ISOSORRBIDE DINITRATE- isosorbdie dinitrate tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

West-ward Pharmaceutical Corp

DCI (Dénomination commune internationale):

ISOSORBIDE DINITRATE

Composition:

ISOSORBIDE DINITRATE 30 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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. 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

Descriptif du produit:

Isosorbide Dinitrate Tablets, USP (Oral) 30 mg: Blue, Round, Scored Tablets; Debossed “WW 773” on Scored side. Bottles of 30 tablets. Bottles of 100 tablets. Bottles of 500 tablets. Bottles of 1000 tablets. Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. 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. Also available: Isosorbide Dinitrate Oral Tablets in the following dosage strengths: 5 mg: in bottles of 100, 500, 1000 or unit dose boxes of 100 tablets. 10 mg: in bottles of 100, 500, 1000 or unit dose boxes of 100 tablets. 20 mg: in bottles of 100, 1000 or unit dose boxes of 100 tablets. Manufactured by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724 Revised December 2010

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

ISOSORRBIDE DINITRATE- ISOSORBDIE DINITRATE TABLET
WEST-WARD PHARMACEUTICAL CORP
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ISOSORBIDE DINITRATE TABLETS
DESCRIPTION
Isosorbide dinitrate (ISDN) is 1,4:3,6-dianhydro-D-glucitol
2,5-dinitrate, an organic nitrate whose
structural formula is:
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). Isosorbidedinitrate
is freely soluble in organic solvents such as acetone, alcohol, and,
but is only sparingly soluble in
water.
Each isosorbide dinitrate tablet contains 30 mg of ISDN.
Inactive ingredients are as follows: Ammonium Phosphate Dibasic,
Colloidal Silicon Dioxide, FD&C
Blue No. 1 Aluminum Lake, Lactose Monohydrate, Magnesium Stearate and
Microcrystalline Cellulose.
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 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 strategy is inappropriate for
organic nitrates. Several well-controlled clinical trials have used
exercise testing to assess the anti-
anginal efficacy of continuously-delivered nitrates. In the large
majority of these trials, active agents
were no more effective than placebo after 24 hours (or less) of
continuous therapy.Attempts to
overcome nitrate toler