NUPENTIN

What it is

NUPENTIN contains the active ingredient gabapentin and is available in 100 mg, 300 mg, and 400 mg capsules.

Approved indications

— Treatment of partial seizures, including secondarily generalised tonic-clonic seizures, initially as add-on therapy in adults and children aged 3 years and above who have not achieved adequate control with standard anti-epileptic drugs. — Treatment of neuropathic pain.

Dosing overview

Dose adjustment is recommended in patients with compromised renal function and in those undergoing haemodialysis.

Key safety warnings

NUPENTIN is a potential drug of abuse and dependence, posing risks that can lead to overdose and death, especially when used with opioids and other CNS depressants. Patients' risk of abuse or dependence should be assessed before prescribing and monitored regularly during treatment, particularly in patients with current or past abuse or dependence of opioids and benzodiazepines. NUPENTIN has been associated with central nervous system depression including sedation, somnolence and serious respiratory depression, which may occur without concomitant opioid use; patients with compromised respiratory function, respiratory or neurological disease, renal impairment and elderly patients are at higher risk, and concomitant use of CNS depressants including opioids with NUPENTIN increases the risk of respiratory depression. Concomitant use of opioids may result in severe sedation, respiratory depression, coma and death. Anti-epileptic drugs including NUPENTIN increase the risk of suicidal thoughts or behaviour in patients taking these drugs for any indication, and patients should be monitored for emergence or worsening of depression, suicidal thoughts or behaviour, and any unusual changes in mood or behaviour. Severe cutaneous adverse reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis and Drug rash with eosinophilia and systemic symptoms, which can be life-threatening or fatal, have been reported rarely in association with NUPENTIN treatment. Withdrawal symptoms have been observed in some patients after discontinuation of NUPENTIN, including severe symptoms in patients taking high doses, with symptoms occurring shortly after discontinuation, usually within 48 hours, and most frequently including anxiety, insomnia, nausea, pains, sweating, tremor, headache, depression, feeling abnormal, dizziness, malaise and diarrhoea.

Contraindications

NUPENTIN is contraindicated in patients who have demonstrated hypersensitivity to gabapentin or the inactive ingredients in the capsules.

Regulatory history

NUPENTIN 100 mg, 300 mg and 400 mg capsules were first listed on the ARTG on 23 July 2004 with licence category RE.