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

aralez pharmaceuticals us inc. - vorapaxar sulfate (unii: in66038e6c) (vorapaxar - unii:zce93644n2) - vorapaxar 2.08 mg - zontivity ® is indicated for the reduction of thrombotic cardiovascular events in patients with a history of myocardial infarction (mi) or with peripheral arterial disease (pad). zontivity has been shown to reduce the rate of a combined endpoint of cardiovascular death, mi, stroke, and urgent coronary revascularization (ucr). zontivity is contraindicated in patients with a history of stroke, tia, or ich because of an increased risk of ich in this population [see adverse reactions (6)] . discontinue zontivity in patients who experience a stroke, tia, or ich [see adverse reactions (6.1) and clinical studies (14)] . zontivity is contraindicated in patients with active pathological bleeding such as ich or peptic ulcer [see warnings and precautions (5.1) and adverse reactions (6.1)] . risk summary based on the potenti

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

aralez pharmaceuticals us inc. - aspirin (unii: r16co5y76e) (aspirin - unii:r16co5y76e), omeprazole (unii: kg60484qx9) (omeprazole - unii:kg60484qx9) - aspirin 81 mg - yosprala, 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 yosprala 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 yosprala is indicated for decreasing the risk of developing aspirin-associated gastric u

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

aralez pharmaceuticals us inc. - fenofibric acid (unii: bgf9mn2hu1) (fenofibric acid - unii:bgf9mn2hu1) - fenofibric acid 35 mg - fibricor is indicated as adjunctive therapy to diet for treatment of severe hypertriglyceridemia (≥ 500 mg/dl). improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention. markedly elevated levels of serum triglycerides > 2000 mg/dl may increase the risk of developing pancreatitis. the effect of fenofibrate therapy on reducing this risk has not been adequately studied. fibricor is indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (ldl-c), total cholesterol (total-c), triglycerides (tg), and apolipoprotein b (apo b), and to increase high-density lipoprotein cholesterol (hdl-c) in patients with primary hypercholesterolemia or mixed dyslipidemia. fenofibrate at a dose equivalent to 105 mg of fibricor was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus [see warnings and precautions (5.1) ]. fibricor is contraindicated in: - pat

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

aralez pharmaceuticals us inc. - metoprolol succinate (unii: th25pd4ccb) (metoprolol - unii:geb06nhm23) - metoprolol tartrate 25 mg - toprol-xl is indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including metoprolol. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than 1 drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program’s joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms

Canada - English - Health Canada

aralez pharmaceuticals canada inc - acetylsalicylic acid; caffeine; butalbital; codeine phosphate - capsule - 330mg; 40mg; 50mg; 15mg - acetylsalicylic acid 330mg; caffeine 40mg; butalbital 50mg; codeine phosphate 15mg - opiate agonists

Canada - English - Health Canada

aralez pharmaceuticals canada inc - butalbital; caffeine; acetylsalicylic acid - capsule - 50mg; 40mg; 330mg - butalbital 50mg; caffeine 40mg; acetylsalicylic acid 330mg - barbiturates

Canada - English - Health Canada

aralez pharmaceuticals canada inc - diclofenac potassium - powder for solution - 50mg - diclofenac potassium 50mg - other nonsteroidal antiimflammatory agents

Canada - English - Health Canada

aralez pharmaceuticals canada inc - sumatriptan (sumatriptan succinate); naproxen sodium - tablet - 85mg; 500mg - sumatriptan (sumatriptan succinate) 85mg; naproxen sodium 500mg - other nonsteroidal antiimflammatory agents

Canada - English - Health Canada

aralez pharmaceuticals canada inc - acetylsalicylic acid; caffeine; codeine phosphate; butalbital - capsule - 330mg; 40mg; 30mg; 50mg - acetylsalicylic acid 330mg; caffeine 40mg; codeine phosphate 30mg; butalbital 50mg - opiate agonists

Canada - English - Health Canada

aralez pharmaceuticals canada inc - polyethylene glycol 3350; sodium sulfate anhydrous; sodium chloride; potassium chloride; sodium ascorbate; ascorbic acid - powder for solution - 100g; 7.5g; 2.691g; 1.015g; 5.9g; 4.7g - polyethylene glycol 3350 100g; sodium sulfate anhydrous 7.5g; sodium chloride 2.691g; potassium chloride 1.015g; sodium ascorbate 5.9g; ascorbic acid 4.7g - cathartics and laxatives