ISOSORBIDE MONONITRATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ISOSORBIDE MONONITRATE (UNII: LX1OH63030) (ISOSORBIDE MONONITRATE - UNII:LX1OH63030)

Available from:

Lannett Company, Inc.

INN (International Name):

ISOSORBIDE MONONITRATE

Composition:

ISOSORBIDE MONONITRATE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Isosorbide Mononitrate Tablets are 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 isosorbide mononitrate 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 isosorbide mononitrate in patients who are taking the soluble guanylate cyclase stimulator riociguat. Concomitant use can cause hypotension.

Product summary:

Isosorbide Mononitrate 10 mg Tablets, USP are white, round, scored and engraved "10" on one side and engraved "KU 106" on the other. They are supplied as follows:      Bottles of 100        NDC 62175-106-01 Isosorbide Mononitrate 20 mg Tablets, USP are white, round, scored and engraved "20" on one side and engraved "KU 107" on the other. They are supplied as follows:      Bottles of 100        NDC 62175-107-01 Store at 20° - 30°C (68° - 86°F) [See USP]. Keep tightly closed. Distributed by: Lannett Company, Inc. Philadelphia, PA 19136 CIA71194G Rev. 06/20

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

ISOSORBIDE MONONITRATE- ISOSORBIDE MONONITRATE TABLET
LANNETT COMPANY, INC.
----------
ISOSORBIDE MONONITRATE TABLETS, USP
RX ONLY
DESCRIPTION:
Isosorbide mononitrate, 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 isosorbide
mononitrate is 1,4:3,6-Dianhydro-D-glucitol 5-nitrate and the compound
has the following structural
formula:
Isosorbide Mononitrate Tablets, USP are available as 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 le