Product Dossier

LYZALON

Product Dossier for LYZALON (pregabalin, Accord Healthcare). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.

What it is

LYZALON contains the active ingredient pregabalin. LYZALON is available as pregabalin capsules in strengths of 25 mg, 75 mg, 150 mg and 300 mg.

Approved indications

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

Dosing overview

The dose range is 150 to 600 mg per day given in two divided doses. For neuropathic pain, pregabalin treatment can be started at a dose of 150 mg per day, given as two divided doses, and 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. Patients with diabetic neuropathy should be assessed for renal impairment prior to commencing LYZALON and dosage adjusted appropriately. For epilepsy, pregabalin treatment can be started with a dose of 150 mg per day given as two divided doses, and the dosage may be increased to 300 mg per day after 1 week, with a maximum dosage of 600 mg per day achieved after an additional week. If LYZALON has to be discontinued, it is recommended to withdraw it gradually over a minimum of one week.

Key safety warnings

LYZALON 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. Patients' risk of misuse, abuse or dependence should be assessed before prescribing and patients should be monitored regularly during treatment, particularly amongst those with current or past misuse, abuse or dependence of opioids and/or benzodiazepines.

PBS listing

LYZALON is listed on the PBS in four strengths: 25 mg, 75 mg, 150 mg and 300 mg capsules, each as a single item with streamlined restriction. Ex-manufacturer prices are A$3.73 for 25 mg, A$4.00 for 75 mg, A$5.94 for 150 mg and A$8.85 for 300 mg.

Regulatory history

LYZALON pregabalin capsules in all four strengths were first registered on the ARTG on 23 March 2016.