ASPIRIN AND EXTENDED-RELEASE DIPYRIDAMOLE capsule, extended release

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Micro Labs Limited

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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 capsule 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 capsules use during pregnancy have not identified a clear association between aspirin and extended-release dipyridamole capsules use and major birth defects, miscarriage, or adverse maternal or fetal ou

Termék összefoglaló:

Aspirin and extended-release Dipyridamole 25 mg/200 mg capsules are available as a hard gelatin capsule, with red opaque colored cap and ivory opaque colored body, size ‘0 Xel’ hard gelatin capsule imprinted with ‘M’ on cap and ‘25’ on body in black ink, containing yellow colored extended-release pellets of Dipyridamole and a yellow colored immediate release pellets of Aspirin. Bottles of 60                                                               NDC 42571-274-60 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.

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

ASPIRIN AND EXTENDED-RELEASE DIPYRIDAMOLE- ASPIRIN AND EXTENDED-
RELEASE DIPYRIDAMOLE CAPSULE, EXTENDED RELEASE
MICRO LABS LIMITED
----------
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 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)
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 capsules 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, abdominal pain, nausea, and diarrhea (6.1)
TO REPORT SUSPECTED ADVERSE REAC