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Local Adverse Reactions
If irritation or sensitivity develops with the use of NAFTIN Gel, treatment should be discontinued.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Long-term studies to evaluate the carcinogenic potential of NAFTIN Gel 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 (12.2X MRHD).
Use In Specific Populations
Pregnancy Category B
There are no adequate and well-controlled trials of NAFTIN Gel in pregnant women. Because animal reproduction studies are not always predictive of human response, NAFTIN Gel 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 4 g 2% gel per day (1.33 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 (36.5X 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 (3.7X 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 (7.3X 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 (36.5X MRHD). No developmental toxicity was noted at 100 mg/kg/day (12.2X MRHD).
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 Gel is administered to a nursing woman.
The safety and effectiveness of NAFTIN Gel have been established in the age group 12-18 with interdigital tinea pedis. Use of NAFTIN Gel in this age group is supported by evidence from adequate and well controlled studies in adults with additional safety and PK data from an open label trial, conducted in 22 adolescents ≥ 12 years of age who were exposed to Naftin Gel at a dose of approximately 4 g/day [see CLINICAL PHARMACOLOGY].
Safety and effectiveness in pediatric patients < 12 years of age have not been established.
During clinical trials, 99 subjects (9%) aged 65 years and over were exposed to NAFTIN Gel. Safety and effectiveness were similar to those reported by younger patients.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/27/2014
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