Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
ISOSORBIDE MONONITRATE (UNII: LX1OH63030) (ISOSORBIDE MONONITRATE - UNII:LX1OH63030)
Ingenus Pharmaceuticals, LLC
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, uncoated, oval shaped tablets debossed with 'ING 175' one side and scored on the other side. They are supplied as follows: Bottles of 100 NDC 50742-175-01 Bottles of 500 NDC 50742-175-05 Isosorbide Mononitrate Extended-Release Tablets USP, 60 mg are white to off-white, uncoated, capsule shaped tablets debossed with 'ING 176' one side and scored on the other side. They are supplied as follows: Bottles of 100 NDC 50742-176-01 Bottles of 500 NDC 50742-176-05 Isosorbide Mononitrate Extended-Release Tablets USP, 120 mg are white to off-white, uncoated, oval shaped tablets debossed with 'ING 177' one side and plain on the other side. They are supplied as follows: Bottles of 100 NDC 50742-177-01 Store at 20o -30o C (68o -86o F) [See USP Controlled Room Temperature]. Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32811-7193 Made in India DRUGS/TS/23/2007 Rev.: 09/2023
Abbreviated New Drug Application
ISOSORBIDE MONONITRATE- ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE INGENUS PHARMACEUTICALS, LLC ---------- ISOSORBIDE MONONITRATE EXTENDED-RELEASE TABLETS, USP 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 tablets contain 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: microcrystalline cellulose, hydroxypropyl cellulose, hypromellose, colloidal silicon dioxide, lactose monohydrate and magnesium stearate. 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 +140° to 146° (2% in water, 20°C). Isosorbide mononitrate is freely soluble in water, acetic acid, alcohol, acetone and ethyl acetate; soluble in ether and chloroform, slightly soluble in toluene; practically insoluble in aliphatic hydrocarbons. _Isosorbide mononitrate extended-release tablets, USP meets USP Dissolution Test 8._ CLINICAL PHARMACOLOGY MECHANISM OF ACTION Isosorbide mononitrate extended-release tablet 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 6 9 6 relaxation of vascular smooth muscle, producing dilatation of peripheral arteries and veins, especially the latter. Dilatation of the veins promotes peripheral pooling of blood and decreases venous return to the heart, thereby reducing left ventricular end-diastolic pressure and pulmonary capillary Izlasiet visu dokumentu