ISOSORBIDE MONONITRATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ISOSORBIDE MONONITRATE (UNII: LX1OH63030) (ISOSORBIDE MONONITRATE - UNII:LX1OH63030)

Available from:

Zydus Pharmaceuticals (USA) 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 ISMN is not sufficiently rapid for this product to be useful in aborting an acute angina 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 30 mg tablets are oval, reddish pink, film-coated tablets, debossed "N" bisect "30" on one side and bisect on the other side, packaged as follows: NDC 68382-650-01 bottle of 100 tablets NDC 68382-650-05 bottle of 500 tablets Isosorbide mononitrate extended-release 60 mg tablets are oval, yellow, film-coated tablets, debossed "N" bisect "60" on one side and bisect on the other side, packaged as follows: NDC 68382-651-01 bottle of 100 tablets NDC 68382-651-05 bottle of 500 tablets Isosorbide mononitrate extended-release 120 mg tablets are oval, white, film-coated tablets, debossed "N120" on one side, packaged as follows: NDC 68382-652-01 bottle of 100 tablets Store at 20° to 25°C (68° - 77°F).  [See USP Controlled Room Temperature.]  Protect from excessive moisture. Manufactured By: Nesher Pharmaceuticals USA LLC St. Louis, MO 63044 Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ISOSORBIDE MONONITRATE- ISOSORBIDE MONONITRATE TABLET
ZYDUS PHARMACEUTICALS (USA) INC.
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ISOSORBIDE MONONITRATE EXTENDED-RELEASE TABLETS
30 MG, 60 MG, AND 120 MG
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 Isosorbide mononitrate extended-release tablet, for oral
administration contains 30
mg, 60 mg or 120 mg of ISMN. In addition, each tablet contains the
following inactive
ingredients: carnauba wax, colloidal silicon dioxide, ethylcellulose,
hypromellose, lactose,
magnesium stearate, polyethylene glycol, polysorbate 80, titanium
dioxide. The 30 mg
tablet also contains D&D Red No. 27 aluminum lake, D&C Red No. 30
aluminum lake,
FD&C Blue No. 2 aluminum lake, and FD&C Yellow No. 6 aluminum lake.
The 60 mg
tablet also contains D&C Yellow No. 10 aluminum lake and FD&C Blue No.
2 aluminum
lake.
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).
ISMN is freely soluble in water, ethanol, methanol, chloroform, ethyl
acetate, and
dichloromethane.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
ISMN extended-release tablets 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,
6
9
6
decreases venous return to the heart, thereby reducing left
ventricul