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Neuropathic Pain: The recommended starting dose for Pregabalin Capsule (Pregabalin) is 75 mg BID (150 mg/day), with or without food. Efficacy of Pregabalin was demonstrated in patients dosed in a range of 150 to 600 mg/day. For the majority of patients, 150 mg BID will be the optimal dose. Efficacy of Pregabalin has been demonstrated within the first week. However, based on individual patient response and tolerability, the dose may be increased to 150 mg BID after an interval of 3 to 7 days, and if needed, to a maximum dose of 300 mg BID after an additional week.
Epilepsy: The recommended effective starting dose for Pregabalin Capsule (Pregabalin) is 75 mg BID (150 mg/day), with or without food. Efficacy of pregabalin was demonstrated in patients dosed in a range of 150 to 600 mg/day. Efficacy of pregabalin has been demonstrated as early as 1 week. However, based on individual patient response and tolerability, the dose may be increased to 150 mg BID after 1 week and if needed, to a maximum dose of 300 mg BID after and 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 and additional week the dosage may be increased to 450 per day. The maximum dosage 600 mg per day may be achieved after an additional week.
Fibromyalgia: The recommended dose of Pregabalin is 300 to 450 mg/day given in two divided doses. 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). Although Pregabalin was also studied at 600 mg/day, there is no view of the dose dependent adverse reactions, treatment which dose above 450 mg/day is not recommended. Because Pregabalin is eliminated primarily renal excretion, adjust the dose in patients with reduced renal function.
Discontinuation of Pregabalin: In accordance with current clinical practice, if Pregabalin Capsule (Pregabalin) has to be discontinued either in neuropathic pain or epilepsy, it is recommended this should be done gradually over a minimum of 1 week.
Patients with 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, dosage reduction in patients with compromised renal function must be individualized according to creatinine clearance (CLcr), as indicated in Table 1 determined using the following formula: see formula.
Click on icon to see table/diagram/imageFor 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).
Click on icon to see table/diagram/imageUse in Patients with Hepatic Impairment: No dosage adjustment is required for patients with hepatic impairment.
Use in Children and Adolescents (12 to 17 years of age): The safety and effectiveness of Pregabalin in pediatric patients below the age of 12 years and adolescents has not been established.
Use in the Elderly (over 65 years of age): Elderly patients may require a dose reduction of Pregabalin due to decreased renal function.
