Imdur (Isosorbide Mononitrate) - Indications and Dosage

INDICATIONS AND USAGE

IMDUR Tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.

DOSAGE AND ADMINISTRATION

The recommended starting dose of IMDUR Tablets is 30 mg (given as a single 30-mg tablet or as ½ of a 60-mg tablet) or 60 mg (given as a single tablet) once daily. After several days, the dosage may be increased to 120 mg (given as a single 120-mg tablet or as two 60-mg tablets) once daily. Rarely, 240 mg may be required. The daily dose of IMDUR Tablets should be taken in the morning on arising. IMDUR Extended Release Tablets should not be chewed or crushed and should be swallowed together with a half-glassful of fluid.

HOW SUPPLIED

IMDUR Extended Release Tablets

30 mg: rose-colored tablets, scored on both sides and branded with the tradename ("IMDUR") on one side and the strength on the other.

Bottles of 100                                          NDC 0085-3306-03
Unit Dose 100 (10 × 10 blister strips)      NDC 0085-3306-01

60 mg: yellow-colored tablets, scored on both sides and branded with the tradename ("IMDUR") on one side and the strength on the other.

Bottles of 100                                          NDC 0085-4110-03
Unit Dose 100 (10 × 10 blister strips)      NDC 0085-4110-01

120 mg: white-colored tablets, branded with the tradename ("IMDUR") on one side and the strength on the other.

Bottles of 100                                          NDC 0085-1153-03
Unit Dose 100 (10 × 10 blister strips)      NDC 0085-1153-04

Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]

Protect unit dose from excessive moisture.

Manufactured for Key Pharmaceuticals, Inc., Kenilworth, NJ 07033 by AstraZeneca PLC, Sweden.
Copyright © 1993, 1996, 1997, 1998, 2002, Key Pharmaceuticals, Inc. All rights reserved.
Rev. 9/03
18692961T