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:

REMEDYREPACK 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 60 mg are Light yellow, biconvex oval shaped tablets, scored on both sides and embossed ‘DX 31’ on one side. NDC: 70518-2207-00 PACKAGING: 90 in 1 BOTTLE PLASTIC Store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature). Protect from excessive moisture. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ISOSORBIDE MONONITRATE- ISOSORBIDE MONONITRATE TABLET, EXTENDED
RELEASE
REMEDYREPACK 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, ISMN 30 mg
tablets, USP contains the following inactive ingredients: colloidal
silicon dioxide,
compressible sugar, hydroxypropyl methylcellulose, lactose
monohydrate, magnesium
stearate. ISMN 60 mg tablets, USP contains the following inactive
ingredients: colloidal
silicon dioxide, compressible sugar, hydroxypropyl methylcellulose,
lactose
monohydrate, magnesium stearate, yellow iron oxide. ISMN 120 mg
tablets, USP
contains the following inactive ingredients: colloidal silicon
dioxide, hydroxypropyl
cellulose, hypromellose, lactose monohydrate, magnesium stearate 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).
6
9
6
Isosorbide mononitrate is freely soluble in water, ethanol, methanol,
chloroform, ethyl
acetate, and dichloromethane. Isosorbide Mononitrate Extended-Release
120mg Tablets,
USP meets USP Dissolution Test 7.
FDA approved dissolution acceptance criteria for Isosorbide
Mononitrate Extended-
Release 30mg and 60mg Tablets, USP differ from that of the USP.
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
clinic