ISOSORBIDE DINITRATE tablet

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

REMEDYREPACK INC.

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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.

उत्पाद समीक्षा:

Isosorbide dinitrate tablets USP, 10 mg, white to off white colored, round shaped, biconvex, uncoated tablets debossed with "1149" on one side and score on other side. NDC: 70518-3637-00 PACKAGING: 30 in 1 BLISTER PACK 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. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

ISOSORBIDE DINITRATE- ISOSORBIDE DINITRATE TABLET
REMEDYREPACK INC.
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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 5 mg, 10 mg, 20 mg or
30 mg of
isosorbide dinitrate. The inactive ingredients in each tablet are
lactose monohydrate,
magnesium stearate, microcrystalline cellulose, povidone and sodium
starch glycolate.
The 5 mg dosage strength also contains FD&C red no. 40 aluminium lake.
The 20 mg
dosage strength also contains FD&C blue no. 1 aluminium lake and D&C
yellow no. 10
aluminium lake. The 30 mg dosage strength also contains FD&C blue no.
1 aluminium
lake.
FDA approved dissolution test specifications differ from USP.
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 con