NAFTIFINE HYDROCHLORIDE cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Naftifine Hydrochloride (UNII: 25UR9N9041) (Naftifine - UNII:4FB1TON47A)

Available from:

Taro Pharmaceuticals U.S.A., Inc.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Naftifine Hydrochloride Cream is indicated for the treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organism Trichophyton rubrum . None Risk Summary There are no available data with Naftifine Hydrochloride Cream in pregnant women to inform the drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, no adverse effects on embryofetal development were seen at oral doses administered during the period of organogenesis up to 18 times the maximum recommended human dose (MRHD) in pregnant rats or subcutaneous doses administered during the period of organogenesis up to 2 times the MRHD in pregnant rats or 4 times the MRHD in pregnant rabbits [see Data] . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and misca

Product summary:

How Supplied Naftifine Hydrochloride Cream USP, 2% is a white to off-white cream supplied in tubes in the following sizes: 30 g – NDC 51672-1368-2 45 g – NDC 51672-1368-6 60 g – NDC 51672-1368-3 Storage: Store Naftifine Hydrochloride Cream USP, 2% at 20° to 25°C (68 ° to 77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NAFTIFINE HYDROCHLORIDE- NAFTIFINE HYDROCHLORIDE CREAM
TARO PHARMACEUTICALS U.S.A., INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NAFTIFINE HYDROCHLORIDE CREAM
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NAFTIFINE
HYDROCHLORIDE CREAM
NAFTIFINE HYDROCHLORIDE CREAM, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1988
INDICATIONS AND USAGE
Naftifine Hydrochloride Cream 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 is not for
ophthalmic, oral, or intravaginal use. (2)
Apply a thin layer of Naftifine Hydrochloride Cream 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
Discontinue treatment if redness or irritation develops with Naftifine
Hydrochloride Cream use. (5.1)
ADVERSE REACTIONS
The most common adverse reaction (≥1%) is pruritus. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT TARO PHARMACEUTICALS
U.S.A., INC., AT 1-866-923-4914
OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 5/2018
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
8.2 Lactation
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 Interdigital Tinea Pedis
14.3 Tinea Co