Isosorbide dinitrate

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

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Prophylaxis of Angina Pectoris

• Isosorbide dinitrate are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of immediate-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.

• Dosing Information

• Initial Dosage

• 5–20 mg PO bid–tid

• Maintenance Dosage

• 10–40 mg PO bid–tid

• A daily dose-free interval of at least 14 hours is advisable to minimize tolerance. The optimal interval will vary with the individual patient, dose and regimen.
• Multiple-dose studies with ISDN and other nitrates have shown that maintenance of continuous 24-hour plasma levels results in refractory tolerance. Every dosing regimen for Isordil Titradose tablets must provide a daily dose-free interval to minimize the development of this tolerance. With immediate-release ISDN, it appears that one daily dose-free interval must be at least 14 hours long.
• The effects of the second and later doses have been smaller and shorter-lasting than the effects of the first.
• Large controlled studies with other nitrates suggest that no dosing regimen with Isordil Titradose tablets should be expected to provide more than about 12 hours of continuous anti-anginal efficacy per day.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

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

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

• Dosing Information

• Dosage

Condition2

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

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

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

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

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

Contraindications

• Condition1

Warnings

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Isosorbide dinitrate 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 dinitrate 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 dinitrate in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

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

Condition1

• Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

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

Pharmacology

There is limited information regarding Isosorbide dinitrate Pharmacology in the drug label.

Mechanism of Action

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

Condition1

• Description

How Supplied

• Isordil® (isosorbide dinitrate) Oral Titradose™ Tablets are available as follows:

5 mg, round, pink tablets imprinted "BPI 152" on one side and deeply scored on reverse side

NDC 64455-152-01, bottles of 100.

40 mg, round, light green tablets imprinted "BPI 192" on one side and deeply scored on reverse side:

NDC 64455-192-01, bottles of 100.

• Store at controlled room temperature, 25°C (77°F); excursions permitted to 15 -30° (59-86°F)

• Protect from light.

• Keep bottles tightly closed.

• Dispense in a light-resistant, tight container.

Storage

There is limited information regarding Isosorbide dinitrate 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 dinitrate in the drug label.

Precautions with Alcohol

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

Brand Names

• Isordil®

Look-Alike Drug Names

• Isordil® — Plendil®

Drug Shortage Status

Price

References

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

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