Chlorzoxazone 500 MG Oral Tablet
Generic Name: CHLORZOXAZONE
Brand Name: CHLORZOXAZONE
- Substance Name(s):
- CHLORZOXAZONE
WARNINGS
SECTION 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.
OVERDOSAGE
SECTION Symptoms Initially, gastrointestinal disturbances such as nausea, vomiting or diarrhea together with drowsiness, dizziness, lightheadedness or headache may occur.
Early in the course there may be malaise or sluggishness followed by marked loss of muscle tone, making voluntary movement impossible.
The deep tendon reflexes may be decreased or absent.
The sensorium remains intact, and there is no peripheral loss of sensation.
Respiratory depression may occur with rapid, irregular respiration and intercostal and substernal retraction.
The blood pressure is lowered, but shock has not been observed.
Treatment Gastric lavage or induction of emesis should be carried out, followed by administration of activated charcoal.
Thereafter, treatment is entirely supportive.
If respirations are depressed, oxygen and artificial respiration should be employed and a patent airway assured by use of an oropharyngeal airway or endotracheal tube.
Hypotension may be counteracted by use of dextran, plasma, concentrated albumin or a vasopressor agent such as norepinephrine.
Cholinergic drugs or analeptic drugs are of no value and should not be used.
DESCRIPTION
SECTION 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: 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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HOW SUPPLIED
SECTION Chlorzoxazone tablets, USP are available as oblong, scored, white tablets debossed with WPI on one side and “39”-“68” on the other side and are packaged in bottles of 100 and 500.
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
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.
Manufactured By: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Distributed By: Watson Pharma, Inc.
Corona, CA 92880 USA Revised: November 2010 195609 PRINCIPAL DISPLAY PANEL NDC 0591-2520-01 Chlorzoxazone Tablets, USP 500 mg New NDC Watson 100 Tablets Rx only Each tablet contains: Chlorzoxazone USP, 500 mg Usual Dosage: See package insert for full prescribing information.
Store at 20ºC-25ºC (68º-77ºF).
[See USP Controlled Room Temperature.] KEEP TIGHTLY CLOSED.
This is a bulk backage.
Dispense contents with a child-resistant closure (as required) and in a tight container as defined in the USP/NF.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Manufactured By: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Code No.
GO/DRUGS/741 195607-1 Distributed By: Watson Pharma, Inc.
INDICATIONS AND USAGE
INDICATIONS & USAGE SECTION 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
DOSAGE & ADMINISTRATION SECTION 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.