ASPIRIN AND DIPYRIDAMOLE capsule, extended release

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Teva Pharmaceuticals USA, Inc.

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 is 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 Data) . Aspi

Povzetek izdelek:

Aspirin and Extended-Release Dipyridamole Capsules are available as: 25 mg/200 mg: Two-piece hard gelatin capsule with a Swedish orange opaque cap and white opaque body. Imprinted in black ink with TEVA over 3064 on the cap and TEVA over 3064 on the body and available in unit-of-use bottles of 60 capsules (NDC 0093-3064-06). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from excessive moisture. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

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, 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 increases 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 48 hours
before using intravenous dipyridamole 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,
abdo