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.

Immediate Release Tablets

The recommended regimen of isosorbide mononitrate tablets is 20 mg (one tablet) twice daily, with the two doses given seven 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 in 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 isosorbide mononitrate tablets provides a daily nitrate-free interval to avoid the development of this tolerance.

As also noted in CLINICAL PHARMACOLOGY, well-controlled studies have shown that tolerance to isosorbide mononitrate tablets is avoided when using the twice-daily regimen in which the two doses are given seven hours apart. This regimen has been shown to have antianginal efficacy beginning one hour after the first dose and lasting at least five hours after the second dose. The duration (if any) of antianginal activity beyond twelve hours has not been studied; large controlled studies with other nitrates suggest that no dosing regimen should be expected to provide more than about twelve hours of continuous antianginal efficacy per day.

In clinical trials, 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.

Extended Release Tablets

The recommended starting dose of isosorbide mononitrate extended release 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 isosorbide mononitrate extended release tablets should be taken in the morning on arising. Isosorbide mononitrate extended release tablets should not be chewed or crushed and should be swallowed together with a half-glassful of fluid.

Ismo Tablets

Each 20 mg Ismo tablet is orange, round, film-coated and engraved with "ISMO 20" on one side and "W" on the reverse side.

Storage: Store at controlled room temperature between 15°C and 30°C (59°F and 86°F).

Dispense in tight container.

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.

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

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

Storage: Store between 2° and 30°C (36° and 86°F).

Protect unit dose from excessive moisture.

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