ISOSORBIDE MONONITRATE tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

isosorbide mononitrate (UNII: LX1OH63030) (isosorbide mononitrate - UNII:LX1OH63030)

Tilgængelig fra:

Physicians Total Care, Inc.

INN (International Name):

isosorbide mononitrate

Sammensætning:

isosorbide mononitrate 10 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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. Allergic reactions to organic nitrates are extremely rare, but they do occur. Isosorbide mononitrate is contraindicated in patients who are allergic to it.

Produkt oversigt:

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: Store at 20° - 30°C (68° - 86°F) [See USP]. Keep tightly closed.

Autorisation status:

New Drug Application Authorized Generic

Produktets egenskaber

ISOSORBIDE MONONITRATE - ISOSORBIDE MONONITRATE TABLET
PHYSICIANS TOTAL CARE, INC.
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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