ASPIRIN AND DIPYRIDAMOLE capsule, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Aspirin (UNII: R16CO5Y76E) (Aspirin - UNII:R16CO5Y76E), Dipyridamole (UNII: 64ALC7F90C) (Dipyridamole - UNII:64ALC7F90C)

Available from:

Dr. Reddy's Laboratories Inc

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 fet

Product summary:

Aspirin and extended-release dipyridamole capsules are available as a hard gelatin capsule, with orange colored cap and white to off white colored body, containing yellow to dark yellow colored extended-release pellets incorporating dipyridamole and white to off white round biconvex film coated tablet incorporating immediate-release aspirin. The capsule body is imprinted with ‘339’ on the body and ‘RDY’ on cap with black ink.   Aspirin and extended-release dipyridamole capsules are supplied in unit-of-use bottles of 60s capsules.   Bottles of 60’s NDC 43598-339-60   Store at 20ºC to 25ºC (68ºF to 77ºF); [See USP Controlled Room Temperature]. Protect from excessive moisture.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ASPIRIN AND DIPYRIDAMOLE- ASPIRIN AND DIPYRIDAMOLE CAPSULE, EXTENDED
RELEASE
DR. REDDY'S 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, FOR ORAL USE
INITIAL U.S. APPROVAL: 1999
INDICATIONS AND USAGE
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)
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 and 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)
TO RE