CHLORZOXAZONE tablet
Country: United States
Language: English
Source: NLM (National Library of Medicine)
Summary of Product characteristics
(SPC)
23-09-2011
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Active ingredient:
CHLORZOXAZONE (UNII: H0DE420U8G) (CHLORZOXAZONE - UNII:H0DE420U8G)
Available from:
STAT Rx USA LLC
INN (International Name):
CHLORZOXAZONE
Composition:
CHLORZOXAZONE 500 mg
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic 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. Chlorzoxazone is contraindicated in patients with known intolerance to the drug.
Product summary:
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
Authorization status:
Abbreviated New Drug Application
Summary of Product characteristics
CHLORZOXAZONE - CHLORZOXAZONE TABLET
STAT RX USA LLC
----------
CHLORZOXAZONE TABLETS, USP 500 MG
REVISED: NOVEMBER 2010
RX ONLY
195609
DESCRIPTION
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:
C H CINO 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.
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.
INDICATIONS AND USAGE
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 clearl
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