Kenyan Health Patient Information Leaflet
Muscle Relaxant [EPC]
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.
DOSAGE AND 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.
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.
HOW SUPPLIED Chlorzoxazone tablets, USP 500 mg are available as Light orange to orange round shaped, flat hexagonal, beveled debossed with āNā on one side of break line and ā500ā on other side of break line and plain on other side. Bottles of 20 NDC 71205-711-20 Bottles of 30 NDC 71205-711-30 Bottles of 60 NDC 71205-711-60 Bottles of 90 NDC 71205-711-90 Store at controlled room temperature 15Ā°- 30Ā°C (59Ā°-86Ā° F). 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. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 Revised: 11/2021