AKM-PREGABALIN

What it is

AKM-PREGABALIN is available as capsules containing pregabalin 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg or 300 mg.

Approved indications

— Treatment of neuropathic pain in adults. — Adjunctive therapy in adults with partial seizures with or without secondary generalisation.

Dosing overview

AKM-PREGABALIN may be taken with or without food. If AKM-PREGABALIN has to be discontinued, it is recommended to withdraw it gradually over a minimum of one week. Pregabalin is eliminated primarily by renal excretion as unchanged drug, and dosage reduction in patients with compromised renal function must be individualised according to creatinine clearance.

Key safety warnings

Pregabalin is a potential drug of misuse, abuse and dependence, and poses risks of misuse, abuse and dependence which can lead to overdose and death especially when used concomitantly with opioids and other CNS depressants. The patient's risk of misuse, abuse or dependence should be assessed before prescribing and the patient should be monitored regularly during treatment, particularly amongst patients with current or past misuse, abuse or dependence of opioids and/or benzodiazepines. The effectiveness of AKM-PREGABALIN in the treatment of neuropathic pain has not been assessed in controlled clinical trials for treatment periods longer than 12 weeks, and the risks and benefits of treatment to an individual patient should be assessed before extending therapy for longer than 12 weeks.

Regulatory history

AKM-PREGABALIN was first listed on the ARTG on 5 June 2018, with 12 registered variants across strengths of 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg in blister pack and bottle presentations.