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

apotex pty ltd - aspirin,clopidogrel hydrogen sulfate -

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

apotex pty ltd - aspirin,clopidogrel hydrogen sulfate -

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

apotex pty ltd - aspirin,clopidogrel hydrogen sulfate -

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

arrotex pharmaceuticals pty ltd - clopidogrel hydrogen sulfate, quantity: 97.88 mg; aspirin, quantity: 75 mg - tablet, film coated - excipient ingredients: maize starch; methylcellulose; hyprolose; zinc stearate; lactose; iron oxide yellow; crospovidone; microcrystalline cellulose; macrogol 8000; colloidal anhydrous silica; hypromellose; titanium dioxide - clopidogrel/aspirin is a fixed dose combination product. clopidogrel/aspirin is intended as continuation of therapy in patients with acute coronary syndrome already initiated with separate clopidogrel and aspirin products:,? unstable angina or non-st-elevation myocardial infarction in order to prevent early and long-term atherothrombotic events (myocardial infarction, stroke, vascular death or refractory ischaemia). clopidogrel/aspirin is 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/aspirin has 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.

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

arrotex pharmaceuticals pty ltd - clopidogrel hydrogen sulfate, quantity: 97.88 mg; aspirin, quantity: 75 mg - tablet, film coated - excipient ingredients: hyprolose; titanium dioxide; iron oxide yellow; zinc stearate; maize starch; microcrystalline cellulose; crospovidone; methylcellulose; hypromellose; lactose; colloidal anhydrous silica; macrogol 8000 - clopidogrel/aspirin is a fixed dose combination product. clopidogrel/aspirin is intended as continuation of therapy in patients with acute coronary syndrome already initiated with separate clopidogrel and aspirin products:,? unstable angina or non-st-elevation myocardial infarction in order to prevent early and long-term atherothrombotic events (myocardial infarction, stroke, vascular death or refractory ischaemia). clopidogrel/aspirin is 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/aspirin has 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)

avkare - aspirin (unii: r16co5y76e) (aspirin - unii:r16co5y76e), dipyridamole (unii: 64alc7f90c) (dipyridamole - unii:64alc7f90c) - aspirin 25 mg - aspirin and extended-release dipyridamole capsules are indicated to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis. aspirin and extended-release dipyridamole capsules are contraindicated in patients with known hypersensitivity to any of the product components. aspirin, usp is contraindicated in patients with known allergy to nonsteroidal anti-inflammatory drug (nsaid) products and in patients with the syndrome of asthma, rhinitis and nasal polyps. aspirin, usp may cause severe urticaria, angioedema or bronchospasm. do not use aspirin, usp in children or teenagers with viral infections because of the risk of reye syndrome. teratogenic effects, pregnancy category d. [see warnings and precautions (5.4)]. aspirin can result in excessive blood loss at delivery as well as prolonged gestation and prolonged labor. because of these effects on the mother and because of adverse fetal effects seen with aspirin during the later stages of pregnancy [see warnings and precautions (5.4)] , avoid aspirin and extended-release dipyridamole in the third trimester of pregnancy and during labor and delivery. both dipyridamole and aspirin are excreted in human milk. exercise caution when aspirin and extended-release dipyridamole capsules are administered to a nursing woman. safety and effectiveness of aspirin and extended-release dipyridamole in pediatric patients have not been studied. due to the aspirin component, use of this product in the pediatric population is not recommended [see contraindications (4.3)] . of the total number of subjects in esps2, 61 percent were 65 and over, while 27 percent were 75 and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out [see clinical pharmacology (12.3)] . aspirin and extended-release dipyridamole has not been studied in patients with hepatic or renal impairment. avoid using aspirin containing products, such as aspirin and extended-release dipyridamole in patients with severe hepatic or severe renal (glomerular filtration rate < 10 ml/min) dysfunction [see  warnings and precautions (5.2,  5.3) and clinical pharmacology (12.3)] .

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

american health packaging - aspirin (unii: r16co5y76e) (aspirin - unii:r16co5y76e), dipyridamole (unii: 64alc7f90c) (dipyridamole - unii:64alc7f90c) - aspirin 25 mg - aspirin and extended-release dipyridamole capsules are indicated to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis. aspirin and extended-release dipyridamole capsules are contraindicated in patients with known hypersensitivity to any of the product components. aspirin, usp is contraindicated in patients with known allergy to nonsteroidal anti-inflammatory drug (nsaid) products and in patients with the syndrome of asthma, rhinitis and nasal polyps. aspirin, usp may cause severe urticaria, angioedema or bronchospasm. do not use aspirin, usp in children or teenagers with viral infections because of the risk of reye syndrome. teratogenic effects, pregnancy category d. [see warnings and precautions (5.4)]. aspirin can result in excessive blood loss at delivery as well as prolonged gestation and prolonged labor. because of these effects on the mother and because of adverse fetal effects seen with aspirin during the later stages of pr

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

innovida phamaceutique corporation - aspirin (unii: r16co5y76e) (aspirin - unii:r16co5y76e), omeprazole (unii: kg60484qx9) (omeprazole - unii:kg60484qx9) - aspirin and omeprazole delayed-release tablets, a combination of aspirin and omeprazole, is indicated for patients who require aspirin for secondary prevention of cardiovascular and cerebrovascular events and who are at risk of developing aspirin associated gastric ulcers. the aspirin component of aspirin and omeprazole delayed-release tablets is indicated for: - reducing the combined risk of death and nonfatal stroke in patients who have had ischemic stroke or transient ischemia of the brain due to fibrin platelet emboli, - reducing the combined risk of death and nonfatal mi in patients with a previous mi or unstable angina pectoris, - reducing the combined risk of mi and sudden death in patients with chronic stable angina pectoris, - use in patients who have undergone revascularization procedures (coronary artery bypass graft [cabg] or percutaneous transluminal coronary angioplasty [ptca]) when there is a pre-existing condition for which aspirin is already indicated. the omeprazole component of aspirin and

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

innovida therapeutique corporation - aspirin (unii: r16co5y76e) (aspirin - unii:r16co5y76e), omeprazole (unii: kg60484qx9) (omeprazole - unii:kg60484qx9) - aspirin and omeprazole delayed-release tabletsa, a combination of aspirin and omeprazole, is indicated for patients who require aspirin for secondary prevention of cardiovascular and cerebrovascular events and who are at risk of developing aspirin associated gastric ulcers. the aspirin component of aspirin and omeprazole delayed-release tabletsa is indicated for: - reducing the combined risk of death and nonfatal stroke in patients who have had ischemic stroke or transient ischemia of the brain due to fibrin platelet emboli, - reducing the combined risk of death and nonfatal mi in patients with a previous mi or unstable angina pectoris, - reducing the combined risk of mi and sudden death in patients with chronic stable angina pectoris, - use in patients who have undergone revascularization procedures (coronary artery bypass graft [cabg] or percutaneous transluminal coronary angioplasty [ptca]) when there is a pre-existing condition for which aspirin is already indicated. the omeprazole component of aspirin an

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

amneal pharmaceuticals llc - aspirin (unii: r16co5y76e) (aspirin - unii:r16co5y76e), dipyridamole (unii: 64alc7f90c) (dipyridamole - unii:64alc7f90c) - aspirin 25 mg - aspirin and extended-release dipyridamole capsules are indicated to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis. aspirin and extended-release dipyridamole capsules are contraindicated in patients with known hypersensitivity to any of the product components. aspirin is contraindicated in patients with known allergy to nonsteroidal anti-inflammatory drug (nsaid) products and in patients with the syndrome of asthma, rhinitis, and nasal polyps. aspirin may cause severe urticaria, angioedema or bronchospasm. do not use aspirin in children or teenagers with viral infections because of the risk of reye syndrome. risk summary available data from published studies and postmarketing experience with aspirin and extended-release dipyridamole use during pregnancy have not identified a clear association between aspirin and extended-release dipyridamole use and major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data) . aspirin and extended-release dipyridamole contains low-dose aspirin which is an nsaid (see clinical considerations) . in animal reproduction studies, there were adverse developmental effects with administration of aspirin in rats and rabbits at doses about 66 and 44 times, respectively, the human exposure at the maximum recommended daily dose of aspirin-dipyridamole. reproduction studies with dipyridamole in mice, rabbits, and rats have revealed no evidence of harm to the fetus up to doses about 25 times the maximum recommended daily human dose of aspirin-dipyridamole. nonclinical data are suggestive of a possible potentiation of aspirin-related fetal toxicity when combined with dipyridamole (see data). the estimated background risk of major birth defects and miscarriage for the indicated population 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. clinical considerations labor and delivery aspirin and extended-release dipyridamole, which contains dipyridamole and low-dose aspirin, increases the risk for bleeding [see warnings and precautions (5.1)] . maternal use of high-dose aspirin can result in excessive blood loss at delivery, prolonged gestation, prolonged labor, intracranial hemorrhage in premature infants, low birth weight, stillbirth, and neonatal death. data human data published data from clinical trials, observational studies, case series, and case reports over several decades have not identified a clear association between aspirin-dipyridamole use in pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes. however, these studies cannot definitively establish the absence of any aspirin-dipyridamole associated risks. methodological limitations of these studies include variability in the timing and dose of drug exposure (e.g., most exposures occurred beyond the first trimester) and the small sample sizes of individual studies. animal data aspirin has been shown to be teratogenic in rats (spina bifida, exencephaly, microphthalmia and coelosomia) and rabbits (congested fetuses, agenesis of skull and upper jaw, generalized edema with malformation of the head, and diaphanous skin) at oral doses of 330 mg/kg/day and 110 mg/kg/day, respectively. these doses, which also resulted in a high resorption rate in rats (63% of implantations versus 5% in controls), are, on a mg/m2 basis, about 66 and 44 times, respectively, the dose of aspirin contained in the maximum recommended daily human dose of aspirin-dipyridamole. reproduction studies with dipyridamole have been performed in mice, rabbits and rats at oral doses of up to 125 mg/kg, 40 mg/kg, and 1,000 mg/kg, respectively (about 1½, 2, and 25 times the maximum recommended daily human oral dose, respectively, on a mg/m2 basis) and have revealed no evidence of harm to the fetus due to dipyridamole. when 330 mg aspirin/kg/day was combined with 75 mg dipyridamole/kg/day in the rat at doses about 66 and 2 times, respectively, the maximum recommended daily human dose, the resorption rate approached 100%. risk summary based on data from a clinical lactation study in breastfeeding women taking low-dose aspirin, the metabolite salicylic acid is present in human milk in low levels (see data) . dipyridamole is also present in human milk. there is no information on the effects of aspirin and extended-release dipyridamole or dipyridamole on the breastfed infant or on milk production. there is insufficient information to determine the effects of aspirin on the breastfed infant and no information on the effects of aspirin on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for aspirin and extended-release dipyridamole and any potential adverse effects on the breastfed child from aspirin and extended-release dipyridamole or from the underlying maternal condition. data a published clinical study involved six exclusively breastfeeding women at 1 to 8 months postpartum who were taking 81 mg aspirin daily. milk samples were collected at steady-state, at 0, 1, 2, 4, 8, 12, and 24 hours after taking a dose of aspirin. aspirin was undetectable in human milk. salicylic acid was present in milk at low levels (average concentration of 24 ng/ml). based on an average milk consumption of 150 ml/kg/day, the calculated relative infant dose was 0.4%. no adverse effects on the breastfed infants were noted. safety and effectiveness of aspirin and extended-release dipyridamole in pediatric patients have not been studied. because of the aspirin component, use of this product in the pediatric population is not recommended [see contraindications (4.3)] . of the total number of subjects in esps2, 61% were 65 and over, while 27% were 75 and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out [see clinical pharmacology (12.3)] . aspirin and extended-release dipyridamole has not been studied in patients with hepatic or renal impairment. avoid using aspirin containing products, such as aspirin and extended-release dipyridamole, in patients with severe hepatic or severe renal (glomerular filtration rate <10 ml/min) dysfunction [see warnings and precautions (5.2, 5.3) and clinical pharmacology (12.3)] .