ASPIRIN AND EXTENDED-RELEASE DIPYRIDAMOLE capsule

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

ANI Pharmaceuticals, Inc.

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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

Podsumowanie produktu:

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 62559-850-60 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from excessive moisture.

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

ASPIRIN AND EXTENDED-RELEASE DIPYRIDAMOLE- ASPIRIN AND EXTENDED-
RELEASE DIPYRIDAMOLE CAPSULE
ANI PHARMACEUTICALS, 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
RECENT MAJOR CHANGES
Warnings and Precautions, Stress testing with intravenous dipyridamole
and other adenosinergic agents
(5.6) 12/2019
INDICATIONS AND USAGE
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
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TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ANI PHARMACEUTICALS,
INC. AT 1-800-308-
6755 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
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)
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 patie