ISOSORBIDE MONONITRATE tablet, extended release

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

A-S Medication Solutions

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Isosorbide mononitrate extended-release tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode. Isosorbide mononitrate extended-release tablets are contraindicated in patients who have shown hypersensitivity or idiosyncratic reactions to other nitrates or nitrites.

Dettagli prodotto:

Product: 50090-5572 NDC: 50090-5572-0 30 TABLET, EXTENDED RELEASE in a BOTTLE NDC: 50090-5572-1 100 TABLET, EXTENDED RELEASE in a BOTTLE NDC: 50090-5572-2 90 TABLET, EXTENDED RELEASE in a BOTTLE

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

ISOSORBIDE MONONITRATE- ISOSORBIDE MONONITRATE TABLET, EXTENDED
RELEASE
A-S MEDICATION SOLUTIONS
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ISOSORBIDE MONONITRATE EXTENDED-RELEASE TABLETS, USP
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.
Isosorbide mononitrate tablets contain either 30 mg, 60 mg or 120 mg
of isosorbide
mononitrate in an extended-release formulation. In addition, each
tablet contains the
following inactive ingredients: microcrystalline cellulose,
hydroxypropyl cellulose,
hypromellose, colloidal silicon dioxide, lactose monohydrate and
magnesium stearate.
The molecular formula of ISMN is C H NO and the molecular weight is
191.14. 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 +140° to
146° (2% in water,
20°C).
Isosorbide mononitrate is freely soluble in water, acetic acid,
alcohol, acetone and ethyl
acetate; soluble in ether and chloroform, slightly soluble in toluene;
practically insoluble in
aliphatic hydrocarbons.
_Isosorbide mononitrate extended-release tablets, USP meets USP
Dissolution Test 8._
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Isosorbide mononitrate extended-release tablet are 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
6
9
6
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 wed