ISOSORBIDE MONONITRATE tablet, 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:

Shandong New Time Pharmaceutical Co., Ltd.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Isosorbide mononitrate extended-release tablets, USP 120 mg are off-white oval tablets, with one side debossed with “LN 2”, and the other side blank. They are supplied as follows: Bottles of 60 NDC 42677-307-01 Bottles of 600 NDC 42677-307-02 Store at 20° to 30°C (68° to 86°F) [See USP Controlled Room Temperature]. Manufactured by: Shandong New Time Pharmaceutical Co., Ltd., 1 North Outer Ring Road, Linyi, Shandong 273400, China LBL 115 Rev. 02/2022

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ISOSORBIDE MONONITRATE- ISOSORBIDE MONONITRATE TABLET, EXTENDED
RELEASE
SHANDONG NEW TIME PHARMACEUTICAL CO., LTD.
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ISOSORBIDE MONONITRATE EXTENDED-RELEASE TABLETS
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 120 mg of isosorbide
mononitrate in an
extended-release formulation. In addition, each tablet contains the
following inactive
ingredients: colloidal silicon dioxide, hydrogenated castor oil,
hypromellose, lactose
monohydrate, magnesium stearate and microcrystalline cellulose.
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 +144° (2%
in water, 20°C).
Isosorbide mononitrate is freely soluble in water, ethanol, methanol,
chloroform, ethyl
acetate, and dichloromethane.
FDA approved dissolution specifications differ from that of the USP.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
The isosorbide mononitrate extended-release tablet, USP 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,
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 ar