Chlorzoxazone label

Chlorzoxazone

Chlorzoxazone Recall

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Side Effects & Adverse Reactions

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.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

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.

History

There is currently no drug history available for this drug.

Other Information

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:

Chlorzoxazone Structural Formula

Chlorzoxazone Structural Formula

Chlorzoxazone Structural Formula

Chlorzoxazone Structural Formula

C7H4CINO2 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.

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Chlorzoxazone Manufacturers

Proficient Rx Lp
No Recall
Chlorzoxazone | Proficient Rx Lp
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.
Physicians Total Care, Inc.
No Recall
Chlorzoxazone | Physicians Total Care, Inc.
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.
Dispensing Solutions, Inc.
No Recall
Chlorzoxazone | Dispensing Solutions, Inc.
Usual Adult Dosage:
One tablet three or four times daily. If adequate response is not obtained with this dose, it may be increased to 1½ tablets (750 mg) three or four times daily. As improvement occurs dosage can usually be reduced.
Watson Laboratories, Inc.
No Recall
Chlorzoxazone | Actavis Pharma, Inc.
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.
Stat Rx Usa Llc
No Recall
Chlorzoxazone | Stat Rx Usa Llc
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.
Lake Erie Medical Dba Quality Care Products Llc
No Recall
Chlorzoxazone | Lake Erie Medical Dba Quality Care Products Llc
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.
Rebel Distributors Corp
No Recall
Chlorzoxazone | Rebel Distributors Corp
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.
Unit Dose Services
No Recall
Chlorzoxazone | Unit Dose Services
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.
Bryant Ranch Prepack
No Recall
Chlorzoxazone | Bryant Ranch Prepack
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.
Rebel Distributors Corp
No Recall
Chlorzoxazone | Rebel Distributors Corp
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.
Dispensing Solutions, Inc.
No Recall
Chlorzoxazone | Dispensing Solutions, Inc.
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.
Clinical Solutions Wholesale
No Recall
Chlorzoxazone | Clinical Solutions Wholesale
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.
A-s Medication Solutions Llc
No Recall
Chlorzoxazone | A-s Medication Solutions Llc
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.
Aidarex Pharmaceuticals Llc
No Recall
Chlorzoxazone | Aidarex Pharmaceuticals Llc
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.
Direct Rx
No Recall
Chlorzoxazone | Direct Rx
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.