AGGRENOX- aspirin and dipyridamole capsule, extended release

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Carilion Materials Management

INN (Alþjóðlegt nafn):

ASPIRIN

Samsetning:

ASPIRIN 25 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

AGGRENOX 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. AGGRENOX 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. 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 AGGRENOX in the third trimester of pregnan

Vörulýsing:

AGGRENOX capsules are available as a hard gelatin capsule, with a red cap and an ivory-colored body, containing yellow extended-release pellets incorporating dipyridamole and a round white tablet incorporating immediate-release aspirin. The capsule body is imprinted in red with the Boehringer Ingelheim logo and with "01A". AGGRENOX capsules are supplied in unit-of-use bottles of 60 capsules (NDC 0597-0001-60). Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Protect from excessive moisture.

Leyfisstaða:

New Drug Application

Vara einkenni

AGGRENOX- ASPIRIN AND DIPYRIDAMOLE CAPSULE, EXTENDED RELEASE
CARILION MATERIALS MANAGEMENT
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AGGRENOX SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR AGGRENOX.
AGGRENOX® (ASPIRIN/EXTENDED-RELEASE DIPYRIDAMOLE) CAPSULES
INITIAL U.S. APPROVAL: 1999
INDICATIONS AND USAGE
AGGRENOX is 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
AGGRENOX increases 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 BOEHRINGER INGELHEIM
PHARMACEUTICALS, INC. AT (800)
542-6257 OR [phone] TTY OR FDA AT 1-800-FDA-1088 OR
WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Co-administration with anticoagulants, antiplatelets, or NSAIDs can
increase risk of bleeding (7.1)
Decreased renal function can occur with co-administrat