ASPIRIN AND EXTENDED - RELEASE DIPYRIDAMOLE CAPSULES, 25 MG / 200 MG- aspirin and extended - release dipyridamole capsule

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Par Pharmaceutical, Inc.

INN (International Name):

ASPIRIN

Sammensetning:

ASPIRIN 25 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 is contraindicated in patients with known hypersensitivity to any of the product components. Aspirin is contraindicated in patients with known allergy to nonsteroidal anti-in 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 bir

Produkt oppsummering:

Aspirin and Extended-Release Dipyridamole Capsulesare available as a hard gelatin capsule, with a red colored cap and an ivory-colored body containing yellow colored extended-release pellets incorporating dipyridamole and a white to off white, film coated, circular bi-convex tablet incorporating immediate-release aspirin. The capsule body is imprinted in black with ‘PAR’ on the cap and ‘730’on the body Aspirin and Extended-Release Dipyridamole Capsulesare supplied in unit-of-use bottles of 60 capsules (NDC 49884-007-02). 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.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

ASPIRIN AND EXTENDED - RELEASE DIPYRIDAMOLE CAPSULES, 25 MG / 200
MG- ASPIRIN AND EXTENDED - RELEASE DIPYRIDAMOLE CAPSULE
PAR PHARMACEUTICAL, 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
INDICATIONS AND USAGE
Aspirin and Extended-Release Dipyridamole Capsule 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
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)
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 Par Pharmaceutical at
1-800-828-9393 or FDA at 1-
800-FDA-1088 or www.fda.gov/medwatch. (6)
DRUG INTERACTIONS
Coadministration with anticoagulants, antiplatelets, or NSAIDS ca