Posted by ed_uk on February 17, 2006, at 15:27:15
Xyrem
Composition: Sodium oxybate.
Presentation: 500mg/ml oral solution.
Class: Central nervous system depressant.
Indications: Treatment of cataplexy in adult patients with narcolepsy.
Dosage: The recommended starting dose is 2.25g (4.5ml) twice a day. One dose should be taken orally on getting into bed and the second dose taken between 2.5 and 4 hours later. The dose should be titrated up to a maximum of 4.5g (9ml) twice a day, by adjusting up or down in increments of 0.75g (1.5ml) per dose. A minimum of two weeks is recommended between dosage increments. Each dose of Xyrem must be diluted before ingestion with 60 ml of water using the dosing cup provided. Food significantly reduces the bioavailability of sodium oxybate. Patients should eat at least two to three hours before taking the medicine and observe the same timing of dosing in relation to meals. If the patient stops medication for more than 14 consecutive days, titration should be restarted from the lowest dose.
Precautions: Patients should be evaluated for a history of drug abuse and such patients should be closely monitored. Use should be avoided in patients with porphyria. Patients should be questioned and monitored for signs of central nervous system or respiratory depression, and alcohol, benzodiazepines and other CNS depressant drugs should not be used concomitantly. Mental alertness and motor co-ordination can be affected and patients should not drive within at least six hours of the dose. Patients should be thoroughly evaluated and monitored if neuropsychological effects occur (see side effects). Reduced sodium intake should be carefully considered in patients with heart failure, hypertension or renal impairment. The starting dose should be halved in patients with hepatic impairment due to reduced clearance of the drug. Seizures have been observed in patients, and therefore use in patients with epilepsy is not recommended. See SPC.
Side effects: Very common (>1/10) sleep disorder, dizziness, headache, nausea (more common in women). Common (>1/100 to <1/10) hypersensitivity, anorexia, abnormal dreams, abnormal thinking, confusion, disorientation, nightmares, sleepwalking, depression, hallucination, agitation, sleep paralysis, somnolence, tremor, amnesia, blurred vision, vomiting, upper abdominal pain, diarrhoea, sweating, rash, muscle cramps, nocturnal enuresis, asthenia, fatigue, feeling drunk, blood pressure increase.
Legal category: CD (Benz) P*M.
Net price: 180ml £360.
Contact details: UCB Pharma, 208 Bath Road, Slough, SL1 3WE. Telephone 01753 534655.
poster:ed_uk
thread:610645
URL: http://www.dr-bob.org/babble/20060212/msgs/610645.html