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:

Aurobindo Pharma Limited

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 in color, biconvex oval shaped, uncoated tablet, debossed with “3” and “0” on either side of score line on one side and “ISON” on the other side. They are supplied as follows: Bottles of 100                                           NDC 59651-539-01 Bottles of 500                                           NDC 59651-539-05 Isosorbide Mononitrate Extended-Release Tablets USP, 60 mg are White to off-white in color, biconvex capsule shaped, uncoated tablet, debossed with “6” and “0” on either side of score line on one side and “ISON” on the other side. They are supplied as follows: Bottles of 100                                            NDC 59651-540-01 Bottles of 500                                            NDC 59651-540-05 Isosorbide Mononitrate Extended-Release Tablets USP, 120 mg are White to off-white in color, biconvex oval shaped, uncoated tablet, debossed with “ISON” on one side and “120” on the other side. They are supplied as follows: Bottles of 100                                            NDC 59651-541-01 Store at 20° to 30°C (68° to 86°F) [See USP Controlled Room Temperature]. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Issued: June 2022

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ISOSORBIDE MONONITRATE - ISOSORBIDE MONONITRATE TABLET, EXTENDED
RELEASE
AUROBINDO PHARMA LIMITED
----------
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, hydrogenated castor
oil, hypromellose, lactose monohydrate, magnesium stearate and
microcrystalline
cellulose.
The molecular formula of isosorbide mononitrate is C H NO and the
molecular weight is
191.14. The chemical name for isosorbide mononitrate is
1,4:3,6-dianhydro-,D-glucitol 5-
nitrate; the compound has the following structural formula:
Isosorbide mononitrate is a white needle crystal or crystalline powder
which is stable in
air and in solution, has a melting point of about 90°C, and a
specific rotation of +170° to
+176°
Isosorbide mononitrate is freely soluble in methanol or acetone,
soluble in water or
chloroform, and practically insoluble in hexane.
FDA approved dissolution test specifications differs from USP.
6
9
6
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
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
relaxatio