Riik: Kanada
keel: inglise
Allikas: Health Canada
CYCLOBENZAPRINE HYDROCHLORIDE
PHARMEL INC
M03BX08
CYCLOBENZAPRINE
10MG
TABLET
CYCLOBENZAPRINE HYDROCHLORIDE 10MG
ORAL
100/500
Prescription
CENTRALLY ACTING SKELETAL MUSCLE RELAXANTS
Active ingredient group (AIG) number: 0112363001; AHFS:
CANCELLED POST MARKET
2004-04-06
PRODUCT MONOGRAPH PR PHL-CYCLOBENZAPRINE (Cyclobenzaprine Hydrochloride Tablets USP) 10 mg SKELETAL MUSCLE RELAXANT PHARMEL INC. Date of Preparation: 8699, 8e Ave., February 10, 2004 Montreal, CANADA H1Z 2X4 CONTROL #: 089628 2 PRODUCT MONOGRAPH PR PHL-CYCLOBENZAPRINE (Cyclobenzaprine Hydrochloride Tablets USP) 10 mg THERAPEUTIC CLASSIFICATION Skeletal - Muscle Relaxant ACTION AND CLINICAL PHARMACOLOGY Cyclobenzaprine hydrochloride relieves skeletal muscle spasm of local origin without interfering with muscle function. It is ineffective in muscle spasm due to central nervous system disease. Controlled clinical studies show that cyclobenzaprine hydrochloride improves the signs and the symptoms of skeletal muscle spasm. Cyclobenzaprine hydrochloride is well absorbed in man. After oral or intravenous doses (10 mg) of 14 C-labelled cyclobenzaprine hydrochloride to human subjects, plasma levels of radioactivity were comparable. In addition, the excretion of radioactivity was similar after both routes (38 to 51 percent in the urine; 14 to 15 percent in the feces), suggesting that oral absorption is almost complete. The half-life varies from one to three days. No effect, on plasma levels or bioavailability was noted in 14 human subjects, when cyclobenzaprine hydrochloride and multiple doses of acetylsalicylic acid was coadministered. Cyclobenzaprine hydrochloride is extensively metabolized in man. In the study with 14 C-labelled drug, about 4 percent of the dose was excreted in the urine as unchanged cyclobenzaprine hydrochloride. The metabolites (probably glucuronides) were excreted as water-soluble conjugates. After oral or intravenous administration of 40 mg of unlabelled cyclobenzaprine hydrochloride to two subjects, only 0.2 to 1.5 percent of the dose was excreted as unchanged drug in the urine within 24 hours. 3 A single 20 mg (2 tablets) dose, comparative two-way cross-over bioavailability study was performed using normal human volunteers on phl-Cyclobenzaprine 10mg tablets versus FLEXRIL 10 mg tablets (Merck Fro Lugege kogu dokumenti