Chlorzoxazone

Chlorzoxazone
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: Chetan Lokhande, M.B.B.S [2]

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Overview

Chlorzoxazone is a skeletal muscle relaxant, spasmolytic that is FDA approved for the treatment of musculoskeletal pain. Common adverse reactions include cardiovascular: lightheadedness, neurologic: dizziness, excitement, paradoxical, somnolence, other: malaise.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Musculoskeletal pain

500 to 750 mg ORALLY 3 to 4 times daily

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

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

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

Chlorzoxazone is contraindicated in patients with known intolerance to the drug.

Warnings

Serious (including fatal) hepatocellular toxicity has been reported rarely in patients receiving chlorzoxazone. The mechanism is unknown but appears to be idiosyncratic and unpredictable. Factors predisposing patients to this rare event are not known. Patients should be instructed to report early signs and/or symptoms of hepatotoxicity such as fever, rash, anorexia, nausea, vomiting, fatigue, right upper quadrant pain, dark urine, or jaundice. Chlorzoxazone should be discontinued immediately and a physician consulted if any of these signs or symptoms develop. Chlorzoxazone use should also be discontinued if a patient develops abnormal liver enzymes (e.g., AST, ALT, alkaline phosphatase and bilirubin.)

The concomitant use of alcohol or other central nervous system depressants may have an additive effect.

Usage in Pregnancy

The safe use of chlorzoxazone has not been established with respect to the possible adverse effects upon fetal development. Therefore, it should be used in women of childbearing potential only when, in the judgement of the physician, the potential benefits outweigh the possible risks.

Adverse Reactions

Clinical Trials Experience

Chlorzoxazone containing products are usually well tolerated. It is possible in rare instances that chlorzoxazone may have been associated with gastrointestinal bleeding. Drowsiness, dizziness, lightheadedness, malaise, or over-stimulation may be noted by an occasional patient. Rarely, allergic-type skin rashes, petechiae, or ecchymoses may develop during treatment. Angioneurotic edema or anaphylactic reactions are extremely rare. There is no evidence that the drug will cause renal damage. Rarely, a patient may note discoloration of the urine resulting from a phenolic metabolite of chlorzoxazone. This finding is of no known clinical significance.

Postmarketing Experience

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

Drug Interactions

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

Use in Specific Populations

Pregnancy

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

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

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

Monitoring

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

IV Compatibility

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

Overdosage

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

Mechanism of Action

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

Structure

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

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

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

Storage

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

Precautions with Alcohol

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

Brand Names

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

Look-Alike Drug Names

There is limited information regarding Chlorzoxazone 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.