البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
ISOSORBIDE MONONITRATE (UNII: LX1OH63030) (ISOSORBIDE MONONITRATE - UNII:LX1OH63030)
Lannett Company, Inc.
ISOSORBIDE MONONITRATE
ISOSORBIDE MONONITRATE 10 mg
ORAL
PRESCRIPTION DRUG
monoket® is indicated for the prevention and treatment 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 is contraindicated in patients who are allergic to it. Do not use monoket® in patients who are taking certain drugs for erectile dysfunction (phosphodiesterase inhibitors), such as sildenafil, tadalafil, or vardenafil. Concomitant use can cause severe hypotension, syncope, or myocardial ischemia. Do not use monoket® in patients who are taking the soluble guanylate cyclase stimulator riociguat. Concomitant use can cause hypotension.
monoket® (isosorbide mononitrate tablets, USP), 10 mg are white, round, scored and engraved "10" on one side and engraved "SCHWARZ 610" on the other. They are supplied as follows: monoket® (isosorbide mononitrate tablets, USP), 20 mg are white, round, scored and engraved "20" on one side and engraved "SCHWARZ 620" on the other. They are supplied as follows: Store at controlled room temperature 20°-30°C (68°-86°F) [See USP]. Keep tightly closed.
New Drug Application
MONOKET- ISOSORBIDE MONONITRATE TABLET LANNETT COMPANY, INC. ---------- MONOKET (ISOSORBIDE MONONITRATE TABLETS, USP) RX ONLY DESCRIPTION monoket , an organic nitrate, is a vasodilator with effects on both arteries and veins. The empirical formula is C H NO and the molecular weight is 191.14. The chemical name for monoket is 1,4:3,6- Dianhydro-D-glucitol 5-nitrate and the compound has the following structural formula: monoket is available in 10 mg and 20 mg tablets. Each tablet also contains as inactive ingredients: lactose, talc, colloidal silicon dioxide, starch, microcrystalline cellulose and aluminum stearate. CLINICAL PHARMACOLOGY Isosorbide mononitrate is the major active metabolite of isosorbide dinitrate (ISDN), and most of the clinical activity of the dinitrate is attributable to the mononitrate. The principal pharmacological action of isosorbide mononitrate is relaxation of vascular smooth muscle and consequent dilatation of peripheral arteries and veins, especially the latter. Dilation 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 wedge pressure (preload). Arteriolar relaxation reduces systemic vascular resistance, systolic arterial pressure, and mean arterial pressure (afterload). Dilatation of the coronary arteries also occurs. The relative importance of preload reduction, afterload reduction and coronary dilatation remains undefined. PHARMACODYNAMICS Dosing regimens for most chronically used drugs are designed to provide plasma concentrations that are continuously greater than a minimally effective concentration. This strategy is inappropriate for organic nitrates. Several well-controlled clinical trials have used exercise testing to assess the antianginal efficacy of continuously-delivered nitrates. In the large majority of these trials, active agents were indistinguishable from placebo after 24 hours (or less) of continuous therapy. Attempts to overcome tolerance by dose e اقرأ الوثيقة كاملة