Posology : מינונים

4.2    Posology and method of administration
Posology
The dose range is 150 to 600 mg per day given in either two or three divided doses.

Neuropathic pain
Pregabalin treatment can be started at 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.

Fibromyalgia
The usual dose of LYRICA for most fibromyalgia patients is 300 to 450 mg/day given in two divided doses. Some patients may derive additional benefit at 600 mg per day. Dosing should begin at 75 mg two times a day (150 mg/day) and may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient benefit with 300 mg/day may be further increased to 225 mg two times a day (450 mg/day). If needed, in some patients, based on individual response and tolerability, the dose may be increased to maximum dosage of 600 mg/day after an additional week.

Generalised anxiety disorder
The dose range is 150 to 600 mg per day given as two or three divided doses. The need for treatment should be reassessed regularly.

Pregabalin treatment can be started with a dose of 150 mg per day. Based on individual patient response and tolerability, the dose may be increased to 300 mg per day after 1 week. Following an additional week the dose may be increased to 450 mg per day. The maximum dose of 600 mg per day may be achieved after an additional week.

Discontinuation of pregabalin
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).

Renal impairment
Pregabalin is eliminated from the systemic circulation primarily by renal excretion as unchanged drug. 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 (CLcr) ), as indicated in Table 1 determined using the following formula:


CLcr(ml/min) 
140 - age (years) x weight (kg)   ( x 0.85 for female patients) 72 x serum creatinine (mg/dl)

Pregabalin is removed effectively from plasma by haemodialysis (50% of drug in 4 hours). For patients receiving haemodialysis, the pregabalin daily dose should be adjusted 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).



Table 1. Pregabalin Dose Adjustment Based on Renal Function

Creatinine clearance (CLcr)
Total pregabalin daily dose*                           Dose regimen
(ml/min)
Starting dose (mg/day)        Maximum dose
(mg/day)
≥ 60                             150                       600                    BID or TID ≥ 30 - < 60                          75                       300                    BID or TID ≥ 15 - < 30                        25 – 50                    150                    QD or BID < 15                              25                        75                        QD Supplementary dosage following haemodialysis (mg)
25                       100                    Single dose+
TID = Three divided doses
BID = Two divided doses
QD = Single daily dose
* Total daily dose (mg/day) should be divided as indicated by dose regimen to provide mg/dose +
Supplementary dose is a single additional dose

Hepatic impairment
No dosage adjustment is required for patients with hepatic impairment (see section 5.2).

Paediatric population
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. Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.

Elderly
Elderly patients may require a dose reduction of pregabalin due to a decreased renal function (see section 5.2).

Method of administration
Lyrica may be taken with or without food.
Lyrica is for oral use only.