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Basic Drug Info
Drug Name:PARAFON FORTE
Manufacturer:ORTHO-McNEIL PHARMACEUTICAL, INC.
Other Info:Printed in U.S.AOMP DIVISIONORTHO-McNEIL PHARMACEUTICAL, INC.Raritan, NJ 088697517501August 2000



Clinical Trials:


Indications and Usage

PARAFON FORTE DSC 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.
Sensory Discomfort -- A feeling of mental or physical uneasiness, pain, or distress.

Contraindications
PARAFON FORTE DSC chlorzoxazone is contraindicated in patients with known intolerance to the drug.
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.

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