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:

Par Pharmaceutical, 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 tablets are contraindicated in patients who are allergic to isosorbide dinitrate or any of its ingredients. Do not use isosorbide dinitrate tablets 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 tablets 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: 40 mg, light green round tablets debossed “par 556” on one side and bisect (functional scoring) on the other side. NDC 49884-556-01, bottles of 100. NDC 49884-556-10, bottles of 1,000. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].   Protect from light.   Keep bottles tightly closed.   Dispense in a light-resistant, tight container. Dist. by: Par Pharmaceutical Chestnut Ridge, NY 10977 U.S.A. Mfg. by: Par Formulations Private Limited, 9/215, Pudupakkam, Kelambakkam - 603 103. Made in India Mfg.Lic.No.: TN00002121 OS556-01-74-01 Issued: 04/2019

Status de autorização:

Abbreviated New Drug Application

Características técnicas

ISOSORBIDE DINITRATE- ISOSORBIDE DINITRATE TABLET
PAR PHARMACEUTICAL, INC.
----------
ISOSORBIDE DINITRATE TABLETS, USP
RX ONLY
DESCRIPTION
Isosorbide dinitrate (ISDN) is 1,4:3,6-dianhydro-D-glucitol
2,5-dinitrate, an organic nitrate
whose structural formula is
and whose molecular weight is 236.14. The organic nitrates are
vasodilators, active on
both arteries and veins.
Isosorbide dinitrate is a white, crystalline powder which is stable in
air and in solution,
has a melting point of 69° to 72°C and has an optical rotation of
+140° (c=1.0, alcohol,
20°C). Isosorbide dinitrate is very slightly soluble in water, very
soluble in acetone,
sparingly soluble in alcohol.
Each Isosorbide Dinitrate Tablet, USP contains 40 mg of isosorbide
dinitrate. The inactive
ingredients in each tablet are anhydrous lactose, D&C yellow #10
aluminum lake, FD&C
blue #1/brilliant blue FCF aluminum lake, FD&C yellow #6/sunset yellow
FCF aluminum
lake, magnesium stearate, microcrystalline cellulose.
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.
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 anti-anginal efficacy of
continuously-delivered
nitrat