Data from FDA - Curated by Toby Galbraith - Last updated 28 July 2017

Indication(s)

INDICATIONS AND USAGE Lorzone® 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.

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Advisory information

contraindications
CONTRAINDICATIONS Lorzone® is contraindicated in patients with known intolerance to the drug.
Special warnings and precautions
PRECAUTIONS Lorzone® should be used with caution in patients with known allergies or with a history of allergic reactions to drugs. If 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.
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, light- headedness, malaise, or overstimulation 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.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION Usual Adult Dosage Lorzone® Tablets (chlorzoxazone USP) 375 mg: One tablet three or four times daily. If adequate response is not obtained with this dose, the 375 mg tablets may be increased to two tablets (750 mg) three or four times daily. As improvement occurs dosage can usually be reduced. Lorzone® Tablets (chlorzoxazone USP) 750 mg: 1/3 tablet (250 mg) three or four times daily. Initial dosage for painful musculoskeletal conditions should be 2/3 tablet (500 mg) three or four times daily. If adequate response is not obtained with this dose, it may be increased to one tablet (750 mg) three or four times daily. As improvement occurs dosage can usually be reduced.

More information

Category Value
Authorisation number ANDA040861
Agency product number H0DE420U8G
Orphan designation No
Product NDC 68025-047,68025-046
Date Last Revised 05-06-2017
Type HUMAN PRESCRIPTION DRUG
RXCUI 1088936
Marketing authorisation holder Vertical Pharmaceuticals, Inc.