Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
ISOSORBIDE MONONITRATE (UNII: LX1OH63030) (ISOSORBIDE MONONITRATE - UNII:LX1OH63030)
REMEDYREPACK INC.
ISOSORBIDE MONONITRATE
ISOSORBIDE MONONITRATE 30 mg
ORAL
PRESCRIPTION DRUG
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. Isosorbide mononitrate extended-release tablets are contraindicated in patients who have shown hypersensitivity or idiosyncratic reactions to other nitrates or nitrites.
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
Abbreviated New Drug Application
ISOSORBIDE MONONITRATE- ISOSORBIDE MONONITRATE TABLET REMEDYREPACK INC. ---------- ISOSORBIDE MONONITRATE EXTENDED-RELEASE TABLETS 30 MG, 60 MG, AND 120 MG RX ONLY 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 H NO 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. CLINICAL PHARMACOLOGY MECHANISM OF ACTION ISMN extended-release tablets are an oral extended-release formulation of ISMN, the major active metabolite of isosorbide dinitrate; most of the clinical activity of the dinitrate is attributable to the mononitrate. The principal pharmacological action of ISMN and all organic nitrates in general is relaxation of vascular smooth muscle, producing dilatation of peripheral arteries and veins, especially the latter. Dilatation of the veins promotes peripheral pooling of blood, decreases venous return to the heart, thereby reducing left ventricular end-diastolic pres Citiți documentul complet