CHLORZOXAZONE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CHLORZOXAZONE (UNII: H0DE420U8G) (CHLORZOXAZONE - UNII:H0DE420U8G)

Available from:

Trigen Laboratories, LLC

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 supplied as follows: 375 mg A white capsule shaped tablet, debossed “ADG” on one side and “375” on the other side, in bottles of 100 tablets, NDC 13811-717-10. 750 mg A white capsule shaped tablet, debossed “ADG” on the trisected side and “750” on the bisected side, in bottles of 100 tablets, NDC 13811-718-10. Dispense in tight container as defined in the official compendium. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Manufactured for: Trigen Laboratories, LLC Alpharetta, GA 30005 www.trigenlab.com 1-770-509-4500 PLR-CHLORZ-00003-1 Code 1167B00 Rev: 11-2021

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CHLORZOXAZONE- CHLORZOXAZONE TABLET
TRIGEN LABORATORIES, LLC
----------
CHLORZOXAZONE TABLETS
For Painful Musculoskeletal Conditions
PRESCRIBING INFORMATION
DESCRIPTION
Each 375 mg Chlorzoxazone tablet contains: Chlorzoxazone USP 375 mg.
Each 750 mg Chlorzoxazone tablet contains: Chlorzoxazone USP 750 mg.
Chemical Name: 5-Chloro-2-benzoxazolinone.
Structural Formula:
Molecular Formula: C
H
CINO
Molecular Weight: 169.56
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.
Inactive ingredients: anhydrous lactose, croscarmellose sodium,
docusate sodium,
magnesium stearate, microcrystalline cellulose, pregelatinized corn
starch and sodium
benzoate.
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
7
4
2
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