645-57. [PubMed 8410977]

24. Gralla R, Lichinitster M, Van Der Vegt S et al. Palonosetron improves prevention of chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy: results of a double-blind randomized phase III trial comparing single doses of palonosetron with andansetron. Ann Oncol. 2003; 14:570-7. [PubMed 12649103]

25. MGI Pharma, Bloomington, MN: Personal communication.

26. MGI Pharma. Aloxi (palonosetron hydrochloride) patient information. Bloomington, MN. Undated. Available at: . Accessed 2006 Dec 6.

More Aloxi resources Aloxi Side Effects (in more detail) Aloxi Use in Pregnancy & Breastfeeding Aloxi Drug Interactions Aloxi Support Group 0 Reviews for Aloxi - Add your own review/rating Aloxi Prescribing Information (FDA) Aloxi Consumer Overview Aloxi Advanced Consumer (Micromedex) - Includes Dosage Information Aloxi MedFacts Consumer Leaflet (Wolters Kluwer) palonosetron Advanced Consumer (Micromedex) - Includes Dosage Information Compare Aloxi with other medications Nausea/Vomiting, Chemotherapy Induced Nausea/Vomiting, Postoperative


More




Aloxi


Related Posts URL Pharma Inc.: