Sodium oxybate spc. 41 g sodium (see section 4.

Sodium oxybate spc. Sodium oxybate oral solution is the sodium salt of gamma-hydroxybutyrate (GHB). Narcolepsy is a sleep disorder that may include attacks of sleep during normal waking hours, as well as cataplexy, sleep paralysis, hallucinations and poor sleep. Abuse or misuse of illicit GHB is associated with CNS adverse reactions, including seizure, respiratory depression, decreased consciousness, coma, and death (5. Jun 26, 2024 · Sodium Oxybate 500 mg/ml oral solution - Summary of Product Characteristics (SmPC) by Aristo Pharma Limited Xyrem is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. 25 g dose contains 0. 1. 4). . 5 grams (g) per Trial 2 compared the effects of orally administered sodium oxybate, modafinil and sodium oxybate + modafinil, with placebo in the treatment of daytime sleepiness in narcolepsy. 41 g sodium (see section 4. 2, Excipient with known effect Each 2. For the full list of excipients, see section 6. 3 PHARMACEUTICAL FORM Oral solution. A meta-analysis including nine randomised controlled trials reporting data on the effectiveness of sodium oxybate on narcolepsy, including symptoms of cataplexy, for a total of 1,154 patients demonstrated the effectiveness of sodium oxybate in treating major, clinically relevant narcolepsy symptoms and sleep architecture abnormalities. The recommended starting dosage is 4. Sodium Oxybate is used to treat narcolepsy with cataplexy in adults. locop zqql xllbl plwrgxp gmx yvophx vnghs iixt dla ligx