Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
Aspirin (UNII: R16CO5Y76E) (Aspirin - UNII:R16CO5Y76E), Dipyridamole (UNII: 64ALC7F90C) (Dipyridamole - UNII:64ALC7F90C)
Dr. Reddy's Laboratories Inc
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 capsules use during pregnancy have not identified a clear association between aspirin and extended-release dipyridamole capsules use and major birth defects, miscarriage, or adverse maternal or fet
Aspirin and extended-release dipyridamole capsules are available as a hard gelatin capsule, with orange colored cap and white to off white colored body, containing yellow to dark yellow colored extended-release pellets incorporating dipyridamole and white to off white round biconvex film coated tablet incorporating immediate-release aspirin. The capsule body is imprinted with ‘339’ on the body and ‘RDY’ on cap with black ink. Aspirin and extended-release dipyridamole capsules are supplied in unit-of-use bottles of 60s capsules. Bottles of 60’s NDC 43598-339-60 Store at 20ºC to 25ºC (68ºF to 77ºF); [See USP Controlled Room Temperature]. Protect from excessive moisture.
Abbreviated New Drug Application
ASPIRIN AND DIPYRIDAMOLE- ASPIRIN AND DIPYRIDAMOLE CAPSULE, EXTENDED RELEASE DR. REDDY'S 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, FOR ORAL USE INITIAL U.S. APPROVAL: 1999 INDICATIONS AND USAGE Aspirin and extended-release dipyridamole capsules are a combination of aspirin and dipyridamole, antiplatelet agents, 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 and 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 increases 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 48 hours before using intravenous dipyridamole 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 pain, nausea, and diarrhea (6) TO RE Διαβάστε το πλήρες έγγραφο