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Zovirax Topical (Acyclovir Sodium Topical) - Indications and Dosage

 
 



INDICATIONS AND USAGE

ZOVIRAX Cream is indicated for the treatment of recurrent herpes labialis (cold sores) in adults and adolescents (12 years of age and older).

DOSAGE AND ADMINISTRATION

ZOVIRAX Cream should be applied 5 times per day for 4 days. Therapy should be initiated as early as possible following onset of signs and symptoms (i.e., during the prodrome or when lesions appear). For adolescents 12 years of age and older, the dosage is the same as in adults.

HOW SUPPLIED

Each gram of ZOVIRAX Cream 5% contains 50 mg acyclovir in an aqueous cream base. ZOVIRAX Cream is supplied as follows:

2-g tubes (NDC 64455-994-42).

5-g tubes (NDC 64455-994-45).

Store at or below 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) (see USP Controlled Room Temperature).

Manufactured by

GlaxoSmithKline

Research Triangle Park, NC 27709

for

Biovail

Pharmaceuticals, Inc.

Bridgewater, NJ 08807

©2004, GlaxoSmithKline. All rights reserved.

January 2004

RL-2061

A005174

PATIENT INFORMATION ABOUT ZOVIRAX® (ACYCLOVIR) CREAM 5%

USE ONLY FOR COLD SORES. FOR EXTERNAL USE ONLY.

Read this information before you start using ZOVIRAX (acyclovir) Cream and each time you refill your prescription. There may be new information. This summary is not meant to take the place of your doctor's advice.

What is ZOVIRAX Cream?

ZOVIRAX Cream is a prescription medicine that is applied to the skin to treat cold sores (herpes labialis) that occur on the face or lips. However, ZOVIRAX Cream is not a cure for cold sores.

Who should not use ZOVIRAX Cream?

Do not use ZOVIRAX Cream if you are allergic to ZOVIRAX (also known as acyclovir), VALTREX® (also known as valacyclovir), or any of the ingredients of ZOVIRAX Cream. Ask your doctor or pharmacist about the inactive ingredients.

Before you start using ZOVIRAX Cream, tell your doctor if you are pregnant, planning to become pregnant, or are breast feeding.

The safety and efficacy of ZOVIRAX Cream have not been studied in patients younger than 12 years of age or in patients whose immune system is not normal.

How do I use ZOVIRAX Cream?

ZOVIRAX Cream is most effective when used early, at the start of a cold sore. For best results, apply the cream at the first sign of a cold sore (such as tingle, redness, bump, or itch).

  • Wash your hands before using ZOVIRAX Cream.
  • Apply ZOVIRAX Cream to clean, dry skin.
  • Apply a layer of ZOVIRAX Cream to cover only the cold sore or cover only the area of tingling (or other symptoms) before the cold sore appears. Rub the cream in until it disappears.
  • Apply the cream 5 times a day for 4 days.
  • Wash your hands with soap and water after applying ZOVIRAX Cream. This should remove any cream left on the hands.

What Should I Avoid While Using ZOVIRAX Cream?

  • Use ZOVIRAX Cream only on your affected skin. Do not swallow ZOVIRAX Cream. Do not apply ZOVIRAX Cream to the eyes, inside the mouth or nose, or on unaffected skin. Do not use ZOVIRAX Cream for genital herpes.
  • Do not cover the cold sore area with a bandage or dressing unless otherwise instructed by your doctor.
  • Do not apply another type of skin product (for example, cosmetics, sun screens, or lip balms) or other skin medication to the cold sore area while using ZOVIRAX Cream unless otherwise instructed by your doctor.
  • Avoid irritation of the cold sore area while using ZOVIRAX Cream.
  • Do not bathe, shower, or swim right after applying ZOVIRAX Cream. This could wash off the medicine.

What Are the Possible Side Effects of ZOVIRAX Cream?

ZOVIRAX Cream was well tolerated in studies in patients with cold sores. The most common skin-related side effects of ZOVIRAX Cream are dry or cracked lips, flakiness or dryness of skin, a burning or stinging feeling, or itching of the skin. Each event occurred in fewer than 1 in 100 patients in clinical studies. Ask a doctor or pharmacist about any concerns about ZOVIRAX Cream.

How Should I Store ZOVIRAX Cream?

Store ZOVIRAX Cream at room temperature (59° to 86°F). Never leave ZOVIRAX Cream in your car in cold or hot weather. Make sure the cap on the tube is tightly closed. Keep ZOVIRAX Cream out of the reach of children.

General Advice about Prescription Medicines

Do not use ZOVIRAX Cream for a condition for which it was not prescribed. Do not give ZOVIRAX Cream to other people, even if they have the same symptoms you have. If you have any concerns about ZOVIRAX Cream, ask your doctor. Your doctor or pharmacist can give you additional information about ZOVIRAX Cream that was written for healthcare professionals.

Manufactured by

GlaxoSmithKline

Research Triangle Park, NC 27709

for

Biovail

Pharmaceuticals, Inc.

Bridgewater, NJ 08807

©2004, GlaxoSmithKline. All rights reserved.

January 2004

RL-2061

A005174

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