Pregabalin Sandoz

Pregabalin Sandoz Dosage/Direction for Use

pregabalin

Manufacturer:

Sandoz

Distributor:

Zuellig Pharma
Full Prescribing Info
Dosage/Direction for Use
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.
Epilepsy: 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 1 week. The maximum dose 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 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.
Fibromyalgia: For the management of fibromyalgia in adults, the recommended dosage of pregabalin is 300-450 mg daily. Pregabalin therapy generally is initiated at a dosage of 150 mg daily (75 mg twice daily); dosage may be increased to 300 mg daily (150 mg twice daily) within 1 week based on efficacy and tolerability. Patients who do not experience adequate benefit with pregabalin 300 mg daily may have dosage further increased to the maximum recommended dosage of 450 mg daily (225 mg twice daily).
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 Precautions and Adverse Reactions).
Special populations: 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 (see Pharmacology: Pharmacokinetics under Actions), 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: See Equation.

Click on icon to see table/diagram/image

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).

Click on icon to see table/diagram/image

Use in patients with hepatic impairment: No dose adjustment is required for patients with hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: The safety and efficacy of Pregabalin in children below the age of 12 years and in adolescents (12-17 years of age) have not been established. No data are available.
Use in the elderly (over 65 years of age): Elderly patients may require a dose reduction of pregabalin due to a decreased renal function (see patients with renal impairment).
Method of administration: Pregabalin may be taken with or without food.
PREGABALIN is for oral use only.
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