ISOSORBIDE DINITRATE tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

BluePoint Laboratories

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 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.

Produkt oppsummering:

Isosorbide dinitrate tablets, USP are available as follows: Isosorbide dinitrate tablets USP, 30 mg, light blue to blue colored, spotted, round shaped, biconvex, uncoated tablets debossed with "1151" on one side and score on other side. NDC 68001-562-00 in bottles of 100 tablets with child-resistant closure Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from Light. Dispense in a light-resistant, tight container. Keep bottles tightly closed. Manufactured by: Zydus Lifesciences Ltd., Baddi, India For Bluepoint Laboratories Rev. 11/22

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

ISOSORBIDE DINITRATE- ISOSORBIDE DINITRATE TABLET
BLUEPOINT LABORATORIES
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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 compound, has a melting
point of 70°C and
has an optical rotation of +140° (c=1, alcohol, 20°C). Isosorbide
dinitrate is very slightly
soluble in water; very soluble in acetone and sparingly soluble in
alcohol.
Each isosorbide dinitrate tablet, USP contains 30 mg of isosorbide
dinitrate. The inactive
ingredients in each tablet are lactose monohydrate, magnesium
stearate,
microcrystalline cellulose, povidone, sodium starch glycolate and FD&C
blue no. 1
aluminium lake.
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
nitrates. In the large majority of these trials, active agents were no
more effective than
placebo after