Ivabradine

Ivabradine
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: Martin Nino [2]

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Overview

Ivabradine is a hyperpolarization-activated cyclic nucleotide-gated channel blocker that is FDA approved for the prevention of hospitalization for worsening heart failure in patients with stable, symptomatic chronic heart failure with left ventricular ejection fraction ≤ 35%, who are in sinus rhythm with resting heart rate ≥ 70 beats per minute and either are on maximally tolerated doses of beta-blockers or have a contraindication to beta-blocker use. Common adverse reactions include bradycardia, hypertension, atrial fibrillation and luminous phenomena (phosphenes) ( ≥ 1%)..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Ivabradine is indicated to reduce the risk of hospitalization for worsening heart failure in patients with stable, symptomatic chronic heart failure with left ventricular ejection fraction ≤ 35%, who are in sinus rhythm with resting heart rate ≥ 70 beats per minute and either are on maximally tolerated doses of beta-blockers or have a contraindication to beta-blocker use

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Stable angina, chronic, in combination with beta-blocker therapy

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Ivabradine FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Contraindications

There is limited information regarding Ivabradine Contraindications in the drug label.

Warnings

There is limited information regarding Ivabradine Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Ivabradine Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Ivabradine Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Ivabradine Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Ivabradine in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Ivabradine in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

There is no FDA guidance on the use of Ivabradine in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Ivabradine in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Ivabradine in geriatric settings.

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

There is limited information regarding Ivabradine Administration in the drug label.

Monitoring

There is limited information regarding Ivabradine Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Ivabradine and IV administrations.

Overdosage

There is limited information regarding Ivabradine overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Ivabradine Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Ivabradine Mechanism of Action in the drug label.

Structure

There is limited information regarding Ivabradine Structure in the drug label.

Pharmacodynamics

There is limited information regarding Ivabradine Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Ivabradine Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Ivabradine Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Ivabradine Clinical Studies in the drug label.

How Supplied

There is limited information regarding Ivabradine How Supplied in the drug label.

Storage

There is limited information regarding Ivabradine 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 Ivabradine Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Ivabradine interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Ivabradine Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Ivabradine Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

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