ASPIRIN AND EXTENDED-RELEASE DIPYRIDAMOLE capsule

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:

AvKARE

INN (International Name):

ASPIRIN

Composition:

ASPIRIN 25 mg

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, USP 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, USP may cause severe urticaria, angioedema or bronchospasm. Do not use aspirin, USP in children or teenagers with viral infections because of the risk of Reye syndrome. Teratogenic Effects, Pregnancy Category D. [see Warnings and Precautions (5.4)]. Aspirin can result in excessive blood loss at delivery as well as prolonged gestation and prolonged labor. Because of these effects on the mother and because of adverse fetal effects seen with aspirin during the later stages of pregnancy [see Warnings and Precautions (5.4)] , avoid aspirin and extended-release dipyridamole in the third trimester of pregnancy and during labor and delivery. Both dipyridamole and aspirin are excreted in human milk. Exercise caution when aspirin and extended-release dipyridamole capsules are administered to a nursing woman. Safety and effectiveness of aspirin and extended-release dipyridamole in pediatric patients have not been studied. Due to the aspirin component, use of this product in the pediatric population is not recommended [see Contraindications (4.3)] . Of the total number of subjects in ESPS2, 61 percent were 65 and over, while 27 percent were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out [see Clinical Pharmacology (12.3)] . Aspirin and extended-release dipyridamole has not been studied in patients with hepatic or renal impairment. Avoid using aspirin containing products, such as aspirin and extended-release dipyridamole in patients with severe hepatic or severe renal (glomerular filtration rate < 10 mL/min) dysfunction [see  Warnings and Precautions (5.2,  5.3) and Clinical Pharmacology (12.3)] .

Product summary:

Aspirin and extended-release dipyridamole capsules, 25 mg/200 mg, are available as two piece hard gelatin capsules, with a red opaque cap and a yellow opaque body, filled with light yellow to yellow extended-release dipyridamole pellets and a white to off-white, round, film-coated, biconvex, unscored, plain aspirin tablet. The capsule is imprinted axially with “AN” in yellow ink on the cap and “596” in red ink on the body. Aspirin and extended-release dipyridamole capsules are supplied as follows: Bottles of 60:                          NDC 42291-116-60 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from excessive moisture.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ASPIRIN AND EXTENDED-RELEASE DIPYRIDAMOLE- ASPIRIN AND EXTENDED-
RELEASE DIPYRIDAMOLE CAPSULE
AVKARE
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HIGHLIGHTS OF PRESCRIBING INFORMATION
ASPIRIN AND EXTENDED-RELEASE DIPYRIDAMOLE CAPSULES
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 capsulesis 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)
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 capsulesincreases 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)
ADVERSE REACTIONS
The most frequently reported adverse reactions (>10% and greater than
placebo) were headache,
dyspepsia, abdominal pain, nausea and diarrhea (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT AVKARE AT
1-855-361-3993 OR
WWW.AVKARE.COM OR FDA AT 1-800-FDA-1088 OR WW