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:

Major Pharmaceuticals

INN (International Name):

ISOSORBIDE MONONITRATE

Composition:

ISOSORBIDE MONONITRATE 30 mg

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 30 mg are white to off-white, oval shaped, film coated tablets having breakline on one side and debossed ‘3-0’ across breakline and ‘1104’ on other side. They are supplied as follows: Cartons of 100 tablets (10 tablets each blister pack x 10), NDC 0904-6449-61 Isosorbide mononitrate extended-release tablets, USP 60 mg are white to off-white, oval shaped, film coated tablets having breakline on one side and ‘60-60’ debossing across breakline and ‘1105’ on the other side. Cartons of 100 tablets (10 tablets each blister pack x 10), NDC 0904-6450-61 Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature] Manufactured by: TORRENT PHARMACEUTICALS LTD., INDIA. Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. Packaged and Distributed By: MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 USA Refer to package label for Distributor's NDC Number 8093911                                                                                             Revised: August 2023

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ISOSORBIDE MONONITRATE- ISOSORBIDE MONONITRATE TABLET, EXTENDED
RELEASE
MAJOR PHARMACEUTICALS
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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 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: colloidal silicon
dioxide, diethyl phthalate,
hydrogenated castor oil, hydroxypropyl cellulose, hypromellose,
lactose monohydrate,
magnesium stearate, microcrystalline cellulose, talc and titanium
dioxide.
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.
For 30 mg: Meets USP Dissolution Test 6.
For 60 mg and 120 mg: Meets USP Dissolution Test 1.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
6
9
6
The isosorbide mononitrate extended-release tablet 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 (