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:

Lannett Company, Inc.

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, capsule-shaped tablets scored on one side and engraved "KU 128" on the unscored side. They are supplied as follows: Bottles of 90 NDC 62175-128-46 Bottles of 100 NDC 62175-128-37 Bottles of 500 NDC 62175-128-41 Bottles of 1000 NDC 62175-128-43 Isosorbide Mononitrate Extended-Release Tablets, USP 60 mg are white, capsule-shaped tablets scored on one side and engraved "KU 119" on the unscored side. They are supplied as follows: Bottles of 90 NDC 62175-119-46 Bottles of 100 NDC 62175-119-37 Bottles of 500 NDC 62175-119-41 Bottles of 1000 NDC 62175-119-43 Isosorbide Mononitrate Extended-Release Tablets, USP 120 mg are white, capsule-shaped tablets engraved "KU 129" on one side. They are supplied as follows: Bottles of 100 NDC 62175-129-37 Bottles of 1000 NDC 62175-129-43 Store at 20°-30°C (68°-86°F) [See USP]. Distributed by: Lannett Company, Inc. Philadelphia, PA 19136 CIA71195F Rev. 02/19

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ISOSORBIDE MONONITRATE- ISOSORBIDE MONONITRATE TABLET, EXTENDED
RELEASE
LANNETT COMPANY, INC.
----------
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, microcrystalline cellulose and talc.
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.
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 arterial pressure (afterload). Dilatation of the c