ASPIRIN AND DIPYRIDAMOLE- aspirin and dipyridamole capsule, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

ASPIRIN

Composition:

ASPIRIN 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. 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 [se

Product summary:

Aspirin and extended-release dipyridamole 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 “TEVA” and with “01A”. Aspirin and extended-release dipyridamole capsules are supplied in unit-of-use bottles of 60 capsules (NDC 0093-3040-06). Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Protect from excessive moisture.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

ASPIRIN AND DIPYRIDAMOLE- ASPIRIN AND DIPYRIDAMOLE CAPSULE, EXTENDED
RELEASE
TEVA PHARMACEUTICALS USA, 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.
INITIAL U.S. APPROVAL: 1999
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)
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)
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 TEVA USA,
PHARMACOVIGILANCE at 1-866-832-8537, or
[e-mail] or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
DR