treatments [18:<18 years of age with both tinea pedis and tinea cruris. Subjects were treated with a median dose of 8.1 g (range 6.6-10.1 g) applied to the affected areas once daily for 2 weeks. The results showed that the systemic exposure increased over the treatment period. Geometric mean (CV%) AUC 0-24 was 138 (50.2) ng*hr/mL on Day 1, and 192 (74.9) ng*hr/mL on Day 14. Geometric mean (CV %) C max was 9.21 ng/mL (48.4) on Day 1 and 12.7 ng/mL (67.2) on day 14. Median fraction of the dose excreted in urine during the treatment period was 0.0030% on Day 1 and 0.0033% on Day 14. Additional pediatric use information for patients aged 2 years to less than 18 years is approved for Merz Pharmaceuticals, LLC s NAFTIN (naftifine hydrochloride) cream. However, due to Merz Pharmaceuticals, LLC s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Microbiology Although the exact mechanism of action against fungi is not known, naftifine hydrochloride appears to interfere with sterol biosynthesis by inhibiting the enzyme squalene2, 3-epoxidase. This inhibition of enzyme activity results in decreased amounts of sterols, especially ergosterol, and a corresponding accumulation of squalene in the cells. Mechanism of Resistance To date, a mechanism of resistance to naftifine has not been identified. Naftifine has been shown to be active against most isolates of the following fungi, both in vitro and in clinical infections, as described in the INDICATIONS AND USAGE section: Trichophyton rubrum Nonclinical Toxicology Carcinogenesis and Mutagenesis and Impairment of Fertility Long-term studies to evaluate the carcinogenic potential of 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 times MRHD). Clinical Studies Tinea cruris Naftifine Hydrochloride Cream, 2% has been investigated for safety and efficacy in a randomized, double-blind, vehicle-controlled, multi-center trial in 146 subjects with symptomatic and dermatophyte culture positive tinea cruris. Subjects were randomized to receive Naftifine Hydrochloride Cream, 2% or vehicle. Subjects applied Naftifine Hydrochloride Cream, 2% or vehicle to the affected area plus a ½-inch margin of healthy skin surrounding the affected area once-daily for 2 weeks. Signs and symptoms of tinea cruris (presence or absence of erythema, pruritus, and scaling) were assessed, and KOH examination and dermatophyte culture were performed at the primary efficacy endpoint at week 4. The mean age of the trial population was 47 years and 87% were male and 43% were white. At baseline, subjects were confirmed to have signs and symptoms of tinea cruris, positive KOH exam, and confirmed dermatophyte presence based on culture results from a central mycology laboratory. The analysis of the intent-to treat population was a comparison of the proportions of subjects with a complete cure at the week 4 visit (see Table 1). Complete cure was defined as both clinical cure (absence of erythema, pruritus, and scaling) and mycological cure (negative KOH and dermatophyte culture). The percentage of subjects experiencing clinical cure and the percentage of subjects experiencing mycological cure at week 4 are presented individually in Table 1 below. Table 1 Efficacy Results for Tinea Cruris Trial (Week 4 Assessment) Endpoint Naftifine Hydrochloride Cream, 2% N=75 Vehicle N=71 Complete Cure a 19 (25%) 2 (3%) Effective Treatment b 45 (60%) 7 (10%) Mycological Cure c 54 (72%) 11 (16%) a. Complete cure is a composite endpoint of both mycological cure and clinical cure. Clinical cure is defined as the absence of erythema, pruritus, and scaling (grade of 0). b. Effective treatment is a negative KOH preparation and negative dermatophyte culture, erythema, scaling, and pruritus grades of 0 or 1 (absent or nearly absent). c. Mycological cure is defined as negative KOH and dermatophyte culture. Interdigital Tinea pedis Naftifine Hydrochloride Cream, 2% has been investigated for efficacy in a randomized, double-blind, vehicle-controlled, multi-center trial in 217 subjects with symptomatic and dermatophyte culture positive interdigital tinea pedis. Subjects were randomized to receive Naftifine Hydrochloride Cream, 2% or vehicle. Subjects applied Naftifine Hydrochloride Cream, 2% or vehicle to the affected area of the foot plus a ½-inch margin of healthy skin surrounding the affected area once-daily for 2 weeks. Signs and symptoms of interdigital tinea pedis (presence or absence of erythema, pruritus, and scaling) were assessed and KOH examination and dermatophyte culture was performed at the primary efficacy endpoint at week 6. The mean age of the trial population was 42 years and 71% were male and 57% were white. At baseline, subjects were confirmed to have signs and symptoms of interdigital tinea pedis, positive KOH exam, and confirmed dermatophyte culture. The primary efficacy endpoint was the proportions of subjects with a complete cure at the week 6 visit (see Table 2). Complete cure was defined as both a clinical cure (absence of erythema, pruritus, and scaling) and mycological cure (negative KOH and dermatophyte culture). The efficacy results at week 6, four weeks following the end of treatment, are presented in Table 2 below. Naftifine Hydrochloride Cream, 2% demonstrated complete cure in subjects with interdigital tinea pedis, but complete cure in subjects with only moccasin type tinea pedis was not demonstrated. Table 2 Efficacy Results for Interdigital Tinea Pedis Trial (Week 6 Assessment) Endpoint Naftifine Hydrochloride Cream, 2% N=147 Vehicle N=70 Complete Cure a 26 (18%) 5 (7%) Effective Treatment b 83 (57%) 14 (20%) Mycological Cure c 99 (67%) 15 (21%) a. Complete cure is a composite endpoint of both mycological cure and clinical cure. Clinical cure is defined as absence of erythema, pruritus, and scaling (grade of 0). b. Effective treatment is a negative KOH preparation and negative dermatophyte culture, erythema, scaling, and pruritus grades of 0 or 1 (absent or near absent). c. Mycological cure is defined as negative KOH and dermatophyte culture. Additional pediatric use information for patients aged 2 years to less than 18 years is approved for Merz Pharmaceuticals, LLC s NAFTIN (naftifine hydrochloride) cream. However, due to Merz Pharmaceuticals, LLC s marketing exclusivity rights, this drug product is not labeled with that pediatric information. HOW SUPPLIED/STORAGE & HANDLING How Supplied Naftifine Hydrochloride Cream USP, 2% is a white to off-white cream supplied in collapsible tubes in the following sizes: 30g NDC 0115-1512-45 45g NDC 0115-1512-46 60g NDC 0115-1512-58 Storage Store Naftifine Hydrochloride Cream USP, 2% at 20 - 25 C (68 - 77 F); excursions permitted to 15 - 30 C (59 - 86 F) [see USP Controlled Room Temperature]. Patient Counseling Information Inform patients that Naftifine Hydrochloride Cream, 2% is for topical use only. Naftifine Hydrochloride Cream, 2% is not intended for oral, intravaginal or ophthalmic use. If irritation or sensitivity develops with the use of Naftifine Hydrochloride Cream, 2% treatment should be discontinued and appropriate therapy instituted. Patients should be directed to contact their physician if these conditions develop following use of Naftifine Hydrochloride Cream, 2%. Manufactured by: TOLMAR Inc., Fort Collins, CO 80526 Distributed by: Impax Generics, Hayward, CA 94544 04005770 Rev. 2 03/17 PRINCIPAL DISPLAY PANEL NAFTIFINE HYDROCHLORIDE naftifine hydrochloride cream Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0115-1512 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NAFTIFINE HYDROCHLORIDE (NAFTIFINE) NAFTIFINE HYDROCHLORIDE 20 mg in 1 g Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL CETYL ALCOHOL CETYL ESTERS WAX ISOPROPYL MYRISTATE POLYSORBATE 60 SODIUM HYDROXIDE SORBITAN MONOSTEARATE STEARYL ALCOHOL WATER HYDROCHLORIC ACID Packaging # Item Code Package Description 1 NDC:0115-1512-45 1 TUBE in 1 CARTON 1 30 g in 1 TUBE 2 NDC:0115-1512-46 1 TUBE in 1 CARTON 2 45 g in 1 TUBE 3 NDC:0115-1512-58 1 TUBE in 1 CARTON 3 60 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206960 05/10/2017 Labeler - Impax Generics (079832487) Revised: 05/2017 Impax Generics Next Pregnancy Warnings Print this page Add to My Med List More about naftifine topical Side Effects During Pregnancy or Breastfeeding Dosage Information Support Group Pricing & Coupons En Español 5 Reviews Add your own review/rating Drug class: topical antifungals Consumer resources Naftifine topical Naftifine Naftifine Topical (Advanced Reading) Professional resources Naftifine Hydrochloride (AHFS Monograph) Naftifine (Wolters Kluwer) Other brands: Naftin Related treatment guides Tinea Corporis Tinea Cruris Tinea Pedis> ]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only B Pregnancy Category No proven risk in humans N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturer Taro Pharmaceuticals U.S.A., Inc. Drug Class Topical antifungals Related Drugs topical antifungals nystatin topical , clotrimazole topical , ketoconazole topical , terbinafine topical , ciclopirox topical , miconazole topical Tinea Corporis clotrimazole topical , ketoconazole topical , Lotrisone , terbinafine topical , Lamisil , ciclopirox topical , miconazole topical , More... Tinea Cruris clotrimazole topical , ketoconazole topical , Lotrisone , terbinafine topical , Lamisil , ciclopirox topical , miconazole topical , More... Tinea Pedis clotrimazole topical , ketoconazole topical , Lotrisone , terbinafine topical , Lamisil , ciclopirox topical , miconazole topical , More... Naftifine topical Rating 5 User Reviews 10 /10 5 User Reviews 10 Rate it!} } that i'm wondering
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