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Fact Table
| Fact Table | |
|---|---|
| Formula | C8H11N5O3 |
| License | FDA approved (NDA 021478; initial U.S. approval 2002); Health Canada marketed/approved (DIN 02039524) |
| Bioavailability | Conventional bioavailability not established; systemic absorption from Zovirax Cream is minimal, with ~0.04% of the daily applied dose recovered in urine |
| Legal status | Prescription only (Rx-only) |
| Chemical Name | 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one |
| Elimination half-life | Not characterized after topical cream use; systemic acyclovir plasma half-life is ~2.5–3.3 hours in adults with normal renal function |
| Dosage (Strength) | 5% cream; each gram contains 50 mg acyclovir; apply topically 5 times daily for 4 days, starting as early as possible after symptoms begin |
| Pregnancy | Minimal systemic absorption; maternal topical use is not expected to result in fetal exposure, and decades of topical-use experience have not identified a drug-associated risk |
| Brands | Zovirax Cream; generic acyclovir cream 5% products may be available |
| Protein binding | 9–33% plasma protein bound for systemic acyclovir; limited relevance after topical cream due minimal systemic absorption |
| PubChem CID | 135398513; 2022 (alternate/legacy PubChem record) |
| MedlinePlus | a606001 |
| ChEBI | 2453 |
| ATC code | D06BB03 |
| DrugBank | DB00787 |
| KEGG | D00222; C06810 |
| Routes of administration | Topical; cutaneous cream for external use only |
Zovirax Cream (acyclovir) is a prescription topical antiviral used to treat cold sores on the lips and face. It works by blocking the herpes simplex virus from replicating, helping to shorten the duration of an outbreak. The cream is applied directly and is approved for adults and adolescents 12 years of age and older.
Directions
Apply Zovirax Cream to the affected area on the lips or face five times daily for four days, starting as soon as possible after noticing the first signs of a cold sore (such as tingling, redness, or a bump). Wash hands before and after applying the cream. Rub the cream in gently until it disappears, and avoid applying it to the eyes, inside the mouth or nose, or on unaffected skin.
Ingredients
The active ingredient in Zovirax Cream 5% is acyclovir 50 mg per gram. Inactive ingredients include cetostearyl alcohol, mineral oil, poloxamer 407, propylene glycol, sodium lauryl sulfate, water, and white petrolatum.
Cautions
Before using this medication, you may want to consult a healthcare provider about the following:
- Any existing health conditions
- Any allergies
- A list of all medications currently being taken
Zovirax Cream is for use on the lips and face only and should not be applied inside the mouth, nose, or eyes, or to mucous membranes.
This medication has not been studied in people with weakened immune systems and is not indicated for that population.
Zovirax Cream is not a treatment for genital herpes and should not be used for that purpose.
This medication may cause skin irritation or contact sensitization at the application site.
Contraindications
Avoid taking or using this medication if any of the following apply:
- Known hypersensitivity to acyclovir or valacyclovir
- Known allergy to any component of the formulation
Side Effects
Common side effects of Zovirax Cream include:
- Dry or cracked lips
- Flaking or dryness of skin at the application site
- Burning or stinging at the application site
- Itching or redness of the skin
Serious allergic reactions to Zovirax Cream are rare but can occur. Signs of a serious reaction include hives, swelling of the face or lips, and difficulty breathing.
Contact a healthcare provider immediately if any of these symptoms occur.
Frequently Asked Questions about Zovirax Cream 5%
What is Zovirax Cream 5%?
Zovirax Cream 5% is a prescription topical antiviral medicine containing acyclovir. Each gram contains 50 mg of acyclovir, equal to 5% strength. It is used on the skin to treat recurrent cold sores caused by herpes simplex virus.
What is Zovirax Cream used for?
Zovirax Cream is used to treat recurring cold sores, also called herpes labialis, on the lips and around the mouth in adults and adolescents 12 years and older with normal immune systems. It is not a cure for cold sores and does not remove the virus from the body.
How does Zovirax Cream work?
Acyclovir works by interfering with herpes simplex virus DNA replication, which helps slow viral activity in the treated area. When started early, it may help shorten the duration of a cold sore episode.
How should Zovirax Cream be applied?
Zovirax Cream is usually applied to the affected area 5 times per day for 4 days. The area should be clean and dry, and the cream should cover the cold sore area, including the outer edge. Hands should be washed before and after application.
When should treatment be started?
Zovirax Cream works best when started as early as possible, such as when tingling, itching, redness, burning, or the first sign of a cold sore appears. Starting later may be less effective.
Can Zovirax Cream be used inside the mouth, nose, eyes, or on genital herpes?
No. Zovirax Cream is for external use only on cold sores of the lips and face. It should not be used in the eyes, inside the mouth or nose, on mucous membranes, or on genital herpes.
What are the common side effects of Zovirax Cream?
Common local side effects may include dry or cracked lips, peeling or flaking skin, skin dryness, burning, stinging, itching, irritation, or application-site reactions. Contact sensitivity or irritation can occur.
Who should not use Zovirax Cream?
Zovirax Cream should not be used by anyone with a known allergy or hypersensitivity to acyclovir, valacyclovir, or any ingredient in the cream. People with weakened immune systems should tell a healthcare professional before use because its effect has not been established in immunocompromised patients.
Can Zovirax Cream be used during pregnancy or breastfeeding?
People who are pregnant, planning pregnancy, or breastfeeding should discuss use with a healthcare professional. The patient labeling notes that it is not known whether Zovirax Cream can harm an unborn baby or whether it passes into breast milk.
How should Zovirax Cream be stored?
Zovirax Cream should be stored at room temperature, generally 68°F to 77°F, with permitted excursions between 59°F and 86°F. Keep the tube tightly closed and out of reach of children.
