Product Description.:
Denavir contains penciclovir, an antiviral agent active against herpes viruses. Denavir is available for topical administration as a 1% white cream. Each gram of Denavir contains 10 mg of penciclovir and the following inactive ingredients: cetomacrogol 1000 BP, cetostearyl alcohol, mineral oil, propylene glycol, purified water and white petrolatum.
Penciclovir is a white to pale yellow solid. At 20?C it has a solubility of 0.2 mg/mL in methanol, 1.3 mg/mL in propylene glycol, and 1.7 mg/mL in water. In aqueous buffer (pH 2) the solubility is 10.0 mg/mL. Penciclovir is not hygroscopic. Its partition coefficient in n-octanol/water at pH 7.5 is 0.024 (logP= -1.62).
INDICATIONS
Denavir (penciclovir cream) is indicated for the treatment of recurrent herpes labialis (cold sores) in adults and children 12 years of age and older.
DOSAGE AND ADMINISTRATION
Denavir should be applied every 2 hours during waking hours for a period of 4 days. Treatment should be started as early as possible (i.e., during the prodrome or when lesions appear).
Side Effects & Drug Interactions
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Denavir?
(penciclovir) Cream 1%
For Dermatologic Use Only
DRUG DESCRIPTION
Denavir contains penciclovir, an antiviral agent active against herpes viruses. Denavir is available for topical administration as a 1% white cream. Each gram of Denavir contains 10 mg of penciclovir and the following inactive ingredients: cetomacrogol 1000 BP, cetostearyl alcohol, mineral oil, propylene glycol, purified water and white petrolatum.
Chemically, penciclovir is known as 9-[4-hydroxy-3-(hydroxymethyl) butyl]guanine. Its molecular formula is C10H15N5O3 its molecular weight is 253.26. It is a synthetic acyclic guanine derivative and has the following structure:
Denavir? (penciclovir) Structural Formula Illustration
Penciclovir
Penciclovir is a white to pale yellow solid. At 20?C it has a solubility of 0.2 mg/mL in methanol, 1.3 mg/mL in propylene glycol, and 1.7 mg/mL in water. In aqueous buffer (pH 2) the solubility is 10.0 mg/mL. Penciclovir is not hygroscopic. Its partition coefficient in n-octanol/water at pH 7.5 is 0.024 (logP= -1.62).
Last updated on RxList: 12/9/2008
INDICATIONS
Denavir (penciclovir cream) is indicated for the treatment of recurrent herpes labialis (cold sores) in adults and children 12 years of age and older.
DOSAGE AND ADMINISTRATION
Denavir should be applied every 2 hours during waking hours for a period of 4 days. Treatment should be started as early as possible (i.e., during the prodrome or when lesions appear).
HOW SUPPLIED
Denavir is supplied in a 1.5 gram tube containing 10 mg of penciclovir per gram. NDC 0067-6024-15
Store at controlled room temperature, 20?-25? C (68?-77?F) [see USP]
QUESTIONS? call 1-800-452-0051 24 hours a day, 7 days a week.
Manufactured by Novartis Pharma GmbH, Wehr, Germany for Novartis Consumer Health, Inc. Parsippany, NJ 07054-0622. FDA Rev date: 10/10/2003
Last updated on RxList: 12/9/2008
SIDE EFFECTS
In two double-blind, placebo-controlled trials, 1516 patients were treated with Denavir (penciclovir cream) and 1541 with placebo. The most frequently reported adverse event was headache, which occurred in 5.3% of the patients treated with Denavir and 5.8% of the placebo-treated patients.
