Isosorbide mononitrate

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]

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Overview

Isosorbide mononitrate is a drug used principally in the treatment of angina pectoris and acts by dilating the blood vessels so as to reduce the blood pressure. It is sold in the USA by Kremers Urban under the trade name Monoket, also sold in the USA under the name Imdur, and marketed in the UK under the trade names: Monosorb, Chemydur. In India, this drug is available under the brand names of Ismo, Isonorm, Monotrate, Solotrate, and Monit.

Category

Vasodilator

US Brand Names

ISOSORBIDE MONONITRATE tablet^® [Zydus Pharmaceuticals (USA) Inc.]

Nesher Pharmaceuticals USA LLC St. Louis, MO 63044

Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534

Principal Display Panel - Bottle Label 30 mg

ZyGenerics NDC 68382-650-01 Isosorbide Mononitrate Extended-Release Tablets

30 mg

Rx only

100 Tablets

P10093 Rev: 06/13

Each tablet contains: Isosorbide mononitrate 30 mg USUAL DOSAGE: See accompanying package outsert for full prescribing information. Dispense in a tight container as defined in the USP/NF. Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature]. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Manufactured by: Nesher Pharmaceuticals USA LLC. St. Louis, MO 63044

Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534

Principal Display Panel - Bottle Label 60 mg

ZyGenerics NDC 68382-651-01 Isosorbide Mononitrate Extended-Release Tablets

60 mg

Rx only

100 Tablets

P10094 Rev: 06/13

Each tablet contains: Isosorbide mononitrate 60 mg USUAL DOSAGE: See accompanying package outsert for full prescribing information. Dispense in a tight container as defined in the USP/NF. Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature]. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Manufactured by: Nesher Pharmaceuticals USA LLC. St. Louis, MO 63044

Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534

FDA Package Insert

| Indications and Usage | Dosage and Administration | Dosage Forms and Strengths | Contraindications | Warnings and Precautions | Adverse Reactions | Drug Interactions | Use in Specific Populations | Overdosage | Description | Clinical Pharmacology | Nonclinical Toxicology | Clinical Studies | How Supplied/Storage and Handling | Patient Counseling Information | Labels and Packages

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 pressure and pulmonary capillary wedge pressure (preload). Arteriolar relaxation reduces systemic vascular resistance, and systolic arterial pressure and mean arterial pressure (afterload). Dilatation of the coronary arteries also occurs. The relative importance of preload reduction, afterload reduction, and coronary dilatation remains undefined.