Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
ISOSORBIDE MONONITRATE (UNII: LX1OH63030) (ISOSORBIDE MONONITRATE - UNII:LX1OH63030)
Aurobindo Pharma Limited
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 isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal 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 Tablets USP, 30 mg are White to off-white in color, biconvex oval shaped, uncoated tablet, debossed with “3” and “0” on either side of score line on one side and “ISON” on the other side. They are supplied as follows: Bottles of 100 NDC 59651-539-01 Bottles of 500 NDC 59651-539-05 Isosorbide Mononitrate Extended-Release Tablets USP, 60 mg are White to off-white in color, biconvex capsule shaped, uncoated tablet, debossed with “6” and “0” on either side of score line on one side and “ISON” on the other side. They are supplied as follows: Bottles of 100 NDC 59651-540-01 Bottles of 500 NDC 59651-540-05 Isosorbide Mononitrate Extended-Release Tablets USP, 120 mg are White to off-white in color, biconvex oval shaped, uncoated tablet, debossed with “ISON” on one side and “120” on the other side. They are supplied as follows: Bottles of 100 NDC 59651-541-01 Store at 20° to 30°C (68° to 86°F) [See USP Controlled Room Temperature]. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Issued: June 2022
Abbreviated New Drug Application
ISOSORBIDE MONONITRATE - ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE AUROBINDO PHARMA LIMITED ---------- ISOSORBIDE MONONITRATE EXTENDED-RELEASE TABLETS, USP 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 tablet, for oral administration, contains either 30 mg, 60 mg or 120 mg of isosorbide mononitrate in an extended-release formulation. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The molecular formula of isosorbide mononitrate is C H NO and the molecular weight is 191.14. The chemical name for isosorbide mononitrate is 1,4:3,6-dianhydro-,D-glucitol 5- nitrate; the compound has the following structural formula: Isosorbide mononitrate is a white needle crystal or crystalline powder which is stable in air and in solution, has a melting point of about 90°C, and a specific rotation of +170° to +176° Isosorbide mononitrate is freely soluble in methanol or acetone, soluble in water or chloroform, and practically insoluble in hexane. FDA approved dissolution test specifications differs from USP. 6 9 6 CLINICAL PHARMACOLOGY MECHANISM OF ACTION The isosorbide mononitrate extended-release tablet is 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 pressure and pulmonary capillary wedge pressure (preload). Arteriolar relaxatio Lesen Sie das vollständige Dokument