CHLORZOXAZONE tablet, orally disintegrating

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Belcher Pharmaceuticals 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, 250 mg are supplied as white, capsule-shaped tablets, debossed “BPL” on one side and “250” on the other side. Bottles of 60 Tablets: NDC 62250-710-13 Dispense in tight container as defined in the USP. Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Manufacture by: Belcher Pharmaceuticals LLC. Largo, FL 33777 L75I D-2111 Rev. 11/2021

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CHLORZOXAZONE- CHLORZOXAZONE TABLET, ORALLY DISINTEGRATING
BELCHER PHARMACEUTICALS LLC
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CHLORZOXAZONE- CHLORZOXAZONE TABLET USP
CHLORZOXAZONE 250 MG
FOR PAINFUL MUSCULOSKELETAL CONDITIONS
DESCRIPTION
Each tablet contains: Chlorzoxazone*…………….250 mg
* 5-Chloro-2-benzoxazolinone
Structural Formula:
_Molecular Formula:_ C H CINO
_Molecular Weight:_ 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.
_Inactive ingredients: _anhydrous lactose, colloidal silicon dioxide,
croscarmellose sodium,
docusate sodium, magnesium stearate, microcrystalline cellulose,
pregelatinized 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
7
4
2
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