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

camber pharmaceuticals, inc. - sodium picosulfate (unii: lr57574hn8) (deacetylbisacodyl - unii:r09078e41y), magnesium oxide (unii: 3a3u0gi71g) (magnesium cation - unii:t6v3lhy838), anhydrous citric acid (unii: xf417d3psl) (anhydrous citric acid - unii:xf417d3psl) - sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution is indicated for cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients 9 years of age and older. sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution is contraindicated in the following conditions: • patients with severe renal impairment (creatinine clearance less than 30 ml/minute) which may result in accumulation of magnesium  [see warnings and precautions ( 5.4)] • gastrointestinal obstruction or ileus [see warnings and precautions ( 5.6)] • bowel perforation [see warnings and precautions ( 5.6)] • toxic colitis or toxic megacolon • gastric retention • hypersensitivity to any of the ingredients in sodium picosulfate, magnesium oxide and anhydrous citric acid for oral solution  [see advers

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

ferring pharmaceuticals inc. - sodium picosulfate (unii: lr57574hn8) (deacetylbisacodyl - unii:r09078e41y), magnesium oxide (unii: 3a3u0gi71g) (magnesium cation - unii:t6v3lhy838), anhydrous citric acid (unii: xf417d3psl) (anhydrous citric acid - unii:xf417d3psl) - sodium picosulfate 10 mg in 16.1 g - prepopik® is indicated for cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients 9 years of age and older. prepopik is contraindicated in the following conditions: - patients with severe renal impairment (creatinine clearance less than 30 ml/minute) which may result in accumulation of magnesium [see warnings and precautions (5.4)] - gastrointestinal obstruction or ileus [see warnings and precautions (5.6)] - bowel perforation [see warnings and precautions (5.6)] - toxic colitis or toxic megacolon - gastric retention - hypersensitivity to any of the ingredients in prepopik [see adverse reactions (6.2)] risk summary there are no data with prepopik use in pregnant women to determine a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in an animal reproduction study, no adverse developmental effects were observed in pregnant rats when sodium picosulfate, magnesium oxide, and anhydrous citric acid were administered orally at doses 1

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

remedyrepack inc. - clopidogrel bisulfate (unii: 08i79htp27) (clopidogrel - unii:a74586sno7) - clopidogrel 75 mg - - clopidogrel tablets are indicated to reduce the rate of myocardial infarction (mi) and stroke in patients with non–st-segment elevation acs (unstable angina [ua]/non–st-elevation myocardial infarction [nstemi]), including patients who are to be managed medically and those who are to be managed with coronary revascularization. clopidogrel tablets should be administered in conjunction with aspirin. - clopidogrel tablets are indicated to reduce the rate of myocardial infarction and stroke in patients with acute st-elevation myocardial infarction (stemi) who are to be managed medically. clopidogrel tablets should be administered in conjunction with aspirin. in patients with established peripheral arterial disease or with a history of recent myocardial infarction (mi) or recent stroke clopidogrel bisulfate tablets are indicated to reduce the rate of mi and stroke. clopidogrel tablets are contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage. clopidogrel tab

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

major pharmaceuticals - clopidogrel bisulfate (unii: 08i79htp27) (clopidogrel - unii:a74586sno7) - clopidogrel 75 mg - in patients with established peripheral arterial disease or with a history of recent myocardial infarction (mi) or recent stroke clopidogrel bisulfate tablets is indicated to reduce the rate of mi and stroke. clopidogrel tablets are contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage. clopidogrel tablets are contraindicated in patients with hypersensitivity (e.g., anaphylaxis) to clopidogrel or any component of the product [see adverse reactions ( 6.2)] . risk summary available data from cases reported in published literature and postmarketing surveillance with clopidogrel use in pregnant women have not identified any drug-associated risks for major birth defects or miscarriage [see data] .there are risks to the pregnant woman and fetus associated with myocardial infarction and stroke [see clinical considerations]. no evidence of fetotoxicity

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

cardinal health 107, llc - clopidogrel bisulfate (unii: 08i79htp27) (clopidogrel - unii:a74586sno7) - clopidogrel 75 mg - in patients with established peripheral arterial disease or with a history of recent myocardial infarction (mi) or recent stroke clopidogrel bisulfate tablets is indicated to reduce the rate of mi and stroke. clopidogrel tablets are contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage. clopidogrel tablets are contraindicated in patients with hypersensitivity (e.g., anaphylaxis) to clopidogrel or any component of the product [see adverse reactions ( 6.2)] . risk summary available data from cases reported in published literature and postmarketing surveillance with clopidogrel use in pregnant women have not identified any drug-associated risks for major birth defects or miscarriage [see data] .there are risks to the pregnant woman and fetus associated with myocardial infarction and stroke [see clinical considerations]. no evidence of fetotoxicity was observed when clopidogrel was administered to pregnant rats and rabbits during organogenesis at doses corresponding to 65 and 78 times the recommended daily human dose [see data]. the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defects, 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. clinical considerations disease-associated maternal and/or embryo/fetal risk myocardial infarction and stroke are medical emergencies. therapy for the pregnant woman should not be withheld because of potential concerns regarding the effects of clopidogrel on the fetus. labor or delivery clopidogrel use during labor or delivery will increase the risk of maternal bleeding and hemorrhage. avoid neuraxial blockade during clopidogrel use because of the risk of spinal hematoma. when possible, discontinue clopidogrel 5 to 7 days prior to labor, delivery, or neuraxial blockade. data human data the available data from published case reports over two decades of postmarketing use have not identified an association with clopidogrel use in pregnancy and major birth defects, miscarriage, or adverse fetal outcomes. animal data embryo-fetal developmental toxicology studies were performed in pregnant rats and rabbits with doses up to 500 and 300 mg/kg/day, respectively, administered during organogenesis. these doses, corresponding to 65 and 78 times the recommended daily human dose, respectively, on a mg/m 2 basis, revealed no evidence of impaired fertility or fetotoxicity due to clopidogrel. risk summary there are no data on the presence of clopidogrel in human milk or the effects on milk production. no adverse effects on breastfed infants have been observed with maternal clopidogrel use during lactation in a small number of postmarketing cases. studies in rats have shown that clopidogrel and/or its metabolites are present in the milk. when a drug is present in animal milk, it is likely that the drug will be present in human milk. the developmental and health benefits of breastfeeding should be considered along with mother's clinical need for clopidogrel and any potential adverse effects on the breastfed infant from clopidogrel or from underlying maternal condition. safety and effectiveness in the pediatric population have not been established. a randomized, placebo-controlled trial (clarinet) did not demonstrate a clinical benefit of clopidogrel in neonates and infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary arterial shunt. possible factors contributing to this outcome were the dose of clopidogrel, the concomitant administration of aspirin, and the late initiation of therapy following shunt palliation. it cannot be ruled out that a trial with a different design would demonstrate a clinical benefit in this patient population. of the total number of subjects in the caprie and cure controlled clinical studies, approximately 50% of patients treated with clopidogrel bisulfate were 65 years of age and older, and 15% were 75 years and older. in commit, approximately 58% of the patients treated with clopidogrel bisulfate were 60 years and older, 26% of whom were 70 years and older. the observed risk of bleeding events with clopidogrel bisulfate plus aspirin versus placebo plus aspirin by age category is provided in table 1 and table 2 for the cure and commit trials, respectively [see adverse reactions ( 6.1)] . no dosage adjustment is necessary in elderly patients. experience is limited in patients with severe and moderate renal impairment [seeclinicalpharmacology( 12.2)]. no dosage adjustment is necessary in patients with hepatic impairment [see clinical pharmacology ( 12.2)] .

Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - quinine bisulfate heptahydrate, quantity: 300 mg - tablet, film coated - excipient ingredients: pregelatinised maize starch; sodium starch glycollate; carnauba wax; magnesium stearate; lactose monohydrate; colloidal anhydrous silica; purified talc; microcrystalline cellulose; povidone; titanium dioxide; hypromellose; macrogol 4000 - treatment of malaria due to strains of p. falciparum resistant to chloroquine and the related 4-aminoquinolines.

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

ferring pharmaceuticals inc. - sodium picosulfate (unii: lr57574hn8) (deacetylbisacodyl - unii:r09078e41y), magnesium oxide (unii: 3a3u0gi71g) (magnesium cation - unii:t6v3lhy838), anhydrous citric acid (unii: xf417d3psl) (anhydrous citric acid - unii:xf417d3psl) - sodium picosulfate 10 mg in 160 ml - clenpiq is indicated for cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients 9 years of age and older. clenpiq is contraindicated in the following conditions: - patients with severe renal impairment (creatinine clearance less than 30 ml/minute), which may result in accumulation of magnesium [see warnings and precautions (5.3)]. - gastrointestinal obstruction or ileus [see warnings and precautions (5.6)]. - bowel perforation [see warnings and precautions (5.6)]. - toxic colitis or toxic megacolon. - gastric retention. - hypersensitivity to any of the ingredients in clenpiq [see adverse reactions (6.2)]. risk summary there are no data with clenpiq use in pregnant women to determine a drug-associated risk of adverse developmental outcomes. in animal reproduction studies, no adverse developmental effects were observed in pregnant rats when sodium picosulfate, magnesium oxide, and anhydrous citric acid were administered orally at doses 1.2 times the recommended human dose based