PENCICLOVIR cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Torrent Pharmaceuticals Limited

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 contraindicated in patients with known hypersensitivity to the product or any of its components. Penciclovir cream is not absorbed systemically following topical administration and maternal use is not expected to result in fetal exposure to the drug. Penciclovir cream is not absorbed systemically by the mother following topical administration and breastfeeding is not expected to result in exposure of the child to penciclovir cream. 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 subjects ≥ 6

Product summary:

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 15o C and 30o C (59o F and 86o F).  [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PENCICLOVIR- PENCICLOVIR CREAM
TORRENT PHARMACEUTICALS LIMITED
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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, FOR TOPICAL ADMINISTRATION
INITIAL U.S. APPROVAL: 1996
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 pediatric
patients 12 years of age and older. (1)
DOSAGE AND ADMINISTRATION
• Apply Penciclovir cream 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
•
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.
DRUG INTERACTIONS
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 7/2023
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 Post-Marketing Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
Only for topical use of herpes labialis on the lips and face. (5)
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