REGADEX Hard capsule Ref.[28042] Active ingredients: Pregabalin

The dose range is 150 to 600 mg per day given in either two or three divided doses.

Pregabalin may be taken with or without food.

Neuropathic pain

Pregabalin treatment can be started at a dose of 150 mg per day. Based on individual patient response and tolerability, the dosage 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.

Epilepsy

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

Fibromyalgia

The recommended dose of pregabalin is 300 to 450 mg per day. Dosing should begin at 75 mg two times a day (150 mg per day) and may be increased to 150 mg two times a day (300 mg per day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient benefit with 300 mg per day may be further increased to 225 mg two times a day (450 mg per day). Although pregabalin was also studied at 600 mg per day, there is no evidence that this dose confers additional benefit and that this dose was less tolerated.

In view of the dose-dependent adverse reactions, treatment with doses above 450 mg per day is not recommended.

Discontinuation of pregabalin

If pregabalin has to be discontinued, it is recommended this should be done gradually over a minimum of 1 week independent of the indication.

Patients with renal impairment

Dosage reduction in patients with compromised renal function must be individualised according to creatinine clearance (CLcr) (see Section 5.2 Pharmacokinetic properties, Pharmacokinetics in special patient groups, Renal impairment), as indicated in Table 1 determined using the following formula:

CL_cr (mL/min) = [140 – age (years)] x weight (kg) / 72 x serum creatinine (mg/dl) (x 0.85 for female patients)

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 Dosage Adjustment Based on Renal Function:

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.

Use in patients with hepatic impairment

No dosage adjustment is required for patients with hepatic impairment (see Section 5.2 Pharmacokinetic properties, Pharmacokinetics in special patient groups, Hepatic impairment).

Use in children and adolescents (12 to 17 years of age)

The safety and effectiveness of pregabalin in paediatric patients below the age of 12 years and adolescents have not been established. The use in children and adolescents is not recommended (see Section 5.3 Preclinical safety data).

Use in the elderly (over 65 years of age)

Elderly patients may require a dose reduction of pregabalin due to decreased renal function (see Section 5.2 Pharmacokinetic properties, Pharmacokinetics in special patient groups, Elderly (over 65 years of age)).

In overdoses up to 15 g, no unexpected adverse reactions were reported. In the post-marketing experience, the most commonly reported adverse events observed when pregabalin was taken in overdose included affective disorder, somnolence, confusional state, depression, agitation, and restlessness. Seizures were also reported. Treatment of pregabalin overdose should include general supportive measures and may include haemodialysis if necessary (see Section 4.2 Posology and method of administration, Table 1).

36 months.

Store at or below 30°C.

The hard capsules are packed in 7 capsules/ Alu-Alu blister x 8.

No special requirements.