United States - English - NLM (National Library of Medicine)

bionpharma inc. - terbinafine hydrochloride (unii: 012c11zu6g) (terbinafine - unii:g7riw8s0xp) - terbinafine tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). prior to initiating treatment, appropriate nail specimens for laboratory testing [potassium hydroxide (koh) preparation, fungal culture, or nail biopsy] should be obtained to confirm the diagnosis of onychomycosis. terbinafine tablets are contraindicated in patients with: - chronic or active liver disease [see warnings and precautions (5.1)] - history of allergic reaction to oral terbinafine because of the risk of anaphylaxis [see adverse reactions (6.2)] ​ risk summary available data from postmarketing cases on the use of terbinafine tablets in pregnant women are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies, terbinafine did not cause malformations or any harm to the fetus when administered to pregnant rabbits and rats during the period of organogenesis at oral doses up to 12 and 23 times the maximum recommended human dose (mrhd) of 250 mg/day, respectively (see data). all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. the background risk of major birth defects and miscarriage for the indicated population is unknown; however, in the u.s. general population, the estimated background risk of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. data animal data in embryo-fetal development studies in rats and rabbits, pregnant animals received orally (by gavage) doses of terbinafine up to 300 mg/kg/day, during the period of organogenesis. there were no maternal or embryo-fetal effects in either species up to the maximum dose tested. the 300 mg/kg/day dose level in rats and rabbits corresponds to 23 and 12 times the mrhd [based on body surface area (bsa) comparisons], respectively. in a rat peri- and postnatal development study, terbinafine doses of up to 300 mg/kg/day (12 times the mrhd based on bsa comparisons) given by oral gavage during late pregnancy and lactation (day 15 of gestation to day 20 post-partum) had no adverse effects on parturition and lactation. risk summary after oral administration, terbinafine is present in human milk. however, there are no data on the effects on the breastfed child or on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for terbinafine tablets and any potential adverse effects on the breastfed child from terbinafine tablets or from the underlying maternal condition. the safety and efficacy of terbinafine tablets have not been established in pediatric patients with onychomycosis. clinical studies of terbinafine tablets did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. in patients with renal impairment (creatinine clearance less than or equal to 50 ml/min), the use of terbinafine tablets has not been adequately studied. terbinafine tablets are contraindicated for patients with chronic or active liver disease [see contraindications (4) and warnings and precautions (5.1)] . cases of liver failure, some leading to liver transplant or death, have occurred with the use of terbinafine tablets in individuals with and without preexisting liver disease. the severity of hepatic events and/or their outcome may be worse in patients with active or chronic liver disease.

United States - English - NLM (National Library of Medicine)

bryant ranch prepack - terbinafine hydrochloride (unii: 012c11zu6g) (terbinafine - unii:g7riw8s0xp) - terbinafine tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). prior to initiating treatment, appropriate nail specimens for laboratory testing [potassium hydroxide (koh) preparation, fungal culture, or nail biopsy] should be obtained to confirm the diagnosis of onychomycosis. terbinafine tablets are contraindicated in patients with: - chronic or active liver disease [see warnings and precautions (5.1)] - history of allergic reaction to oral terbinafine because of the risk of anaphylaxis [see adverse reactions (6.2)] ​ risk summary available data from postmarketing cases on the use of terbinafine tablets in pregnant women are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies, terbinafine did not cause malformations or any harm to the fetus when administered to pregnant rabbits and rats during the period of organogenesis at oral doses up to 12 and 23 times the maximum recommended human dose (mrhd) of 250 mg/day, respectively (see data). all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. the background risk of major birth defects and miscarriage for the indicated population is unknown; however, in the u.s. general population, the estimated background risk of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. data animal data in embryo-fetal development studies in rats and rabbits, pregnant animals received orally (by gavage) doses of terbinafine up to 300 mg/kg/day, during the period of organogenesis. there were no maternal or embryo-fetal effects in either species up to the maximum dose tested. the 300 mg/kg/day dose level in rats and rabbits corresponds to 23 and 12 times the mrhd [based on body surface area (bsa) comparisons], respectively. in a rat peri- and postnatal development study, terbinafine doses of up to 300 mg/kg/day (12 times the mrhd based on bsa comparisons) given by oral gavage during late pregnancy and lactation (day 15 of gestation to day 20 post-partum) had no adverse effects on parturition and lactation. risk summary after oral administration, terbinafine is present in human milk. however, there are no data on the effects on the breastfed child or on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for terbinafine tablets and any potential adverse effects on the breastfed child from terbinafine tablets or from the underlying maternal condition. the safety and efficacy of terbinafine tablets have not been established in pediatric patients with onychomycosis. clinical studies of terbinafine tablets did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. in patients with renal impairment (creatinine clearance less than or equal to 50 ml/min), the use of terbinafine tablets has not been adequately studied. terbinafine tablets are contraindicated for patients with chronic or active liver disease [see contraindications (4) and warnings and precautions (5.1)] . cases of liver failure, some leading to liver transplant or death, have occurred with the use of terbinafine tablets in individuals with and without preexisting liver disease. the severity of hepatic events and/or their outcome may be worse in patients with active or chronic liver disease.

United States - English - NLM (National Library of Medicine)

proficient rx lp - terbinafine hydrochloride (unii: 012c11zu6g) (terbinafine - unii:g7riw8s0xp) - terbinafine hydrochloride 1 g in 100 g - antifungal

United States - English - NLM (National Library of Medicine)

walgreen company - terbinafine hydrochloride (unii: 012c11zu6g) (terbinafine - unii:g7riw8s0xp) - terbinafine hydrochloride 1 g in 100 g - antifungal - cures most jock itch (tinea cruris) - relieves itching, burning, cracking and scaling which accompanies this condition

United States - English - NLM (National Library of Medicine)

exelan pharmaceuticals inc. - terbinafine hydrochloride (unii: 012c11zu6g) (terbinafine - unii:g7riw8s0xp) - terbinafine hydrochloride 250 mg - terbinafine tablets, usp are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). prior to initiating treatment, appropriate nail specimens for laboratory testing [potassium hydroxide (koh) preparation, fungal culture, or nail biopsy] should be obtained to confirm the diagnosis of onychomycosis. terbinafine tablets are contraindicated in patients with: - history of allergic reaction to oral terbinafine because of the risk of anaphylaxis [see adverse reactions (6.2)] - chronic or active liver disease [see warnings and precautions (5.1)] risk summary available data from postmarketing cases on the use of terbinafine tablets in pregnant women are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies, terbinafine did not cause malformations or any harm to the fetus when administered to pregnant rabbits and rats during the period of organogenesis at oral dos

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - terbinafine hydrochloride (unii: 012c11zu6g) (terbinafine - unii:g7riw8s0xp) - antifungal - cures most athlete's foot (tinea pedis) - cures most jock itch (tinea cruris) and ringworm (tinea corporis) - relieves itching, burning, cracking and scaling which accompany these conditions

United States - English - NLM (National Library of Medicine)

pharmacy value alliance llc - terbinafine hydrochloride (unii: 012c11zu6g) (terbinafine - unii:g7riw8s0xp) - terbinafine 1 g in 100 g - antifungal - cures most athlete's foot (tinea pedis) - cures most jock itch (tinea cruris) and ringworm (tinea corporis) - relieves itching, burning, cracking and scaling which accompany these conditions

United States - English - NLM (National Library of Medicine)

cipla usa inc. - terbinafine hydrochloride (unii: 012c11zu6g) (terbinafine - unii:g7riw8s0xp) - terbinafine 250 - terbinafine tablets, usp are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). prior to initiating treatment, appropriate nail specimens for laboratory testing [potassium hydroxide (koh) preparation, fungal culture, or nail biopsy] should be obtained to confirm the diagnosis of onychomycosis. terbinafine tablets are contraindicated in patients with: •  history of allergic reaction to oral terbinafine because of the risk of anaphylaxis [see adverse reactions (6.2)] •  chronic or active liver disease [see warnings and precautions (5.1)] risk summary available data from postmarketing cases on the use of terbinafine tablets in pregnant women are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies, terbinafine did not cause malformations or any harm to the fetus when administered to pregnant rabbits and rats during the period of organogenesis at oral d

Australia - English - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - terbinafine hydrochloride, quantity: 281.25 mg (equivalent: terbinafine, qty 250 mg) - tablet - excipient ingredients: hypromellose; microcrystalline cellulose; croscarmellose sodium; colloidal anhydrous silica; magnesium stearate - treatment in adults of ringworm (tinea corporis, tinea cruris and tinea pedis) due to infection caused by dermatophytes such as trichophyton (e.g. t. rubrum, t. mentagrophytes, t. verrucosum, t. violaceum), microsporum canis and epidermophyton floccosum, where oral therapy is considered appropriate owing to the site, severity or extent of the infection, and the infection is not responsive to topical therapy. onychomycosis in adults (fungal infection of the nail) caused by dermatophyte fungi.

Australia - English - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - terbinafine hydrochloride, quantity: 281.25 mg (equivalent: terbinafine, qty 250 mg) - tablet, uncoated - excipient ingredients: magnesium stearate; potato starch; sodium starch glycollate; hypromellose; colloidal anhydrous silica - treatment of ringworm (tinea corporis, tinea cruris and tinea pedis) due to infection caused by dermatophytes such as trichophyton (e.g. t. rubrum, t.mentagrophytes, t.verrucosum, t.violaceum), microsporum canis and epidermophyton floccosum, where oral therapy is considered appropriate owing to the site, severity or extent of the infection, and the infection is not responsive to other available treatments. onychomycosis (fungal infection of the nail) caused by dermatophyte fungi.