البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E), DIPYRIDAMOLE (UNII: 64ALC7F90C) (DIPYRIDAMOLE - UNII:64ALC7F90C)
Micro Labs Limited
ORAL
PRESCRIPTION DRUG
Aspirin and extended-release dipyridamole capsule is 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 capsule is 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 fetal ou
Aspirin and extended-release Dipyridamole 25 mg/200 mg capsules are available as a hard gelatin capsule, with red opaque colored cap and ivory opaque colored body, size ‘0 Xel’ hard gelatin capsule imprinted with ‘M’ on cap and ‘25’ on body in black ink, containing yellow colored extended-release pellets of Dipyridamole and a yellow colored immediate release pellets of Aspirin. Bottles of 60 NDC 42571-274-60 Store at 25 ° C (77 ° F); excursions permitted to 15 ° to 30 ° C (59 ° to 86 ° F) [see USP Controlled Room Temperature]. Protect from excessive moisture.
Abbreviated New Drug Application
ASPIRIN AND EXTENDED-RELEASE DIPYRIDAMOLE- ASPIRIN AND EXTENDED- RELEASE DIPYRIDAMOLE CAPSULE, EXTENDED RELEASE MICRO LABS LIMITED ---------- 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 capsule is 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/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 (6.1) TO REPORT SUSPECTED ADVERSE REAC اقرأ الوثيقة كاملة