ISOSORBIDE MONONITRATE tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

REMEDYREPACK INC.

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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 samenvatting:

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: NDC: 70518-2000-00 NDC: 70518-2000-01 PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 90 in 1 BOTTLE PLASTIC Store at 20° - 30°C (68° - 86°F) [See USP]. Keep tightly closed. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Autorisatie-status:

New Drug Application Authorized Generic

Productkenmerken

ISOSORBIDE MONONITRATE- ISOSORBIDE MONONITRATE TABLET
REMEDYREPACK 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.
6
9
6
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