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

sigma pharmaceuticals plc - dipyridamole - oral tablet - 100mg

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

thame laboratories ltd - dipyridamole - oral suspension - 40mg/1ml

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

boehringer ingelheim pharmaceuticals, inc. - dipyridamole (unii: 64alc7f90c) (dipyridamole - unii:64alc7f90c) - dipyridamole 25 mg - persantine tablets are indicated as an adjunct to coumarin anticoagulants in the prevention of postoperative thromboembolic complications of cardiac valve replacement. hypersensitivity to dipyridamole and any of the other components.

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

arrotex pharmaceuticals pty ltd - aspirin, quantity: 25 mg; dipyridamole, quantity: 200 mg - capsule, modified release - excipient ingredients: triacetin; pregelatinised maize starch; sucrose; microcrystalline cellulose; purified talc; acacia; tartaric acid; hypromellose; gelatin; hypromellose phthalate; methacrylic acid copolymer; stearic acid; iron oxide red; iron oxide yellow; titanium dioxide; povidone; sodium benzoate; potable water; simethicone; cetostearyl alcohol - for the prevention of recurrent ischaemic stroke and transient ischaemic attacks.

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

arrotex pharmaceuticals pty ltd - aspirin, quantity: 25 mg; dipyridamole, quantity: 200 mg - capsule, modified release - excipient ingredients: hypromellose; gelatin; triacetin; methacrylic acid copolymer; purified talc; microcrystalline cellulose; hypromellose phthalate; acacia; tartaric acid; pregelatinised maize starch; sucrose; stearic acid; iron oxide red; iron oxide yellow; titanium dioxide; povidone; sodium benzoate; potable water; simethicone; cetostearyl alcohol - for the prevention of recurrent ischaemic stroke and transient ischaemic attacks.

Canada - English - Health Canada

fresenius kabi canada ltd - dipyridamole - liquid - 5mg - dipyridamole 5mg - miscellaneous vasodilatating agents

Canada - English - Health Canada

novopharm limited - dipyridamole - solution - 5mg - dipyridamole 5mg - miscellaneous vasodilatating agents

Israel - English - Ministry of Health

rafa laboratories ltd - dipyridamole - tablets - dipyridamole 75 mg - dipyridamole - dipyridamole - as an adjunct to oral anticoagulants for prophylaxis of thromboembolism associated with prosthetic heart valves. reduction of proteinuria in the nephrotis syndrome. treatment of membranoproliferative glomerulonephritis. prevention of pre-eclampsia in the final trimester of pregnancy. prevention of transplant artery stenosis. prevention of post-operative thromboembolic complications of coronary artery surgery. in combination with acetylsalicylic acid in cases of recurrent deep vein thrombosis resistant to oral anticoagulants. prevention of thrombogenic manifestations. as an alternative to exercise stress in thallium myocardial imaging particularly in patients unable to exercise or in those for whom exercise may be contraindicated.

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)] .

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

northstar rx llc - aspirin (unii: r16co5y76e) (aspirin - unii:r16co5y76e), dipyridamole (unii: 64alc7f90c) (dipyridamole - unii:64alc7f90c) - 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 capsules use during pregnancy have not identified a clear association between aspirin and extended-release dipyridamole capsules use and major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data). aspirin and extended-release dipyridamole capsules 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 capsules, 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 capsules 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 capsules and any potential adverse effects on the breastfed child from aspirin and extended-release dipyridamole capsules 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 capsules 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 capsules have not been studied in patients with hepatic or renal impairment. avoid using aspirin containing products, such as aspirin and extended-release dipyridamole capsules 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 )].