Product Dossier

NEUROCCORD

Product Dossier for NEUROCCORD (pregabalin, Pharmacor). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.

What it is

Neuroccord is pregabalin, available as capsules in strengths of 25 mg, 75 mg, 150 mg and 300 mg.

Approved indications

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

Dosing overview

Neuroccord may be taken with or without food. If discontinuation is necessary, Neuroccord should be withdrawn gradually over a minimum of one week.

Key safety warnings

Neuroccord is a potential drug of misuse, abuse and dependence, with risks that can lead to overdose and death especially when used with opioids and other CNS depressants. Assess the patient's risk of misuse, abuse or dependence before prescribing and monitor patients regularly during treatment, particularly those with current or past misuse, abuse or dependence of opioids and benzodiazepines. Severe cutaneous adverse reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, which can be life-threatening or fatal, have been reported rarely with pregabalin. Patients should be advised of signs and symptoms and monitored closely for skin reactions; if these appear, pregabalin should be withdrawn immediately. Antiepileptic drugs including pregabalin increase the risk of suicidal thoughts or behaviour in patients taking these drugs for any indication. Patients should be monitored for emergence or worsening of depression, suicidal thoughts or behaviour, and unusual changes in mood or behaviour. Neuroccord causes dizziness and somnolence, which generally begin shortly after initiation and occur more frequently at higher doses. Concomitant use with opioids may result in severe sedation, respiratory depression, coma and death; dosages should be limited to the minimum required and patients monitored for signs of respiratory depression and sedation. Withdrawal symptoms have been observed after discontinuation of Neuroccord, including insomnia, headache, nausea, anxiety, hyperhidrosis and diarrhoea.

Contraindications

Neuroccord is contraindicated in patients who have demonstrated hypersensitivity to pregabalin or to any of the excipients.

Regulatory history

Neuroccord pregabalin capsules in strengths of 25 mg, 75 mg, 150 mg and 300 mg were first listed on the ARTG on 23 March 2016.