Sodium oxybate

UK SPC (Sodium Oxybate 500 mg/mL oral solution) section 4.2: 'The recommended starting dose is 4.5 g/day sodium oxybate divided into two equal doses of 2.25 g/dose. The dose should be titrated to effect based on efficacy and tolerability up to a maximum of 9 g/day divided into two equal doses of 4.5 g/dose by adjusting up or down in dose increments of 1.5 g/day (i.e. 0.75 g/dose).' A minimum of one to two weeks is recommended between dose increments. The dose of 9 g/day should not be exceeded, because of the possible occurrence of severe symptoms at doses of 18 g/day or above. Single doses of 4.5 g should not be given unless the patient has previously been titrated to that dose level. If the patient stops taking the product for more than 14 consecutive days, titration should be restarted from the lowest dose. Both doses should be made up at the same time on retiring to bed; each measured dose is dispensed into the supplied dosing cup and diluted with 60 mL of water, and doses must be taken within 24 hours of preparation or discarded. Because food significantly reduces bioavailability, patients should eat at least 2-3 hours before the first (bedtime) dose and always keep the same timing of dosing in relation to meals. Hepatic impairment: the starting dose should be halved in all patients with hepatic impairment, with close monitoring of the response to dose increments. Elderly: monitor closely for impaired motor and/or cognitive function. Paediatrics: safety and efficacy in children and adolescents aged 0 to 18 years have not been established and no data are available — verify any paediatric use against a children's formulary. Treatment should be initiated by and remain under the guidance of a physician experienced in the treatment of sleep disorders. NOTE ON INTERACTIONS: the UK SPC section 4.5 was not captured in this bundle; the interaction entries below are taken from the cross-referenced warnings in section 4.4 — verify against section 4.5 of the UK SPC.