DENAVIR- penciclovir cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Prestium Pharma, Inc.

INN (International Name):

PENCICLOVIR

Composition:

PENCICLOVIR 10 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

DENAVIR 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. DENAVIR 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 clearly needed. There

Product summary:

DENAVIR is supplied in a 1.5 gram and 5 gram tube containing 10 mg of penciclovir per gram. NDC 50816-624-01 NDC 40076-624-05 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

Summary of Product characteristics

DENAVIR- PENCICLOVIR CREAM
PRESTIUM PHARMA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DENAVIR SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR_ _DENAVIR .
DENAVIR (PENCICLOVIR) CREAM, FOR TOPICAL ADMINISTRATION
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
DENAVIR is a nucleoside analog HSV DNA polymerase inhibitor indicated
for:
•
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
ADVERSE REACTIONS
•
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PRESTIUM PHARMA, INC.
AT 1-866-897-5002 OR FDA AT 1-
800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
No drug interaction studies have been performed with DENAVIR. Due to
minimal systemic absorption of DENAVIR,
systemic drug interactions are unlikely (7).
USE IN SPECIFIC POPULATIONS
•
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 9/2013
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
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The treatment of recurrent herpes labialis (cold sores) in adults and
children 12 years of age and older (1)
DENAVIR 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).
Topical cream containing 1% penciclovir (3).
In patients with known hypersensitivity to the product or any of its
components (4).
Only for topical use of herpes labialis on the lips and face (5).
One or more local skin reactions were reported by 3% of the patients
treated with DENAVIR and 4% of placebo-
treated patients (6.1).
Pregnancy Category B (8.1)
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 OVERDOSAGE
11 D