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Naftin Cream

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Naftin Cream

Warnings
Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Local Adverse Reactions

If irritation or sensitivity develops with the use of NAFTIN (naftifine hydrochloride) Cream, 2% treatment should be discontinued. Patients should be directed to contact their physician if these conditions develop following use of NAFTIN (naftifine hydrochloride) Cream, 2%.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies to evaluate the carcinogenic potential of NAFTIN (naftifine hydrochloride) Cream, 2% have not been performed.

Naftifine hydrochloride revealed no evidence of mutagenic or clastogenic potential based on the results of two in vitro genotoxicity tests (Ames assay and Chinese hamster ovary cell chromosome aberration assay) and one in vivo genotoxicity test (mouse bone marrow micronucleus assay).

Oral administration of naftifine hydrochloride to rats, throughout mating, gestation, parturition and lactation, demonstrated no effects on growth, fertility or reproduction, at doses up to 100 mg/kg/day (6.1X MRHD).

Use In Specific Populations

Pregnancy

Pregnancy Category B. There are no adequate and well-controlled studies of NAFTIN (naftifine hydrochloride) Cream, 2% in pregnant women. Because animal reproduction studies are not always predictive of human response, NAFTIN (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 organogenesis (gestational days 6 – 15) to pregnant female rats. No treatment-related effects on embryofetal toxicity or teratogenicity were noted at doses up to 300 mg/kg/day (18.2X MRHD). Subcutaneous doses of 10 and 30 mg/kg/day naftifine hydrochloride were administered during the period of organogenesis (gestational days 6 – 15) to pregnant female rats. No treatment-related effects on embryofetal toxicity or teratogenicity were noted at 30 mg/kg/day (1.8X MRHD). Subcutaneous doses of 3, 10 and 30 mg/kg/day naftifine hydrochloride were administered during the period of organogenesis (gestational days 6 – 18) to pregnant female rabbits. No treatment related effects on embryofetal toxicity or teratogenicity were noted at 30 mg/kg/day (3.6X MRHD).

A peri- and post-natal development study was conducted in rats. Oral doses of 30, 100 and 300 mg/kg/day naftifine hydrochloride were administered to female rats from gestational day 14 to lactation day 21. Reduced body weight gain of females during gestation and of the offspring during lactation was noted at 300 mg/kg/day (18.2X MRHD). No developmental toxicity was noted at 100 mg/kg/day (6.1X MRHD).

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when NAFTIN (naftifine hydrochloride) Cream, 2% is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established. The number of pediatric patients .12 years of age studied were too small to adequately assess safety and efficacy.

Geriatric Use

Clinical studies of NAFTIN (naftifine hydrochloride) Cream, 2% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Last reviewed on RxList: 2/3/2012
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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