PENCICLOVIR- penciclovir cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Renaissance Pharma, Inc.

INN (International Name):

PENCICLOVIR

Composition:

PENCICLOVIR 10 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Penciclovir Cream is contraindicated in patients with known hypersensitivity to the product or any of its components. Category   B There are no adequate and well-controlled studies in pregnant women. Animal Data   No adverse effects on the course and outcome of pregnancy or on fetal development were noted in rats and rabbits following the intravenous administration of penciclovir at doses of 80 and 60 mg/kg/day, respectively (estimated human equivalent doses of 13 and 18 mg/kg/day for the rat and rabbit, respectively, based on body surface area conversion; the body surface area doses being 260 and 355x the maximum recommended dose following topical application of the penciclovir cream). Because animal reproduction studies are not always predictive of human response, penciclovir should be used during pregnancy only if clear

Product summary:

Penciclovir Cream, 1% is supplied in a 5 gram tube containing 10 mg of penciclovir per gram. NDC 40085-415-05 Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature].

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

PENCICLOVIR- PENCICLOVIR CREAM
RENAISSANCE PHARMA, 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, FOR TOPICAL ADMINISTRATION
INITIAL U.S. APPROVAL: 1996
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 and older (1)
DOSAGE AND ADMINISTRATION
Penciclovir Cream should be applied every 2 hours during waking hours
for a period of 4 days (2).
Treatment should be started 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
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 patients
treated with
Penciclovir Cream and 4% of placebo-treated patients (6.1).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT RENAISSANCE PHARMA,
INC. AT 1-877-622-2334 OR FDA AT
1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
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 (7).
USE IN SPECIFIC POPULATIONS
Pregnancy Category B (8.1)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 8/2015
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
8.3 NURSING MOTHERS
8.4 PEDIATRIC USE
8.5 GERIATRIC USE
10. OVERD