Drug Catalog - Product Detail
ISOSORBIDE MONONIT ER TAB 60MG 500CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 68382-0651-05 | ZYDUS PHARMACEUTICALS (USA) | 500 | 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. Each Isosorbide mononitrate extended-release tablet, for oral administration contains 30 mg, 60 mg or 120 mg of ISMN. In addition, each tablet contains the following inactive ingredients: carnauba wax, colloidal silicon dioxide, ethylcellulose, hypromellose, lactose, magnesium stearate, polyethylene glycol, polysorbate 80, titanium dioxide. The 30 mg tablet also contains D&D Red No. 27 aluminum lake, D&C Red No. 30 aluminum lake, FD&C Blue No. 2 aluminum lake, and FD&C Yellow No. 6 aluminum lake. The 60 mg tablet also contains D&C Yellow No. 10 aluminum lake and FD&C Blue No. 2 aluminum lake. The molecular formula of ISMN is C 6 H 9 NO 6 and the molecular weight is 191.14. 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). ISMN is freely soluble in water, ethanol, methanol, chloroform, ethyl acetate, and dichloromethane. chemical structure
How Supplied
HOW SUPPLIED Isosorbide mononitrate extended-release 30 mg tablets are oval, reddish pink, film-coated tablets, debossed "N" bisect "30" on one side and bisect on the other side, packaged as follows: NDC 68382-650-01 bottle of 100 tablets NDC 68382-650-05 bottle of 500 tablets Isosorbide mononitrate extended-release 60 mg tablets are oval, yellow, film-coated tablets, debossed "N" bisect "60" on one side and bisect on the other side, packaged as follows: NDC 68382-651-01 bottle of 100 tablets NDC 68382-651-05 bottle of 500 tablets Isosorbide mononitrate extended-release 120 mg tablets are oval, white, film-coated tablets, debossed "N120" on one side, packaged as follows: NDC 68382-652-01 bottle of 100 tablets Store at 20° to 25°C (68° - 77°F). [See USP Controlled Room Temperature.] Protect from excessive moisture. Manufactured By: Nesher Pharmaceuticals USA LLC St. Louis, MO 63044 Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534
Indications & Usage
INDICATIONS AND USAGE Isosorbide mononitrate extended-release tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral ISMN is not sufficiently rapid for this product to be useful in aborting an acute angina episode.
Dosage and Administration
DOSAGE AND ADMINISTRATION The recommended starting dose of Isosorbide mononitrate extended-release tablets 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 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.