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Lyrica

Pregabalin

1. NAME OF THE MEDICINAL PRODUCT

LYRICA 50 mg, 75mg and 150mg hard capsules.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

50mg

Each hard capsule contains 50 mg of pregabalin.

75mg

Each hard capsule contains 75 mg of pregabalin.

150mg

Each hard capsule contains 150 mg of pregabalin.

Pregabalin capsules also contain lactose monohydrate. For a full list of excipients, see section 6.1 List of excipients.

3. PHARMACEUTICAL FORM

50mg hard capsules White, marked "Pfizer" on the cap and "PGN 50" on the body with black ink. The body is also marked with a black band.

75mg hard capsules White and orange, marked "Pfizer" on the cap and "PGN 75" on the body with black ink.

150mg hard capsules White, marked "Pfizer" on the cap and "PGN 150" on the body with black ink.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Neuropathic pain

Pregabalin is indicated for the treatment of neuropathic pain in adults.

Epilepsy

Pregabalin is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.

Generalised Anxiety Disorder

Pregabalin is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.

Fibromyalgia

Pregabalin is indicated for the management of fibromyalgia.

4.2 Posology and method of administration

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/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 one 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 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/day is not recommended (see section 4.8 Undesirable effects). Because LYRICA is eliminated primarily by renal excretion, the dose should be adjusted for patients with reduced renal function (creatinine clearance less than 60 mL/min - see section 4.2 Posology and method of administration, Patients with renal impairment).

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 section 4.8 Undesirable effects).

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

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 dosage adjustment based on renal function

TID = Three divided doses

BID = Two divided doses

* 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

Pregabalin is not recommended for use in children below the age of 12 years and adolescents (12 - 17 years of age) due to insufficient data on safety and efficacy (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 a decreased renal function (see section 5.2 Pharmacokinetic properties, Pharmacokinetics in special patient groups, Elderly (over 65 of age).

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