penciclovir 10 MG/ML Topical Cream [Denavir]

INDICATIONS AND USAGE Penciclovir Cream, 1% is a deoxynucleoside analog HSV DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in adults and children 12 years of age or older. Penciclovir Cream, 1% is a deoxynucleoside analog HSV DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in adults and pediatric patients 12 years of age and older. ( 1 )

DOSAGE AND ADMINISTRATION Apply Penciclovir Cream, 1% every 2 hours during waking hours for a period of 4 days. Start treatment as early as possible (i.e., during the prodrome or when lesions appear). • Apply Penciclovir Cream, 1% every 2 hours during waking hours for a period of 4 days. ( 2 ) • Start treatment as early as possible (i.e., during the prodrome or when lesions appear). ( 2 )

WARNINGS AND PRECAUTIONS • Only for topical use of herpes labialis on the lips and face. ( 5 ) 5.1 General Penciclovir Cream, 1% 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. Lesions that do not improve or that worsen on therapy should be evaluated for secondary bacterial infection. The effect of Penciclovir Cream, 1% has not been established in immunocompromised patients.

CONTRAINDICATIONS Penciclovir Cream, 1% is contraindicated in patients with known hypersensitivity to the product or any of its components. • Contraindicated in patients with known hypersensitivity to the product or any of its components. ( 4 )

Mechanism of Action Penciclovir is an antiviral agent active against alpha herpes viruses [see Microbiology (12.4) ]. Mechanism of Action Penciclovir has inhibitory activity against herpes simplex virus types 1 (HSV-1) and 2 (HSV-2). In cells infected with HSV-1 or HSV-2, the viral thymidine kinase phosphorylates penciclovir to a monophosphate form that, in turn, is converted by cellular kinases to the active form penciclovir triphosphate. Biochemical studies demonstrate that penciclovir triphosphate inhibits HSV DNA polymerase competitively with deoxyguanosine triphosphate. Consequently, α-herpes viral DNA synthesis and, therefore, replication are selectively inhibited. Penciclovir triphosphate has an intracellular half-life of 10 hours in HSV-1 and 20 hours in HSV-2 infected cells grown in culture. However, the clinical significance of the intracellular half-life is unknown.