ASPIRIN AND DIPYRIDAMOLE capsule, extended release

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

aspirin (UNII: R16CO5Y76E) (aspirin - UNII:R16CO5Y76E), dipyridamole (UNII: 64ALC7F90C) (dipyridamole - UNII:64ALC7F90C)

Saatavilla:

Slate Run Pharmaceuticals, LLC

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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

Tuoteyhteenveto:

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 the Boehringer Ingelheim logo and with "01A". Aspirin and Extended-Release Dipyridamole Capsules 25 mg/200 mg are supplied in unit-of-use bottles of 60 capsules (NDC 70436-092-05). Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Protect from excessive moisture.

Valtuutuksen tilan:

New Drug Application Authorized Generic

Valmisteyhteenveto

ASPIRIN AND DIPYRIDAMOLE- ASPIRIN AND DIPYRIDAMOLE CAPSULE, EXTENDED
RELEASE
SLATE RUN PHARMACEUTICALS, LLC
----------
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
•
DOSAGE AND ADMINISTRATION
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
ADVERSE REACTIONS
•
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BOEHRINGER INGELHEIM
PHARMACEUTICALS,
INC. AT [phone] OR FDA AT 1-800-FDA-1088 OR
https://www.fda.gov/safety/medwatch-fda-
safety-information-and-adverse-event-reporting-program
DRUG INTERACTIONS
•
•
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 6/2021
Aspirin and extended-release dipyridamole capsules are a combination
of aspirin and dipyridamole,
antiplatelet agents, 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 (2.1)
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)
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