In post-marketing experience with carisoprodol , cases of dependence, isolation and abuse have been reported with prolonged use. Most cases of dependence, isolation and abuse occurred in patients who had a history of addiction or who used carisoprodol combination with other medications with abuse potential. Withdrawal symptoms have been reported following abrupt discontinuation women's sleepwear shirt and soma after prolonged use. To reduce the women's sleepwear shirt and soma likelihood of carisoprodol addiction, withdrawal and abuse carisoprodol should be used with caution in patients predisposed to addiction, and patients taking other CNS depressants, including alcohol, and should not be used more than two to three weeks carisoprodol in relieving acute musculoskeletal pain. One of the metabolites of carisoprodol , meprobamate (a controlled substance), can lead to dependence [see Clinical Pharmacology (12.3)]. There have been postmarketing women's sleepwear shirt and soma reports of seizures in patients who received carisoprodol.
Most of these cases occurred in the establishment of an overdose of multiple drugs (including drug abuse, illicit drugs and alcohol) [see Overdosage (10)]. Because clinical trials are conducted under widely varying conditions, rates adverse effects observed in clinical trials of a drug can not be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice. The data described below are based on 839 patients gathered from a double-blind, randomized, multicenter, placebo-controlled trial of a week in adult patients with acute infection, mechanical pain, lower back [see Clinical Studies (14)]. In the study, patients women's sleepwear shirt and soma were treated with 350 mg of carisoprodol or placebo three times daily and at bedtime for seven days. The average age was 41 years with females and males 54% 46% 74% ofCaucasians, 16% Black, 9%, other 2%. There were no deaths and no serious adverse reaction to the test.
In the study, 2.7% and 5.4% of patients treated with placebo and 350 mg of carisoprodol, women's sleepwear shirt and soma respectively abandonnéestraitement due to adverse events, 0.5% and 1.8% of placebo-treated patients and 350 mg of carisoprodol, respectively, discontinued due to adverse events in the women's sleepwear shirt and soma central nervous system. Table 1 shows the adverse events reported with a frequency greater than 2% and more frequently than placebo-treated patients in the trial described above carisoprodol. The following events were reported duranteposterior to the approval of the use of carisoprodol.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiovascular: tachycardia, flushing, orthostatic hypotension and facial [see Overdosage (10)]. CNS: drowsiness, dizziness, ataxia, tremor, agitation, irritability, headache, depressive reactions, syncope, insomnia and seizures [see Overdosage (10)]. Gastrointestinal: nausea, vomiting and epigastric pain. The sedative effects of CNS depressants and carisoprodol (eg, alcohol, benzodiazepines, opioids, tricyclic antidepressants) may be additive. Therefore, caution should be exercised with patients who take women's sleepwear shirt and soma more than one of these CNS depressants simultaneously.
Concomitant use of carisoprodol and meprobamate, a metabolite of carisoprodol is not recommended [see Warnings and Precautions (5.1)]. Carisoprodol is metabolized in the liver by CYP2C19 to form meprobamate [see Clinical Pharmacology (12.3)]. Co-administration of CYP2C19 inhibitors such as omeprazole or fluvoxamine, with carisoprodol may cause increased exposure of carisoprodol and decreased exposure of meprobamate. Co-administration of CYP2C19 inducers, such as rifampicin or St John's wort with carisoprodol may cause a reduction in exposure to carisoprodol and increased exposure of meprobamate. Low doses of aspirin also showed an effect of induction of CYP2C19. The impact of the potential exposure of changes in terms of drug efficacy or safety of carisoprodol is unknown.
Pregnancy There are no data on the use women's sleepwear shirt and soma of carisoprodol pregnancy. Animal studies indicate that carisoprodol crosses the placenta and causes women's sleepwear shirt and soma adverse effects on fetal growth and postnatal survival. The major metabolite of carisoprodol, meprobamate, is an approved anxiolytic. Retrospective, post-marketing studies do not show a consistent association between maternal consumption of meprobamate and an increased risk of birth defects in women's sleepwear shirt and soma particular. Teratogenic effects: Animal studies have not adequately evaluated the teratogenic effects of carisoprodol.