ASPIRIN-DIPYRIDAMOLE capsule

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E), DIPYRIDAMOLE (UNII: 64ALC7F90C) (DIPYRIDAMOLE - UNII:64ALC7F90C)

Disponible desde:

Zydus Pharmaceuticals USA Inc.

Designación común internacional (DCI):

ASPIRIN

Composición:

ASPIRIN 25 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 capsule use during pregnancy have not identified a clear association between aspirin and extended-release dipyridamole capsule use and major birth defects, miscarriage, or adverse maternal or fetal

Resumen del producto:

Aspirin and Extended-release Dipyridamole Capsules, 25 mg/200 mg are two piece, hard shell, size 00 capsules with an opaque red cap printed '618' with black ink and OPAQUE WHITE BODY, containing yellow extended-release pellets incorporating dipyridamole and one white to off-white, round, biconvex, film-coated tablet incorporating immediate-release aspirin and are supplied as follows: NDC 68382-618-14 in bottle of 60 capsules Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] Protect from excessive moisture.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

ASPIRIN-DIPYRIDAMOLE- ASPIRIN-DIPYRIDAMOLE CAPSULE
ZYDUS PHARMACEUTICALS USA INC.
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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
RECENT MAJOR CHANGES
Warnings and Precautions, Stress testing with intravenous dipyridamole
and other adenosinergic
agents (5.6)
12/2019
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 (2.1)
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)
Interrupt aspirin and extended-release dipyridamole capsules 24 to 48
hours before using intravenous
dipyridamole or 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 p