Penciclovir
Generic Name: penciclovir
Brand Names:
Penciclovir
11 DESCRIPTION Penciclovir cream 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 petrolatum. Chemically, penciclovir is known as 9-[4-hydroxy-3-(hydroxymethyl)butyl] guanine.
Overview
11 DESCRIPTION Penciclovir cream 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 petrolatum. Chemically, penciclovir is known as 9-[4-hydroxy-3-(hydroxymethyl)butyl] guanine.
Uses
1 INDICATIONS AND USAGE Penciclovir cream 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 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
2 DOSAGE AND ADMINISTRATION Apply penciclovir cream 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 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).
Side Effects
6 ADVERSE REACTIONS • One or more local skin reactions were reported by 3% of the subjects treated with penciclovir cream and 4% of placebo-treated patients. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc. 1-800-912-9561 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. In two double-blind, placebo-controlled trials, 1,516 patients were treated with penciclovir cream and 1,541 with placebo.
Interactions
7 DRUG INTERACTIONS No drug interaction studies have been performed with penciclovir cream. Due to minimal systemic absorption of penciclovir cream, systemic drug interactions are unlikely.
Warnings
5 WARNINGS AND PRECAUTIONS • Only for topical use of herpes labialis on the lips and face. ( 5 ) 5.1 General Penciclovir cream 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 has not been established in immunocompromised patients. 4 CONTRAINDICATIONS Penciclovir cream 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 )
Pregnancy
8.1 Pregnancy Risk Summary Penciclovir cream is not absorbed systemically following topical administration and maternal use is not expected to result in fetal exposure to the drug.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Penciclovir Cream is supplied in a 5 gram tube containing 10 mg of penciclovir per gram in a homogenous cream base, which is equivalent to 1% (w/w). The white cream is available as follows: NDC 13668-661-10 carton containing one 5 gram tube Store at 20ºC to 25ºC (68ºF to 77ºF) excursions permitted between 15 o C and 30 o C (59 o F and 86 o F).
Frequently Asked Questions
What is Penciclovir used for?▼
1 INDICATIONS AND USAGE Penciclovir cream 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 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 )
What are the side effects of Penciclovir?▼
6 ADVERSE REACTIONS • One or more local skin reactions were reported by 3% of the subjects treated with penciclovir cream and 4% of placebo-treated patients. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc. 1-800-912-9561 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. In two double-blind, placebo-controlled trials, 1,516 patients were treated with penciclovir cream and 1,541 with placebo.
Can I take Penciclovir during pregnancy?▼
8.1 Pregnancy Risk Summary Penciclovir cream is not absorbed systemically following topical administration and maternal use is not expected to result in fetal exposure to the drug.
What are the important warnings for Penciclovir?▼
5 WARNINGS AND PRECAUTIONS • Only for topical use of herpes labialis on the lips and face. ( 5 ) 5.1 General Penciclovir cream 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 has not been established in immunocompromised patients. 4 CONTRAINDICATIONS Penciclovir cream 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 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.