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:

NCS HealthCare of KY, Inc dba Vangard Labs

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 Tablets are contraindicated in patients who have shown hypersensitivity or idiosyncratic reactions to other nitrates or nitrites.

Product summary:

Isosorbide Mononitrate Extended-Release Tablets, 30 mg: Film coated light rose, oval tablet; embossed “WW” on one scored side and "30" on the other scored side. Isosorbide Mononitrate Extended-Release Tablets, 60 mg: Film coated light yellow, oval tablet; embossed “WW” on one scored side and "60" on the other scored side. 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. Manufactured by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724 Revised February 2012

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ISOSORBIDE MONONITRATE- ISOSORBIDE MONONITRATE TABLET, FILM COATED,
EXTENDED RELEASE
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
----------
ISOSORBIDE MONONITRATE ER
REV. 02/12
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, 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