Denavir Teratogenic Effects-Pregnancy Category B. No adverse effects on the course and outcome of pregnancy or on fetal development were noted in rats and rabbits following the intravenous administration of Denavir at doses of 80 and 60 mg/kg/day, respectively (estimated human equivalent doses of 13 and 18 mg/kg/day for the rat and rabbit, respectively, based on body surface area conversion; the body surface area doses being 260 and 355x the maximum recommended dose following topical application of the Denavir cream). There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Denavir should be used during pregnancy only if clearly needed.
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There is no information on whether Denavir is excreted in human milk after topical administration. However, following oral administration of famciclovir (the oral prodrug of Denavir) to lactating rats, Denavir was excreted in breast milk at concentrations higher than those seen in the plasma. Therefore, a decision should be made whether to discontinue the drug, taking into account the importance of the drug to the mother. There are no data on the safety of Denavir in newborns.
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An open-label, uncontrolled trial with Denavir cream 1% was conducted in 102 patients, ages 12-17 years, with recurrent herpes labialis. The frequency of adverse events was generally similar to the frequency previously reported for adult patients. Safety and effectiveness in pediatric patients less than 12 years of age have not been established.
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In 74 patients ≥ 65 years of age, the adverse events profile was comparable to that observed in younger patients.
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Denavir is contraindicated in patients with known hypersensitivity to the product or any of its components.
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Denavir (penciclovir cream) is indicated for the treatment of recurrent herpes labialis (cold sores) in adults and children 12 years of age and older.
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Denavir was studied in two double-blind, placebo (vehicle)-controlled trials for the treatment of recurrent herpes labialis in which otherwise healthy adults were randomized to either Denavir or placebo. Therapy was to be initiated by the subjects within 1 hour of noticing signs or symptoms and continued for 4 days, with application of study medication every 2 hours while awake. In both studies, the mean duration of lesions was approximately one-half-day shorter in the subjects treated with Denavir (N=1,516) as compared to subjects treated with placebo (N=1,541) (approximately 4.5 days versus 5 days, respectively). The mean duration of lesion pain was also approximately one-half-day shorter in the Denavir group compared to the placebo group.
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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.
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).
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Denavir General side effects
Topical penciclovir is generally well tolerated. Incidence of adverse effects in clinical trials was similar to that of placebo.
Denavir Nervous system side effects
Nervous system side effects have included headache (5.3%).
Denavir Dermatologic side effects
Dermatologic side effects have included application site reactions (1.3%), hypesthesia/local anesthesia (0.9%), and erythematous rash (0.1%). Local edema, pain, paresthesia, pruritus, skin discoloration, urticaria, and aggravation of the condition have also been reported.
Denavir Other side effects
Other side effects have included taste perversion (0.2%), and oral/pharyngeal edema, and parosmia.
Please note – some side effects for Denavir may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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Penciclovir topical is available with a prescription under the brand name Denavir in a 1% cream formulation. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.
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