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:

Accord Healthcare Inc.

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, uncoated, oval, biconvex tablets with breakline on one side and debossed with ‘FY1’ on the other side. They are supplied as follows: Bottles of 90 NDC           16729-396-15 Bottles of 100 NDC         16729-396-01 Bottles of 500 NDC         16729-396-16 Bottles of 1000 NDC       16729-396-17 Isosorbide mononitrate extended-release tablets, USP 60 mg having functional scoring are white to off-white, uncoated, capsule shaped, biconvex tablets with breakline on one side and debossed with ‘FY2’ on the other side. They are supplied as follows: Bottles of 90 NDC           16729-397-15 Bottles of 100 NDC         16729-397-01 Bottles of 500 NDC         16729-397-16 Bottles of 1000 NDC       16729-397-17 Isosorbide mononitrate extended-release tablets, USP 120 mg are white to off-white, uncoated, oval, biconvex tablets debossed with ‘FY3’ on one side and plain on the other side. They are supplied as follows: Bottles of 90 NDC           16729-398-15 Bottles of 100 NDC         16729-398-01 Bottles of 500 NDC         16729-398-16 Bottles of 1000 NDC       16729-398-17 Store at 20°C to 30°C (68°F to 86°F) [See USP]. Manufactured For: Accord Healthcare, Inc., 1009, Slater Road, Suite 210-B, Durham, NC 27703, USA Manufactured By: Intas Pharmaceuticals Limited, Plot No 5 to 14, Pharmez, Sarkhej-Bavla, National Highway No 8-A, Near Village Matoda, Tal Sanand, Ahmedabad - 382 213, Gujarat, India 51 1074 0 711382 Issued July 2018

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ISOSORBIDE MONONITRATE- ISOSORBIDE MONONITRATE TABLET, EXTENDED
RELEASE
ACCORD HEALTHCARE INC.
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ISOSORBIDE MONONITRATE EXTENDED-RELEASE TABLETS
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: lactose monohydrate,
microcrystalline
cellulose, hydroxy propyl methyl cellulose, hydrogenated castor oil,
talc, colloidal
anhydrous silica, 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 +144° (2%
in water, 20°C).
Isosorbide mononitrate is freely soluble in water, ethanol, methanol,
chloroform, ethyl
acetate, and dichloromethane.
Dissolution method pending.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
The isosorbide mononitrate extended-release tablet is an oral
extended-release
formulation of ISMN, the major active metabolite of isosorbide
dinitrate; most of the
6
9
6
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 arterial