New Zealand - English - Medsafe (Medicines Safety Authority)

sandoz new zealand limited - clopidogrel bisulfate 97.875mg equivalent to 75 mg clopidogrel;   - film coated tablet - 75 mg - active: clopidogrel bisulfate 97.875mg equivalent to 75 mg clopidogrel   excipient: hydrogenated vegetable oil hyprolose mannitol microcrystalline cellulose opacode black s-1-17823 opadry pink purified water - prevention of vascular ischaemia associated with atherothrombotic events (myocardial infarction, stroke and vascular death) in patients with a history of symptomatic atherosclerotic disease.

New Zealand - English - Medsafe (Medicines Safety Authority)

dr reddy's new zealand limited - clopidogrel bisulfate 97.875mg equivalent to 75 mg clopidogrel - film coated tablet - 75 mg - active: clopidogrel bisulfate 97.875mg equivalent to 75 mg clopidogrel excipient: castor oil croscarmellose sodium mannitol microcrystalline cellulose opadry pink 03b54202 purified water - prevention of vascular ischaemia associated with atherothrombotic events (mi, stroke and vascular death) in patients with a history of symptomatic atherosclerotic disease.

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

mylan pharmaceuticals inc. - 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 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 tablets are contraindicated in patients with hypersensitivity (e.g., anaphylaxis) to clopidogrel or any component of the product [see adverse reactions (6.2)] . 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

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

cardinal health - 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 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 tablets are contraindicated in patients with hypersensitivity (e.g., anaphylaxis) to clopidogrel or any component of the product [see adverse reactions (6.2)] . reproduction studies performed in rats and rabbits at doses up to 500 and 300 mg/kg/day, respectively (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. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of a human response, clopidogrel tablets should be used during pregnancy only if clearly needed. studies in

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

mylan institutional 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 . 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 . - 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

air flow products limited - clopidogrel bisulfate 97.875mg equivalent to clopidogrel 75 mg - film coated tablet - 75 mg - active: clopidogrel bisulfate 97.875mg equivalent to clopidogrel 75 mg excipient: colloidal silicon dioxide hydrogenated castor oil hyprolose microcelac 100 opadry pink 31k34575 - prevention of vascular ischaemia associated with atherothrombotic events (myocardial infarction, stroke and vascular death) in patients with a history of symptomatic atherosclerotic disease. acute coronary syndrome clopidogrel is indicated in combination with aspirin for patients with: - unstable angina or non-st elevation myocardial infarction in order to prevent early and long-term atherothrombotic events (myocardial infarction, stroke, vascular death and refractory ischaemia). clopidogrel tablets are indicated for the treatment of acute coronary syndrome whether or not patients undergo cardiac revascularisation (surgical or pci, with or without stent). - st-segment elevation acute myocardial infarction in order to prevent atherothrombotic events. in this population, clopidogrel tablets have been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction or stroke in medically treated patients eligible for thrombolytic therapy.

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)] .

New Zealand - English - Medsafe (Medicines Safety Authority)

sanofi-aventis new zealand limited - clopidogrel bisulfate, form ii 97.875mg equivalent to clopidogrel base 75mg;  ;   - film coated tablet - 75 mg - active: clopidogrel bisulfate, form ii 97.875mg equivalent to clopidogrel base 75mg     excipient: carnauba wax hydrogenated castor oil hyprolose macrogol 6000 mannitol microcrystalline cellulose opadry pink 32k14834

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

nucare pharmaceuticals,inc. - clopidogrel bisulfate (unii: 08i79htp27) (clopidogrel - unii:a74586sno7) - clopidogrel 75 mg - - clopidogrel tablets are indicated to reduce the rate of myocardial infarction and stroke (mi) 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. managed - 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. and in patients with established peripheral arterial disease or with a history of myocardial infarction (mi) or recent stroke clopidogrel tablets are indicated to reduce the rate of mi and stroke. in patients with established peripheral arterial disease or with a history of recent myocardial infarction (mi) or recent stroke clopidogrel tablets are

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

nucare pharmaceuticals,inc. - clopidogrel bisulfate (unii: 08i79htp27) (clopidogrel - unii:a74586sno7) - clopidogrel 75 mg - - clopidogrel tablets are indicated to reduce the rate of myocardial infarction and stroke (mi) 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. managed - 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. and in patients with established peripheral arterial disease or with a history of myocardial infarction (mi) or recent stroke clopidogrel tablets are indicated to reduce the rate of mi and stroke. in patients with established peripheral arterial disease or with a history of recent myocardial infarction (mi) or recent stroke clopidogrel tablets are