Overview
11 DESCRIPTION Penciclovir cream 1% contains penciclovir, an antiviral agent active against herpes viruses. Penciclovir cream is available for topical administration as a 1% white cream. Each gram of penciclovir cream contains 10 mg of penciclovir and the following inactive ingredients: cetostearyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water and white...
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Penciclovir is an antiviral agent active against alpha herpes viruses [see Microbiology ( 12.4 )] . 12.3 Pharmacokinetics Measurable penciclovir concentrations were not detected in plasma or urine of healthy male volunteers (n=12) following single or repeat application of the 1% cream at a dose of 180 mg penciclovir daily (approximately 67 times the estimated usual clinical dose). Pediatric Patients: The systemic absorption of penciclovir following topical administration has not been evaluated in patients 395 μM, n=9), respectively.
Indications
- 1 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 )
Common Doses
- Refer to label
Dosage
2 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 )
Contraindications
- 4 CONTRAINDICATIONS Penciclovir 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 )
Side Effects
- 6 ADVERSE REACTIONS One or more local skin reactions were reported by 3% of the subjects treated with penciclovir and 4% of placebo-treated patients. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Interactions
- 7 DRUG INTERACTIONS No drug interaction studies have been performed with penciclovir. Due to minimal systemic absorption of penciclovir, systemic drug interactions are unlikely.