ISOSORBIDE- isosorbide dinitrate tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

ISOSORBIDE DINITRATE (UNII: IA7306519N) (ISOSORBIDE - UNII:WXR179L51S)

Saatavilla:

Hikma Pharmaceutical

INN (Kansainvälinen yleisnimi):

ISOSORBIDE DINITRATE

Koostumus:

ISOSORBIDE DINITRATE 5 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Isosorbide dinitrate oral 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. Allergic reactions to organic nitrates are extremely rare, but they do occur. The isosorbide dinitrate tablet is contraindicated in patients who are allergic to isosorbide dinitrate or any of its other ingredients.

Tuoteyhteenveto:

Isosorbide Dinitrate Tablets USP (Oral) 5 mg: White, round, scored tablets imprinted "West-ward 769". Isosorbide Dinitrate Tablets USP (Oral) 10 mg: White, round, scored tablets imprinted "WW" on one side and "771" on the other side. Isosorbide Dinitrate Tablets USP (Oral) 20 mg: Green, round, scored tablet imprinted "WW" on one side and "772" on the other side. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Also available: Isosorbide Dinitrate Sublingual Tablets in the following dosage strengths: 2.5 mg; in bottles of 100, 1000 or unit dose boxes of 100 tablets. 5 mg; in bottles of 100, 1000 or unit dose boxes of 100 tablets. Manufactured by: Hikma Pharmaceuticals P.O. Box 182400, Amman 11118-Jordan Distributed by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724 Revised April 2008

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

ISOSORBIDE- ISOSORBIDE DINITRATE TABLET
HIKMA PHARMACEUTICAL
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ISOSORBIDE DINITRATE TABLETS, USP (ORAL)
Rev 04/08
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 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 concentration.
This strat