ISOSORBIDE- isosorbide dinitrate tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

State of Florida DOH Central Pharmacy

INN (Kansainvälinen yleisnimi):

ISOSORBIDE DINITRATE

Koostumus:

ISOSORBIDE DINITRATE 10 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 ISDN 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 ISDN 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. They are supplied by State of Florida DOH Central Pharmacy as follows: 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: West-ward Pharmaceutical Corp. Eatontown, NJ 07724 This Product was Repackaged By: State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

ISOSORBIDE - ISOSORBIDE DINITRATE TABLET
STATE OF FLORIDA DOH CENTRAL PHARMACY
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ISOSORBIDE DINITRATE TABLETS, USP (ORAL)
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.
ISDN 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). ISDN 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
ISDN.
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 ISDN 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 lesistance, 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-