Denavir

Denavir Information

Brand Name: Denavir

Generic Name: Penciclovir

Denavir (penciclovir cream) is indicated for the treatment of recurrent herpes labialis (cold sores) in adults.

Denavir Ingredients and Composition

How Does Denavir Work?

Microbiology: Mechanism of Antiviral Activity

The antiviral compound Denavir (penciclovir) has in vitro inhibitory activity against herpes simplex virus types 1 (HSV-1) and 2 (HSV-2). In cells infected with HSV-1 or HSV-2 viral thymidine kinase phosphorylates penciclovir to a monophosphate form which, in turn, is converted to penciclovir triphosphate by cellular kinases. In vitro studies demonstrate that penciclovir triphosphate inhibits HSV polymerase competitively with deoxyguanosine triphosphate. Consequently, herpes viral DNA synthesis and, therefore, replication are selectively inhibited.

How To Take Denavir and Denavir 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).

If you suspect a Denavir Overdose

Since penciclovir, the active ingredient of Denavir, is poorly absorbed following oral administration adverse reactions related to penciclovir ingestion are unlikely. There is no information on overdose.

Denavir Side Effects

Denavir Precautions and Contraindications

General

Denavir should only be used on herpes labialis on the lips and face. Because no data are available, application to human mucous membranes is not recommended. Particular care should be taken to avoid application in or near the eyes since it may cause irritation. The effect of Denavir has not been established in immunocompromised patients.

Contraindications to Denavir

Denavir is contraindicated in patients with known hypersensitivity to the product or any of its components.

Taking Denavir during Pregnancy or Breast-feeding

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 (penciclovir) 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 penciclovir cream). There are, however no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, penciclovir should be used during pregnancy only if clearly needed.

Nursing Mothers

There is no information on whether Denavir (penciclovir) is excreted in human milk after topical administration. However, following oral administration of famciclovir (the oral prodrug of penciclovir) to lactating rats, penciclovir 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 penciclovir in newborns.

Denavir Clinical Trials and Studies

Denavir Pill Identification / ID and Appearance

Denavir is supplied in a 1.5 gram tube containing 10 mg of penciclovir per gram.

Storing Denavir

Store Denavir at controlled room temperature. 20°- 25° C (68°- 77°)