ASPIRIN AND DIPYRIDAMOLE capsule

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

aspirin (UNII: R16CO5Y76E) (aspirin - UNII:R16CO5Y76E)

MAH:

Roxane Laboratories, Inc.

INN:

aspirin

composition:

aspirin 25 mg

prescription_type:

PRESCRIPTION DRUG

authorization_status:

New Drug Application Authorized Generic

SPC

ASPIRIN AND DIPYRIDAMOLE- ASPIRIN AND DIPYRIDAMOLE CAPSULE
ROXANE LABORATORIES, 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
INITIAL U.S. APPROVAL: 1999
RECENT MAJOR CHANGES
Warnings and Precautions
Risk of Bleeding (5.1)
9/2012
INDICATIONS AND USAGE
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
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TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BOEHRINGER INGELHEIM
PHARMACEUTICALS, INC. AT (800)
542-6257 OR [phone] TTY OR FDA AT 1-800-FDA-1088 OR
WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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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)
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)
Capsule: 25 mg aspirin/200 mg extended-release dipyridamole (3)
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)
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)
Can cause fetal harm when administered to a pregnant woman, especially
in the third trimester (5.4)
The mo