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

Usual Adult Dosage

One tablet three or four times daily. If adequate response is not obtained with this dose, it may be increased to one and one-half tablets (750 mg) three or four times daily. As improvement occurs dosage can usually be reduced.

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

Symptoms

Initially, gastrointestinal disturbances such as nausea, vomiting or diarrhea together with drowsiness, dizziness, lightheadedness or headache may occur. Early in the course there may be malaise or sluggishness followed by marked loss of muscle tone, making voluntary movement impossible. The deep tendon reflexes may be decreased or absent. The sensorium remains intact, and there is no peripheral loss of sensation. Respiratory depression may occur with rapid, irregular respiration and intercostal and substernal retraction. The blood pressure is lowered, but shock has not been observed.

Treatment

Gastric lavage or induction of emesis should be carried out, followed by administration of activated charcoal. Thereafter, treatment is entirely supportive. If respirations are depressed, oxygen and artificial respiration should be employed and a patent airway assured by use of an oropharyngeal airway or endotracheal tube. Hypotension may be counteracted by use of dextran, plasma, concentrated albumin or a vasopressor agent such as norepinephrine. Cholinergic drugs or analeptic drugs are of no value and should not be used.

Pharmacology

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

Chlorzoxazone tablets, USP are available as oblong, scored, white tablets debossed with WPI on one side and "39"-"68" on the other side and are packaged in bottles of 100 and 500.

Storage

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense contents with a child-resistant closure (as required) and in a tight container as defined in the USP/NF.

Keep out of the reach of children.

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.

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