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Xyrem
sodium oxybate
Black Box Warnings .
Appropriate Use
restricted distribution through Xywav and Xyrem REMS Program at www.xywavxyremrems.com or 1-866-997-3688 due to risks of CNS depression, abuse, and misuse; prescribers and patients must enroll and use centralized pharmacy that is specially certified
CNS Depressant
obtundation and clinically significant respiratory depression occurred in adult patients at recommended doses; many patients in clinical trials for narcolepsy also received CNS stimulants
Abuse and Misuse
sodium oxybate is sodium salt of gamma hydroxybutyrate (GHB); GHB abuse or misuse, either alone or in combination with other CNS depressants, may lead to seizures, respiratory depression, decr. level of consciousness, coma, and death
Adult Dosing .
Dosage forms: SOLUTION: 0.5 g per mL
Restricted Distribution in US
- [1-866-997-3688 or www.xywavxyremrems.com for more info]
narcolepsy
- [6-9 g PO qhs in 2 divided doses]
- Start: 4.5 g PO qhs in 2 divided doses, incr. by 1.5 g/day qwk; Max: 9 g/day; Info: for patients with cataplexy or excessive daytime sleepiness; give doses at night in bed 2.5-4h apart; give at least 2h after meal
renal dosing
- [see below]
- renal impairment: not defined, caution advised
- HD/PD: not defined
hepatic dosing
- [adjust dose amount]
- hepatic impairment: decr. usual start dose by 50%
Peds Dosing .
- Dosage forms: SOLUTION: 0.5 g per mL
Restricted Distribution in US
- [1-866-997-3688 or www.xywavxyremrems.com for more info]
narcolepsy
- [7 yo and older, 20-29 kg]
- Dose: 2-6 g PO qhs in 2 divided doses; Start: up to 2 g PO qhs in 2 divided doses, then may incr. by up to 1 g/day qwk; Max: 3 g/dose up to 6 g/day; Info: for patients with cataplexy or excessive daytime sleepiness; give doses at night in bed 2.5-4h apart; give at least 2h after meal
- [7 yo and older, 30-44 kg]
- Dose: 3-7.5 g PO qhs in 2 divided doses; Start: up to 3 g PO qhs in 2 divided doses, then may incr. by up to 1 g/day qwk; Max: 3.75 g/dose up to 7.5 g/day; Info: for patients with cataplexy or excessive daytime sleepiness; give doses at night in bed 2.5-4h apart; give at least 2h after meal
- [7 yo and older, >45 kg]
- Dose: 4.5-9 g PO qhs in 2 divided doses; Start: up to 4.5 g PO qhs in 2 divided doses, then may incr. by up to 1.5 g/day qwk; Max: 4.5 g/dose up to 9 g/day; Info: for patients with cataplexy or excessive daytime sleepiness; give doses at night in bed 2.5-4h apart; give at least 2h after meal
renal dosing
- [see below]
- renal impairment: not defined, caution advised
- HD/PD: not defined
hepatic dosing
- [adjust dose amount]
- hepatic impairment: decr. usual start dose by 50%