País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E), OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9)
Aralez Pharmaceuticals Us Inc.
ASPIRIN
ASPIRIN 81 mg
ORAL
PRESCRIPTION DRUG
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
YOSPRALA (aspirin 81 mg/omeprazole 40 mg) and (aspirin 325 mg/omeprazole 40 mg) delayed-release tablets are oval, blue-green, film-coated tablets printed with 81/40 and 325/40 respectively in black ink. YOSPRALA tablets are packaged in high density polyethylene (HDPE) bottles with desiccants and are supplied as: NDC 70347-081-30 Bottles of 30 tablets YOSPRALA 81/40 NDC 70347-081-90 Bottles of 90 tablets YOSPRALA 81/40 NDC 70347-325-30 Bottles of 30 tablets YOSPRALA 325/40 NDC 70347-325-90 Bottles of 90 tablets YOSPRALA 325/40 Storage : Store at 25°C (77°F); excursions permitted to 15-30°C (59 to 86°F) [see USP Controlled Room Temperature]. Store in the original container with desiccant and keep the bottle tightly closed to protect from moisture. Dispense in a tight container if package is subdivided.
New Drug Application
Aralez Pharmaceuticals Us Inc. ---------- MEDICATION GUIDE YOSPRALA™ (yo SPRA lah) (aspirin and omeprazole) delayed-release tablets What is the most important information I should know about YOSPRALA? You should take YOSPRALA exactly as prescribed, at the lowest dose possible and for the shortest time needed. YOSPRALA may help reduce the risk of stomach ulcers from aspirin use, but you could still have bleeding and stomach or intestine ulcers, or other serious stomach or intestine problems. Talk with your doctor. Tell your doctor if you have unexpected bleeding, if you bleed more than usual, or if your bleeding lasts longer than is normal for you, such as increased bruising or more frequent nose bleeds. YOSPRALA contains aspirin, a nonsteroidal anti-inflammatory drug (NSAID) and omeprazole, a proton pump inhibitor (PPI) medicine. Before taking YOSPRALA, tell your doctor if you take: • aspirin, or any prescription or over-the-counter medicines containing aspirin or other NSAIDs • clopidogrel bisulphate (PLAVIX®). You should not take clopidogrel bisulphate (PLAVIX®) if you take YOSPRALA. • ticagrelor (BRILINTA®). Do not stop taking YOSPRALA without talking with your doctor. Stopping YOSPRALA suddenly could increase your risk of having a heart attack or stroke. YOSPRALA can cause serious side effects, including: • A type of kidney problem (acute interstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including YOSPRALA, may develop a kidney problem called acute interstitial nephritis that can happen at any time during treatment with YOSPRALA. Call your doctor right away if you have a decrease in the amount that you urinate or if you have blood in your urine. • Diarrhea caused by an infection (Clostridium difficile) in your intestines. Call your doctor right away if you have watery stools or stomach pain that does not go away. You may or may not have a fever. • Bone fractures (hip, wrist, or spine). Bone fractures in the hip, wrist, or spine may happen in people who take Llegiu el document complet
YOSPRALA- ASPIRIN AND OMEPRAZOLE TABLET, FILM COATED ARALEZ PHARMACEUTICALS US INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE YOSPRALA SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR YOSPRALA. YOSPRALA (ASPIRIN AND OMEPRAZOLE) DELAYED-RELEASE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2016 RECENT MAJOR CHANGES Warnings and Precautions, Fundic Gland Polyps (5.20) 06/2018 INDICATIONS AND USAGE YOSPRALA is a combination of aspirin, an anti-platelet agent, and omeprazole, a proton pump inhibitor (PPI), 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 ulcers in patients at risk for developing aspirin-associated gastric ulcers due to age (≥ 55) or documented history of gastric ulcers. (1) Limitations of Use: Not for use as the initial dose of aspirin therapy during onset of acute coronary syndrome, acute myocardial infarction or before percutaneous coronary intervention. (1) Has not been shown to reduce the risk of gastrointestinal bleeding due to aspirin. (1) Do not substitute YOSPRALA with the single-ingredient products of aspirin and Llegiu el document complet