Lorzone Tablets

Name: Lorzone Tablets

Lorzone Tablets - Clinical Pharmacology

Chlorzoxazone is a centrally-acting agent for painful musculoskeletal conditions. Data available from animal experiments as well as human study indicate that chlorzoxazone acts primarily at the level of the spinal cord and subcortical areas of the brain where it inhibits multisynaptic reflex arcs involved in producing and maintaining skeletal muscle spasm of varied etiology. The clinical result is a reduction of the skeletal muscle spasm with relief of pain and increased mobility of the involved muscles. Blood levels of chlorzoxazone can be detected in people during the first 30 minutes and peak levels may be reached, in the majority of the subjects, in about 1 to 2 hours after oral administration of chlorzoxazone. Chlorzoxazone is rapidly metabolized and is excreted in the urine, primarily in a conjugated form as the glucuronide. Less than one percent of a dose of chlorzoxazone is excreted unchanged in the urine in 24 hours.

Contraindications

Lorzone® is contraindicated in patients with known intolerance to the drug.

Overdosage

Symptoms: Initially, gastrointestinal disturbances such a 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 intercostals 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.

Lorzone Tablets 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.

PRINCIPAL DISPLAY PANEL - 750 mg

LORZONE 
chlorzoxazone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68025-046
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORZOXAZONE (CHLORZOXAZONE) CHLORZOXAZONE 375 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE  
CELLULOSE, MICROCRYSTALLINE  
CROSCARMELLOSE SODIUM  
DOCUSATE SODIUM  
MAGNESIUM STEARATE  
SODIUM BENZOATE  
STARCH, CORN  
Product Characteristics
Color WHITE Score no score
Shape OVAL (CAPSULE-SHAPED) Size 17mm
Flavor Imprint Code ADG;375
Contains     
Packaging
# Item Code Package Description
1 NDC:68025-046-10 100 TABLET in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040861 10/01/2011
LORZONE 
chlorzoxazone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68025-047
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORZOXAZONE (CHLORZOXAZONE) CHLORZOXAZONE 750 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE  
CELLULOSE, MICROCRYSTALLINE  
CROSCARMELLOSE SODIUM  
DOCUSATE SODIUM  
MAGNESIUM STEARATE  
SODIUM BENZOATE  
STARCH, CORN  
Product Characteristics
Color WHITE Score 3 pieces
Shape OVAL (CAPSULE-SHAPED) Size 20mm
Flavor Imprint Code ADG;750
Contains     
Packaging
# Item Code Package Description
1 NDC:68025-047-10 100 TABLET in 1 BOTTLE, PLASTIC
2 NDC:68025-047-02 2 POUCH in 1 BOX, UNIT-DOSE
2 NDC:68025-047-01 1 TABLET in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040861 10/01/2011
Labeler - Vertical Pharmaceuticals, Inc. (173169017)
Revised: 06/2017   Vertical Pharmaceuticals, Inc.
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