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:

Aphena Pharma Solutions - Tennessee, LLC

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 shaped tablets debossed with 'ING 175' one side and scored on the other side. They are supplied as follows: Bottles of 100 NDC 51407-208-01 Bottles of 500 NDC 51407-208-05 Isosorbide Mononitrate Extended Release Tablets USP, 60 mg are white to off-white, uncoated, capsule shaped tablets debossed with 'ING 176' one side and scored on the other side. They are supplied as follows: Bottles of 100 NDC 51407-209-01 Bottles of 500 NDC 51407-209-05 Isosorbide Mononitrate Extended Release Tablets USP, 120 mg are white to off-white, uncoated, oval shaped tablets debossed with 'ING 177' one side and plain on the other side. They are supplied as follows: Bottles of 100 NDC 51407-210-01 Store at 20 o -30 o C (68 o -86 o F) [See USP Controlled Room Temperature]. Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408 Made in India Rev.: 10/2018 Marketed/Packaged by: GSMS, Inc Camarillo, CA 93012 USA

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ISOSORBIDE MONONITRATE- ISOSORBIDE MONONITRATE TABLET, EXTENDED
RELEASE
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
ISOSORBIDE MONONITRATE EXTENDED-RELEASE TABLETS, USP
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 tablets contain 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:
microcrystalline cellulose, hydroxypropyl cellulose, hypromellose,
colloidal silicon dioxide, lactose
monohydrate and 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 +140° to 146° (2%
in water, 20°C).
Isosorbide mononitrate is freely soluble in water, acetic acid,
alcohol, acetone and ethyl acetate;
soluble in ether and chloroform, slightly soluble in toluene;
practically insoluble in aliphatic
hydrocarbons.
_FDA approved dissolution test differs from the USP dissolution test._
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Isosorbide mononitrate extended-release tablet are 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 wedge pr