ISOSORBIDE- 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:

BluePoint Laboratories

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 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 5 mg: White, Round, Scored Tablets Debossed "West-ward 769". NDC 68001-373-00 Bottles of 100 Isosorbide Dinitrate Tablets, USP 10 mg: White, Round, Scored Tablets Debossed "WW" on one side and "771" on the other side. NDC 68001-374-00 Bottles of 100 Isosorbide Dinitrate Tablets, USP 20 mg: Green, Round, Scored Tablets Debossed "WW" on one side and "772" on the other side. NDC 68001-375-00 Bottles of 100 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 For BluePoint Laboratories

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ISOSORBIDE- ISOSORBIDE DINITRATE TABLET
BLUEPOINT LABORATORIES
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ISOSORBIDE DINITRATE TABLETS, USP
Rev 10/08
R 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
X
are continuously greater than a minimally effective concentration.
This stra