Aggrenox (Aspirin / Extended-Release Dipyridamole) - Indications and Dosage

INDICATIONS AND USAGE

Aggrenox® (aspirin/extended-release dipyridamole) capsules 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.

DOSAGE AND ADMINISTRATION

The recommended dose of Aggrenox® (aspirin/extended-release dipyridamole) capsules is one capsule given orally twice daily, one in the morning and one in the evening. The capsules should be swallowed whole without chewing. AGGRENOX capsules may be administered with or without food.

Alternative Regimen in Case of Intolerable Headaches

In the event of intolerable headaches during initial treatment, switch to one capsule at bedtime and low-dose aspirin in the morning. Because there are no outcome data with this regimen and headaches become less of a problem as treatment continues, patients should return to the usual regimen as soon as possible, usually within one week.

AGGRENOX capsules is not interchangeable with the individual components of aspirin and Persantine^® Tablets.

HOW SUPPLIED

AGGRENOX capsules is available as a hard gelatin capsule, with a red cap and an ivory-colored body, 24.0 mm in length, 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 is 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.

Marketed by:
Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT 06877 USA

Manufactured by:
Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany

Licensed from:
Boehringer Ingelheim International GmbH

©Copyright Boehringer Ingelheim International GmbH
2007, ALL RIGHTS RESERVED

Patent No. 6,015,577

January 31, 2007

OT1000D

42633/US/7