Pregabalin Teva

Pregabalin Teva Dosage/Direction for Use

pregabalin

Manufacturer:

Pliva Ltd

Distributor:

DKLL

Marketer:

Teva 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: The usual dose range for most patients is 300 mg to 400 mg per 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.
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).
Patients with renal impairment: Pregabalin is eliminated from the systemic circulation primarily by renal excretion as unchanged active substance.
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:
CLcr (ml/min) = [(1.23 x [140 - age(years)] x weight(kg))/Serum creatinine(μmol/l)](x 0.85 for female patients)
Pregabalin is removed effectively from plasma by haemodialysis (50% of active substance 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

Patients with hepatic impairment: No dose adjustment is required for patients with hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).
Elderly (over 65 years of age) population: Elderly patients may require a dose reduction of pregabalin due to a decreased renal function (see Patients with renal impairment as previously mentioned).
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. Currently available data are described in Adverse Reactions and Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions but no recommendation on a posology can be made.
Method of administration: Pregabalin Teva may be taken with or without food.
Pregabalin Teva is for oral use only.
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