ISOSORBIDE- isosorbide mononitrate tablet, film coated, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Carilion Materials Management

INN (International Name):

ISOSORBIDE MONONITRATE

Composition:

ISOSORBIDE MONONITRATE 30 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Isosorbide Mononitrate Extended-Release Tablets, USP 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.

Product summary:

Product: 68151-1418 NDC: 68151-1418-0 1 TABLET, FILM COATED, EXTENDED RELEASE in a PACKAGE

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ISOSORBIDE- ISOSORBIDE MONONITRATE TABLET, FILM COATED, EXTENDED
RELEASE
CARILION MATERIALS MANAGEMENT
----------
ISOSORBIDE MONONITRATE ER TABLETS
ISOSORBIDE MONONITRATE
EXTENDED-RELEASE
TABLETS, USP
REV. 05/16
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.
Isosorbide Mononitrate Extended-Release Tablets, USP, for oral
administration, contain 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, hypromellose, 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 the USP Dissolution Test No.
3.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION:
The Isosorbide Mononitrate Extended-Release Tablets, USP 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 hear