Lamisil Tablets 250mg


LAMISIL Tablets 250 mg

(terbinafine)

Patient Information Leaflet

What you need to know about Lamisil Tablets

Your doctor has decided that you need this medicine to help treat your condition.

Please read this leaflet carefully before you start to take your medicine. It contains important information. Keep the leaflet in a safe place because you may want to read it again.

If you have any other questions, or if there is something you don’t understand, please ask your doctor or pharmacist.

This medicine has been prescribed for you. Never give it to someone else. It may not be the right medicine for them even if their symptoms seem to be the same as yours.

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

In this leaflet: 1. What Lamisil Tablets are, and what they are used for 2. Things to consider before you start to take Lamisil Tablets 3. How to take Lamisil Tablets 4. Possible side effects 5. How to store Lamisil Tablets 6. Further information What Lamisil Tablets are and what they are used for

Terbinafine, the active ingredient in Lamisil Tablets, is an antifungal medicine.

Lamisil Tablets are used to treat a number of fungal infections of the skin and nails.

Things to consider before you start to take Lamisil Tablets Some people MUST NOT take Lamisil Tablets. Talk to your doctor if: you think you may be allergic to terbinafine or to any of the other ingredients of Lamisil Tablets. (These are listed in Section 6.) you are breast-feeding.

You should also ask yourself these questions before taking Lamisil Tablets. If the answer to any of these questions is YES, tell your doctor or pharmacist because Lamisil Tablets might not be the right medicine for you.

Are you pregnant or trying to become pregnant? Do you have any problems with your kidneys or liver? Do you have psoriasis?

Children should not normally be given Lamisil Tablets.

Are you taking other medicines?

Some medicines can interfere with your treatment. Tell your doctor if you are taking any of the following:

Rifampicin for infections Cimetidine for gastric problems such as indigestion or ulcer Antidepressants including tricyclic antidepressants, SSRIs (selective serotonin reuptake inhibitors), or MAOIs (monoamine oxidase inhibitors) Oral contraceptives (as irregular periods and breakthrough bleeding may occur in some female patients) Beta-blockers or anti-arrhythmics for heart problems Warfarin, a medicine used to thin your blood Medicines to treat heart problems (eg propafenone) Ciclosporin, a medicine used to control your body’s immune system in order to prevent rejection of transplanted organs Caffeine

Always tell your doctor about all the medicines you are taking. This means medicines you have bought yourself as well as medicines on prescription from your doctor.

Will there be any problems with driving or using machinery?

Some people have reported feeling dizzy or giddy while they are taking Lamisil Tablets. If you feel like this you should not drive or operate machinery.

How to take Lamisil Tablets

The doctor will decide what dose of Lamisil Tablets you should take. Always take the tablets exactly as your doctor has told you to. The dose will be on the pharmacist’s label. Check the label carefully. It should tell you how many tablets to take, and how often. If you are not sure, ask your doctor or pharmacist. Keep taking the tablets for as long as you have been told unless you have any problems. In that case, check with your doctor.

The usual dose for adults, including the elderly, is 250 mg once a day. For skin infections continue taking the tablets for 2 to 6 weeks. For nail infections treatment usually lasts for between 6 weeks and 3 months, although some patients with toenail infections may need to be treated for 6 months or longer. If your kidneys are not working very well, your doctor may reduce the dose of Lamisil Tablets you take. Swallow the tablets whole with a glass of water. What if you forget to take a dose?

If you miss taking a Lamisil Tablet, do not worry. Take it as soon as you remember. Take your next tablet at the usual time, then carry on as normal until you have finished all the tablets. It is important that you finish all the tablets you have been given unless your doctor tells you to stop taking them.

What if you take too many tablets?

All tablets can be risky if you take too many. If you take too many Lamisil Tablets at once, tell your doctor or hospital casualty department as soon as possible. Take your medicine pack with you so that people can see what you have taken.

Possible side effects

Lamisil Tablets are suitable for most people, but, like all medicines, they can sometimes cause side effects. Any side effects are usually mild or moderate and don’t last for too long.

Some side effects can be serious

Stop taking the tablets and tell your doctor immediately if you notice any of the following rare symptoms:

Yellowing of your skin or eyes. Unusually dark urine or pale faeces, unexplained persistent nausea, stomach problems, loss of appetite or unusual tiredness or weakness (this may indicate liver problems) Severe skin reactions including rash, light sensitivity, blistering or wheals, and swelling, mainly of the face or throat. Weakness, unusual bleeding, bruising or frequent infections (this may be a sign of blood disorders)

The most common side effects are:-

Headache Stomach problems such as loss of appetite, ache, indigestion, feeling bloated or sick Diarrhoea Itching, rash or swelling Pains in the muscles and joints. The side effects listed below have also been reported.

Up to 1 in 100 people have experienced:

Taste loss and taste disturbance. This usually disappears when you stop taking the medicine. However, a very small number of people, (less than 1 in 10,000), have reported that the taste disturbance lasts for some time and, as a result, they go off their food and lose weight.

Up to 1 in 1,000 people have experienced:

Feeling unwell, dizzy. Numbness or tingling.

Up to 1 in 10,000 people have experienced:

Feeling tired. Decrease in the number of some blood cells. You may notice that you seem to bleed or bruise more easily than normal, or you may catch infections easily and these might be more severe than usual. Depression and anxiety. Psoriasis like skin eruptions, or worsening of any psoriasis. Vertigo. Onset or worsening of a condition called lupus (a long-term illness with symptoms including skin rash and pain in the muscles and joints).

The following have also been reported:

Psoriasis like skin eruptions, or worsening of psoriasis, severe skin reactions including a rash or eruption of small pus containing blisters. Signs of blood disorders: weakness, unusual bleeding, bruising or frequent infections.

If any of the symptoms become troublesome, or if you notice anything else not mentioned here, please go and see your doctor. He/she may want to give you a different medicine.

How to store Lamisil Tablets

Store the tablets in their original pack away from direct light. Do not store above 25?C.

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

Do not take the tablets after their expiry date which is printed on the outside of the pack.

If your doctor tells you to stop taking Lamisil Tablets, please take any unused tablets back to your pharmacist to be destroyed. Only keep the tablets if the doctor tells you to. Do not throw them away with your normal household water or waste. This will help to protect the environment.

Further information

Lamisil Tablets are round, whitish or very pale yellow tablets marked with a score line on one side and ‘LAMISIL 250’ on the other, and they contain 250 mg of the active ingredient terbinafine. They also contain the inactive ingredients magnesium stearate, colloidal anhydrous silica, hydroxypropylmethylcellulose, sodium carboxymethyl starch and microcrystalline cellulose.

They come in blister packs of 7, 14 or 28 tablets. Not all pack sizes are marketed.

The product licence holder is Novartis Pharmaceuticals UK Limited Frimley Business Park Frimley Camberley Surrey GU16 7SR England Lamisil Tablets are made by Novartis Pharmaceuticals UK Ltd Wimblehurst Road Horsham West Sussex RH12 5AB England

The leaflet was revised in November 2009.

If you would like any more information, or would like the leaflet in a different format, please contact Medical Information at Novartis Pharmaceuticals UK Ltd, telephone number 01276 698370.

LAMISIL is a registered trade mark

Copyright Novartis Pharmaceuticals UK Limited


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Gardasil



Dosage Form: injection, suspension
FULL PRESCRIBING INFORMATION Indications and Usage for Gardasil Girls and Women

Gardasil®1 is a vaccine indicated in girls and women 9 through 26 years of age for the prevention of the following diseases caused by Human Papillomavirus (HPV) types included in the vaccine:

 Cervical, vulvar, vaginal, and anal cancer caused by HPV types 16 and 18 Genital warts (condyloma acuminata) caused by HPV types 6 and 11

And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18:

Cervical intraepithelial neoplasia (CIN) grade 2/3 and Cervical adenocarcinoma in situ (AIS) Cervical intraepithelial neoplasia (CIN) grade 1 Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3 Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3  Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3 Boys and Men

 Gardasil is indicated in boys and men 9 through 26 years of age for the prevention of the following diseases caused by HPV types included in the vaccine:

 Anal cancer caused by HPV types 16 and 18  Genital warts (condyloma acuminata) caused by HPV types 6 and 11

 And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18:

 Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3 Limitations of Gardasil Use and Effectiveness

  The health care provider should inform the patient, parent, or guardian that vaccination does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening. Women who receive Gardasil should continue to undergo cervical cancer screening per standard of care. [See Patient Counseling Information (17).]

 Recipients of Gardasil should not discontinue anal cancer screening if it has been recommended by a health care provider. [See Patient Counseling Information (17).]

  Gardasil has not been demonstrated to provide protection against disease from vaccine and non-vaccine HPV types to which a person has previously been exposed through sexual activity. [See Clinical Studies (14.4, 14.5).]

  Gardasil is not intended to be used for treatment of active external genital lesions; cervical, vulvar, vaginal, and anal cancers; CIN; VIN; VaIN; or AIN.

  Gardasil has not been demonstrated to protect against diseases due to HPV types not contained in the vaccine. [See Clinical Studies (14.4, 14.5).]

  Not all vulvar, vaginal, and anal cancers are caused by HPV, and Gardasil protects only against those vulvar, vaginal, and anal cancers caused by HPV 16 and 18.

Gardasil does not protect against genital diseases not caused by HPV.

Vaccination with Gardasil may not result in protection in all vaccine recipients.

Gardasil Dosage and Administration Dosage

Gardasil should be administered intramuscularly as a 0.5-mL dose at the following schedule: 0, 2 months, 6 months. [See Clinical Studies (14.8).]

Method of Administration

For intramuscular use only.

Shake well before use. Thorough agitation immediately before administration is necessary to maintain suspension of the vaccine. Gardasil should not be diluted or mixed with other vaccines. After thorough agitation, Gardasil is a white, cloudy liquid. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use the product if particulates are present or if it appears discolored.

Gardasil should be administered intramuscularly in the deltoid region of the upper arm or in the higher anterolateral area of the thigh.

Syncope has been reported following vaccination with Gardasil and may result in falling with injury; observation for 15 minutes after administration is recommended. [See Warnings and Precautions (5.1).]

Single-Dose Vial Use

Withdraw the 0.5-mL dose of vaccine from the single-dose vial using a sterile needle and syringe and use promptly.

Prefilled Syringe Use With and Without Needle Guard (Safety) Device

Prefilled Syringe With Needle Guard (Safety) Device

Instructions for using the prefilled single-dose syringes preassembled with needle guard (safety) device

NOTE: Please use the enclosed needle for administration. If a different needle is chosen, it should fit securely on the syringe and be no longer than 1 inch to ensure proper functioning of the needle guard device. Two detachable labels are provided which can be removed after the needle is guarded.

At any of the following steps, avoid contact with the Trigger Fingers to keep from activating the safety device prematurely.

Remove Syringe Tip Cap and Needle Cap. Attach Luer Needle by pressing both Anti-Rotation Tabs to secure syringe and by twisting the Luer Needle in a clockwise direction until secured to the syringe. Remove Needle Sheath. Administer injection per standard protocol as stated above under DOSAGE AND ADMINISTRATION. Depress the Plunger while grasping the Finger Flange until the entire dose has been given. The Needle Guard Device will NOT activate to cover and protect the needle unless the ENTIRE dose has been given. While the Plunger is still depressed, remove needle from the vaccine recipient. Slowly release the Plunger and allow syringe to move up until the entire needle is guarded. For documentation of vaccination, remove detachable labels by pulling slowly on them. Dispose in approved sharps container.

Prefilled Syringe Without Needle Guard (Safety) Device

This package does not contain a needle guard (safety device) or a needle. Shake well before use. Attach the needle by twisting in a clockwise direction until the needle fits securely on the syringe. Administer the entire dose as per standard protocol.

Dosage Forms and Strengths

Gardasil is a suspension for intramuscular administration available in 0.5-mL single dose vials and prefilled syringes. See Description (11) for the complete listing of ingredients.

Contraindications

Hypersensitivity, including severe allergic reactions to yeast (a vaccine component), or after a previous dose of Gardasil. [See Description (11).]

Warnings and Precautions Syncope

Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following vaccination with Gardasil. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion by maintaining a supine or Trendelenburg position.

Managing Allergic Reactions

Appropriate medical treatment and supervision must be readily available in case of anaphylactic reactions following the administration of Gardasil.

Adverse Reactions

Overall Summary of Adverse Reactions

Headache, fever, nausea, and dizziness; and local injection site reactions (pain, swelling, erythema, pruritus, and bruising) occurred after administration with Gardasil.

Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following vaccination with Gardasil and may result in falling with injury; observation for 15 minutes after administration is recommended. [See Warnings and Precautions (5.1).] 

Anaphylaxis has been reported following vaccination with Gardasil.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.

Studies in Girls, Women, Boys, and Men 9 Through 26 Years of Age

In 6 clinical trials (4 Amorphous Aluminum Hydroxyphosphate Sulfate [AAHS]-controlled, 1 saline placebo-controlled, and 1 uncontrolled), 14,273 individuals were administered Gardasil or AAHS control or saline placebo on the day of enrollment, and approximately 2 and 6 months thereafter, and safety was evaluated using vaccination report cards (VRC)-aided surveillance for 14 days after each injection of Gardasil or AAHS control or saline placebo in these individuals. The individuals who were monitored using VRC-aided surveillance included 8180 individuals 9 through 26 years of age at enrollment who received Gardasil and 6093 individuals who received AAHS control or saline placebo. Few individuals (0.2%) discontinued due to adverse reactions. The race distribution of the girls and women in the safety population was as follows: 62.3% White; 17.6% Hispanic (Black and White); 6.8% Asian; 6.7% Other; 6.4% Black; and 0.3% American Indian. The race distribution of the boys and men in the safety population was as follows: 42.0% White; 19.7% Hispanic (Black and White); 11.0% Asian; 11.2% Other; 15.9% Black; and 0.1% American Indian.

Common Injection-Site Adverse Reactions in Girls and Women 9 Through 26 Years of Age

The injection site adverse reactions that were observed among recipients of Gardasil at a frequency of at least 1.0% and also at a greater frequency than that observed among AAHS control or saline placebo recipients are shown in Table 1.

Table 1: Injection-Site Adverse Reactions in Girls and Women 9 Through 26 Years of Age*

Adverse Reaction

(1 to 5 Days Postvaccination)

Gardasil

(N = 5088)

%

AAHS Control†

(N = 3470)

%

Saline

Placebo

(N = 320)

%

* The injection-site adverse reactions that were observed among recipients of Gardasil were at a frequency of at least 1.0% and also at a greater frequency than that observed among AAHS control or saline placebo recipients. † AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate

Injection Site

    Pain

    Swelling

    Erythema

    Pruritus

    Bruising


83.9

25.4

24.7

3.2

2.8


75.4

15.8

18.4

2.8

3.2


48.6

7.3

12.1

0.6

1.6

Common Injection-Site Adverse Reactions in Boys and Men 9 Through 26 Years of Age

The injection site adverse reactions that were observed among recipients of Gardasil at a frequency of at least 1.0% and also at a greater frequency than that observed among AAHS control or saline placebo recipients are shown in Table 2.

Table 2: Injection-Site Adverse Reactions in Boys and Men 9 Through 26 Years of Age*

Adverse Reaction

(1 to 5 Days Postvaccination)

Gardasil

(N = 3093)

%

AAHS Control†

(N = 2029)

%

Saline

Placebo

(N = 274)

%

* The injection-site adverse reactions that were observed among recipients of Gardasil were at a frequency of at least 1.0% and also at a greater frequency than that observed among AAHS control or saline placebo recipients. † AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate

Injection Site

    Pain

    Erythema

    Swelling

    Hematoma


61.4

16.7

13.9

1.0


50.8

14.1

9.6

0.3


41.6

14.5

8.2

3.3

Evaluation of Injection-Site Adverse Reactions by Dose in Girls and Women 9 Through 26 Years of Age

An analysis of injection-site adverse reactions in girls and women by dose is shown in Table 3. Of those girls and women who reported an injection-site reaction, 94.3% judged their injection-site adverse reaction to be mild or moderate in intensity.

Table 3: Postdose Evaluation of Injection-Site Adverse Reactions in Girls and Women 9 Through 26 Years of Age (1 to 5 Days Postvaccination)

Gardasil

(% occurrence)

AAHS Control*

(% occurrence)

Saline Placebo

(% occurrence) * AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate † N = Number of individuals with follow-up ‡ Intensity of swelling and erythema was measured by size (inches): Mild = 0 to ?1; Moderate = >1 to ?2; Severe = >2.

Adverse

Reaction

Post-

dose

1

N† = 5011

Post-

dose

2

N = 4924

Post-

dose

3

N = 4818

Post-

dose

1

N = 3410

Post-

dose

2

N = 3351

Post-

dose

3

N = 3295

Post-

dose

1

N = 315

Post-

dose

2

N = 301

Post-

dose

3

N = 300

Pain

Mild/Moderate

Severe

63.4

62.5

0.9

60.7

59.7

1.0

62.7

61.2

1.5

57.0

56.6

0.4

47.8

47.3

0.5

49.6

48.9

0.6

33.7

33.3

0.3

20.3

20.3

0.0

27.3

27.0

0.3

Swelling‡

Mild/Moderate

Severe

10.2

9.6

0.6

12.8

11.9

0.8

15.1

14.2

0.9

8.2

8.1

0.2

7.5

7.2

0.2

7.6

7.3

0.2

4.4

4.4

0.0

3.0

3.0

0.0

3.3

3.3

0.0

Erythema‡

Mild/Moderate

Severe

9.2

9.0

0.2

12.1

11.7

0.3

14.7

14.3

0.4

9.8

9.5

0.3

8.4

8.4

0.1

8.9

8.8

0.1

7.3

7.3

0.0

5.3

5.3

0.0

5.7

5.7

0.0

Evaluation of Injection-Site Adverse Reactions by Dose in Boys and Men 9 Through 26 Years of Age

An analysis of injection-site adverse reactions in boys and men by dose is shown in Table 4. Of those boys and men who reported an injection-site reaction, 96.4% judged their injection-site adverse reaction to be mild or moderate in intensity.

Table 4: Postdose Evaluation of Injection-Site Adverse Reactions in Boys and Men 9 Through 26 Years of Age (1 to 5 Days Postvaccination)

Gardasil

(% occurrence)

AAHS Control*

(% occurrence)

Saline Placebo

(% occurrence)

Adverse

Reaction

Post-

dose

1

N† = 3003

Post-

dose

2

N = 2898

Post-

dose

3

N = 2826

Post-

dose

1

N = 1950

Post-

dose

2

N = 1854

Post-

dose

3

N = 1799

Post-

dose

1

N = 269

Post-

dose

2

N = 263

Post-

dose

3

N = 259 * AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate † N = Number of individuals with follow-up ‡ Intensity of swelling and erythema was measured by size (inches): Mild = 0 to ?1; Moderate = >1 to ?2; Severe = >2.

Pain

Mild/Moderate

Severe

44.7

44.5

0.2

36.9

36.4

0.5

34.4

34.1

0.3

38.4

37.9

0.4

28.2

28.2

0.1

25.8

25.5

0.3

27.5

27.5

0.0

20.5

20.2

0.4

16.2

16.2

0.0

Swelling‡

Mild/Moderate

Severe

5.6

5.3

0.2

6.6

6.2

0.3

7.7

7.1

0.5

5.6

5.4

0.2

4.5

4.5

0.0

4.1

4.0

0.1

4.8

4.8

0.0

1.5

1.5

0.0

3.5

3.1

0.4

Erythema‡

Mild/Moderate

Severe

7.2

6.8

0.3

8.0

7.7

0.2

8.7

8.3

0.3

8.3

8.0

0.2

6.3

6.2

0.1

5.7

5.6

0.1

7.1

7.1

0.0

5.7

5.7

0.0

5.0

5.0

0.0

Common Systemic Adverse Reactions in Girls and Women 9 Through 26 Years of Age

Headache was the most commonly reported systemic adverse reaction in both treatment groups (Gardasil = 28.2% and AAHS control or saline placebo = 28.4%). Fever was the next most commonly reported systemic adverse reaction in both treatment groups (Gardasil = 13.0% and AAHS control or saline placebo = 11.2%).

Adverse reactions that were observed among recipients of Gardasil, at a frequency of greater than or equal to 1.0% where the incidence in the Gardasil group was greater than or equal to the incidence in the AAHS control or saline placebo group, are shown in Table 5.

Table 5: Common Systemic Adverse Reactions in Girls and Women 9 Through 26 Years of Age (Gardasil ?Control)*

Adverse Reactions

(1 to 15 Days Postvaccination)

Gardasil

(N = 5088)

%

AAHS Control† or Saline Placebo

(N = 3790)

% * The adverse reactions in this table are those that were observed among recipients of Gardasil at a frequency of at least 1.0% and greater than or equal to those observed among AAHS control or saline placebo recipients. † AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate Pyrexia 13.0 11.2 Nausea 6.7 6.5 Dizziness 4.0 3.7 Diarrhea 3.6 3.5 Vomiting 2.4 1.9 Cough 2.0 1.5 Toothache 1.5 1.4 Upper respiratory tract infection 1.5 1.5 Malaise 1.4 1.2 Arthralgia 1.2 0.9 Insomnia 1.2 0.9 Nasal congestion 1.1 0.9

Common Systemic Adverse Reactions in Boys and Men 9 Through 26 Years of Age

Headache was the most commonly reported systemic adverse reaction in both treatment groups (Gardasil = 12.3% and AAHS control or saline placebo = 11.2%). Fever was the next most commonly reported systemic adverse reaction in both treatment groups (Gardasil = 8.3% and AAHS control or saline placebo = 6.5%).

Adverse reactions that were observed among recipients of Gardasil, at a frequency of greater than or equal to 1.0% where the incidence in the group that received Gardasil was greater than or equal to the incidence in the AAHS control or saline placebo group, are shown in Table 6.

Table 6: Common Systemic Adverse Reactions in Boys and Men 9 Through 26 Years of Age (Gardasil ?Control)*

Adverse Reactions

(1 to 15 Days Postvaccination)

Gardasil

(N = 3093)

%

AAHS Control† or Saline Placebo

(N = 2303)

% * The adverse reactions in this table are those that were observed among recipients of Gardasil at a frequency of at least 1.0% and greater than or equal to those observed among AAHS control or saline placebo recipients. † AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate Headache 12.3 11.2 Pyrexia 8.3 6.5 Oropharyngeal pain 2.8 2.1 Diarrhea 2.7 2.2 Nasopharyngitis 2.6 2.6 Nausea 2.0 1.0 Upper respiratory tract infection 1.5 1.0 Abdominal pain upper 1.4 1.4 Myalgia 1.3 0.7 Dizziness 1.2 0.9 Vomiting 1.0 0.8

Evaluation of Fever by Dose in Girls and Women 9 Through 26 Years of Age

An analysis of fever in girls and women by dose is shown in Table 7.

Table 7: Postdose Evaluation of Fever in Girls and Women 9 Through 26 Years of Age (1 to 5 Days Postvaccination)

Gardasil

(% occurrence)

AAHS Control* or Saline Placebo

(% occurrence) * AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate † N = Number of subjects with follow-up

Temperature

(°F)

Postdose 1

N† = 4945

Postdose 2

N = 4804

Postdose 3

N = 4671

Postdose 1

N = 3681

Postdose 2

N = 3564

Postdose 3

N = 3467 ?100 to <102 3.7 4.1 4.4 3.1 3.8 3.6 ?102 0.3 0.5 0.5 0.2 0.4 0.5

Evaluation of Fever by Dose in Boys and Men 9 Through 26 Years of Age

An analysis of fever in boys and men by dose is shown in Table 8.

Table 8: Postdose Evaluation of Fever in Boys and Men 9 Through 26 Years of Age (1 to 5 Days Postvaccination)

Gardasil

(% occurrence)

AAHS Control* or Saline Placebo

(% occurrence)

Temperature

(°F)

Postdose 1

N† = 2972

Postdose 2

N = 2849

Postdose 3

N = 2792

Postdose 1

N = 2194

Postdose 2

N = 2079

Postdose 3

N = 2046 * AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate † N = Number of individuals with follow-up ?100 to <102 2.4 2.5 2.3 2.1 2.2 1.6 ?102 0.6 0.5 0.5 0.5 0.3 0.3

Serious Adverse Reactions in the Entire Study Population

Across the clinical studies, 258 individuals (Gardasil N = 128 or 0.8%; placebo N = 130 or 1.0%) out of 29,323 (Gardasil N = 15,706; AAHS control N = 13,023; or saline placebo N = 594) individuals (9- through 45-year-old girls and women; and 9- through 26-year-old boys and men) reported a serious systemic adverse reaction.

Of the entire study population (29,323 individuals), 0.04% of the reported serious systemic adverse reactions were judged to be vaccine related by the study investigator. The most frequently (frequency of 4 cases or greater with either Gardasil, AAHS control, saline placebo, or the total of all three) reported serious systemic adverse reactions, regardless of causality, were:

Headache [0.02% Gardasil (3 cases) vs. 0.02% AAHS control (2 cases)],
Gastroenteritis [0.02% Gardasil (3 cases) vs. 0.02% AAHS control (2 cases)],
Appendicitis [0.03% Gardasil (5 cases) vs. 0.01% AAHS control (1 case)],
Pelvic inflammatory disease [0.02% Gardasil (3 cases) vs. 0.03% AAHS control (4 cases)],
Urinary tract infection [0.01% Gardasil (2 cases) vs. 0.02% AAHS control (2 cases)],
Pneumonia [0.01% Gardasil (2 cases) vs. 0.02% AAHS control (2 cases)],
Pyelonephritis [0.01% Gardasil (2 cases) vs. 0.02% AAHS control (3 cases)],
Pulmonary embolism [0.01% Gardasil (2 cases) vs. 0.02% AAHS control (2 cases)].

One case (0.006% Gardasil; 0.0% AAHS control or saline placebo) of bronchospasm; and 2 cases (0.01% Gardasil; 0.0% AAHS control or saline placebo) of asthma were reported as serious systemic adverse reactions that occurred following any vaccination visit.

In addition, there was 1 individual in the clinical trials, in the group that received Gardasil, who reported two injection-site serious adverse reactions (injection-site pain and injection-site joint movement impairment).

Deaths in the Entire Study Population

Across the clinical studies, 40 deaths (Gardasil N = 21 or 0.1%; placebo N = 19 or 0.1%) were reported in 29,323 (Gardasil N = 15,706; AAHS control N = 13,023, saline placebo N = 594) individuals (9- through 45-year-old girls and women; and 9- through 26-year-old boys and men). The events reported were consistent with events expected in healthy adolescent and adult populations. The most common cause of death was motor vehicle accident (5 individuals who received Gardasil and 4 individuals who received AAHS control), followed by drug overdose/suicide (2 individuals who received Gardasil and 6 individuals who received AAHS control), gun shot wound (1 individual who received Gardasil and 3 individuals who received AAHS control), and pulmonary embolus/deep vein thrombosis (1 individual who received Gardasil and 1 individual who received AAHS control). In addition, there were 2 cases of sepsis, 1 case of pancreatic cancer, 1 case of arrhythmia, 1 case of pulmonary tuberculosis, 1 case of hyperthyroidism, 1 case of post-operative pulmonary embolism and acute renal failure, 1 case of traumatic brain injury/cardiac arrest, 1 case of systemic lupus erythematosus, 1 case of cerebrovascular accident, 1 case of breast cancer, and 1 case of nasopharyngeal cancer in the group that received Gardasil; 1 case of asphyxia, 1 case of acute lymphocytic leukemia, 1 case of chemical poisoning, and 1 case of myocardial ischemia in the AAHS control group; and 1 case of medulloblastoma in the saline placebo group.

Systemic Autoimmune Disorders in Girls and Women 9 Through 26 Years of Age

In the clinical studies, 9- through 26-year-old girls and women were evaluated for new medical conditions that occurred over the course of follow-up. New medical conditions potentially indicative of a systemic autoimmune disorder seen in the group that received Gardasil or AAHS control or saline placebo are shown in Table 9. This population includes all girls and women who received at least one dose of Gardasil or AAHS control or saline placebo, and had safety data available.

Table 9: Summary of Girls and Women 9 Through 26 Years of Age Who Reported an Incident Condition Potentially Indicative of a Systemic Autoimmune Disorder After Enrollment in Clinical Trials of Gardasil, Regardless of Causality Conditions

Gardasil

(N = 10,706)

AAHS Control* or Saline Placebo

(N = 9412) n (%) n (%) N = Number of individuals enrolled
n = Number of individuals with specific new Medical Conditions
NOTE: Although an individual may have had two or more new Medical Conditions, the individual is counted only once within a category. The same individual may appear in different categories. * AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate † Arthralgia/Arthritis/Arthropathy includes the following terms: Arthralgia, Arthritis, Arthritis reactive, and Arthropathy ‡ Hyperthyroidism includes the following terms: Basedow's disease, Goiter, Toxic nodular goiter, and Hyperthyroidism § Hypothyroidism includes the following terms: Hypothyroidism and thyroiditis ¶ Inflammatory bowel disease includes the following terms: Colitis ulcerative, Crohn's disease, and Inflammatory bowel disease # Nephritis includes the following terms: Nephritis, Glomerulonephritis minimal lesion, Glomerulonephritis proliferative ? Pigmentation disorder includes the following terms: Pigmentation disorder, Skin depigmentation, and Vitiligo ? Psoriasis includes the following terms: Psoriasis, Pustular psoriasis, and Psoriatic arthropathy ? Rheumatoid arthritis includes juvenile rheumatoid arthritis. One woman counted in the rheumatoid arthritis group reported rheumatoid arthritis as an adverse experience at Day 130. Arthralgia/Arthritis/Arthropathy† 120 (1.1) 98 (1.0) Autoimmune Thyroiditis 4 (0.0) 1 (0.0) Celiac Disease 10 (0.1) 6 (0.1) Diabetes Mellitus Insulin-dependent 2 (0.0) 2 (0.0) Erythema Nodosum 2 (0.0) 4 (0.0) Hyperthyroidism‡
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sildenafil


sil-DEN-a-fil

Commonly used brand name(s)

In the U.S.

Revatio Viagra

Available Dosage Forms:

Tablet

Therapeutic Class: Antihypertensive, Peripheral Vasodilator

Pharmacologic Class: Phosphodiesterase Type 5 Inhibitor

Uses For sildenafil

Sildenafil is used to treat men who have erectile dysfunction (also called sexual impotence). Sildenafil belongs to a group of medicines called phosphodiesterase 5 (PDE5) inhibitors. These medicines prevent an enzyme called phosphodiesterase type-5 from working too quickly. The penis is one of the areas where this enzyme works.

The penis is one of the areas in the body where the phosphodiesterase enzyme works. By controlling the enzyme, sildenafil helps to maintain an erection after the penis is stroked. Without physical action to the penis, such as that occurring during sexual intercourse, sildenafil will not work to cause an erection.

Sildenafil is also used in both men and women to treat the symptoms of pulmonary arterial hypertension. This is a type of high blood pressure that occurs between the heart and the lungs. When hypertension occurs in the lungs, the heart must work harder to pump enough blood through the lungs. Sildenafil works on the PDE5 enzyme in the lungs to relax the blood vessels. This will increase the supply of blood to the lungs and reduce the workload of the heart.

sildenafil is available only with your doctor's prescription.

Before Using sildenafil

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

Allergies

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

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of sildenafil in children with pulmonary arterial hypertension. Safety and efficacy have not been established.

Sildenafil should never be used in children for erectile dysfunction.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sildenafil in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require an adjustment in the dose for patients receiving sildenafil.

Pregnancy Pregnancy Category Explanation All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus. Breast Feeding

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking sildenafil, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using sildenafil with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Amprenavir Amyl Nitrite Atazanavir Boceprevir Darunavir Erythrityl Tetranitrate Fosamprenavir Indinavir Isosorbide Dinitrate Isosorbide Mononitrate Lopinavir Molsidomine Nelfinavir Nitroglycerin Nitroprusside Pentaerythritol Tetranitrate Ritonavir Saquinavir Telaprevir Tipranavir

Using sildenafil with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Cannabis Dihydrocodeine Nefazodone Telithromycin Voriconazole

Using sildenafil with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Alfuzosin Bosentan Bunazosin Ciprofloxacin Delavirdine Doxazosin Erythromycin Etravirine Itraconazole Ketoconazole Moxisylyte Nebivolol Prazosin Rifapentine Silodosin Tamsulosin Terazosin Trimazosin Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using sildenafil with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use sildenafil, or give you special instructions about the use of food, alcohol, or tobacco.

Grapefruit Juice Pomelo Juice Other Medical Problems

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

Abnormal penis, including a curved penis or birth defects or Angina (chest pain) or Arrhythmia (irregular heartbeat) or Bleeding problem, history of or Coronary artery disease or Heart attack (within the last 6 months) or Heart disease or Hypertension (high blood pressure) or Hypotension (low blood pressure) or Leukemia (type of blood cancer) or Multiple myeloma (bone marrow cancer) or Priapism, history of or Retinitis pigmentosa (an inherited eye disorder) or Sickle-cell anemia (blood disorder) or Stomach ulcer, history of or Stroke (within the last 6 months)—Use with caution. May cause side effects to become worse. Age greater than 50 years or Coronary artery disease or Crowded disc or low cup to disc ratio in the eye (an eye disorder) or Diabetes or Heart disease or Hyperlipidemia (high fats in the blood) or Hypertension (high blood pressure) or Non-arteritic anterior ischemic optic neuropathy or NAION (serious eye condition), history of or Smoking—May increase the chance for a serious side effect in the eye called NAION. Kidney disease, severe or Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body. Pulmonary veno-occlusive disease or PVOD (a type of lung disease)—May make this condition worse. Proper Use of sildenafil

sildenafil comes with patient instructions. Read and follow these instructions carefully each time you get a refill of your medicine. Ask your doctor if you have any questions.

Use sildenafil exactly as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. If too much is used, the chance of side effects is increased.

When using sildenafil for pulmonary arterial hypertension, you may take it with or without food.

sildenafil usually begins to work for erectile dysfunction within 30 minutes after taking it. It continues to work for up to 4 hours, although its action is usually less after 2 hours.

Use only the brand of sildenafil that your doctor prescribed. Different brands may not work the same way.

Dosing

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

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

For oral dosage form (tablets): For treatment of erectile dysfunction: Adults up to 65 years of age—50 milligrams (mg) as a single dose no more than once a day, 1 hour before sexual intercourse. Alternatively, the medicine may be taken 30 minutes to 4 hours before sexual intercourse. Your doctor may adjust your dose if needed. Adults 65 years of age and older—25 mg as a single dose no more than once a day, 1 hour before sexual intercourse. Alternatively, the medicine may be taken 30 minutes to 4 hours before sexual intercourse. Your doctor may adjust your dose if needed. Teenagers and children—Not recommended for this age group. For treatment of pulmonary arterial hypertension: Adults—20 milligrams (mg) three times a day. Each dose should be taken about 4 to 6 hours apart. Children—Use and dose must be determined by your doctor. Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using sildenafil

It is important that you tell all of your doctors that you take sildenafil. If you need emergency medical care for a heart problem, it is important that your doctor knows when you last took sildenafil.

If you will be taking sildenafil for pulmonary arterial hypertension, your doctor will want to check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

If you take sildenafil for pulmonary arterial hypertension, do not take Viagra® or other PDE5 inhibitors, such as tadalafil (Cialis®) or vardenafil (Levitra®). Viagra® also contains sildenafil. If you take too much sildenafil or take it together with these medicines, the chance for side effects will be higher.

Sildenafil should not be used with any other medicine or device that causes erections.

If you experience a prolonged or painful erection for 4 hours or more, contact your doctor immediately. This condition may require prompt medical treatment to prevent tissue damage to the penis and possibly permanent impotence.

sildenafil does not protect you against sexually transmitted diseases. Use protective measures and ask your doctor if you have any questions about this.

Do not use sildenafil if you are also using a nitrate medicine for chest pain (angina). Some examples of nitrate medicines are: isosorbide, nitroglycerin, Imdur®, Nitro-Bid®, Nitro-Dur®, Nitrol® ointment, Nitrolingual® spray, Nitrostat®, and Transderm Nitro®. Some illegal ("street") drugs or "poppers" also contain nitrates, such as amyl nitrate, butyl nitrate, or nitrite.

It is important to tell your doctor about any heart problems you have now or may have had in the past. sildenafil can cause serious side effects in patients with heart problems.

If you experience a sudden loss of vision in one or both eyes, stop using sildenafil and contact your doctor right away. This could be a symptom of a very serious eye condition called non-arteritic anterior ischemic optic neuropathy (NAION).

Stop using sildenafil and check with your doctor right away if you have a sudden decrease in hearing or loss of hearing. You might also have dizziness and ringing in the ears.

If you already use medicine for high blood pressure (hypertension), sildenafil could make your blood pressure go too low. Call your doctor right away if you have more than one of these symptoms: blurred vision; confusion; dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly; sweating; or unusual tiredness or weakness.

sildenafil Side Effects

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

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

Less common Bladder pain burning feeling in the chest or stomach burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings cloudy or bloody urine dizziness increased frequency of urination indigestion pain on urination stomach upset tenderness in the stomach area Rare Abnormal vision anxiety behavior change similar to drunkenness bleeding of the eye blurred vision bone pain breast enlargement chest pain chills cold sweats confusion convulsions (seizures) cool and pale skin deafness or hearing loss decrease in amount of urine or the frequency of urination decreased vision difficulty in concentrating dizziness or lightheadedness, especially when getting up from a lying or sitting position suddenly double vision drowsiness dry eyes dry mouth dryness, redness, scaling, or peeling of the skin excessive hunger eye pain fainting or faintness fast, irregular, or pounding heartbeat feeling of something in the eye fever or chills headache (severe or continuing) heart failure hives increase in the size of the pupil increased sweating increased thirst itching of the skin low blood pressure lower back or side pain migraine headache nausea (severe or continuing) nervousness nightmares numbness of the hands painful, swollen joints prolonged, painful erection of penis redness, burning, or swelling of the eyes redness, itching, or tearing of the eyes restless sleep seeing shades of colors differently than before sensitivity to light shakiness shortness of breath skin lesions with swelling skin paleness skin rash skin ulcers slurred speech sore throat sudden weakness swelling of the face, hands, feet, or lower legs trouble with breathing twitching of the muscles unusual feeling of burning or stinging of the skin unusual tiredness or weakness vision changes vision loss, temporary Incidence not known Blindness

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

More common Aches or pains in the muscles bloody nose diarrhea difficult or labored breathing flushing headache nasal congestion pain or tenderness around the eyes and cheekbones redness of the skin sneezing stomach discomfort following meals stuffy or runny nose trouble sleeping unusually warm skin Rare Abdominal or stomach pain abnormal dreams anxiety clumsiness or unsteadiness cough diarrhea or stomach cramps (severe or continuing) difficulty in swallowing ear pain increased amount of saliva increased skin sensitivity lack of coordination loss of bladder control mental depression nausea numbness or tingling of the hands, legs, or feet rectal bleeding redness or irritation of the tongue redness, soreness, swelling, or bleeding of the gums ringing or buzzing in the ears sensation of motion, usually whirling, either of one's self or of one's surroundings sexual problems in men (continuing), including failure to experience a sexual orgasm sleepiness sores in the mouth and on the lips tense muscles tightness of the chest or wheezing trembling and shaking vomiting waking to urinate at night worsening of asthma

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

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

See also: sildenafil side effects (in more detail)

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

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

More sildenafil resources Sildenafil Side Effects (in more detail) Sildenafil Dosage Sildenafil Use in Pregnancy & Breastfeeding Sildenafil Drug Interactions Sildenafil Support Group 53 Reviews for Sildenafil - Add your own review/rating Sildenafil MedFacts Consumer Leaflet (Wolters Kluwer) Revatio Consumer Overview Revatio Prescribing Information (FDA) Sildenafil Citrate Monograph (AHFS DI) Viagra Prescribing Information (FDA) Viagra MedFacts Consumer Leaflet (Wolters Kluwer) Viagra Consumer Overview Compare sildenafil with other medications Erectile Dysfunction Pulmonary Arterial Hypertension Sexual Dysfunction, SSRI Induced
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Procto-Pak 1% cream, ointment, suppository


Generic Name: hydrocortisone rectal (cream, ointment, suppository) (hye dro KORT i zone REK tal)
Brand Names: Anucort-HC, Anumed-HC, Anusol-HC, Cortizone-10 Anal Itch Cream, Hemorrhoidal HC, Hemril-30, Hemril-HC Uniserts, Preparation H Hydrocortisone, Procto-Kit 1%, Procto-Kit 2.5%, Procto-Pak 1%, Proctocort, Proctocream-HC, Proctosert HC, Proctosol-HC, Proctozone HC, Proctozone-H, Recort Plus, Rectasol-HC, Tucks HC

What is hydrocortisone rectal?

Hydrocortisone is a steroid medicine that reduces inflammation in the body.

The information in this medication guide is specific to hydrocortisone rectal cream, ointment, or suppository.

Hydrocortisone rectal is used to treat itching or swelling caused by hemorrhoids or other inflammatory conditions of the rectum or anus.

Hydrocortisone rectal is also used together with other medications to treat ulcerative colitis, proctitis, and other inflammatory conditions of the lower intestines and rectal area.

Hydrocortisone rectal may also be used for purposes not listed in this medication guide.

What is the most important information I should know about hydrocortisone rectal?

The information in this medication guide is specific to hydrocortisone rectal cream, ointment, or suppository.

Do not take hydrocortisone rectal by mouth. It is for use only in your rectum.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions. You may need to use this medication for up to 8 weeks.

Call your doctor at once if you have any bleeding from your rectum, feeling short of breath (even with mild exertion), swelling of your ankles or feet, or rapid weight gain.

There may be other drugs that can interact with hydrocortisone rectal. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Call your doctor if your symptoms do not improve or if they get worse after using this medicine for a few days.

What should I discuss with my health care provider before using hydrocortisone rectal?

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have:

congestive heart failure;

a history of tuberculosis;

stomach ulcer or diverticulitis;

a colostomy or ileostomy;

fever or any type of infection;

kidney disease;

high blood pressure; or

myasthenia gravis.

Also tell your doctor if you have diabetes. Steroid medicines may increase the glucose (sugar) levels in your blood or urine. You may also need to adjust the dose of your diabetes medications.

FDA pregnancy category C. It is not known whether hydrocortisone rectal will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether hydrocortisone passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I use hydrocortisone rectal?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Do not take hydrocortisone rectal by mouth. It is for use only in your rectum.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions. You may need to use this medication for up to 8 weeks.

Wash your hands before and after using this medicine.

Try to empty your bowel and bladder just before using hydrocortisone rectal.

Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands. The rectal suppository can stain clothing or other fabrics it comes into contact with.

For best results from the suppository, lie down after inserting it and hold in the suppository. The suppository will melt quickly once inserted and you should feel little or no discomfort while holding it in.

For best results from the cream, use only the applicator provided with the medication. Otherwise, follow the directions provided with your rectal cream.

Avoid using the bathroom for one to three hours after inserting the cream or suppository.

Apply the ointment to the rectum and surrounding skin of the rectal area as directed on the package label.

Call your doctor if your symptoms do not improve or if they get worse after using this medicine for a few days.

Store the rectal cream at room temperature away from moisture and heat. Store the rectal suppositories at cool room temperature away from moisture and heat. Do not refrigerate or freeze them. What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose of hydrocortisone rectal is not expected to produce life-threatening symptoms. However, long-term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while using hydrocortisone rectal ?

Avoid getting a vaccine during your treatment with hydrocortisone rectal. Vaccines may not work as well while you are using a steroid medicine.

Hydrocortisone rectal side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

feeling short of breath, even with mild exertion;

swelling of your ankles or feet;

muscle weakness;

rapid weight gain, especially in your face and midsection;

severe rectal pain or burning;

bleeding from your rectum;

severe stomach pain;

sudden and severe headache or pain behind your eyes; or

seizure (convulsions).

Less serious side effects may include:

mild rectal pain or burning;

acne;

changes in your menstrual periods;

increased sweating; or

increased facial or body hair growth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect hydrocortisone rectal ?

Before using hydrocortisone rectal, tell your doctor if you also use insulin or take oral diabetes medication.

There may be other drugs that can interact with hydrocortisone rectal. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Procto-Pak 1% resources Procto-Pak 1% Side Effects (in more detail) Procto-Pak 1% Use in Pregnancy & Breastfeeding Procto-Pak 1% Drug Interactions Procto-Pak 1% Support Group 0 Reviews for Procto-Pak% - Add your own review/rating Compare Procto-Pak 1% with other medications Anal Itching Aphthous Stomatitis, Recurrent Atopic Dermatitis Dermatitis Eczema Gingivitis Hemorrhoids Proctitis Pruritus Psoriasis Seborrheic Dermatitis Ulcerative Colitis, Active Where can I get more information? Your pharmacist can provide more information about hydrocortisone rectal cream, ointment, or suppository.

See also: Procto-Pak% side effects (in more detail)


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Lamisil Cream


1. Name Of The Medicinal Product

LAMISIL® Cream

2. Qualitative And Quantitative Composition

Terbinafine hydrochloride 1.0% w/w

3. Pharmaceutical Form

White, smooth or almost smooth glossy cream

4. Clinical Particulars 4.1 Therapeutic Indications

Fungal infections of the skin caused by Trichophyton (eg. T. Rubrum, T.Mentagrophytes, T. Verrucosum, T. Violaceum), Microsporum canis and Epidermophyton floccosum.

Yeast infections of the skin, principally those caused by the genus Candida (eg. C. albicans).

Pityriasis (tinea) versicolor due to Pityrosporum orbiculare (also known as Malassezia furfur).

4.2 Posology And Method Of Administration

LAMISIL can be applied once or twice daily. Cleanse and dry the affected areas thoroughly before application of LAMISIL. Apply the cream to the affected skin and surrounding area in a thin layer and rub in lightly. In the case of intertriginous infections (submammary, interdigital, intergluteal, inguinal) the application may be covered with a gauze strip, especially at night.

The likely durations of treatment are as follows:

Tinea corporis, cruris: 1 to 2 weeks

Tinea pedis: 1 week

Cutaneous candidiasis: 2 weeks

Pityriasis versicolor: 2 weeks

Relief of clinical symptoms usually occurs within a few days. Irregular use or premature discontinuation of treatment carries the risk of recurrence. If there are no signs of improvement after two weeks, the diagnosis should be verified.

Children

The experience with topical LAMISIL in children is still limited and its use cannot therefore be recommended.

Use in the elderly

There is no evidence to suggest that elderly patients require different dosages or experience side-effects different to those of younger patients.

Method of administration

Via the topical route.

4.3 Contraindications

Hypersensitivity to terbinafine or any of the excipients contained in the cream.

4.4 Special Warnings And Precautions For Use

LAMISIL Cream is for external use only. Contact with the eyes should be avoided. In case of accidental contact with the eyes, rinse the eyes thoroughly with running water.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

There are no known drug interactions with LAMISIL Cream.

4.6 Pregnancy And Lactation

Foetal toxicity and fertility studies in animals suggest no adverse effects.

There is no clinical experience with LAMISIL Cream in pregnant women, therefore, unless the potential benefits outweigh any potential risks, LAMISIL Cream should not be administered during pregnancy.

Terbinafine is excreted in breast milk and therefore mothers should not receive LAMISIL whilst breast-feeding. Infants should also not be allowed to come into contact with any treated skin, including the breast.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Redness, itching or stinging occasionally occur at the site of application; however, treatment rarely has to be discontinued for this reason. This must be distinguished from allergic reactions such as pruritus, rash, bullous eruptions and hives which are very rare but require discontinuation.

4.9 Overdose

The low systemic absorption of topical terbinafine cream renders overdosage extremely unlikely. Accidental ingestion of the contents of one 30g tube of LAMISIL Cream, which contains 300mg terbinafine hydrochloride, is comparable to one LAMISIL 250mg tablet (adult oral unit dose).

No case of overdosage has been reported with LAMISIL Cream. However, should a larger amount of LAMISIL Cream be inadvertently ingested, adverse effects similar to those observed with an overdosage of LAMISIL tablets are to be expected. These include headache, nausea, epigastric pain and dizziness.

The recommended treatment of overdosage consists of eliminating the drug, primarily by the administration of activated charcoal, and giving symptomatic supportive therapy, if needed.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Antifungal for topical use (ATC code D01A E15)

Terbinafine is an allylamine which has a broad spectrum of antifungal activity. At low concentrations terbinafine is fungicidal against dermatophytes, moulds and certain dimorphic fungi. The activity versus yeasts is fungicidal or fungistatic depending of the species.

Terbinafine interferes specifically with fungal sterol biosynthesis at an early step. This leads to a deficiency in ergosterol and to an intracellular accumulation of squalene, resulting in fungal cell death. Terbinafine acts by inhibition of squalene epoxidase in the fungal cell membrane. The enzyme squalene epoidase is not linked to the cytochrome P450 system.

5.2 Pharmacokinetic Properties

Less than 5% of the dose is absorbed after topical application to humans; systemic exposure is therefore very slight.

5.3 Preclinical Safety Data

None stated

6. Pharmaceutical Particulars 6.1 List Of Excipients

Sodium hydroxide, benzyl alcohol, sorbitan monostearate, cetyl palmitate, cetyl alcohol, stearyl alcohol, polysorbate 60, isopropyl myristate, demineralised water.

6.2 Incompatibilities

None known.

6.3 Shelf Life

Aluminium tube: 5 years.

Polypropylene dispenser tube: 3 years.

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

Aluminium tube with membrane, with an interior coating of phenol-epoxy based lacquer, closed with a polypropylene cap, containing 15g or 30g LAMISIL Cream.

Polypropylene dispenser tube with polypropylene screw-cap closure containing 15 or 30g LAMISIL cream

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Novartis Consumer Health UK Limited

Wimblehurst Road

Horsham

West Sussex

RH 12 5AB

United Kingdom

8. Marketing Authorisation Number(S)

PL 00030/0421

9. Date Of First Authorisation/Renewal Of The Authorisation

3 October 1990 / 18 April 2001

10. Date Of Revision Of The Text

27th April 2009

Legal category: POM


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Zema-Pak


dexamethasone
Dosage Form: tablets
Zema-Pak 6 Day
Zema-Pak 10 Day
Zema-Pak 13 Day

Each tablet in the Zema-Pak 6 Day pack (21 tablets); the Zema-Pak 10 Day (35 tablets); or Zema-Pak 13 Day pack (51 tablets) contains:
Dexamethasone USP, 1.5mg.

Rx Only

Zema-Pak Description

Dexamethasone tablets USP, 1.5mg for oral adminsitration, inactive ingredients are microcrystalline cellulose NF, anhydrous lactose NF, FD&C Red #40 aluminum lake, croscarmellose sodium NF, and magnesium stearate NF. The molecular weight for dexamethasone is 392.47. It is designated chemicalyas9-fluoro-113,17,21-trihydroxy-16oz-methylpregna-1,4-diene-3,20-dione.the empirical formula is C22H29FO5 and the structural formula is:

Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water.

Zema-Pak - Clinical Pharmacology

Glucocorticoids, naturally occurring and synthetic, are adrenocortical steroids that are readily absorbed from the gastrointestinal tract. Glucocorticoids cause varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli. Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have sodium-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs including dexamethasone are primarily used for their anti-inflammatory effects in disorders of many organ systems. At equipotent anti-inflammatory doses, dexamethasone almost completely lacks the sodium-retaining property of hydrocortisone and closely related derivatives of hydrocortisone.

Indications and Usage for Zema-Pak Allergic states

Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness.

Dermatologic diseases

Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome).

Endocrine disorders

Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis.

Gastrointestinal diseases

To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis.

Hematologic disorders

Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia.

Miscellaneous

Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy.

Neoplastic diseases

For the palliative management of leukemias and lymphomas.

Nervous system

Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury.

Ophthalmic diseases

Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids.

Renal diseases

To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus.

Respiratory diseases

Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.

Rheumatic disorders

As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.

Contraindications

Systemic fungal infections (see WARNINGS, Fungal infections).

Dexamethasone USP tablets are contraindicated in patients who are hypersensitive to any components of this product.

Warnings General

Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy (see ADVERSE REACTIONS). Increased dosage of rapidly acting corticosteroids is indicated in patients on corticosteroid therapy subjected to any unusual stress before, during, and after the stressful situation.

Cardio-renal

Average and large doses of corticosteroids can cause elevation of blood pressure, sodium and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion.

Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients.

Endocrine

Corticosteroids can produce reversible hypothalamic-pituitary adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Adrenocortical insufficiency may result from too rapid withdrawal of corticosteroids and may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. If the patient is receiving steroids already, dosage may have to be increased. Metabolic clearance of corticosteroids is decreased in hypothyroid patients and increased in hyperthyroid patients. Changes in thyroid status of the patient may necessitate adjustment in dosage.

Infections General

Patients who are on corticosteroids are more susceptible to infections than are healthy individuals. There may be decreased resistance and inability to localize infection when corticosteroids are used. Infection with any pathogen (viral, bacterial, fungal, protozoan or helminthic) in any location of the body may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents. These infections may be mild to severe. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases. Corticosteroids may also mask some signs of current infection.

Fungal Infections

Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control life-threatening drug reactions. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure (see PRECAUTIONS, Drug Interactions, Amphotericin B injection and potassium-depleting agents).

Special Pathogens

Latent disease may be activated or there may be an exacerbation of intercurrent infections due to pathogens, including those caused by Amoeba, Candida, Cryptococcus, Mycobacterium, Nocardia, Pneumocystis, Toxoplasma.

It is recommended that latent amebiasis or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or any patient with unexplained diarrhea. Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia.

Corticosteroids should not be used in cerebral malaria.

Tuberculosis

The use of corticosteroids in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate antituberculous regimen. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.

Vaccination

Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered. However, the response to such vaccines cannot be predicted. Immunization procedures may be undertaken in patients who are receiving corticosteroids as replacement therapy, e.g., for Addison's disease.

Viral Infections

Chickenpox and measles can have a more serious or even fatal course in pediatric and adult patients on corticosteroids. In pediatric and adult patients who have not had these diseases, particular care should be taken to avoid exposure. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with immune globulin (IG) may be indicated. (See the respective package inserts for VZIG and IG for complete prescribing information.) If chickenpox develops, treatment with antiviral agents should be considered.

Ophthalmic

Use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses. The use of oral corticosteroids is not recommended in the treatment of optic neuritis and may lead to an increase in the risk of new episodes. Corticosteroids should not be used in active ocular herpes simplex.

Precautions General

The lowest possible dose of corticosteroids should be used to control the condition under treatment. When reduction in dosage is possible, the reduction should be gradual.

Since complications of treatment with corticosteroids are dependent on the size of the dose and the duration of treatment, a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used.

Kaposi's sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement.

Cardio-renal

As sodium retention with resultant edema and potassium loss may occur in patients receiving corticosteroids, these agents should be used with caution in patients with congestive heart failure, hypertension, or renal insufficiency.

Endocrine

Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently.

Gastrointestinal

Steroids should be used with caution in active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation. Signs of peritoneal irritation following gastrointestinal perforation in patients receiving corticosteroids may be minimal or absent.

There is an enhanced effect due to decreased metabolism of corticosteroids in patients with cirrhosis.

Musculoskeletal

Corticosteroids decrease bone formation and increase bone resorption both through their effect on calcium regulation (i.e., decreasing absorption and increasing excretion) and inhibition of osteoblast function. This, together with a decrease in the protein matrix of the bone secondary to an increase in protein catabolism, and reduced sex hormone production, may lead to inhibition of bone growth in pediatric patients and the development of osteoporosis at any age. Special consideration should be given to patients at increased risk of osteoporosis (e.g., postmenopausal women) before initiating corticosteroid therapy.

Neuro-psychiatric

Although controlled clinical trials have shown corticosteroids to be effective in speeding the resolution of acute exacerbations of multiple sclerosis, they do not show that they affect the ultimate outcome or natural history of the disease. The studies do show that relatively high doses of corticosteroids are necessary to demonstrate a significant effect. (See DOSAGE AND ADMINISTRATION.)

An acute myopathy has been observed with the use of high doses of corticosteroids, most often occurring in patients with disorders of neuromuscular transmission (e.g., myasthenia gravis), or in patients receiving concomitant therapy with neuromuscular blocking drugs (e.g., pancuronium). This acute myopathy is generalized, may involve ocular and respiratory muscles, and may result in quadriparesis. Elevation of creatinine kinase may occur. Clinical improvement or recovery after stopping corticosteroids may require weeks to years.

Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.

Ophthalmic

Intraocular pressure may become elevated in some individuals. If steroid therapy is continued for more than 6 weeks, intraocular pressure should be monitored.

Information for Patients

Patients should be warned not to discontinue the use of corticosteroids abruptly or without medical supervision. As prolonged use may cause adrenal insufficiency and make patients dependent on corticosteroids, they should advise any medical attendants that they are taking corticosteroids and they should seek medical advice at once should they develop an acute illness including fever or other signs of infection. Following prolonged therapy, withdrawal of corticosteroids may result in symptoms of the corticosteroid withdrawal syndrome including myalgia, arthralgia, and malaise.

Persons who are on corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.

Drug Interactions Aminoglutethimide

Aminoglutethimide may diminish adrenal suppression by corticosteroids.

Amphotericin B injection and potassium-depleting agents

When corticosteroids are administered concomitantly with potassium-depleting agents (e.g., amphotericin B, diuretics), patients should be observed closely for development of hypokalemia. In addition, there have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure.

Antibiotics

Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance (see Drug Interactions, Hepatic Enzyme Inducers, Inhibitors and Substrates).

Anticholinesterases

Concomitant use of anticholinesterase agents and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy.

Anticoagulants, oral

Co-administration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect.

Antidiabetics

Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required.

Antitubercular drugs

Serum concentrations of isoniazid may be decreased.

Cholestyramine

Cholestyramine may increase the clearance of corticosteroids.

Cyclosporine

Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use.

Dexamethasone suppression test (DST)

False-negative results in the dexamethasone suppression test (DST) in patients being treated with indomethacin have been reported. Thus, results of the DST should be interpreted with caution in these patients.

Digitalis glycosides

Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia.

Ephedrine

Ephedrine may enhance the metabolic clearance of corticosteroids, resulting in decreased blood levels and lessened physiologic activity, thus requiring an increase in corticosteroid dosage.

Estrogens, including oral contraceptives

Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect.

Hepatic Enzyme Inducers, Inhibitors and Substrates

Drugs which induce cytochrome P450 3A4 (CYP 3A4) enzyme activity (e.g., barbiturates, phenytoin, carbamazepine, rifampin) may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased. Drugs which inhibit CYP 3A4 (e.g., ketoconazole, macrolide antibiotics such as erythromycin) have the potential to result in increased plasma concentrations of corticosteroids. Dexamethasone is a moderate inducer of CYP 3A4. Co-administration with other drugs that are metabolized by CYP 3A4 (e.g., indinavir, erythromycin) may increase their clearance, resulting in decreased plasma concentration.

Ketoconazole

Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to increased risk of corticosteroid side effects. In addition, ketoconazole alone can inhibit adrenal corticosteroid synthesis and may cause adrenal insufficiency during corticosteroid withdrawal.

Nonsteroidal anti-inflammatory agents (NSAIDS)

Concomitant use of aspirin (or other nonsteroidal anti-inflammatory agents) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids.

Phenytoin

In post-marketing experience, there have been reports of both increases and decreases in phenytoin levels with dexamethasone co-administration, leading to alterations in seizure control.

Skin tests

Corticosteroids may suppress reactions to skin tests.

Thalidomide

Co-administration with thalidomide should be employed cautiously, as toxic epidermal necrolysis has been reported with concomitant use.

Vaccines

Patients on corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. Routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible (see WARNINGS, Infections, Vaccination).

Carcinogenesis, Mutagenesis, Impairment of Fertility

No adequate studies have been conducted in animals to determine whether corticosteroids have a potential for carcinogenesis or mutagenesis.

Steroids may increase or decrease motility and number of spermatozoa in some patients.

Pregnancy Teratogenic Effects Pregnancy Category C

Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.

Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from corticosteroids, 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

The efficacy and safety of corticosteroids in the pediatric population are based on the well-established course of effect of corticosteroids, which is similar in pediatric and adult populations. Published studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephrotic syndrome (patients >2 years of age), and aggressive lymphomas and leukemias (patients >1 month of age). Other indications for pediatric use of corticosteroids, e.g., severe asthma and wheezing, are based on adequate and well-controlled trials conducted in adults, on the premises that the course of the diseases and their pathophysiology are considered to be substantially similar in both populations.

The adverse effects of corticosteroids in pediatric patients are similar to those in adults (see ADVERSE REACTIONS). Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis. Pediatric patients who are treated with corticosteroids by any route, including systemically administered corticosteroids, may experience a decrease in their growth velocity. This negative impact of corticosteroids on growth has been observed at low systemic doses and in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression (i.e., cosyntropin stimulation and basal cortisol plasma levels). Growth velocity may therefore be a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The linear growth of pediatric patients treated with corticosteroids should be monitored, and the potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of treatment alternatives. In order to minimize the potential growth effects of corticosteroids, pediatric patients should be titrated to the lowest effective dose.

Geriatric Use

Clinical studies 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. In particular, the increased risk of diabetes mellitus, fluid retention and hypertension in elderly patients treated with corticosteroids should be considered.

ADVERSE REACTIONS (listed alphabetically, under each subsection)

The following adverse reactions have been reported with dexamethasone or other corticosteroids:

Allergic reactions: Anaphylactoid reaction, anaphylaxis, angioedema.

Cardiovascular: Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction (see WARNINGS, Cardio-renal), edema, pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.

Dermatologic: Acne, allergic dermatitis, dry scaly skin, ecchymoses and petechiae, erythema, impaired wound healing, increased sweating, rash, striae, suppression of reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria.

Endocrine: Decreased carbohydrate and glucose tolerance, development of cushingoid state, hyperglycemia, glycosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic agents in diabetes, manifestations of latent diabetes mellitus, menstrual irregularities, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery, or illness), suppression of growth in pediatric patients.

Fluid and electrolyte disturbances: Congestive heart failure in susceptible patients, fluid retention, hypokalemic alkalosis, potassium loss, sodium retention.

Gastrointestinal: Abdominal distention, elevation in serum liver enzyme levels (usually reversible upon discontinuation), hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine (particularly in patients with inflammatory bowel disease), ulcerative esophagitis.

Metabolic: Negative nitrogen balance due to protein catabolism.

Musculoskeletal: Aseptic necrosis of femoral and humeral heads, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, steroid myopathy, tendon rupture, vertebral compression fractures.

Neurological/Psychiatric: Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo.

Ophthalmic: Exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts.

Other: Abnormal fat deposits, decreased resistance to infection, hiccups, increased or decreased motility and number of spermatozoa, malaise, moon face, weight gain.

Overdosage

Treatment of overdosage is by supportive and symptomatic therapy. In the case of acute overdosage, according to the patient's condition, supportive therapy may include gastric lavage or emesis.

Zema-Pak Dosage and Administration For oral administration

The initial dosage of dexamethasone varies from 0.75 to 9 mg a day depending on the disease being treated.

It Should Be Emphasized That Dosage Requirements Are Variable And Must Be Individualized On The Basis Of The Disease Under Treatment And The Response Of The Patient.

After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage that maintains an adequate clinical response is reached.

Situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment. In this latter situation it may be necessary to increase the dosage of the corticosteroid for a period of time consistent with the patient's condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.

In the treatment of acute exacerbations of multiple sclerosis, daily doses of 30 mg of dexamethasone for a week followed by 4 to 12 mg every other day for one month have been shown to be effective (see PRECAUTIONS, Neuro-psychiatric).

In pediatric patients, the initial dose of dexamethasone may vary depending on the specific disease entity being treated. The range of initial doses is 0.02 to 0.3 mg/kg/day in three or four divided doses (0.6 to 9 mg/m2bsa/day).

For the purpose of comparison, the following is the equivalent milligram dosage of the various corticosteroids:

Dexamethasone, 1.5 Methylprednisolone, 8 Prednisone, 10 Triamcinolone, 8 Prednisolone, 10 Betamethasone, 1.5 Hydrocortisone, 40 Paramethasone, 4 Cortisone, 50

These dose relationships apply only to oral or intravenous administration of these compounds. When these substances or their derivatives are injected intramuscularly or into joint spaces, their relative properties may be greatly altered.

In cerebral edema, Dexamethasone Sodium Phosphate injection, USP is generally administered initially in a dosage of 10 mg intravenously followed by 4 mg every six hours intramuscularly until the symptoms of cerebral edema subside. Response is usually noted within 12 to 24 hours and dosage may be reduced after two to four days and gradually discontinued over a period of five to seven days. For palliative management of patients with recurrent or inoperable brain tumors, maintenance therapy with either Dexamethasone Sodium Phosphate injection, USP or dexamethasone tablets in a dosage of 2 mg two or three times daily may be effective.

Dexamethasone suppression tests Tests for Cushing's syndrome
Give 1.0 mg of Dexamethasone USP orally at 11:00 p.m. Blood is drawn for plasma cortisol determination at 8:00 a.m. the following morning.
For greater accuracy, give 0.5 mg of Dexamethasone USP orally every 6 hours for 48 hours. Twenty-four hour urine collections are made for determination of 17-hydroxycorticosteroid excretion. Test to distinguish Cushing's syndrome due to pituitary ACTH excess from Cushing's syndrome due to other causes.
Give 2.0 mg of Dexamethasone USP orally every 6 hours for 48 hours. Twenty-four hour urine collections are made for determination of 17-hydroxycorticosteroid excretion. How is Zema-Pak Supplied

Each Zema-Pak 6 Day contains 21 dexamethasone, USP, 1.5mg tablets (NDC 44183-509-21)

Each Zema-Pak 10 Day contains 35 dexamethasone, USP, 1.5mg tablets (NDC 44183-507-35)

Each Zema-Pak 13 Day contains 51 dexamethasone, USP, 1.5mg tablets (NDC 44183-508-51)

Each round, pink dexamethasone tablet is scored and coded "54/943".

Storage

Store at controlled room temperature 68 to 77°F (20 to 25°C).

Rx Only

Keep This and All Medications Out of the Reach of Children.

Manufactured for
Macoven Pharmaceuticals
Magnolia, Texas

MI 0086
Rev. 8/09

PRINCIPAL DISPLAY PANEL - 21 Tablet Carton

NDC 44183-509-21

21 Tablets

Zema-Pak

6 DAY

TAPERED ORAL STEROID THERAPY
Each Tablet Contains:
Dexamethasone, USP . . . 1.5 mg

Usual Adult Dosage: See enclosed
product literature for additional information.
Use Only as Directed by Physician

Rx ONLY

Manufactured for:
Macoven Pharmaceuticals
Magnolia, TX 77354

LOT
EXP

Marketed also by: Pernix Therapeutics, LLC
Gonzales, LA 70737

PRINCIPAL DISPLAY PANEL - 35 Tablet Carton

NDC 44183-507-35

35 Tablets

Zema-Pak

10 DAY

TAPERED ORAL STEROID THERAPY
Each Tablet Contains:
Dexamethasone, USP . . . 1.5 mg

See enclosed product literature
for additional information.
Use Only as Directed by Physician

Rx ONLY

Manufactured for:
Macoven Pharmaceuticals
Magnolia, TX 77354

LOT
EXP

Marketed also by: Pernix Therapeutics, LLC
Gonzales, LA 70737

PRINCIPAL DISPLAY PANEL - 51 Tablet Carton

NDC 44183-508-51

51 Tablets

Zema-Pak

13 DAY

TAPERED ORAL STEROID THERAPY
Each Tablet Contains:
Dexamethasone, USP . . . 1.5 mg

Usual Adult Dosage: See enclosed
product literature for additional information.
Use Only as Directed by Physician

Rx ONLY

Manufactured for:
Macoven Pharmaceuticals
Magnolia, TX 77354

LOT
EXP

Marketed also by: Pernix Therapeutics, LLC
Gonzales, LA 70737


ZEMA PAK 
dexamethasone  tablet Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 44183-509 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dexamethasone (Dexamethasone) Dexamethasone 1.5 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE   ANHYDROUS LACTOSE   FD&C RED NO. 40   ALUMINUM OXIDE   CROSCARMELLOSE SODIUM   MAGNESIUM STEARATE   Product Characteristics Color PINK Score 2 pieces Shape ROUND Size 6mm Flavor Imprint Code 54;943 Contains          Packaging # NDC Package Description Multilevel Packaging 1 44183-509-21 21 TABLET In 1 DOSE PACK None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA084610 07/07/2006
ZEMA PAK 
dexamethasone  tablet Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 44183-507 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dexamethasone (Dexamethasone) Dexamethasone 1.5 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE   ANHYDROUS LACTOSE   FD&C RED NO. 40   ALUMINUM OXIDE   CROSCARMELLOSE SODIUM   MAGNESIUM STEARATE   Product Characteristics Color PINK Score 2 pieces Shape ROUND Size 6mm Flavor Imprint Code 54;943 Contains          Packaging # NDC Package Description Multilevel Packaging 1 44183-507-35 35 TABLET In 1 DOSE PACK None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA084610 07/07/2006
ZEMA PAK 
dexamethasone  tablet Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 44183-508 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dexamethasone (Dexamethasone) Dexamethasone 1.5 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE   ANHYDROUS LACTOSE   FD&C RED NO. 40   ALUMINUM OXIDE   CROSCARMELLOSE SODIUM   MAGNESIUM STEARATE   Product Characteristics Color PINK Score 2 pieces Shape ROUND Size 6mm Flavor Imprint Code 54;943 Contains          Packaging # NDC Package Description Multilevel Packaging 1 44183-508-51 51 TABLET In 1 DOSE PACK None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA084610 07/07/2006
Labeler - Macoven Pharmaceuticals LLC (832591965) Revised: 09/2010Macoven Pharmaceuticals LLC
More Zema-Pak resources Zema-Pak Side Effects (in more detail) Zema-Pak Dosage Zema-Pak Use in Pregnancy & Breastfeeding Zema-Pak Drug Interactions 0 Reviews for Zema-Pak - Add your own review/rating Compare Zema-Pak with other m
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Lamisil AT 1% Cream


1. Name Of The Medicinal Product

Lamisil AT ® 1% Cream

2. Qualitative And Quantitative Composition

Terbinafine hydrochloride 1% w/w

3. Pharmaceutical Form

Cream

4. Clinical Particulars 4.1 Therapeutic Indications

The treatment of tinea pedis (athlete's foot) and tinea cruris (dhobie itch/jock itch) caused by Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum) and Epidermophyton floccosum.

4.2 Posology And Method Of Administration

Adults

Lamisil AT 1% Cream is applied once daily.

The affected area should be cleaned and dried thoroughly before application of Lamisil AT 1% Cream. The cream should be applied to the affected skin and surrounding area in a thin layer and rubbed in lightly. In the case of intertriginous infections (interdigital, intergluteal, inguinal) the application may be covered with a gauze strip, especially at night.

Duration of treatment is one week for tinea pedis and tinea cruris. Relief of clinical symptoms usually occurs within a few days. Irregular use or premature discontinuation of treatment carries the risk of recurrence. If there are no signs of improvement after two weeks, the diagnosis should be verified by a physician.

Children

The experience with topical Lamisil AT 1% Cream in children is still limited and its use in children under 16 years cannot therefore be recommended.

Use in the elderly

There is no evidence to suggest that elderly patients require different dosages or experience side-effects different to those of younger patients.

Method of administration

Topical administration.

4.3 Contraindications

Hypersensitivity to terbinafine or any of the excipients contained in the cream.

4.4 Special Warnings And Precautions For Use

Lamisil AT 1% cream is for external use only. Contact with the eyes should be avoided. In case of accidental contact with the eyes, rinse the eyes thoroughly with running water.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

There are no known drug interactions with Lamisil AT 1% Cream.

4.6 Pregnancy And Lactation

Foetal toxicity and fertility studies in animals suggest no adverse effects.

There is no clinical experience with Lamisil AT 1% Cream in pregnant women. Therefore, unless the potential benefits outweigh any potential risks, Lamisil AT 1% Cream should not be administered during pregnancy.

Terbinafine is excreted in breast milk, and therefore mothers should not receive Lamisil AT 1% Cream whilst breast-feeding. Infants should also not be allowed to come into contact with any treated skin, including the breast.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Redness, itching or stinging occasionally occur at the site of application; however, treatment rarely has to be discontinued for this reason. These harmless symptons must be distinguished from allergic reactions such as pruritus, rash, bullous eruptions and hives, which are rare but require discontinuation.

4.9 Overdose

No adverse events in relation to ingestion of Lamisil AT 1% Cream have been reported to the company. However, if accidental ingestion of Lamisil AT 1% Cream occurs, an appropriate method of gastric emptying may be used if considered appropriate.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Terbinafine is an allylamine that has a broad spectrum of antifungal activity. At low concentrations Terbinafine is fungicidal against dermatophytes, moulds and certain dimorphic fungi.

Terbinafine interferes specifically with fungal sterol biosynthesis at an early step. This leads to a deficiency in ergosterol and to an intracellular accumulation of squalene, resulting in fungal cell death. Terbinafine acts by inhibition of squalene epoxidase in the fungal cell membrane.

The enzyme squalene epoxidase is not linked to the cytochrome P-450 system. Terbinafine does not influence the metabolism of hormones or other drugs.

Terbinafine provides long-lasting protection. More than 90% of patients with interdigital tinea pedis (athlete's foot) treated with Terbinafine 1 % cream for one week show no mycological evidence of relapse or re-infection by three months after start of treatment. No such data on tinea cruris are available.

5.2 Pharmacokinetic Properties

Less than 5% of the dose is absorbed after topical application to humans: systemic exposure is therefore very slight.

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

Sodium hydroxide

benzyl alcohol

sorbitan stearate

cetyl palmitate

cetyl alcohol

stearyl alcohol

polysorbate 60

isopropyl myristate

purified water.

6.2 Incompatibilities

None known.

6.3 Shelf Life

Aluminium tube: 5 years

Polypropylene dispenser: 3 years

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

Aluminium tube with membrane, with an interior coating of phenol-epoxy based lacquer, closed with a polypropylene cap, containing 7 g, 7.5 g, 10 g, or 15 g Lamisil AT 1% Cream.

Polypropylene dispenser tube with polypropylene screw-cap closure containing 7 g, 7.5 g, 10 g, or 15 g LAMISIL AT.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Novartis Consumer Health UK Ltd, trading as Novartis Consumer Health

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

8. Marketing Authorisation Number(S)

PL 00030/0144

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: 18 August 2000

Date of last renewal: 10 February 2009.

10. Date Of Revision Of The Text

27 April 2009.

Legal Category GSL


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AccessPak for HIV PEP Basic


Generic Name: emtricitabine and tenofovir (em trye SYE ta been and ten OF oh vir)
Brand Names: AccessPak for HIV PEP Basic, Truvada

What is AccessPak for HIV PEP Basic (emtricitabine and tenofovir)?

Emtricitabine and tenofovir are antiviral drugs that work by preventing HIV (human immunodeficiency virus) cells from multiplying in the body.

The combination of emtricitabine and tenofovir is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). Emtricitabine and tenofovir is not a cure for HIV or AIDS.

Emtricitabine and tenofovir may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about AccessPak for HIV PEP Basic (emtricitabine and tenofovir)? You should not take this medication if you are allergic to emtricitabine (Emtriva) or tenofovir (Viread).

Do not take this medication with other medicines that also contain emtricitabine or tenofovir (Atripla, Emtriva, Viread), or lamivudine (Combivir, Epivir, Epzicom, or Trizivir).

Some people develop lactic acidosis while taking emtricitabine and tenofovir. Early symptoms may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired. Emtricitabine and tenofovir can cause severe or fatal liver problems. Call your doctor at once if you have symptoms such as nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes). What should I discuss with my healthcare provider before taking AccessPak for HIV PEP Basic (emtricitabine and tenofovir)? You should not take this medication if you are allergic to emtricitabine (Emtriva) or tenofovir (Viread). Do not take this medication with other medicines that also contain emtricitabine or tenofovir (Atripla, Emtriva, Viread), or lamivudine (Combivir, Epivir, Epzicom, or Trizivir).

If you have any of these other conditions, you may need an emtricitabine and tenofovir dose adjustment or special tests:

liver or kidney disease;

osteopenia (low bone mineral density); or

if you also have hepatitis B infection.

Some people develop a life-threatening condition called lactic acidosis while taking emtricitabine and tenofovir. You may be more likely to develop lactic acidosis if you are overweight or have liver disease, if you are a woman, or if you have taken HIV or AIDS medications for a long time. Talk with your doctor about your individual risk. FDA pregnancy category B. Emtricitabine and tenofovir is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of emtricitabine and tenofovir on the baby.

Women with HIV or AIDS should not breast-feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk. Do not give this medicine to anyone under 18 without the advice of a doctor. How should I take AccessPak for HIV PEP Basic (emtricitabine and tenofovir)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

You may take this medication with or without food.

Use emtricitabine and tenofovir regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

To be sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. Your kidney and liver function or bone density may also need to be tested. Visit your doctor regularly.

If you have hepatitis B you may develop liver symptoms after you stop taking emtricitabine and tenofovir, even months after stopping. Your doctor may want to check your liver function at regular visits for several months after you stop using the medicine. Do not miss any follow-up visits to your doctor.

HIV/AIDS is usually treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Every person with HIV or AIDS should remain under the care of a doctor.

Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with the packet of moisture-absorbing preservative that comes with emtricitabine and tenofovir. What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while taking AccessPak for HIV PEP Basic (emtricitabine and tenofovir)? Taking this medication will not prevent you from passing HIV to other people. Avoid having unprotected sex or sharing razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person. AccessPak for HIV PEP Basic (emtricitabine and tenofovir) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as:

muscle pain or weakness;

numb or cold feeling in your arms and legs;

trouble breathing;

feeling dizzy, light-headed, tired, or very weak;

stomach pain, nausea with vomiting; or

fast or uneven heart rate.

Call your doctor at once if you have any of these other serious side effects:

signs of liver damage - nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

increased thirst, urinating more or less than usual or not at all;

swelling, rapid weight gain, feeling short of breath; or

signs of infection such as fever, chills, skin lesions, or cough with yellow or green mucus.

Less serious side effects may include:

diarrhea, mild nausea;

headache, tired feeling;

dizziness, depressed mood;

sleep problems (insomnia), strange dreams;

mild itching or skin rash;

runny or stuffy nose, cough; or

changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect AccessPak for HIV PEP Basic (emtricitabine and tenofovir)?

Emtricitabine and tenofovir can harm your kidneys. This effect is increased when you also use other medicines harmful to the kidneys. You may need dose adjustments or special tests if you have recently used:

lithium (Lithobid);

methotrexate (Rheumatrex, Trexall);

pain or arthritis medicines such as aspirin (Anacin, Excedrin), acetaminophen (Tylenol), diclofenac (Cataflam, Voltaren), etodolac (Lodine), ibuprofen (Advil, Motrin), indomethacin (Indocin), naproxen (Aleve, Naprosyn), and others;

medicines used to prevent organ transplant rejection, such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune) or tacrolimus (Prograf);

an IV antibiotic such as gentamicin (Garamycin), vancomycin (Vancocin, Vancoled), and others;

antiviral medicines such as adefovir (Hepsera), cidofovir (Vistide), or foscarnet (Foscavir); or

cancer medicine such as aldesleukin (Proleukin), carmustine (BiCNU, Gliadel), cisplatin (Platinol), ifosfamide (Ifex), oxaliplatin (Eloxatin), plicamycin (Mithracin), streptozocin (Zanosar), or tretinoin (Vesanoid).

You may need dose adjustments or special tests when taking any of these medications together with emtricitabine and tenofovir.

Other medications that can affect emtricitabine and tenofovir include:

the herpes medications acyclovir (Zovirax) or valacyclovir (Valtrex);

medications to treat cytomegalovirus (CMV) such as cidofovir (Vistide), ganciclovir (Cytovene) or valganciclovir (Valcyte); or

certain other HIV medicines such as atazanavir (Reyataz), didanosine (Videx), indinavir (Crixivan), saquinavir (Invirase), lopinavir/ritonavir (Kaletra), or ritonavir (Norvir).

This list is not complete and other drugs may interact with emtricitabine and tenofovir. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More AccessPak for HIV PEP Basic resources AccessPak for HIV PEP Basic Side Effects (in more detail) AccessPak for HIV PEP Basic Use in Pregnancy & Breastfeeding AccessPak for HIV PEP Basic Drug Interactions 0 Reviews for AccessPak for HIV PEP Basic - Add your own review/rating Truvada Prescribing Information (FDA) Truvada Advanced Consumer (Micromedex) - Includes Dosage Information Truvada MedFacts Consumer Leaflet (Wolters Kluwer) Truvada Consumer Overview Compare AccessPak for HIV PEP Basic with other medications HIV Infection Nonoccupational Exposure Where can I get more information? Your pharmacist can provide more information about emtricitabine and tenofovir.

See also: AccessPak for HIV PEP Basic side effects (in more detail)


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Sex hormones


Sex hormones are steroid hormones that are mainly produced by the testes or the ovaries. Sex hormones are responsible for controlling reproductive function and sexual development. Estrogens and progestins are female sex hormones and androgens are male sex hormones.

See also 5-alpha-reductase inhibitors androgens and anabolic steroids contraceptives estrogens gonadotropin releasing hormones gonadotropins hormone replacement therapy miscellaneous sex hormones progestins sex hormone combinations Drug List:
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Lamisil


Generic Name: terbinafine (ter BIN na feen)
Brand Names: LamISIL

What is terbinafine?

Terbinafine is an antifungal antibiotic.

Terbinafine is used to treat infections caused by fungus that affect the fingernails or toenails. Terbinafine oral granules are used to treat a fungal infection of scalp hair follicles in children who are at least 4 years old.

Terbinafine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about terbinafine?

Before using terbinafine, tell your doctor if you have liver or kidney disease, or an autoimmune disorder such as lupus or psoriasis.

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Terbinafine will not treat a viral infection such as the common cold or flu. Some people taking terbinafine have developed severe liver damage leading to liver transplant or death. It is not clear whether terbinafine actually caused the liver damage in these patients. In most cases, the patient had a serious medical condition before taking terbinafine.

Call your doctor at once if you have symptoms of liver damage, such as nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). These events can occur whether or not you have ever had liver problems before.

To be sure this medicine is not causing harmful effects, your blood may need to be tested often. Your liver function may also need to be tested. Visit your doctor regularly.

It may take several months for your nails to return to their normal appearance after your treatment with terbinafine.

What should I discuss with my healthcare provider before taking terbinafine? You should not use this medication if you are allergic to terbinafine.

To make sure you can safely take terbinafine, tell your doctor if you have any of these other conditions:

liver disease; kidney disease;

a history of depression; or

an autoimmune disorder such as lupus or psoriasis.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Terbinafine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take terbinafine?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take the terbinafine tablet with a full glass (8 ounces) of water.

Terbinafine granules should be sprinkled into a spoonful of pudding or mashed potatoes (do not mix with applesauce, fruit juice, or other acidic foods). Swallow this mixture right away without chewing. Do not save the mixture for later use.

The terbinafine granule mixture should be taken with a meal.

Terbinafine is usually taken for 6 to 12 weeks.

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Terbinafine will not treat a viral infection such as the common cold or flu.

To be sure this medicine is not causing harmful effects, your blood may need to be tested often. Your liver function may also need to be tested. Visit your doctor regularly.

It may take several months for your nails to return to their normal appearance after your treatment with terbinafine.

Store at room temperature away from moisture, heat, and light.

Keep the terbinafine oral granules in their sealed packet until you are ready to use.

See also: Lamisil dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include dizziness, stomach pain, nausea, vomiting, skin rash, or urinating more than usual.

What should I avoid while taking terbinafine? Avoid coffee, tea, cola, energy drinks or other sources of caffeine while taking this medication. Avoid exposure to sunlight or tanning beds. Lamivudine can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Terbinafine side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Some people taking terbinafine have developed severe liver damage leading to liver transplant or death. It is not clear whether terbinafine actually caused the liver damage in these patients. In most cases, the patient had a serious medical condition before taking terbinafine.

Call your doctor at once if you have symptoms of liver damage, such as nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). These events can occur whether or not you have ever had liver problems before.

Stop taking terbinafine and call your doctor at once if you have a serious side effect such as:

fever, chills, body aches, flu symptoms, sores in your mouth and throat;

joint pain or swelling, swollen glands, patchy skin color, or a butterfly-shaped skin rash over your cheeks and nose;

changes in mood or behavior;

weight loss due to taste changes;

raised, silvery flaking of the skin; or

severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

upset stomach, gas, diarrhea, mild nausea or stomach pain;

headache;

mild skin rash or itching; or

unusual or unpleasant taste in your mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect terbinafine?

Before taking terbinafine, tell your doctor if you are taking any of the following medicines:

cimetidine (Tagamet, Tagamet HB);

cyclosporine (Gengraf, Neoral, Sandimmune);

rifampin (Rifater, Rifadin, Rimactane, Rifamate);

another antifungal medicine, such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Oravig), or voriconazole (Vfend);

a blood thinner such as warfarin (Coumadin, Jantoven);

a heart rhythm medication such as amiodarone (Cordarone, Pacerone), propafenone (Rythmol) or flecainide (Tambocor);

an "SSRI" antidepressant such as fluoxetine (Prozac), fluvoxamine (Luvox), or paroxetine (Paxil);

a tricyclic antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), desipramine (Norpramin), imipramine (Janimine, Tofranil), and others;

an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate); or

a beta-blocker such as betaxolol (Kerlone), carvedilol (Coreg), labetalol (Normodyne), metoprolol (Dutoprol, Lopressor, Toprol), pindolol (Visken), propranolol (Inderal), or timolol (Blocadren).

This list is not complete and other drugs may interact with terbinafine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Lamisil resources Lamisil Side Effects (in more detail) Lamisil Dosage Lamisil Use in Pregnancy & Breastfeeding Drug Images Lamisil Drug Interactions Lamisil Support Group 23 Reviews for Lamisil - Add your own review/rating Lamisil Prescribing Information (FDA) Lamisil Consumer Overview Lamisil Monograph (AHFS DI) Lamisil MedFacts Consumer Leaflet (Wolters Kluwer) Lamisil Advanced Consumer (Micromedex) - Includes Dosage Information Terbinafine Prescribing Information (FDA) Terbinafine Professional Patient Advice (Wolters Kluwer) Compare Lamisil with other medications Cutaneous Candidiasis Onychomycosis, Fingernail Onychomycosis, Toenail Tinea Capitis Tinea Corporis Tinea Cruris Tinea Pedis Where can I get more information? Your pharmacist can provide more information about terbinafine.

See also: Lamisil side effects (in more detail)


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