United States - English - 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)] .

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

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

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

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) ].

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

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

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

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

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

northstar rxllc - 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 tablets 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 tablets are 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 leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels. treatment with allopurinol tablets should be discontinued when the potential for overproduction of uric acid is no longer present. - the management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day

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

actavis pharma, 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

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

par pharmaceutical, 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 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. data human data 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. 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/m2 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/m2 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 tablets 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 tablets 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 tablets 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 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)].

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

mylan institutional 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 tablets reduce 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 tablets are 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 leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels. treatment with allopurinol tablets should be discontinued when the potential for overproduction of uric acid is no longer present. - the management of 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. therapy in such patients should be carefully assessed initially and reassessed periodically to determine in each case that treatment is beneficial and that the benefits outweigh the risks. patients who have developed a severe reaction to allopurinol tablets should not be restarted on the drug.

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

aphena pharma solutions - tennessee, llc - allopurinol (unii: 63cz7gjn5i) (allopurinol - unii:63cz7gjn5i) - allopurinol 300 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: patients who have developed a severe reaction to allopurinol should not be restarted on the drug.