Isosorbide mononitrate description

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Isosorbide mononitrate
ISOSORBIDE MONONITRATE tablet® FDA Package Insert
Indications and Usage
Dosage and Administration
Dosage Forms and Strengths
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Overdosage
Description
Clinical Pharmacology
Clinical Studies
How Supplied/Storage and Handling
Patient Counseling Information
Labels and Packages
Clinical Trials
ClinicalTrials.gov

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Pratik Bahekar, MBBS [2]


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 C6H9NO6 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. [1]



References

  1. "ISOSORBIDE MONONITRATE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]". Retrieved 30 January 2014.