国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E), DIPYRIDAMOLE (UNII: 64ALC7F90C) (DIPYRIDAMOLE - UNII:64ALC7F90C)
Zydus Pharmaceuticals USA Inc.
ASPIRIN
ASPIRIN 25 mg
ORAL
PRESCRIPTION DRUG
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 capsule use during pregnancy have not identified a clear association between aspirin and extended-release dipyridamole capsule use and major birth defects, miscarriage, or adverse maternal or fetal
Aspirin and Extended-release Dipyridamole Capsules, 25 mg/200 mg are two piece, hard shell, size 00 capsules with an opaque red cap printed '618' with black ink and OPAQUE WHITE BODY, containing yellow extended-release pellets incorporating dipyridamole and one white to off-white, round, biconvex, film-coated tablet incorporating immediate-release aspirin and are supplied as follows: NDC 68382-618-14 in bottle of 60 capsules Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] Protect from excessive moisture.
Abbreviated New Drug Application
ASPIRIN-DIPYRIDAMOLE- ASPIRIN-DIPYRIDAMOLE CAPSULE ZYDUS PHARMACEUTICALS USA INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ASPIRIN AND EXTENDED- RELEASE DIPYRIDAMOLE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ASPIRIN AND EXTENDED-RELEASE DIPYRIDAMOLE CAPSULES. ASPIRIN AND EXTENDED-RELEASE DIPYRIDAMOLE CAPSULES, FOR ORAL USE INITIAL U.S. APPROVAL: 1999 RECENT MAJOR CHANGES Warnings and Precautions, Stress testing with intravenous dipyridamole and other adenosinergic agents (5.6) 12/2019 INDICATIONS AND USAGE Aspirin and extended-release dipyridamole capsules are a combination antiplatelet agent indicated to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis (1) DOSAGE AND ADMINISTRATION One capsule twice daily (morning and evening) with or without food (2) In case of intolerable headaches during initial treatment, switch to one capsule at bedtime and low- dose aspirin in the morning; resume BID dosing within one week (2.1) Do not chew capsule (2) NOT INTERCHANGEABLE WITH THE INDIVIDUAL COMPONENTS OF ASPIRIN AND DIPYRIDAMOLE TABLETS (2) Dispense in this unit-of-use container (16) DOSAGE FORMS AND STRENGTHS Capsule: 25 mg aspirin/200 mg extended-release dipyridamole (3) CONTRAINDICATIONS Hypersensitivity to any product ingredients (4.1) Patients with known allergy to NSAIDs (4.2) Patients with the syndrome of asthma, rhinitis, and nasal polyps (4.2) WARNINGS AND PRECAUTIONS Aspirin and extended-release dipyridamole capsules increase the risk of bleeding (5.1) Avoid use in patients with severe hepatic or renal insufficiency (5.2, 5.3) Interrupt aspirin and extended-release dipyridamole capsules 24 to 48 hours before using intravenous dipyridamole or or other adenosinergic agents for stress testing (5.6, 7.1) ADVERSE REACTIONS The most frequently reported adverse reactions (>10% and greater than placebo) were headache, dyspepsia, abdominal p 完全なドキュメントを読む