国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
aspirin (UNII: R16CO5Y76E) (aspirin - UNII:R16CO5Y76E)
Roxane Laboratories, Inc.
aspirin
aspirin 25 mg
PRESCRIPTION DRUG
New Drug Application Authorized Generic
ASPIRIN AND DIPYRIDAMOLE- ASPIRIN AND DIPYRIDAMOLE CAPSULE ROXANE LABORATORIES, 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 INITIAL U.S. APPROVAL: 1999 RECENT MAJOR CHANGES Warnings and Precautions Risk of Bleeding (5.1) 9/2012 INDICATIONS AND USAGE • DOSAGE AND ADMINISTRATION • • • • • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS • • • WARNINGS AND PRECAUTIONS • • • ADVERSE REACTIONS • TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BOEHRINGER INGELHEIM PHARMACEUTICALS, INC. AT (800) 542-6257 OR (800) 459-9906 TTY OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. DRUG INTERACTIONS • • 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) 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) 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) Capsule: 25 mg aspirin/200 mg extended-release dipyridamole (3) 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) Aspirin and Extended Release Dipyridamole Capsules increases the risk of bleeding (5.1) Avoid use in patients with severe hepatic or renal insufficiency (5.2, 5.3) Can cause fetal harm when administered to a pregnant woman, especially in the third trimester (5.4) The mo 阅读完整的文件