দেশ: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E), DIPYRIDAMOLE (UNII: 64ALC7F90C) (DIPYRIDAMOLE - UNII:64ALC7F90C)
Sun Pharmaceutical Industries, 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 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 use during pregnancy have not identified a clear association between aspirin and extended-release dipyridamole use and major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data) . Aspi
Aspirin and extended-release dipyridamole capsules are available as a hard gelatin capsule, size '00', with a red cap and an ivory-colored body, containing yellow extended-release pellets incorporating dipyridamole and a round white to off white tablet incorporating immediate-release aspirin. The capsule is imprinted in black ink with the "927"on cap and body. Aspirin and extended-release dipyridamole capsules 25 mg/250 mg are supplied as below: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Protect from excessive moisture.
Abbreviated New Drug Application
ASPIRIN AND DIPYRIDAMOLE EXTENDED RELEASE - ASPIRIN AND DIPYRIDAMOLE EXTENDED RELEASE CAPSULE SUN PHARMACEUTICAL INDUSTRIES, 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 ONLY INITIAL U.S. APPROVAL: 1999 INDICATIONS AND USAGE Aspirin and dipyridamole is 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 twice daily (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) 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 REACTIONS, CONTACT SUN PHARMACEUTICAL INDUSTRIES, INC. AT 1-800-818-4555 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH DRUG INTERACTIONS Coadministration with anti-coagulants, antiplatelets, or NSAIDS can increase সম্পূর্ণ নথি পড়ুন