
Published studies indicate that patients who are CYP2C19 poor metabolizers have a 4 times increase in exposure to carisoprodol, soma liver function and concomitant exposure to 50% decrease compared with normal CYP2C19 metabolizers meprobamate. The prevalence of poor metabolizers in Caucasians and African Americans is about 35% and in Asians is approximately 1.520%. The long-term studies in animals have not been conducted to evaluate the carcinogenic soma liver function potential of carisoprodol. Carisoprodol is not formally evaluated for genotoxicity. In published studies, carisoprodol was mutagenic soma liver function in the in vitro test of mouse lymphoma soma liver function cells in the absence of soma liver function metabolizing enzymes, but was not mutagenic in the presence of metabolizing enzymes. Carisoprodol was clastogenic in the chromosomal aberration test in vitro with cells of Chinese hamster ovary, with or without the presence of metabolizing enzymes. Other types of genotoxicity tests yielded negative results. Carisoprodol was not mutagenic in reverse mutation assay of Ames strains of S. typhimurium, with or without metabolizing enzymes, and was not clastogenic in a cell in vivo mouse soma liver function micronucleus circulating blood. Carisoprodol has not been formally evaluated the effects on fertility.
Published reproductive studies of carisoprodol in mice found no alteration in fertility although an alteration in reproductive cycles characterized by a greater time spent in estrus was observed soma liver function with a dose of carisoprodol 1200 mg / kg / day . In a toxicology study of 13 weeks do not determine soma liver function the fertility of the mouse testis weight and sperm motility was reduced at a dose of 1200 mg / kg / day. In both studies, the NOEL was 750 mg / kg / day, equivalent to about 2.6 times the equivalent human dose of 350 mg four times soma liver function daily, based on a soma liver function comparison of the body surface. The importance of soma liver function these findings for human fertility is unknown. The safety and efficacy of carisoprodol in relieving acute pain idiopathic mechanical lower back was assessed on a 7-day double-blind, randomized, multicenter, placebo-controlled American (Study 1). Patients had to be between 18 and 65 and have severe back pain (3 days) to be included in the test.
Patients with chronic back pain, an increased risk of vertebral fracture (eg, history of osteoporosis), history of spinal pathology (eg, herniated disc, spinal stenosis soma liver function or spondylolisthesis) with back pain show inflammation, or neurological deficits were excluded from participation. Concomitant use of analgesics (paracetamol, for example, NSAIDs, tramadol agonists, opioids), other muscle relaxants, botulinum toxin, sedatives (eg barbiturates, benzodiazepines, promethazine hydrochloride) and anti-epileptic drugs was prohibited.
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