Isosorbide mononitrate

Isosorbide mononitrate
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gerald Chi

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Overview

Isosorbide mononitrate is an anti-anginal nitrate that is FDA approved for the {{{indicationType}}} of angina pectoris due to coronary artery disease.. Common adverse reactions include dizziness and headache.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Prophylaxis of Angina Pectoris

• Dosing Information

• The recommended starting dose is 30 mg (given as a single 30 mg tablet or as 1/2 of a 60 mg tablet) or 60 mg (given as a single tablet) once daily.
• After several days, the dosage may be increased to 120 mg (given as a single 120 mg tablet or as two 60 mg tablets) once daily. Rarely, 240 mg may be required.
• The daily dose of IMDUR Tablets should be taken in the morning on arising.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Isosorbide mononitrate in adult patients.

Non–Guideline-Supported Use

Prophylaxis of Rebleeding of Esophageal Varices

• Dosing Information

• 10 mg twice daily and titrated to 20 mg twice daily unless hypotension or headache occurred.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Isosorbide mononitrate in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Isosorbide mononitrate in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Isosorbide mononitrate in pediatric patients.

Contraindications

• Hypersensitivity or idiosyncratic reactions to other nitrates or nitrites.

Warnings

• Amplification of the vasodilatory effects of IMDUR by sildenafil can result in severe hypotension. The time course and dose dependence of this interaction have not been studied. Appropriate supportive care has not been studied, but it seems reasonable to treat this as a nitrate overdose, with elevation of the extremities and with central volume expansion.

• The benefits of ISMN in patients with acute myocardial infarction or congestive heart failure have not been established; because the effects of isosorbide mononitrate are difficult to terminate rapidly, this drug is not recommended in these settings.

• If isosorbide mononitrate is used in these conditions, careful clinical or hemodynamic monitoring must be used to avoid the hazards of hypotension and tachycardia.

Precautions

• Severe hypotension, particularly with upright posture, may occur with even small doses of isosorbide mononitrate. This drug should, therefore, be used with caution in patients who may be volume depleted or who, for whatever reason, are already hypotensive. Hypotension induced by isosorbide mononitrate may be accompanied by paradoxical bradycardia and increased angina pectoris.

• Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy.

• In industrial workers who have had long-term exposure to unknown (presumably high) doses of organic nitrates, tolerance clearly occurs. Chest pain, acute myocardial infarction, and even sudden death have occurred during temporary withdrawal of nitrates from these workers, demonstrating the existence of true physical dependence. The importance of these observations to the routine, clinical use of oral isosorbide mononitrate is not known.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Isosorbide mononitrate in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Isosorbide mononitrate in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Isosorbide mononitrate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Isosorbide mononitrate during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Isosorbide mononitrate with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Isosorbide mononitrate with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Isosorbide mononitrate with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Isosorbide mononitrate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Isosorbide mononitrate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Isosorbide mononitrate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Isosorbide mononitrate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Isosorbide mononitrate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Isosorbide mononitrate in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• IMDUR Extended Release Tablets should not be chewed or crushed and should be swallowed together with a half-glassful of fluid. Do not break the 30 mg tablet.

Monitoring

There is limited information regarding Monitoring of Isosorbide mononitrate in the drug label.

Condition1

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Isosorbide mononitrate in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Isosorbide mononitrate in the drug label.

Pharmacology

Mechanism of Action

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Isosorbide mononitrate in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Isosorbide mononitrate in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Isosorbide mononitrate in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Isosorbide mononitrate in the drug label.

Condition1

• Description

How Supplied

Storage

There is limited information regarding Isosorbide mononitrate Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Isosorbide mononitrate in the drug label.

Precautions with Alcohol

• Alcohol-Isosorbide mononitrate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• IMDUR®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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