ISOSORBIDE MONONITRATE tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Actavis Pharma, Inc.

Designació comuna internacional (DCI):

ISOSORBIDE MONONITRATE

Composición:

ISOSORBIDE MONONITRATE 10 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Isosorbide mononitrate tablets, USP 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.

Resumen del producto:

Isosorbide mononitrate tablets, USP are available as follows: 10 mg — Each blue, round, tablet imprinted with and 631 on one side and scored on the other side, contains 10 mg of isosorbide mononitrate (diluted), USP. Tablets are supplied in bottles of 100 (NDC 0228-2631-11). 20 mg — Each blue, round, tablet imprinted with and 620 on one side and scored on the other side, contains 20 mg of isosorbide mononitrate (diluted), USP. Tablets are supplied in bottles of 100 (NDC 0228-2620-11). Dispense in tight containers as defined in the USP. Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF). Keep tightly closed. Manufactured In Bulgaria By: Balkanpharma - Dupnitsa AD Dupnitsa 2600, Bulgaria Manufactured For:  Teva Pharmaceuticals Parsippany, NJ 07054 Rev. A 10/2022

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

ISOSORBIDE MONONITRATE- ISOSORBIDE MONONITRATE TABLET
ACTAVIS PHARMA, INC.
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ISOSORBIDE MONONITRATE TABLETS, USP
RX ONLY
DESCRIPTION
Isosorbide mononitrate (diluted), USP, an organic nitrate, is a
vasodilator with effects on
both arteries and veins. The molecular 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, for oral administration, contain
10 mg or 20 mg of
isosorbide mononitrate (diluted), USP. In addition, each tablet
contains the following
inactive ingredients: calcium stearate, colloidal silicon dioxide,
corn starch, FD&C Blue #1
HT Aluminum Lake, lactose monohydrate, microcrystalline cellulose, and
talc.
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).
Dilation 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-