Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

zydus pharmaceuticals usa inc. - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - clobetasol propionate 0.05 g in 1 ml - clobetasol propionate spray, 0.05% is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (bsa) in patients 18 years of age or older. patients should be instructed to use clobetasol propionate spray, 0.05% for the minimum amount of time necessary to achieve the desired results [see dosage and administration (2) ]. use in patients under 18 years of age is not recommended because safety has not been established and because numerically high rates of hpa axis suppression were seen with other clobetasol propionate topical formulations. [see use in specific populations (8.4)] clobetasol propionate spray, 0.05% should not be used on the face, axillae, or groin.  clobetasol propionate spray, 0.05% should not be used if there is atrophy at the treatment site. clobetasol propionate spray, 0.05% should not be used in the treatment of rosacea or perioral dermatitis. none. risk summary there are no available data on

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

teligent pharma, inc. - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - clobetasol propionate .05 mg in 100 ml - clobetasol propionate lotion 0.05% is a super-high potent topical corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses only in patients 18 years of age or older. treatment should be limited to 2 consecutive weeks. for moderate to severe plaque psoriasis, treatment may be extended for an additional 2 weeks for localized lesions (less than 10% body surface area) that have not sufficiently improved after the initial 2-week treatment. any additional benefits of extending treatment should be weighed against the risk of hypothalamic-pituitary-adrenal (hpa) axis suppression before prescribing for more than 2 weeks. the total dosage should not exceed 50 g (50 ml or 1.75 fl. oz) per week. patients should be instructed to use clobetasol propionate lotion 0.05% for the minimum amount of time necessary to achieve the desired results [see dosage and administration (2) ]. use in patients under 18 years of age is not recommended

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

actavis pharma, inc. - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - clobetasol propionate 0.05 g in 100 ml - clobetasol propionate lotion, 0.05% is a super-high potent topical corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses only in patients 18 years of age or older. treatment should be limited to 2 consecutive weeks. for moderate to severe plaque psoriasis, treatment may be extended for an additional 2 weeks for localized lesions (less than 10% body surface area) that have not sufficiently improved after the initial 2-week treatment. any additional benefits of extending treatment should be weighed against the risk of hypothalamic-pituitary-adrenal (hpa) axis suppression before prescribing for more than 2 weeks. the total dosage should not exceed 50 g (50 ml or 1.75 fl. oz) per week. patients should be instructed to use clobetasol propionate lotion, 0.05% for the minimum amount of time necessary to achieve the desired results [see dosage and administration (2)]. use in patients under 18 years of age is not recommended due to n

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

paddock laboratories, llc - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - clobetasol propionate 0.5 mg in 1 ml - clobetasol propionate lotion, 0.05%, is a super-high potent topical corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses only in patients 18 years of age or older. treatment should be limited to 2 consecutive weeks. for moderate to severe plaque psoriasis, treatment may be extended for an additional 2 weeks for localized lesions (less than 10% body surface area) that have not sufficiently improved after the initial 2-week treatment. any additional benefits of extending treatment should be weighed against the risk of hypothalamic-pituitary-adrenal (hpa) axis suppression before prescribing for more than 2 weeks. the total dosage should not exceed 50 g (50 ml or 1.75 fl. oz.) per week. patients should be instructed to use clobetasol propionate lotion, 0.05%, for the minimum amount of time necessary to achieve the desired results [see dosage and administration (2) ]. use in patients under 18 years of age is not recommended due

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

taro pharmaceuticals u.s.a., inc. - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - clobetasol propionate 0.5 mg in 1 ml - clobetasol propionate lotion, 0.05% is a super-high potent topical corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses only in patients 18 years of age or older. treatment should be limited to 2 consecutive weeks. for moderate to severe plaque psoriasis, treatment may be extended for an additional 2 weeks for localized lesions (less than 10% body surface area) that have not sufficiently improved after the initial 2-week treatment. any additional benefits of extending treatment should be weighed against the risk of hypothalamic-pituitary-adrenal (hpa) axis suppression before prescribing for more than 2 weeks. the total dosage should not exceed 50 g (50 ml or 1.75 fl. oz) per week. patients should be instructed to use clobetasol propionate lotion, 0.05% for the minimum amount of time necessary to achieve the desired results [see dosage and administration (2) ]. use in patients under 18 years of age is not recommended due to

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

physicians total care, inc. - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - clobetasol propionate 0.462 mg in 1 ml - clobetasol propionate topical solution is indicated for shortterm topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 ml/week because of the potential for the drug to suppress the hpa axis. this product is not recommended for use in pediatric patients under 12 years of age. clobetasol propionate topical solution is contraindicated in patients with primary infections of the scalp, or in patients who are hypersensitive to clobetasol propionate, other corticosteroids, or any ingredient in this preparation.

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

preferred pharmaceuticals, inc. - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - clobetasol propionate 0.5 mg in 1 g - clobetasol propionate cream and ointment are super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamicpituitary- adrenal (hpa) axis. use in pediatric patients under 12 years of age is not recommended. as with other highly active corticosteroids, therapy should be discontinued when control has been achieved. if no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. clobetasol propionate cream and ointment, usp, 0.05% are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

rebel distributors corp - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - clobetasol propionate 0.5 mg in 1 g - clobetasol propionate cream and ointment are super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamicpituitary- adrenal (hpa) axis. use in pediatric patients under 12 years of age is not recommended. as with other highly active corticosteroids, therapy should be discontinued when control has been achieved. if no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. clobetasol propionate cream and ointment, usp, 0.05% are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

sun pharmaceutical industries, inc. - allopurinol (unii: 63cz7gjn5i) (allopurinol - unii:63cz7gjn5i) - allopurinol 100 mg - allopurinol tablets are indicated for: - the management of adults with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy) - the management of adult and pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels - the management of adult patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients, despite lifestyle changes (such as reduction of dietary sodium, non-dairy animal protein, oxalate rich foods, refined sugars and increases in oral fluids and fruits and vegetables) limitations of use allopurinol tablets are not recommended for the treatment of asymptomatic hyperuricemia. allopurinol tablets are contraindicated in patients with a history of hypersensitivity reaction to allopurinol or to any of the ingredients of allopurinol tablets. based on findings in animals, allopurinol tablets may cause fetal harm when administered to a pregnant woman. adverse developmental outcomes have been described in exposed animals (see data) . allopurinol and its metabolite oxypurinol have been shown to cross the placenta following administration of maternal allopurinol. available limited published data on allopurinol use in pregnant women do not demonstrate a clear pattern or increase in frequency of adverse developmental outcomes. among approximately 50 pregnancies described in published literature, 2 infants with major congenital malformations have been reported with following maternal allopurinol exposure. advise pregnant women of the potential risk to a fetus. 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. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. experience with allopurinol tablets during human pregnancy has been limited partly because women of reproductive age rarely require treatment with allopurinol tablets. a case report published in 2011 described the outcome of a full-term pregnancy in a 35-year-old woman who had recurrent kidney stones since age 18 who took allopurinol throughout the pregnancy. the child had multiple complex birth defects and died at 8 days of life. a second report in 2013 provided data on 31 prospectively ascertained pregnancies involving mothers exposed to allopurinol for varying durations during the first trimester. the overall rate of major fetal malformations and spontaneous abortions was reported to be within the normal expected range; however, one child had severe malformations similar to those described in the cited earlier case report. there was no evidence of fetotoxicity or teratogenicity in rats or rabbits treated during the period of organogenesis with oral allopurinol at doses up to 200 mg/kg/day and up to 100 mg/kg/day, respectively (about 2.4 times the human dose on a mg/m 2 basis). however, there is a published report in pregnant mice that single intraperitoneal doses of 50 mg/kg or 100 mg/kg (about 0.3 or 0.6 times the human dose on a mg/m 2 basis) of allopurinol on gestation days 10 or 13 produced significant increases in fetal deaths and teratogenic effects (cleft palate, harelip, and digital defects). it is uncertain whether these findings represented a fetal effect or an effect secondary to maternal toxicity. allopurinol and oxypurinol are present in human milk. based on information from a single case report, allopurinol and its active metabolite, oxypurinol, were detected in the milk of a mother receiving 300 mg of allopurinol daily at 5 weeks postpartum. the estimated relative infant dose were 0.14 mg/kg and 0.2 mg/kg of allopurinol and between 7.2 mg/kg to 8 mg/kg of oxypurinol daily. there was no report of effects of allopurinol on the breastfed infant or on milk production. because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatments with allopurinol tablets and for one week after the last dose. the safety and effectiveness of allopurinol for the management of pediatric patients with leukemia, lymphoma and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels have been established in approximately 200 pediatric patients. the efficacy and safety profile observed in this patient population were similar to that observed in adults. the safety and effectiveness of allopurinol tablets have not been established for the treatment of signs and symptoms of primary or secondary gout in pediatric patients. the safety and effectiveness of allopurinol tablets have not been established for the management of pediatric patients with recurrent calcium oxalate calculi. the safety and effectiveness of allopurinol tablets have not been established in pediatric patients with rare inborn errors of purine metabolism. allopurinol tablets and its primary active metabolite, oxipurinol, are eliminated by the kidneys; therefore, changes in renal function have a profound effect on exposure. in patients with decreased renal function or who have concurrent illnesses which can affect renal function, perform periodic laboratory parameters of renal function and reassess the patient's dosage of allopurinol tablets [see dosage and administration (2.6), warnings and precautions (5.3)] .

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

physicians total care, inc. - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - clobetasol propionate 0.5 mg in 1 g - clobetasol propionate foam, 0.05% is a super-potent topical corticosteroid indicated for short-term topical treatment of the inflammatory and pruritic manifestations of moderate to severe corticosteroid- responsive dermatoses of the scalp, and for short-term topical treatment of mild to moderate plaque-type psoriasis on non-scalp regions excluding the face and intertriginous areas. treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (hpa) axis. in a controlled pharmacokinetic study, some subjects experienced reversible suppression of the adrenals following 14 days of clobetasol propionate foam, 0.05% therapy (see adverse reactions ). use in children under 12 years of age is not recommended. clobetasol propionate foam, 0.05% is contraindicated in patients who are hypersensitive to clobetasol propionate, to other corticosteroids, or to any ingredient in this preparation.