Zovirax acyclovir

Get an overview of ZOVIRAX (acyclovir cream), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in Zovirax can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as Zovirax.

Drug Basics

Brand Name: Zovirax

Generic Name: ACYCLOVIR

Drug Type: HUMAN PRESCRIPTION DRUG

Route: TOPICAL

Dosage Form: CREAM

Data Current As Of: 2018-10-05

indications & usage

ZOVIRAX Cream is a herpes simplex virus (HSV) nucleoside analogue DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults and adolescents 12 years of age and older.

dosage & administration

ZOVIRAX Cream should be applied 5 times per day for 4 days. Therapy should be initiated as early as possible following the onset of signs or symptoms of herpes labialis, 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.

dosage forms & strengths

Each gram of ZOVIRAX Cream 5% contains 50 mg of acyclovir.

warnings & precautions

general

ZOVIRAX Cream should only be applied on the affected external aspects of the lips and face in patients with herpes labialis. Because no data are available, application to human mucous membranes is not recommended. ZOVIRAX Cream is intended for cutaneous use only and should not be used in the eye or inside the mouth or nose.

contact sensitization

ZOVIRAX Cream has a potential for irritation and contact sensitization [see Adverse Reactions (6.1) ].

The effect of ZOVIRAX Cream has not been established in immunocompromised patients.

drug interactions

Clinical experience has identified no interactions resulting from topical or systemic administration of other drugs concomitantly with ZOVIRAX Cream. Due to minimal systemic absorption of ZOVIRAX Cream, systemic drug interactions are unlikely.

overdosage

Overdosage by topical application of ZOVIRAX Cream is unlikely because of minimal systemic exposure [see Clinical Pharmacology (12.3) ]. There is no information available for overdose.

how supplied / storage & handling

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

  •  5 g tubes     NDC 0187-0994-45

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

patient counseling information

Advise the patient to read the FDA-approved patient labeling (Patient Information).

General

Patients should be informed that ZOVIRAX Cream is a prescription topical cream for the treatment of cold sores (recurrent herpes labialis) that occur on the face and lips. ZOVIRAX Cream is not a cure for cold sores. Patients should be instructed that ZOVIRAX Cream is intended for cutaneous use only for herpes labialis of the lips and around the mouth. Patients should be advised that ZOVIRAX Cream should not be used in the eye, inside the mouth or nose, or on the genitals. Patients should be instructed to avoid applying other topical products to the affected area while using ZOVIRAX Cream.

Do not use if you are allergic to ZOVIRAX Cream or any of the ingredients in ZOVIRAX Cream. Before you use ZOVIRAX Cream, tell your doctor if you are pregnant, planning to become pregnant, or are breast-feeding.

Instructions for Use

Treatment should be initiated at the earliest sign or symptom of recurrence. Patients should be instructed to wash hands prior to application and ensure the face and/or lips are clean and dry. Patients should be advised to apply ZOVIRAX Cream topically 5 times per day for 4 days. Patients should be instructed to topically apply a quantity of ZOVIRAX Cream sufficient to cover the affected area, including the outer margin. Patients should be advised to avoid unnecessary rubbing of the affected area to avoid aggravating or transferring the infection. Patients should be instructed to wash their hands with soap and water after using ZOVIRAX Cream. Keep out of reach of children.

Possible Side Effects

Common skin-related side effects that occurred when ZOVIRAX Cream was applied include application site reactions. ZOVIRAX Cream has the potential for irritation and contact sensitization.

Manufactured for: Valeant Pharmaceuticals North America LLC

Bridgewater, NJ 08807 USA

By: Valeant Pharmaceuticals International, Inc.

Laval, Quebec H7L 4A8, Canada

Zovirax is a trademark of GlaxoSmithKline LLC used under license.

© Valeant Pharmaceuticals North America LLC

9462202

patient informationzovirax (zho-vahy-rex)(acyclovir) cream 5%

Important information: ZOVIRAX Cream is for use on cold sores on the lips and around the mouth only. ZOVIRAX Cream should not be used in your eyes, mouth, nose, or on your genitals.

What is ZOVIRAX Cream?

  • ZOVIRAX Cream is a prescription medicine used to treat cold sores (herpes labialis) that are recurring in adults and children 12 years of age and older, and who have normal immune systems.
  • ZOVIRAX Cream is not a cure for cold sores.
  • It is not known if ZOVIRAX Cream is safe and effective in children less than 12 years of age.

Who should not use ZOVIRAX Cream?

Do not use ZOVIRAX Cream if you are:

  • allergic to ZOVIRAX Cream or any of the ingredients in ZOVIRAX Cream. See the end of this leaflet for a complete list of ingredients in ZOVIRAX Cream.

What should I tell my healthcare provider before using ZOVIRAX Cream?

Before using ZOVIRAX Cream, tell your healthcare provider about all of your medical conditions, including if you:

  • become sick very easily (have a weak immune system).
  • are pregnant or plan to become pregnant. It is not known if ZOVIRAX Cream will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if ZOVIRAX Cream passes into your breast milk. You should not breastfeed if you have a cold sore near or on your breast.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use ZOVIRAX Cream?

  • Use ZOVIRAX Cream exactly as your healthcare provider tells you to use it.
  • Use ZOVIRAX Cream as soon as you have the first symptoms of a cold sore such as itching, redness, burning or tingling, or when the cold sore appears.
  • Wash your hands with soap and water before and after applying ZOVIRAX Cream.
  • The affected area should be clean and dry before applying ZOVIRAX Cream.
  • Apply ZOVIRAX Cream to the affected area 5 times each day for 4 days, including the outer edge.
  • You should not apply other skin products to the affected area during treatment with ZOVIRAX Cream.
  • Do not rub the cold sore because this may cause the cold sore to spread to other areas around your mouth or make your cold sore worse.

What are the possible side effects of ZOVIRAX Cream?

The most common side effects of ZOVIRAX Cream are skin reactions at the treatment site and may include: dry or cracked lips, peeling, flaking or dryness of the skin, a burning or stinging feeling, and itching.

These are not all the possible side effects of ZOVIRAX Cream. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store ZOVIRAX Cream?

  • Store ZOVIRAX Cream at room temperature between 68° to 77°F (20° to 25°C).
  • Keep ZOVIRAX Cream and all medicines out of reach of children.

General information about the safe and effective use of ZOVIRAX Cream

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. 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. It may harm them. You can ask your pharmacist or healthcare provider for information about ZOVIRAX Cream that is written for health professionals.

What are the ingredients in ZOVIRAX Cream?

Active ingredient: acyclovir

Inactive ingredients: cetostearyl alcohol, mineral oil, poloxamer 407, propylene glycol, sodium lauryl sulfate, water, and white petrolatum

Manufactured for: Valeant Pharmaceuticals North America LLC
Bridgewater, NJ 08807 USA
By: Valeant Pharmaceuticals International, Inc.
Laval, Quebec H7L 4A8, Canada
Zovirax is a trademark of GlaxoSmithKline LLC used under license.
© Valeant Pharmaceuticals North America LLC
For more information, call 1-800-321-4576.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Revised: 04/2018
9462202

also known as

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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