NAFTIFINE HYDROCHLORIDE cream

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

NAFTIFINE HYDROCHLORIDE (UNII: 25UR9N9041) (NAFTIFINE - UNII:4FB1TON47A)

Доступна з:

Renaissance Pharma, Inc.

Адміністрація маршрут:

TOPICAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Naftifine Hydrochloride Cream, 2% is indicated for the treatment of: interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organism Trichophyton rubrum . None Pregnancy Category B. There are no adequate and well-controlled studies of Naftifine Hydrochloride Cream, 2% in pregnant women. Because animal reproduction studies are not always predictive of human response, Naftifine Hydrochloride Cream, 2% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The animal multiples of human exposure calculations were based on daily dose body surface area comparison (mg/m2 ) for the reproductive toxicology studies described in this section and in Section 13.1. The Maximum Recommended Human Dose (MRHD) was set at 8 g 2% cream per day (2.67 mg/kg/day for a 60 kg individual). Systemic embryofetal development studies were conducted in rats and rabbits. Oral doses of 30, 100 and 300 mg/kg/day naftifine hydrochloride were administered during the period of o

Огляд продуктів:

How Supplied Naftifine Hydrochloride Cream, 2% is a white to off-white cream supplied in collapsible tubes in the following sizes: 30g – NDC 40085-203-30 45g – NDC 40085-203-45 60g – NDC 40085-203-60 Storage Store Naftifine Hydrochloride Cream, 2% at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature] .

Статус Авторизація:

New Drug Application

Характеристики продукта

NAFTIFINE HYDROCHLORIDE- NAFTIFINE HYDROCHLORIDE CREAM
RENAISSANCE PHARMA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NAFTIFINE HYDROCHLORIDE CREAM, 2% SAFELY
AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR NAFTIFINE HYDROCHLORIDE CREAM,
2%.
NAFTIFINE HYDROCHLORIDE CREAM, 2% FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1988
INDICATIONS AND USAGE
Naftifine Hydrochloride Cream, 2% is an allylamine antifungal
indicated for the treatment of interdigital tinea pedis, tinea
cruris, and tinea corporis caused by the organism _Trichophyton
rubrum_ (1)
DOSAGE AND ADMINISTRATION
For topical use only. Naftifine Hydrochloride Cream, 2% is not for
ophthalmic, oral, or intravaginal use. (2)
Apply a thin layer of Naftifine Hydrochloride Cream, 2% once-daily to
the affected areas plus a ½ inch margin of healthy
surrounding skin for 2 weeks. (2)
DOSAGE FORMS AND STRENGTHS
Cream: 2% (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
If redness or irritation develops with the use of Naftifine
Hydrochloride Cream, 2% treatment should be discontinued. (5.1)
ADVERSE REACTIONS
THE MOST COMMON ADVERSE REACTION (≥1%) IS PRURITUS. (6.1)TO REPORT
SUSPECTED ADVERSE REACTIONS,
CONTACT RENAISSAINCE PHARMA, INC AT 1-877-622-2334 OR FDA AT
1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 2/2016
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 Local Adverse Reactions
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
12.4 Microbiology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Tinea Cruris
14.2 Interdi