United Kingdom - English - myHealthbox

milpharm limited - allopurinol - tablets - 300mg - preparations inhibiting uric acid production - it is indicated for reducing urate/uric acid formation in conditions where urate/uric acid deposition has already occurred (e.g. gouty arthritis, skin tophi, nephrolithiasis) or is a predictable clinical risk (e.g. treatment of malignancy potentially leading to acute uric acid nephropathy). the main clinical conditions where urate/uric acid deposition may occur are: idiopathic gout; uric acid lithiasis; acute uric acid nephropathy; neoplastic disease and myeloproliferative disease with high cell turnover rates, in which high urate levels occur either spontaneously, or after cytotoxic therapy; certain enzyme disorders which lead to overproduction of urate, for example: hypoxanthine-guanine phosphoribosyltransferase, including lesch-nyhan syndrome; glucose-6-phosphatase including glycogen storage disease; phosphoribosylpyrophosphate synthetase, phosphoribosylpyrophosphate amidotransferase; adenine phosphoribosyltransferase. allopurinol is indicated for management of 2,8-dihydroxyadenine (2,8-dha) renal stones r

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

mylan pharmaceuticals inc. - allopurinol (unii: 63cz7gjn5i) (allopurinol - unii:63cz7gjn5i) - allopurinol 100 mg - allopurinol tablets are indicated for: 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/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. 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)] .

Ireland - English - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - allopurinol - tablet - 100 milligram(s) - preparations inhibiting uric acid production; allopurinol

Ireland - English - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - allopurinol - tablet - 300 milligram(s) - preparations inhibiting uric acid production; allopurinol

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

de pharmaceuticals - allopurinol - oral tablet - 100mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

de pharmaceuticals - allopurinol - oral tablet - 300mg

Ireland - English - HPRA (Health Products Regulatory Authority)

teva pharma b.v. - allopurinol - tablet - 100 milligram(s) - preparations inhibiting uric acid production; allopurinol

Ireland - English - HPRA (Health Products Regulatory Authority)

teva pharma b.v. - allopurinol - tablet - 300 milligram(s) - preparations inhibiting uric acid production; allopurinol

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

mylan pharmaceuticals inc. - mercaptopurine (unii: e7wed276i5) (mercaptopurine anhydrous - unii:pkk6muz20g) - mercaptopurine 50 mg - mercaptopurine tablets are indicated for treatment of adult and pediatric patients with acute lymphoblastic leukemia (all) as part of a combination chemotherapy maintenance regimen. none. mercaptopurine tablets can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . pregnant women who receive mercaptopurine have an increased incidence of miscarriage and stillbirth (see data) . advise pregnant women of the potential risk to a fetus. the estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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. women receiving mercaptopurine in the first trimester of pregnancy have an increased incidence of miscarriage; the risk of malformation in offspring surviving first trimester exposure is not known. in a series of 28 women receiving mercaptopurine after the first trimester of pregnancy, 3 mothers died prior to delivery, 1 delivered a stillborn child, and 1 aborted; there were no cases of macroscopically abnormal fetuses. mercaptopurine was embryo-lethal and teratogenic in several animal species (rat, mouse, rabbit, and hamster) at doses less than the recommended human dose. there are no data on the presence of mercaptopurine or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with mercaptopurine tablets and for 1 week after the last dose. mercaptopurine tablets can cause fetal harm when administered to pregnant women [see use in specific populations (8.1)] . verify the pregnancy status in females of reproductive potential prior to initiating mercaptopurine tablets [see use in specific populations (8.1)] . advise females of reproductive potential to use effective contraception during treatment with mercaptopurine tablets and for 6 months after the last dose. based on genotoxicity findings, advise males with female partners of reproductive potential to use effective contraception during treatment with mercaptopurine tablets and for 3 months after the last dose [see nonclinical toxicology (13.1)] . based on findings from animal studies, mercaptopurine tablets can impair female and male fertility [see nonclinical toxicology (13.1)] . the long-term effects of mercaptopurine on female and male fertility, including the reversibility have not been studied. safety and effectiveness of mercaptopurine tablets have been established in pediatric patients. use of mercaptopurine tablets in pediatrics is supported by evidence from the published literature and clinical experience. symptomatic hypoglycemia has been reported in pediatric patients with all receiving mercaptopurine. reported cases were in pediatrics less than 6 years of age or with a low body mass index. clinical studies of mercaptopurine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or another drug therapy. use the lowest recommended starting dosage for mercaptopurine tablets or increase the dosing interval to every 36-48 hours in patients with renal impairment (clcr less than 50 ml/min). adjust the dose to maintain absolute neutrophil count (anc) at a desirable level and for adverse reactions [see dosage and administration (2.3)] . use the lowest recommended starting dosage for mercaptopurine tablets in patients with hepatic impairment. adjust the dose to maintain absolute neutrophil count (anc) at a desirable level and for adverse reactions [see dosage and administration (2.3)] .

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

sigma pharmaceuticals plc - allopurinol - oral tablet - 100mg