Ranolazine

Ranolazine
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: Sheng Shi, M.D. [2]

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Overview

Ranolazine is {{{aOrAn}}} Anti-anginal that is FDA approved for the {{{indicationType}}} of treatment of chronic angina.. Common adverse reactions include constipation, nausea , dizziness , headache.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

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Chronic Angina

• Dosing Information

* initial dosage: 500 mg PO bid increase

* maximum dosage: 1000 mg PO bid (based on clinical symptoms)

Off-Label Use and Dosage (Adult)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

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

Off-Label Use and Dosage (Pediatric)

Contraindications

RANEXA is contraindicated in patients:

• Taking strong inhibitors of CYP3A [see Drug Interactions (7.1)]
• Taking inducers of CYP3A [see Drug Interactions (7.1)]
• With liver cirrhosis [see Use in Specific Populations (8.6)]

Warnings

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Adverse Reactions

Clinical Trials Experience

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

Postmarketing Experience

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

Drug Interactions

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

Use in Specific Populations

Pregnancy

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

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

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

Monitoring

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

IV Compatibility

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

Overdosage

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

Mechanism of Action

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

Structure

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

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

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

Storage

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

Precautions with Alcohol

Alcohol-Ranolazine 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 Ranolazine Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Ranolazine 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.