PENCICLOVIR cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PENCICLOVIR (UNII: 359HUE8FJC) (PENCICLOVIR - UNII:359HUE8FJC)

Available from:

Teva Pharmaceuticals USA, Inc.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 is contraindicated in patients with known hypersensitivity to the product or any of its components. Risk Summary Penciclovir is not absorbed systemically following topical administration and maternal use is not expected to result in fetal exposure to the drug. Risk Summary Penciclovir is not absorbed systemically by the mother following topical administration and breastfeeding is not expected to result in exposure of the child to penciclovir. An open-label, uncontrolled trial with penciclovir cream 1% was conducted in 102 subjects, ages 12 to 17 years, with recurrent herpes labialis. The frequency of adverse events was generally similar to the frequency previously reported for adult patients. Safety and effectiveness in pediatric patients less than 12 years of age have not been established. In 74 subject

Product summary:

Penciclovir cream 1% is supplied in a 5 gram tube containing 10 mg of penciclovir per gram in a cream base, which is equivalent to 1% (w/w). The white cream is available as follows: NDC 0093- 3186- 20 - carton containing one 5 gram tube Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PENCICLOVIR- PENCICLOVIR CREAM
TEVA PHARMACEUTICALS USA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PENCICLOVIR CREAM
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
PENCICLOVIR CREAM.
PENCICLOVIR CREAM 1%, FOR TOPICAL USE ONLY
INITIAL U.S. APPROVAL: 1996
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
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. (2)
Start treatment as early as possible (i.e., during the prodrome or
when lesions appear). (2)
DOSAGE FORMS AND STRENGTHS
Topical cream containing 1% penciclovir (3).
CONTRAINDICATIONS
Contraindicated in patients with known hypersensitivity to the product
or any of its components. (4)
WARNINGS AND PRECAUTIONS
Only for topical use of herpes labialis on the lips and face. (5)
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.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 3/2019
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 General
6 ADVERSE REACTIONS
6.1 Clinical Studies
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
12.4 Microbiology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HAN