ISOSORBIDE DINITRATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cardinal Health 107, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Isosorbide Dinitrate Tablets, USP 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 other 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.

Product summary:

Isosorbide Dinitrate Tablets, USP 10 mg: White, Round, Scored Tablets Debossed “WW” on one side and “771” on the other side. Overbagged with 10 tablets per bag, NDC 55154-7990-0 Isosorbide Dinitrate Tablets, USP 20 mg: Green, Round, Scored Tablets Debossed “WW” on one side and “772” on the other side. Overbagged with 10 tablets per bag, NDC 55154-7991-0 Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Manufactured by: HIKMA Pharmaceuticals P.O. Box 182400 Amman 11118 – Jordan Distributed by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724 USA Distributed by: Cardinal Health Dublin, OH 43017 L55014810224 L55014990224 Revised October 2019

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ISOSORBIDE DINITRATE- ISOSORBIDE DINITRATE TABLET
CARDINAL HEALTH 107, LLC
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ISOSORBIDE DINITRATE
TABLETS, USP
REV. 10/19
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, 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.
Each Isosorbide Dinitrate Tablet, USP contains 5 mg, 10 mg, or 20 mg
of isosorbide
dinitrate.
Inactive ingredients are as follows:
5 MG AND 10 MG: Ammonium phosphate dibasic, anhydrous lactose,
magnesium
stearate, microcrystalline cellulose, sodium starch glycolate.
20 MG: Ammonium phosphate dibasic, anhydrous lactose, D&C Yellow No.
10 Lake,
FD&C Blue No. 1 Lake, FD&C Yellow No. 6 Lake, magnesium stearate,
microcrystalline
cellulose, sodium starch glycolate.
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 concentrati