Country: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
CHLORZOXAZONE (UNII: H0DE420U8G) (CHLORZOXAZONE - UNII:H0DE420U8G)
Trigen Laboratories, LLC
ORAL
PRESCRIPTION DRUG
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.
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
Abbreviated New Drug Application
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 Прочитајте комплетан документ