国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E), DIPYRIDAMOLE (UNII: 64ALC7F90C) (DIPYRIDAMOLE - UNII:64ALC7F90C)
Carilion Materials Management
ASPIRIN
ASPIRIN 25 mg
ORAL
PRESCRIPTION DRUG
AGGRENOX 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. AGGRENOX 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. Teratogenic Effects, Pregnancy Category D. [see Warnings and Precautions (5.4) ]. Aspirin can result in excessive blood loss at delivery as well as prolonged gestation and prolonged labor. Because of these effects on the mother and because of adverse fetal effects seen with aspirin during the later stages of pregnancy [see Warnings and Precautions (5.4) ], avoid AGGRENOX in the third trimester of pregnan
AGGRENOX capsules are available as a hard gelatin capsule, with a red cap and an ivory-colored body, containing yellow extended-release pellets incorporating dipyridamole and a round white tablet incorporating immediate-release aspirin. The capsule body is imprinted in red with the Boehringer Ingelheim logo and with "01A". AGGRENOX capsules are supplied in unit-of-use bottles of 60 capsules (NDC 0597-0001-60). Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Protect from excessive moisture.
New Drug Application
AGGRENOX- ASPIRIN AND DIPYRIDAMOLE CAPSULE, EXTENDED RELEASE CARILION MATERIALS MANAGEMENT ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE AGGRENOX SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AGGRENOX. AGGRENOX® (ASPIRIN/EXTENDED-RELEASE DIPYRIDAMOLE) CAPSULES INITIAL U.S. APPROVAL: 1999 INDICATIONS AND USAGE AGGRENOX 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 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/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 AGGRENOX 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) ADVERSE REACTIONS The most frequently reported adverse reactions (>10% and greater than placebo) were headache, dyspepsia, abdominal pain, nausea, and diarrhea (6) 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 Co-administration with anticoagulants, antiplatelets, or NSAIDs can increase risk of bleeding (7.1) Decreased renal function can occur with co-administrat 完全なドキュメントを読む