Also caution patients against these hazardous activities for at least 6 hours after taking XYREM. In addition, if short-term use of an opioid (eg, post- or perioperative) is required, interruption of treatment with XYREM should be considered.Īfter first initiating treatment and until certain that XYREM does not affect them adversely (eg, impair judgment, thinking, or motor skills), caution patients against hazardous activities requiring complete mental alertness or motor coordination such as operating hazardous machinery, including automobiles or airplanes. If use of these CNS depressants in combination with XYREM is required, dose reduction or discontinuation of one or more CNS depressants (including XYREM) should be considered. The concurrent use of XYREM with other CNS depressants, including but not limited to opioid analgesics, benzodiazepines, sedating antidepressants or antipsychotics, sedating anti-epileptic drugs, general anesthetics, muscle relaxants, and/or illicit CNS depressants, may increase the risk of respiratory depression, hypotension, profound sedation, syncope, and death. WARNINGS AND PRECAUTIONS Central Nervous System Depression patients with succinic semialdehyde dehydrogenase deficiency.combination with sedative hypnotics or alcohol.Change in number of cataplexy attacks from baseline (2-week, single-blind, lead-in phase) to end point (2-week, double-blind treatment phase)ĬONTRAINDICATIONS XYREM is contraindicated for use in:.Evaluate the continued efficacy of XYREM after long-term use for the treatment of cataplexy in patients with narcolepsy.80% were taking concomitant stimulant medications.3 g or 4.5 g per night (4% and 16% of patients, respectively).Mean duration of prior treatment with XYREM: 21 months.Median frequency of cataplexy attacks over 2 weeks: 3.0.Continuous treatment with XYREM for at least 6 months prior to study.A history of 5 or more cataplexy attacks per week prior to receiving any treatment for cataplexy.55 narcolepsy patients with inclusion criteria featuring:.Compared effects of continuing established dosages of 3 g, 4.5 g, 6 g, 7.5 g, or 9 g per night with placebo after a 2-week, single-blind, lead-in baseline phase.Assessed the long-term efficacy of orally administered XYREM compared with placebo.Randomized, double-blind, placebo-controlled, multicenter trial.
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