Penciclovir
Dosage form: cream
Drug class:Topical antivirals
Medically reviewed by Drugs.com. Last updated on Jul 22, 2021.
On This Page
- Indications and Usage
- Dosage and Administration
- Dosage Forms and Strengths
- Contraindications
- Warnings and Precautions
- Adverse Reactions/Side Effects
- Clinical Studies
- Drug Interactions
- Use In Specific Populations
- Overdosage
- Description
- Clinical Pharmacology
- Nonclinical Toxicology
- How Supplied/Storage and Handling
- Patient Counseling Information
1. INDICATIONS AND USAGE
Penciclovir Cream is a nucleoside 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.
2. DOSAGE AND ADMINISTRATION
Penciclovir Cream 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).
3. DOSAGE FORMS AND STRENGTHS
Each gram of Penciclovir Cream contains 10 mg of Penciclovir in a cream base, which is equivalent to 1% (w/w).
4. CONTRAINDICATIONS
Penciclovir Cream is contraindicated in patients with known hypersensitivity to the product or any of its components.
5. WARNINGS AND PRECAUTIONS
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.
6. ADVERSE REACTIONS
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 t...