Drug Catalog - Product Detail
ISOSORBIDE MONONITRATE ER TABS 60 MG 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00143-2260-01 | HIKMA | 100 | 60MG | TABLET |
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Description
DESCRIPTION Isosorbide mononitrate (ISMN), an organic nitrate and the major biologically active metabolite of isosorbide dinitrate (ISDN), is a vasodilator with effects on both arteries and veins. Isosorbide Mononitrate Extended-Release Tablets, USP, for oral administration, contain 30 mg or 60 mg of isosorbide mononitrate in an extended-release formulation. In addition, each tablet contains the following inactive ingredients: ammonium phosphate dibasic, anhydrous lactose, carnauba wax, colloidal silicon dioxide, magnesium stearate, and synthetic paraffin wax. Film coating and polishing solution contains: hypromellose, polyethylene glycol, red iron oxide (30 mg tablet only), titanium dioxide, and yellow iron oxide (60 mg tablet only). The chemical name for ISMN is 1,4:3,6-dianhydro-, D-glucitol 5-nitrate; the compound has the following structural formula: ISMN is a white, crystalline, odorless compound which is stable in air and in solution, has a melting point of about 90°C, and an optical rotation of +144° (2% in water, 20°C). Isosorbide mononitrate is freely soluble in water, ethanol, methanol, chloroform, ethyl acetate, and dichloromethane. This drug product meets USP Dissolution Test No. 3. Structural Formula
How Supplied
HOW SUPPLIED Isosorbide Mononitrate Extended-Release Tablets, 30 mg: Film-Coated Light Rose, Oval Tablets; Debossed "WW" on one Scored side and "30" on the other Scored side. Bottles of 100 tablets. Bottles of 500 tablets. Bottles of 1000 tablets. Isosorbide Mononitrate Extended-Release Tablets, 60 mg: Film-Coated Light Yellow, Oval Tablets; Debossed "WW" on one Scored side and "60" on the other Scored side. Bottles of 100 tablets. Bottles of 500 tablets. Bottles of 1000 tablets. Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724 Revised May 2016
Indications & Usage
INDICATIONS AND USAGE Isosorbide Mononitrate Extended-Release Tablets, USP 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
DOSAGE AND ADMINISTRATION The recommended starting dose of Isosorbide Mononitrate Extended-Release Tablets, USP is 30 mg (given as a single 30 mg tablet or as 1/2 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 Tablets should be taken in the morning on arising. Isosorbide Mononitrate Extended-Release Tablets, USP should not be chewed or crushed and should be swallowed together with a half-glassful of fluid.