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Chlorzoxazone
Overview
What is Chlorzoxazone?
Chlorzoxazone USP is a centrally acting skeletal muscle relaxant, available as tablets of 500 mg for oral administration. Its chemical name is 5-Chloro-2-benzoxazolinone, and its structural formula is:
C
H
CINO
MW 169.57
Chlorzoxazone USP is a white or practically white, practically odorless, crystalline powder. Chlorzoxazone is slightly soluble in water; sparingly soluble in alcohol, in isopropyl alcohol, and in methanol; soluble in solutions of alkali hydroxides and ammonia.
Chlorzoxazone tablets contain the inactive ingredients Docusate Sodium, Lactose (hydrous), Magnesium Stearate, Microcrystalline Cellulose, Pregelatinized Starch, Sodium Benzoate, and Sodium Starch Glycolate.
What does Chlorzoxazone look like?
What are the available doses of Chlorzoxazone?
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What should I talk to my health care provider before I take Chlorzoxazone?
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How should I use Chlorzoxazone?
Chlorzoxazone is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Chlorzoxazone does not directly relax tense skeletal muscles in man.
What interacts with Chlorzoxazone?
Chlorzoxazone is contraindicated in patients with known intolerance to the drug.
What are the warnings of Chlorzoxazone?
Cyclobenzaprine may enhance the effects of alcohol, barbiturates, and other CNS depressants.
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 judgment of the physician, the potential benefits outweigh the possible risks.
What are the precautions of Chlorzoxazone?
Chlorzoxazone should be used with caution in patients with known allergies or with a history of allergic reactions to drugs. If a sensitivity reaction occurs such as urticaria, redness, or itching of the skin, the drug should be stopped.
If any symptoms suggestive of liver dysfunction are observed, the drug should be discontinued.
What are the side effects of Chlorzoxazone?
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.
To report SUSPECTED ADVERSE EVENTS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or
for voluntary reporting of adverse reactions.
What should I look out for while using Chlorzoxazone?
Chlorzoxazone is contraindicated in patients with known intolerance to the drug.
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.
What might happen if I take too much Chlorzoxazone?
How should I store and handle Chlorzoxazone?
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light.Chlorzoxazone tablets, USP are available as oblong, scored, white tablets debossed with on one side and "39"-"68" on the other side and are packaged in bottles of 10, 20, 24, 28, 30 and 40. 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.Chlorzoxazone tablets, USP are available as oblong, scored, white tablets debossed with on one side and "39"-"68" on the other side and are packaged in bottles of 10, 20, 24, 28, 30 and 40. 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.Chlorzoxazone tablets, USP are available as oblong, scored, white tablets debossed with on one side and "39"-"68" on the other side and are packaged in bottles of 10, 20, 24, 28, 30 and 40. 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.Chlorzoxazone tablets, USP are available as oblong, scored, white tablets debossed with on one side and "39"-"68" on the other side and are packaged in bottles of 10, 20, 24, 28, 30 and 40. 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.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Chlorzoxazone is a centrally-acting agent for painful musculoskeletal conditions. Data available from animal experiments as well as human study indicate that chlorzoxazone acts primarily at the level of the spinal cord and subcortical areas of the brain where it inhibits multisynaptic reflex arcs involved in producing and maintaining skeletal muscle spasm of varied etiology. The clinical result is a reduction of the skeletal muscle spasm with relief of pain and increased mobility of the involved muscles. Blood levels of chlorzoxazone can be detected in people during the first 30 minutes and peak levels may be reached, in the majority of the subjects, in about 1 to 2 hours after oral administration of chlorzoxazone. Chlorzoxazone is rapidly metabolized and is excreted in the urine, primarily in a conjugated form as the glucuronide. Less than one percent of a dose of chlorzoxazone is excreted unchanged in the urine in 24 hours.
Non-Clinical Toxicology
Chlorzoxazone is contraindicated in patients with known intolerance to the drug.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.
The use of benzodiazepines, opioids, antihistamines, antipsychotics, anti-anxiety agents, or other CNS depressants (including alcohol) concomitantly with hydrocodone bitartrate and homatropine methylbromide syrup may cause an additive CNS depressant effect, profound sedation, respiratory depression, coma, and death and should be avoided (see ).
The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone.
Chlorzoxazone should be used with caution in patients with known allergies or with a history of allergic reactions to drugs. If a sensitivity reaction occurs such as urticaria, redness, or itching of the skin, the drug should be stopped.
If any symptoms suggestive of liver dysfunction are observed, the drug should be discontinued.
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.
To report SUSPECTED ADVERSE EVENTS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or for voluntary reporting of adverse reactions.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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