Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.Įlderly patients may require a dose reduction of pregabalin due to a decreased renal function (see section 5.2). The safety and efficacy of Lyrica in children below the age of 12 years and in adolescents (12-17 years of age) have not been established. No dose adjustment is required for patients with hepatic impairment (see section 5.2). + Supplementary dose is a single additional dose * Total daily dose (mg/day) should be divided as indicated by dose regimen to provide mg/dose Supplementary dosage following haemodialysis (mg) Pregabalin Dose Adjustment Based on Renal Function In addition to the daily dose, a supplementary dose should be given immediately following every 4 hour haemodialysis treatment (see Table 1).
For patients receiving haemodialysis, the pregabalin daily dose should be adjusted based on renal function. Pregabalin is removed effectively from plasma by haemodialysis (50% of drug in 4 hours). As pregabalin clearance is directly proportional to creatinine clearance (see section 5.2), dose reduction in patients with compromised renal function must be individualised according to creatinine clearance (CL cr), as indicated in Table 1 determined using the following formula: Pregabalin is eliminated from the systemic circulation primarily by renal excretion as unchanged drug. In accordance with current clinical practice, if pregabalin has to be discontinued, it is recommended this should be done gradually over a minimum of 1 week independent of the indication (see sections 4.4 and 4.8). The maximum dose of 600 mg per day may be achieved after an additional week. Following an additional week the dose may be increased to 450 mg per day. Based on individual patient response and tolerability, the dose may be increased to 300 mg per day after 1 week. Pregabalin treatment can be started with a dose of 150 mg per day. The need for treatment should be reassessed regularly. The dose range is 150 to 600 mg per day given as two or three divided doses. Pregabalin treatment can be started with a dose of 150 mg per day given as two or three divided doses. Based on individual patient response and tolerability, the dose may be increased to 300 mg per day after an interval of 3 to 7 days, and if needed, to a maximum dose of 600 mg per day after an additional 7-day interval.
Pregabalin treatment can be started at a dose of 150 mg per day given as two or three divided doses.
The dose range is 150 to 600 mg per day given in either two or three divided doses. Date of first authorisation/renewal of the authorisation
0 kommentar(er)
