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Penciclovir
  • Professionals
  • FDA PI

Penciclovir

Dosage form: cream
Drug class:Topical antivirals

Medically reviewed by Drugs.com. Last updated on Jul 22, 2021.

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...