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

taro pharmaceuticals u.s.a., inc. - alclometasone dipropionate (unii: s56pql4n1v) (alclometasone - unii:136h45tb7b) - alclometasone dipropionate 0.5 mg in 1 g - alclometasone dipropionate cream usp, 0.05% is a low to medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. alclometasone dipropionate cream may be used in pediatric patients 1 year of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established (see precautions: pediatric use ). since the safety and efficacy of alclometasone dipropionate cream have not been established in pediatric patients below 1 year of age, their use in this age-group is not recommended. alclometasone dipropionate cream usp, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components in this preparation. in studies where geriatric patients (65 years of age or older, see precautions ) have been treated with alclometasone dipropionate cream, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

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

taro pharmaceuticals u.s.a., inc. - alclometasone dipropionate (unii: s56pql4n1v) (alclometasone - unii:136h45tb7b) - alclometasone dipropionate 0.5 mg in 1 g - alclometasone dipropionate ointment usp, 0.05% is a low to medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. alclometasone dipropionate ointment may be used in pediatric patients 1 year of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established (see precautions: pediatric use ). since the safety and efficacy of alclometasone dipropionate ointment has not been established in pediatric patients below 1 year of age, their use in this age-group is not recommended. alclometasone dipropionate ointment usp, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components in this preparation.

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

taro pharmaceuticals u.s.a., inc. - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - fluocinolone acetonide 0.11 mg in 118.28 ml - fluocinolone acetonide topical oil is indicated for the topical treatment of atopic dermatitis in adult patients. fluocinolone acetonide topical oil is indicated for the topical treatment of moderate to severe atopic dermatitis in pediatric patients, 3 months and older for up to 4 weeks. safety and effectiveness in pediatric patients younger than 3 months of age have not been established. apply the least amount of fluocinolone acetonide topical oil needed to cover the affected areas. as with other corticosteroids, fluocinolone acetonide topical oil should be discontinued when control of disease is achieved. contact the physician if no improvement is seen within 2 weeks. fluocinolone acetonide topical oil should not be applied to the diaper area; diapers or plastic pants may constitute occlusive use. fluocinolone acetonide topical oil should not be used on the face, axillae, or groin unless directed by the physician. application to intertriginous areas should be avoided due to the increased risk of local adver

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

taro pharmaceuticals u.s.a., inc. - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - metronidazole 10 mg in 1 g - metronidazole gel usp, 1% is indicated for the topical treatment of inflammatory lesions of rosacea. metronidazole gel usp, 1% is contraindicated in patients with a history of hypersensitivity to metronidazole or to any other ingredient in the formulation. teratogenic effects: pregnancy category b. there are no adequate and well-controlled studies with the use of metronidazole in pregnant women. metronidazole crosses the placental barrier and enters the fetal circulation rapidly. no fetotoxicity was observed after oral administration of metronidazole in rats or mice at 200 and 20 times, respectively, the expected clinical dose. however, oral metronidazole has shown carcinogenic activity in rodents. because animal reproduction studies are not always predictive of human response, metronidazole should be used during pregnancy only if clearly needed. after oral administration, metronidazole is secreted in breast milk in concentrations similar to those found in the plasma. even though blood levels taken after top

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

taro pharmaceuticals u.s.a., inc. - ciclopirox (unii: 19w019zdrj) (ciclopirox - unii:19w019zdrj) - ciclopirox 80 mg in 1 ml - (to understand fully the indication for this product, please read the entire indications and usage section of the labeling.) ciclopirox topical solution, 8%, (nail lacquer), as a component of a comprehensive management program, is indicated as topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to trichophyton rubrum . the comprehensive management program includes removal of the unattached, infected nails as frequently as monthly, by a health care professional who has special competence in the diagnosis and treatment of nail disorders, including minor nail procedures. - no studies have been conducted to determine whether ciclopirox might reduce the effectiveness of systemic antifungal agents for onychomycosis. therefore, the concomitant use of 8% ciclopirox topical solution and systemic antifungal agents for onychomycosis, is not recommended. - ciclopirox topical solution, 8%, (nail lacquer), should be used only under me

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

taro pharmaceuticals u.s.a., inc. - betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - betamethasone dipropionate 0.64 mg in 1 g - betamethasone dipropionate cream is a medium-potency corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 13 years and older. betamethasone dipropionate cream is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation.

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

taro pharmaceuticals u.s.a., inc. - adapalene (unii: 1l4806j2qf) (adapalene - unii:1l4806j2qf) - adapalene 3 mg in 1 g - adapalene gel, 0.3% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. adapalene gel, 0.3% is contraindicated in patients who have known hypersensitivity to adapalene or any excipient of adapalene gel, 0.3% [see warnings and precautions (5.1)] . risk summary available data from clinical trials with adapalene gel, 0.3% use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. in animal reproduction studies, oral administration of adapalene to pregnant rats and rabbits during organogenesis at dose exposures 40 and 81 times, respectively, the human exposure at the maximum recommended human dose (mrhd) of 2 g resulted in fetal skeletal and visceral malformations (see data) . the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defects, loss, or other adverse outcomes. in the u.s. general population the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and 15 to 20%, respectively. data animal data no malformations were observed in rats treated with oral adapalene doses of 0.15 to 5 mg/kg/day, up to 8 times the mrhd based on a mg/m 2 comparison. however, malformations were observed in rats and rabbits when treated with oral doses of ≥ 25 mg/kg/day adapalene (40 and 81 times the mrhd, respectively, based on a mg/m 2 comparison). findings included cleft palate, microphthalmia, encephalocele, and skeletal abnormalities in rats and umbilical hernia, exophthalmos, and kidney and skeletal abnormalities in rabbits. dermal adapalene embryofetal development studies in rats and rabbits at doses up to 6 mg/kg/day (9.7 and 19.5 times the mrhd, respectively, based on a mg/m 2 comparison) exhibited no fetotoxicity and only minimal increases in skeletal variations (supernumerary ribs in both species and delayed ossification in rabbits). risk summary there are no data on the presence of topical adapalene gel or its metabolite in human milk, the effects on the breastfed infant, or the effects on milk production. in animal studies, adapalene is present in rat milk with oral administration of the drug. when a drug is present in animal milk, it is likely that the drug will be present in human milk. it is possible that topical administration of large amounts of adapalene could result in sufficient systemic absorption to produce detectable quantities in human milk (see clinical considerations) . the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for adapalene gel, 0.3% and any potential adverse effects on the breastfed child from adapalene gel, 0.3%, or from the underlying maternal condition. clinical considerations to minimize potential exposure to the breastfed infant via breastmilk, use adapalene gel, 0.3% on the smallest area of skin and for the shortest duration possible while breastfeeding. avoid application of adapalene gel, 0.3% to areas with increased risk for potential ingestion by or ocular exposure to the breastfeeding child. safety and effectiveness have not been established in pediatric patients below the age of 12. clinical studies of adapalene gel, 0.3% did not include subjects 65 years of age and older to determine whether they respond differently than younger subjects. safety and effectiveness in geriatric patients age 65 and above have not been established.

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

taro pharmaceuticals u.s.a., inc. - clotrimazole (unii: g07gz97h65) (clotrimazole - unii:g07gz97h65), betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - clotrimazole 10 mg in 1 ml - clotrimazole and betamethasone dipropionate lotion is indicated in patients 17 years and older for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to epidermophyton floccosum, trichophyton mentagrophytes and trichophyton rubrum. effective treatment without the risks associated with topical corticosteroid use may be obtained using a topical antifungal agent that does not contain a corticosteroid, especially for noninflammatory tinea infections. the efficacy of clotrimazole and betamethasone dipropionate lotion for the treatment of infections caused by zoophilic dermatophytes (e.g., microsporum canis ) has not been established. clotrimazole and betamethasone dipropionate lotion is contraindicated in patients who are sensitive to clotrimazole, betamethasone dipropionate, other corticosteroids or imidazoles, or to any ingredient in this preparation.

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

taro pharmaceuticals u.s.a., inc. - brompheniramine maleate (unii: ixa7c9zn03) (brompheniramine - unii:h57g17p2fn), pseudoephedrine hydrochloride (unii: 6v9v2ryj8n) (pseudoephedrine - unii:7cuc9ddi9f), dextromethorphan hydrobromide (unii: 9d2rti9kyh) (dextromethorphan - unii:7355x3rots) - brompheniramine maleate 2 mg in 5 ml - brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup is indicated for relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold. hypersensitivity to any of the ingredients. do not use in the newborn, in premature infants, in nursing mothers, or in patients with severe hypertension or severe coronary artery disease. do not use dextromethorphan in patients receiving monoamine oxidase (maoi) inhibitors (see drug interactions ). antihistamines should not be used to treat lower respiratory tract conditions including asthma.

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

taro pharmaceuticals u.s.a., inc. - gabapentin (unii: 6cw7f3g59x) (gabapentin - unii:6cw7f3g59x) - gabapentin 250 mg in 5 ml - gabapentin is indicated for the management of postherpetic neuralgia in adults. gabapentin is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. gabapentin is also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 to 12 years. gabapentin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. gabapentin is not a scheduled drug. gabapentin does not exhibit affinity for benzodiazepine, opiate (mu, delta or kappa), or cannabinoid 1 receptor sites. a small number of postmarketing cases report gabapentin misuse and abuse. these individuals were taking higher than recommended doses of gabapentin for unapproved uses. most of the individuals described in these reports had a history of poly-substance abuse or used gabapentin to relieve symptoms of withdrawal from other substances. when prescribing gabapentin carefully ev