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.

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.

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

wockhardt usa llc. - terbinafine hydrochloride (unii: 012c11zu6g) (terbinafine - unii:g7riw8s0xp) - terbinafine 250 mg - terbinafine hydrochloride 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 hydrochloride 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) ] pregnancy category b there are no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, and because treatment of onychomycosis can be postponed until after pregnancy is completed, it is recommended that terbinafine hydrochloride tablets not be initiated during pregnancy. oral reproduction studies

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

harris pharmaceutical, inc. - terbinafine hydrochloride (unii: 012c11zu6g) (terbinafine - unii:g7riw8s0xp) - terbinafine hydrochloride 250 mg - 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

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

pd-rx pharmaceuticals, inc. - terbinafine hydrochloride (unii: 012c11zu6g) (terbinafine - unii:g7riw8s0xp) - terbinafine hydrochloride 250 mg - 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 admi

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

direct rx - 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)] 8.1 pregnancy 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 or

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

camber pharmaceuticals, 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 (koh preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis of onychomycosis. terbinafine tablets are contraindicated in individuals with a history of allergic reaction to oral terbinafine because of the risk of anaphylaxis. pregnancy category b: there are no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, and because treatment of onychomycosis can be postponed until after pregnancy is completed, it is recommended that terbinafine not be initiated during pregnancy. oral reproduction studies have been performed in rabbits and rats at doses up to 300 mg/kg/day (12x to 23x the mrhd, in rabbits and rats, respectively, based on bsa) and have revealed no evidence of impaired

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

proficient rx lp - 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 (koh preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis of onychomycosis. terbinafine tablets are contraindicated in individuals with a history of allergic reaction to oral terbinafine because of the risk of anaphylaxis. pregnancy category b: there are no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, and because treatment of onychomycosis can be postponed until after pregnancy is completed, it is recommended that terbinafine not be initiated during pregnancy. oral reproduction studies have been performed in rabbits and rats at doses up to 300 mg/kg/day (12x to 23x the mrhd, in rabbits and rats, respectively, based on bsa) and have revealed no evidence of impaired

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

northstar rx llc - terbinafine hydrochloride (unii: 012c11zu6g) (terbinafine - unii:g7riw8s0xp) - terbinafine 250 mg - 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

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

harris pharmaceutical, inc. - terbinafine hydrochloride (unii: 012c11zu6g) (terbinafine - unii:g7riw8s0xp) - terbinafine 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, usp are contraindicated in individuals with a history of allergic reaction to oral terbinafine because of the risk of anaphylaxis. pregnancy category b there are no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response and because treatment of onychomycosis can be postponed until after pregnancy is completed, it is recommended that terbinafine tablets not be initiated during pregnancy. oral reproduction studies have been performed in rabbits and rats at doses up to 300 mg/kg/day [12x to 23x the maximum recommended human dose (mrhd), in rabbits and rats, respe