ISOSORBIDE MONONITRATE- 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:

REMEDYREPACK 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
REMEDYREPACK INC.
----------
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,
decreases venous return to the heart,
thereby reducing left ventricular end-diastolic pres