Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)
Impax Generics
ASPIRIN
ASPIRIN 25 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
ASPIRIN AND DIPYRIDAMOLE- ASPIRIN AND DIPYRIDAMOLE CAPSULE, EXTENDED RELEASE IMPAX GENERICS ---------- 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 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) 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, USP /200 mg extended-release dipyridamole, USP (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) Can cause fetal harm when administered to a pregnant woman, especially in the third trimester (5.4) ADVERSE REACTIONS The most frequently reported adverse reactions (greater than 10% and greater than placebo) were headache, dyspepsia, abdominal pain, nausea, and diarrhea (6) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT IMPAX LABORATORIES, INC. AT 1-800-934-6729 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. DRUG INTERACTIO Lue koko asiakirja