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padagis israel pharmaceuticals ltd - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - clobetasol propionate 0.5 mg in 1 g - clobetasol propionate foam, 0.05% (emulsion) is indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years and older. none. risk summary there are no available data on clobetasol propionate foam, 0.05% (emulsion) use in pregnant women to inform of a drug associated risk for adverse developmental outcomes. published data report a significantly increased risk of low birth weight with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. advise pregnant women of the potential risk to a fetus and to use clobetasol propionate foam, 0.05% (emulsion) on the smallest area of skin and for the shortest duration possible (see data ). in animal reproduction studies, increased malformations, such as cleft palate and skeletal abnormalities, were observed after subcutaneous administration of clobetasol propionate to pregnant mice and rabbits. no comparison of animal exposure with human exposure was compu

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

padagis israel pharmaceuticals ltd - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - clobetasol propionate 0.5 mg in 1 g - clobetasol propionate foam, 0.05% is a corticosteroid indicated for treatment of moderate to severe plaque psoriasis of the scalp and mild to moderate plaque psoriasis of non-scalp regions of the body excluding the face and intertriginous areas in patients 12 years and older. none. risk summary there are no available data on clobetasol propionate foam, 0.05% use in pregnant women to inform of a drug-associated risk for adverse developmental outcomes. published data report a significantly increased risk of low birth weight with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. advise pregnant women of the potential risk to a fetus and to use clobetasol propionate foam, 0.05% on the smallest area of skin and for the shortest duration possible (see data ). in animal reproduction studies, increased malformations, such as cleft palate and skeletal abnormalities, were observed after subcutaneous administration of clobetasol propionate to pregnant mice and rabbits.

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mylan pharmaceuticals inc. - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - clobetasol propionate 0.5 mg in 1 g - clobetasol propionate ointment is a super-high potency corticosteroid formulation 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 hypothalamic-pituitary-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 ointment, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

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renaissance pharma, inc. - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - clobetasol propionate 0.5 mg in 1 g - clobetasol propionate foam is a corticosteroid indicated for treatment of moderate to severe plaque psoriasis of the scalp and mild to moderate plaque psoriasis of non-scalp regions of the body excluding the face and intertriginous areas in patients 12 years and older. none. there are no adequate and well-controlled studies in pregnant women. clobetasol propionate foam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically. some corticosteroids have been shown to be teratogenic after dermal application to laboratory animals. clobetasol propionate has not been tested for teratogenicity when applied topically; however, it is absorbed percutaneously, and when administered subcutaneously, it was a significant teratogen in both the rabbit and the mouse. clobetasol propionate has greater teratogenic potential than steroids that are less potent. teratogenicity studi

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akorn - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - clobetasol propionate .5 mg in 1 ml - clobetasol propionate shampoo, 0.05%, is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe forms of scalp psoriasis in subjects 18 years of age and older. treatment should be limited to 4 consecutive 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 shampoo, 0.05%, for the minimum time period necessary to achieve the desired results [see dosage and administration (2) ]. use in patients younger than 18 years of age is not recommended due to numerically high rates of hypothalamic-pituitary-adrenal (hpa) axis suppression [see warnings and precautions (5.1) and use in specific populations (8.4) ]. clobetasol propionate shampoo, 0.05%, should not be used on the face, groin or axillae. avoid any contact of the drug product with the eyes and lips. in case of contact, rinse thoroughly with water all parts of the body that came in contact with the shampoo. none teratogenic e

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e. fougera & co. a division of fougera pharmaceuticals inc. - clobetasol propionate (unii: 779619577m) (clobetasol - unii:adn79d536h) - clobetasol propionate 0.5 mg in 1 g - clobetasol propionate cream, 0.05% (emollient) is a super-high potency corticosteroid indicated for: clobetasol propionate cream, 0.05% (emollient) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age and older. treatment should be limited to 2 consecutive weeks, and the total dosage should not exceed 50 grams per week. clobetasol propionate cream, 0.05% (emollient) is indicated for the topical treatment of moderate to severe plaque-type psoriasis. treatment beyond 4 consecutive weeks is not recommended. use in pediatric patients under 16 years of age is not recommended. clobetasol propionate cream, 0.05% (emollient) should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae. the total dosage should not exceed 50 grams per week. avoid use if skin atrophy is present at the treatment site. none pregnancy category c. there are no adequate and well-controlled

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remedyrepack inc. - allopurinol (unii: 63cz7gjn5i) (allopurinol - unii:63cz7gjn5i) - allopurinol 100 mg - this is not an innocuous drug. it is not recommended for the treatment of asymptomatic hyperuricemia. allopurinol reduces serum and urinary uric acid concentrations. its use should be individualized for each patient and requires an understanding of its mode of action and pharmacokinetics (see clinical pharmacology, contraindications, warnings, and precautions). allopurinol is indicated in: - the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy). the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy). - the management of patients with leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels. treatment with allopurinol should be discontinued when the potential for overproduction of uric acid is no longer present. the mana

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accord healthcare 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, oxylate 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. risk summary based on findings in animals, allopurinol 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. data human data experience with allopurinol during human pregnancy has been limited partly because women of reproductive age rarely require treatment with allopurinol. 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. animal data 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. risk summary 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 and for one week after the last dose. hyperuricemia associated with cancer therapy 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. primary or secondary gout the safety and effectiveness of allopurinol have not been established for the treatment of signs and symptoms of primary or secondary gout in pediatric patients. recurrent calcium oxalate calculi the safety and effectiveness of allopurinol have not been established for the management of pediatric patients with recurrent calcium oxalate calculi. inborn errors of metabolism the safety and effectiveness of allopurinol have not been established in pediatric patients with rare inborn errors of purine metabolism. allopurinol 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 [ see dosage and administration (2.6), warnings and precautions (5.3) ].

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hikma pharmaceuticals usa inc. - allopurinol sodium (unii: 428673rc2z) (allopurinol - unii:63cz7gjn5i) - allopurinol 500 mg in 25 ml - allopurinol sodium for injection is indicated for 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 and who cannot tolerate oral therapy. allopurinol sodium for injection is contraindicated in patients with a history of severe reaction to any formulation of allopurinol. based on findings in animals, allopurinol sodium for injection 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 malf

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dr. reddy's laboratories limited - allopurinol (unii: 63cz7gjn5i) (allopurinol - unii:63cz7gjn5i) - allopurinol 100 mg - this is  not an innocuous drug. it  is  not recommended for the treatment of asymptomatic hyperuricemia. allopurinol reduces serum and urinary uric acid concentrations. its use should be individualized for each patient and requires an understanding of its mode of action and pharmacokinetics (see clinical pharmacology , contraindications , warnings and precautions ). allopurinol is indicated in: - the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis and/or nephropathy). the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis and/or nephropathy). - the management of patients with leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels. treatment with allopurinol should be discontinued when the potential for overproduction of uric acid is no longer present - th