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Lumryz
sodium oxybate
Black Box Warnings .
Appropriate Use
restricted distribution through Lumryz REMS Program at www.lumryzrems.com or 1-877-453-1029 due to risks of CNS depression, abuse, and misuse; prescribers and pharmacies must be specially certified, and pts must enroll
CNS Depressant
clinically significant respiratory depression and obtundation may occur at recommended doses; many pts 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 w/ other CNS depressants, may lead to seizures, respiratory depression, decr. level of consciousness, coma, and death
Adult Dosing .
Dosage forms: ER SUSP: 4.5 g per pkt, 6 g per pkt, 7.5 g per pkt, 9 g per pkt; convenience pack
Restricted Distribution in US
- [1-877-453-1029 or www.lumryzrems.com for more info]
Special Note
- [convenience pack components]
- Info: 28-day starter pack contains 4.5 g pkt x7 and 6 g pkt x14 and 7.5 g pkt x7
narcolepsy w/ cataplexy or excessive daytime sleepiness
- [6-9 g PO qhs]
- Start: 4.5 g PO qhs, incr. by 1.5 g/day qwk; Max: 9 g/day; Info: give in bed at least 2h after meal; may switch from IR to ER form at nearest equivalent total daily dose
renal dosing
- [see below]
- renal impairment: not defined, caution advised
- HD/PD: not defined
hepatic dosing
- [see below]
- hepatic impairment: avoid use as initial tx, dose adjustment not possible w/ ER form, use IR form
Peds Dosing .
- Dosage forms: ER SUSP: 4.5 g per pkt, 6 g per pkt, 7.5 g per pkt, 9 g per pkt; convenience pack
Restricted Distribution in US
- [1-877-453-1029 or www.lumryzrems.com for more info]
Special Note
- [convenience pack components]
- Info: 28-day starter pack contains 4.5 g pkt x7 and 6 g pkt x14 and 7.5 g pkt x7
narcolepsy w/ cataplexy or excessive daytime sleepiness
- [7 yo and older, 20-29 kg]
- Dose: 4.5-6 g PO qhs; Start: after stabilized on nearest equivalent total daily dose w/ IR form; Max: 6 g/day; Info: give in bed at least 2h after meal
- [7 yo and older, 30-44 kg]
- Dose: 4.5-7.5 g PO qhs; Start: after stabilized on nearest equivalent total daily dose w/ IR form; Max: 7.5 g/day; Info: give in bed at least 2h after meal
- [7 yo and older, >45 kg]
- Dose: 4.5-9 g PO qhs; Start: 4.5 g PO qhs, then may incr. by 1.5 g/day qwk; Max: 9 g/day; Info: give in bed at least 2h after meal; may switch from IR to ER form at nearest equivalent total daily dose
renal dosing
- [see below]
- renal impairment: not defined, caution advised
- HD/PD: not defined
hepatic dosing
- [see below]
- hepatic impairment: avoid use as initial tx, dose adjustment not possible w/ ER form, use IR form