CHLORZOXAZONE
Generic: CHLORZOXAZONE
Basic Information
Manufacturer
Proficient Rx LP
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
0a8ee5fa-f393-4568-81bd-269f9a4cecd6
Indications & Usage
INDICATIONS 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.
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.
Warnings
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 judgment of the physician, the potential benefits outweigh the possible risks.
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.
Adverse Reactions
ADVERSE REACTIONS 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 Aurobindo Pharma USA, Inc.
at 1-866-850-2876 or FDA at 1-800- FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.
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 Aurobindo Pharma USA, Inc.
at 1-866-850-2876 or FDA at 1-800- FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.