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Ismo

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Ismo

Ismo

INDICATIONS

Ismo (isosorbide mononitrate) 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

(SEE INDICATIONS AND USAGE)

The recommended regimen of Ismo (isosorbide mononitrate) tablets is 20 mg (one tablet) twice daily, with the two doses given 7 hours apart. For most patients, this can be accomplished by taking the first dose on awakening and the second dose 7 hours later. Dosage adjustments are not necessary for elderly patients or patients with altered renal or hepatic function. As noted above (CLINICAL PHARMACOLOGY), multiple studies of organic nitrates have shown that maintenance of continuous 24-hour plasma levels results in refractory tolerance. The dosing regimen for Ismo (isosorbide mononitrate) tablets provides a daily nitrate-free interval to avoid the development of this tolerance. As also noted under CLINICAL PHARMACOLOGY, well-controlled studies have shown that tolerance to Ismo (isosorbide mononitrate) tablets is avoided when using the twice-daily regimen in which the two doses are given 7 hours apart. This regimen has been shown to have antianginal efficacy beginning 1 hour after the first dose and lasting at least 5 hours after the second dose. The duration (if any) of antianginal activity beyond 12 hours has not been studied; large controlled studies with other nitrates suggest that no dosing regimen should be expected to provide more than about 12 hours of continuous antianginal efficacy per day.

In clinical trials, Ismo (isosorbide mononitrate) tablets have been administered in a variety of regimens. Single doses less than 20 mg have not been adequately studied, while single doses greater than 20 mg have demonstrated no greater efficacy than doses of 20 mg.

HOW SUPPLIED

Ismo (isosorbide mononitrate) tablets, 20 mg, are available in bottles of 100 (NDC 67857-702-01). Each orange, round, film-coated tablet is engraved "ISMO (isosorbide mononitrate) 20" on one side and scored on the reverse side.

Store at 20 - 25° C (68 -77° F) [See USP Controlled Room Temperature]. Dispense in tight container.

Manufactured by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724. Manufactured for: Reddy Pharmaceuticals, LLC. Bridgewater, NJ 08807

Last reviewed on RxList: 4/13/2009
This monograph has been modified to include the generic and brand name in many instances.

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