APO-PREGABALIN

What it is

APO-PREGABALIN contains the active ingredient pregabalin and is available in capsules of 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg or 300 mg.

Approved indications

— Neuropathic pain in adults. — Adjunctive therapy in adults with partial seizures with or without secondary generalisation.

Dosing overview

APO-PREGABALIN may be taken with or without food. If APO-PREGABALIN has to be discontinued, it is recommended to withdraw it gradually over a minimum of one week. Patients with diabetic neuropathy should be assessed for renal impairment prior to commencing APO-PREGABALIN and dosage adjusted appropriately.

Key safety warnings

APO-PREGABALIN is a potential drug of misuse, abuse, and dependence, and poses risks 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 monitored regularly during treatment, particularly amongst patients with current or past misuse, abuse or dependence of opioids and/or benzodiazepines. The effectiveness of APO-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 should be assessed before extending therapy for longer than 12 weeks.

Regulatory history

APO-PREGABALIN was first listed on the Australian Register of Therapeutic Goods on 23 July 2019 across 16 variant entries covering capsule strengths from 25 mg to 300 mg in blister and bottle pack sizes.