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

nucare pharmaceuticals,inc. - clotrimazole (unii: g07gz97h65) (clotrimazole - unii:g07gz97h65), betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - clotrimazole and betamethasone dipropionate cream usp is a combination of an azole antifungal and corticosteroid and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to epidermophyton floccosum, trichophyton mentagrophytes, and trichophyton rubrum in patients 17 years and older. none. teratogenic effects, pregnancy category c there are no adequate and well-controlled studies with clotrimazole and betamethasone dipropionate cream in pregnant women. therefore, clotrimazole and betamethasone dipropionate cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. there have been no teratogenic studies performed in animals or humans with the combination of clotrimazole and betamethasone dipropionate. corticosteroids are generally teratogenic in laboratory animals when administered at relatively low dosage levels. studies in pregnant rats with intravaginal doses up

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

remedyrepack inc. - clotrimazole (unii: g07gz97h65) (clotrimazole - unii:g07gz97h65), betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - clotrimazole and betamethasone dipropionate cream is a combination of an azole antifungal and corticosteroid and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to epidermophyton floccosum, trichophyton mentagrophytes, and trichophyton rubrum in patients 17 years and older. none. risk summary there are no available data on topical betamethasone dipropionate or clotrimazole use in pregnant women to identify clotrimazole and betamethasone dipropionate cream associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. observational studies suggest an increased risk of low birthweight infants with the use of potent or very potent topical corticosteroid during pregnancy . advise pregnant women that clotrimazole and betamethasone dipropionate cream may increase the risk of having a low birthweight infant and to use clotrimazole and betamethasone dipropionate cream on the smallest area of skin and for the shortest duration possible. there have been no reproduction studies performed in animals or humans with the combination of clotrimazole and betamethasone dipropionate. in an animal reproduction study, betamethasone dipropionate caused malformations (i.e., umbilical hernias, cephalocele, and cleft palate) in pregnant rabbits when given by the intramuscular route during organogenesis [see data]. the available data do not allow the calculation of relevant comparisons between the systemic exposure of clotrimazole and/or betamethasone dipropionate observed in the animal studies to the systemic exposure that would be expected in humans after topical use of clotrimazole and betamethasone dipropionate cream. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data - animal data clotrimazole studies in pregnant rats treated during organogenesis with intravaginal doses up to 100 mg/kg/day revealed no evidence of fetotoxicity due to clotrimazole exposure. no increase in fetal malformations was noted in pregnant rats receiving oral (gastric tube) clotrimazole doses up to 100 mg/kg/day during gestation days 6 to 15. however, clotrimazole dosed at 100 mg/kg/day was embryotoxic (increased resorptions), fetotoxic (reduced fetal weights), and maternally toxic (reduced body weight gain) to rats. clotrimazole dosed at 200 mg/kg/day was maternally lethal, and therefore, fetuses were not evaluated in this group. also in this study, doses up to 50 mg/kg/day had no adverse effects on dams or fetuses. however, in the combined fertility, embryofetal development, and postnatal development study conducted in rats, 50 mg/kg/day clotrimazole was associated with reduced maternal weight gain and reduced numbers of offspring reared to 4 weeks [see nonclinical toxicology ( 13.1)] . oral clotrimazole doses of 25, 50, 100, and 200 mg/kg/day did not cause malformations in pregnant mice. no evidence of maternal toxicity or embryotoxicity was seen in pregnant rabbits dosed orally during organogenesis with 60, 120, or 180 mg/kg/day. betamethasone dipropionate betamethasone dipropionate caused malformations when given to pregnant rabbits during organogenesis by the intramuscular route at doses of 0.05 mg/kg/day. the abnormalities observed included umbilical hernias, cephalocele, and cleft palates. risk summary there are no data regarding the excretion of betamethasone dipropionate or clotrimazole into breast milk, the effects on the breastfed infant, or the effects on milk production after topical application to women who are breastfeeding. it is possible that topical administration of betamethasone dipropionate could result in sufficient systemic absorption to produce detectable quantities in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for clotrimazole and betamethasone dipropionate cream and any potential adverse effects on the breastfed infant from clotrimazole and betamethasone dipropionate cream or from the underlying maternal condition. clinical considerations to minimize potential exposure to the breastfed infant via breast milk, use clotrimazole and betamethasone dipropionate cream on the smallest area of skin and for the shortest duration possible while breastfeeding. advise breastfeeding women not to apply clotrimazole and betamethasone dipropionate cream directly to the nipple and areola to avoid direct infant exposure [see use in specific populations ( 8.4)] . the use of clotrimazole and betamethasone dipropionate cream in patients under 17 years of age is not recommended. adverse events consistent with corticosteroid use have been observed in pediatric patients treated with clotrimazole and betamethasone dipropionate cream. in open-label trials, 17 of 43 (39.5%) evaluable pediatric subjects (aged 12 to 16 years old) using clotrimazole and betamethasone dipropionate cream for treatment of tinea pedis demonstrated adrenal suppression as determined by cosyntropin testing. in another open-label trial, 8 of 17 (47.1%) evaluable pediatric subjects (aged 12 to 16 years old) using clotrimazole and betamethasone dipropionate cream for treatment of tinea cruris demonstrated adrenal suppression as determined by cosyntropin testing. because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of hpa axis suppression when they are treated with topical corticosteroids. they are, therefore also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. pediatric patients may be more susceptible than adults to skin atrophy, including striae, when they are treated with topical corticosteroids. hpa axis suppression, cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids [see warnings and precautions ( 5.1)]. avoid use of clotrimazole and betamethasone dipropionate cream in the treatment of diaper dermatitis. clinical studies of clotrimazole and betamethasone dipropionate cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. however, greater sensitivity of some older individuals cannot be ruled out. the use of clotrimazole and betamethasone dipropionate cream under occlusion, such as in diaper dermatitis, is not recommended. postmarket adverse event reporting for clotrimazole and betamethasone dipropionate cream in patients aged 65 and above includes reports of skin atrophy and rare reports of skin ulceration. caution should be exercised with the use of these corticosteroid-containing topical products on thinning skin.

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

remedyrepack inc. - clotrimazole (unii: g07gz97h65) (clotrimazole - unii:g07gz97h65), betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - clotrimazole and betamethasone dipropionate cream is a combination of an azole antifungal and corticosteroid and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to epidermophyton floccosum , trichophyton mentagrophytes , and trichophyton rubrum in patients 17 years and older. none. risk summary there are no available data on topical betamethasone dipropionate or clotrimazole use in pregnant women to identify a clotrimazole and betamethasone dipropionate cream associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. observational studies suggest an increased risk of low birthweight infants with the use of potent or very potent topical corticosteroid during pregnancy. advise pregnant women that clotrimazole and betamethasone dipropionate cream may increase the risk of having a low birthweight infant and to use clotrimazole and betamethasone dipropionate cream on the smallest area of skin and for the shortest duration possible. there have been no reproduction studies performed in animals or humans with the combination of clotrimazole and betamethasone dipropionate. in an animal reproduction study, betamethasone dipropionate caused malformations (i.e., umbilical hernias, cephalocele, and cleft palate) in pregnant rabbits when given by the intramuscular route during organogenesis [see data] . the available data do not allow the calculation of relevant comparisons between the systemic exposure of clotrimazole and/or betamethasone dipropionate observed in the animal studies to the systemic exposure that would be expected in humans after topical use of clotrimazole and betamethasone dipropionate cream. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data clotrimazole studies in pregnant rats treated during organogenesis with intravaginal doses up to 100 mg/kg/day revealed no evidence of fetotoxicity due to clotrimazole exposure. no increase in fetal malformations was noted in pregnant rats receiving oral (gastric tube) clotrimazole doses up to 100 mg/kg/day during gestation days 6 to 15. however, clotrimazole dosed at 100 mg/kg/day was embryotoxic (increased resorptions), fetotoxic (reduced fetal weights), and maternally toxic (reduced body weight gain) to rats. clotrimazole dosed at 200 mg/kg/day was maternally lethal, and therefore, fetuses were not evaluated in this group. also in this study, doses up to 50 mg/kg/day had no adverse effects on dams or fetuses. however, in the combined fertility, embryofetal development, and postnatal development study conducted in rats, 50 mg/kg/day clotrimazole was associated with reduced maternal weight gain and reduced numbers of offspring reared to 4 weeks [see nonclinical toxicology (13.1)] . oral clotrimazole doses of 25, 50, 100, and 200 mg/kg/day did not cause malformations in pregnant mice. no evidence of maternal toxicity or embryotoxicity was seen in pregnant rabbits dosed orally during organogenesis with 60, 120, or 180 mg/kg/day. betamethasone dipropionate betamethasone dipropionate caused malformations when given to pregnant rabbits during organogenesis by the intramuscular route at doses of 0.05 mg/kg/day. the abnormalities observed included umbilical hernias, cephalocele, and cleft palates. risk summary there are no data regarding the excretion of betamethasone dipropionate or clotrimazole into breast milk, the effects on the breastfed infant, or the effects on milk production after topical application to women who are breastfeeding. it is possible that topical administration of betamethasone dipropionate could result in sufficient systemic absorption to produce detectable quantities in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for clotrimazole and betamethasone dipropionate cream and any potential adverse effects on the breastfed infant from clotrimazole and betamethasone dipropionate cream or from the underlying maternal condition. clinical considerations to minimize potential exposure to the breastfed infant via breast milk, use clotrimazole and betamethasone dipropionate cream on the smallest area of skin and for the shortest duration possible while breastfeeding. advise breastfeeding women not to apply clotrimazole and betamethasone dipropionate cream directly to the nipple and areola to avoid direct infant exposure [see use in specific populations (8.4)] . the use of clotrimazole and betamethasone dipropionate cream in patients under 17 years of age is not recommended. adverse events consistent with corticosteroid use have been observed in pediatric patients treated with clotrimazole and betamethasone dipropionate cream. in open-label trials, 17 of 43 (39.5%) evaluable pediatric subjects (aged 12 to 16 years old) using clotrimazole and betamethasone dipropionate cream for treatment of tinea pedis demonstrated adrenal suppression as determined by cosyntropin testing. in another open-label trial, 8 of 17 (47.1%) evaluable pediatric subjects (aged 12 to 16 years old) using clotrimazole and betamethasone dipropionate cream for treatment of tinea cruris demonstrated adrenal suppression as determined by cosyntropin testing. because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of hpa axis suppression when they are treated with topical corticosteroids. they are, therefore also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. pediatric patients may be more susceptible than adults to skin atrophy, including striae, when they are treated with topical corticosteroids. hpa axis suppression, cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids [see warnings and precautions (5.1)] . avoid use of clotrimazole and betamethasone dipropionate cream in the treatment of diaper dermatitis. clinical studies of clotrimazole and betamethasone dipropionate cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. however, greater sensitivity of some older individuals cannot be ruled out. the use of clotrimazole and betamethasone dipropionate cream under occlusion, such as in diaper dermatitis, is not recommended. postmarket adverse event reporting for clotrimazole and betamethasone dipropionate cream in patients aged 65 and above includes reports of skin atrophy and rare reports of skin ulceration. caution should be exercised with the use of these corticosteroid-containing topical products on thinning skin.

Canada - English - Health Canada

taro pharmaceuticals inc - clotrimazole - cream - 2% - clotrimazole 2% - azoles

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

nucare pharmaceuticals,inc. - clotrimazole (unii: g07gz97h65) (clotrimazole - unii:g07gz97h65) - clotrimazole cream usp is indicated for the topical treatment of candidiasis due to candida albicans and tinea versicolor due to malassezia furfur . clotrimazole is also available as a nonprescription item which is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to trichophyton rubrum, trichophyton mentagrophytes, epidermophyton floccosum, and microsporum canis . clotrimazole cream usp is contraindicated in individuals sensitive to its components.

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

nucare pharmaceuticals,inc. - clotrimazole (unii: g07gz97h65) (clotrimazole - unii:g07gz97h65), betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - clotrimazole and betamethasone dipropionate cream is a combination of an azole antifungal and corticosteroid and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to epidermophyton floccosum , trichophyton mentagrophytes , and trichophyton rubrum in patients 17 years and older. none. risk summary there are no available data on topical betamethasone dipropionate or clotrimazole use in pregnant women to identify a clotrimazole and betamethasone dipropionate cream associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. observational studies suggest an increased risk of low birthweight infants with the use of potent or very potent topical corticosteroid during pregnancy. advise pregnant women that clotrimazole and betamethasone dipropionate cream may increase the risk of having a low birthweight infant and to use clotrimazole and betamethasone dipropionate cream on the sma

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

proficient rx lp - clotrimazole (unii: g07gz97h65) (clotrimazole - unii:g07gz97h65), betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - clotrimazole and betamethasone dipropionate cream is a combination of an azole antifungal and corticosteroid and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to epidermophyton floccosum, trichophyton mentagrophytes, and trichophyton rubrum in patients 17 years and older. none. risk summary there are no available data on topical betamethasone dipropionate or clotrimazole use in pregnant women to identify clotrimazole and betamethasone dipropionate cream associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. observational studies suggest an increased risk of low birthweight infants with the use of potent or very potent topical corticosteroid during pregnancy. advise pregnant women that clotrimazole and betamethasone dipropionate cream may increase the risk of having a low birthweight infant and to use clotrimazole and betamethasone dipropionate cream on the smallest area of skin and for the shortest d

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

proficient rx lp - clotrimazole (unii: g07gz97h65) (clotrimazole - unii:g07gz97h65) - clotrimazole cream usp is indicated for the topical treatment of candidiasis due to candida albicans and tinea versicolor due to malassezia furfur . clotrimazole is also available as a nonprescription item which is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to trichophyton rubrum, trichophyton mentagrophytes, epidermophyton floccosum, and microsporum canis . clotrimazole cream usp is contraindicated in individuals sensitive to its components.

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

nucare pharmaceuticals,inc. - clotrimazole (unii: g07gz97h65) (clotrimazole - unii:g07gz97h65), betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - clotrimazole and betamethasone dipropionate cream is a combination of an azole antifungal and corticosteroid and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to epidermophyton floccosum , trichophyton mentagrophytes , and trichophyton rubrum in patients 17 years and older. none. risk summary there are no available data on topical betamethasone dipropionate or clotrimazole use in pregnant women to identify a clotrimazole and betamethasone dipropionate cream associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. observational studies suggest an increased risk of low birthweight infants with the use of potent or very potent topical corticosteroid during pregnancy. advise pregnant women that clotrimazole and betamethasone dipropionate cream may increase the risk of having a low birthweight infant and to use clotrimazole and betamethasone dipropionate cream on the sma

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

nucare pharmaceuticals,inc. - clotrimazole (unii: g07gz97h65) (clotrimazole - unii:g07gz97h65) - clotrimazole cream usp is indicated for the topical treatment of candidiasis due to candida albicans and tinea versicolor due to malassezia furfur . clotrimazole is also available as a nonprescription item which is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to trichophyton rubrum, trichophyton mentagrophytes, epidermophyton floccosum, and microsporum canis . clotrimazole cream usp is contraindicated in individuals sensitive to its components.