Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
PENCICLOVIR (UNII: 359HUE8FJC) (PENCICLOVIR - UNII:359HUE8FJC)
Prestium Pharma, Inc.
PENCICLOVIR
PENCICLOVIR 10 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
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
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].
New Drug Application
DENAVIR- PENCICLOVIR CREAM PRESTIUM PHARMA, INC. ---------- 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 ® ® ® ® 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 Les hele dokumentet