BETAMETHASONE SODIUM PHOSPHATE AND BETAMETHASONE ACETATE injection, suspension Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

betamethasone sodium phosphate and betamethasone acetate injection, suspension

remedyrepack inc. - betamethasone sodium phosphate (unii: 7bk02scl3w) (betamethasone - unii:9842x06q6m), betamethasone acetate (unii: ti05ao53l7) (betamethasone - unii:9842x06q6m) - when oral therapy is not feasible, the intramuscular use of betamethasone sodium phosphate and betamethasone acetate injectable suspension is indicated as follows: control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (stevens-johnson syndrome). congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. hydrocortisone or cortisone is the drug of choice in primary or secondary adrenocortical insufficiency. synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance. to tide the patient over a critical period of the disease in r

BETNOVATE CREAM Israel - Inggeris - Ministry of Health

betnovate cream

glaxo smith kline (israel) ltd - betamethasone as valerate - cream - betamethasone as valerate 0.1 %w/w - betamethasone - betamethasone - betamethasone valerate is a potent topical corticosteroid indicated for adults, elderly and children over 1 year for the relief of the inflammatory and pruritic manifestations of steroid responsive dermatoses.

BETNOVATE OINTMENT Israel - Inggeris - Ministry of Health

betnovate ointment

glaxo smith kline (israel) ltd - betamethasone as valerate - ointment - betamethasone as valerate 0.1 %w/w - betamethasone - betamethasone - betamethasone valerate is a potent topical corticosteroid indicated for adults, elderly and children over 1 year for the relief of the inflammatory and pruritic manifestations of steroid responsive dermatoses.these include the following:atopic dermatitis (including infantile atopic dermatitis)nummular dermatitis (discoid eczema)prurigo nodularispsoriasis (excluding widespread plaque psoriasis)lichen simplex chronicus (neurodermatitis) and lichen planusseborrhoeic dermatitisirritant or allergic contact dermatitisdiscoid lupus erythematosusadjunct to systemic steroid therapy in generalised erythroderma

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE cream Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

clotrimazole and betamethasone dipropionate cream

glenmark pharmaceuticals inc. usa - clotrimazole (unii: g07gz97h65) (clotrimazole - unii:g07gz97h65), betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - clotrimazole 10 mg in 1 g - 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 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 ( error! hyperlink reference not valid. )] . 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 ( error! hyperlink reference not valid. )] . 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 ( error! hyperlink reference not valid. )]. 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.

Betamethasone valerate 0.1% ointment United Kingdom - Inggeris - MHRA (Medicines & Healthcare Products Regulatory Agency)

betamethasone valerate 0.1% ointment

a a h pharmaceuticals ltd - betamethasone valerate - cutaneous ointment - 1mg/1gram

Betamethasone valerate 0.1% ointment United Kingdom - Inggeris - MHRA (Medicines & Healthcare Products Regulatory Agency)

betamethasone valerate 0.1% ointment

alliance healthcare (distribution) ltd - betamethasone valerate - cutaneous ointment - 1mg/1gram