ISOSORBIDE DINITRATE tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

ISOSORBIDE DINITRATE (UNII: IA7306519N) (ISOSORBIDE DINITRATE - UNII:IA7306519N)

Disponível em:

REMEDYREPACK INC.

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Isosorbide dinitrate tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of immediate-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode. Isosorbide dinitrate is contraindicated in patients who are allergic to isosorbide dinitrate or any of its other ingredients. Do not use isosorbide dinitrate 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 dinitrate in patients who are taking the soluble guanylate cyclase stimulator riociguat. Concomitant use can cause hypotension.

Resumo do produto:

Isosorbide dinitrate tablets, USP are available as follows: 30 mg oral, blue, round, bisected tablets, debossed with "PAR 009" on one side and plain on the other side. NDC: 70518-2306-00 PACKAGING: 30 in 1 BLISTER PACK Store at room temperature, approximately 25°C (77°F). Protect from light. Keep bottles tightly closed. Dispense in a light-resistant, tight container. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Status de autorização:

Abbreviated New Drug Application

Características técnicas

ISOSORBIDE DINITRATE- ISOSORBIDE DINITRATE TABLET
REMEDYREPACK INC.
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ISOSORBIDE DINITRATE
DESCRIPTION
Isosorbide dinitrate, an organic nitrate, is a vasodilator with
effects on both arteries and
veins. The chemical name for isosorbide dinitrate is
1,4:3,6-dianhydro-D-glucitol 2, 5-
dinitrate. The compound has the following structural formula:
C
H
N
0
MW
236.14
Isosorbide dinitrate is a white, crystalline, odorless compound which
is stable in air and
in solution, has a melting point of 70°C and has an optical rotation
of +134° (c=1.0,
alcohol, 20°C). Isosorbide dinitrate is freely soluble in organic
solvents such as acetone,
alcohol, and ether, but is only sparingly soluble in water.
Isosorbide dinitrate tablets are available for oral administration as
5 mg, 10 mg, 20 mg,
or 30 mg tablets.
Each tablet contains the following inactive ingredients: lactose
anhydrous, magnesium
stearate, microcrystalline cellulose, sodium starch glycolate and
stearic acid. In addition,
the 20 mg tablet contains D&C Yellow #10, FD&C Blue #1, and FD&C
Yellow #6; the 30
mg tablet contains FD&C Blue #1.
CLINICAL PHARMACOLOGY
The principal pharmacological action of isosorbide dinitrate is
relaxation of vascular
smooth muscle and consequent dilatation of peripheral arteries and
veins, especially the
latter. Dilatation 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.
6
8
2
8
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
we