ISOSORBIDE MONONITRATE tablet film coated extended release

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

ISOSORBIDE MONONITRATE (UNII: LX1OH63030) (ISOSORBIDE MONONITRATE - UNII:LX1OH63030)

Disponible depuis:

McKesson Contract Packaging

DCI (Dénomination commune internationale):

ISOSORBIDE MONONITRATE

Composition:

ISOSORBIDE MONONITRATE 30 mg

Type d'ordonnance:

PRESCRIPTION DRUG

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

ISOSORBIDE MONONITRATE- ISOSORBIDE MONONITRATE TABLET, FILM COATED,
EXTENDED RELEASE
MCKESSON CONTRACT PACKAGING
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ISOSORBIDE MONONITRATE
EXTENDED-RELEASE
TABLETS, USP
RX ONLY
DESCRIPTION
Isosorbide mononitrate (ISMN), an organic nitrate and the major
biologically active metabolite of
isosorbide dinitrate (ISDN), is a vasodilator with effects on both
arteries and veins.
Each tablet, for oral administration, contains 30 mg or 60 mg of
isosorbide mononitrate in an extended-
release formulation. In addition, each tablet contains the following
inactive ingredients: ammonium
phosphate dibasic, anhydrous lactose, carnauba wax, colloidal silicon
dioxide, magnesium stearate, and
synthetic paraffin wax. Film coating and polishing solution contains:
hypromellose, polyethylene
glycol, red iron oxide (30 mg tablet only), titanium dioxide, and
yellow iron oxide (60 mg tablet only).
The chemical name for ISMN is 1,4:3,6-dianhydro-, D-glucitol
5-nitrate; the compound has the
following structural formula:
ISMN is a white, crystalline, odorless compound which is stable in air
and in solution, has a melting
point of about 90°C, and an optical rotation of +144° (2% in water,
20°C).
Isosorbide mononitrate is freely soluble in water, ethanol, methanol,
chloroform, ethyl acetate, and
dichloromethane. This drug product meets USP Dissolution Test No. 3.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
The Isosorbide Mononitrate product is an oral extended-release
formulation of ISMN, the major active
metabolite of isosorbide dinitrate; most of the clinical activity of
the dinitrate is attributable to the
mononitrate.
The principal pharmacological action of ISMN and all organic nitrates
in general is relaxation of
vascular smooth muscle, producing 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 r