Product Dossier

NEURONTIN

Product Dossier for NEURONTIN (gabapentin, Viatris). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.

What it is

NEURONTIN is available as 600 mg and 800 mg tablets containing gabapentin . The 600 mg tablets are white to off white, oval shaped, film coated tablets, while the 800 mg tablets are white to off white, capsule shaped, film coated tablets .

Approved indications

— Partial seizures, including secondarily generalised tonic-clonic seizures, initially as add-on therapy in adults who have not achieved adequate control with standard antiepileptic drugs. — Neuropathic pain.

Dosing overview

NEURONTIN 600 mg and 800 mg tablets are unscored and cannot be broken, and can only be used in stabilised patients . Alternative brands of gabapentin must be used for initiation of treatment .

Dosage adjustment is recommended in patients with neuropathic pain or epilepsy who have compromised renal function or who are undergoing haemodialysis .

Key safety warnings

NEURONTIN is a potential drug of abuse and dependence, posing risks which can lead to overdose and death especially when used concomitantly with opioids and other CNS depressants . Assess the patient's risk of abuse or dependence before prescribing and monitor the patient regularly during treatment, particularly amongst patients with current or past abuse or dependence of opioids and/or benzodiazepines .

PBS listing

NEURONTIN 600 mg tablets are listed on the PBS as 2 items with streamlined and authority required restrictions, with an ex-manufacturer price of A$21.21 . NEURONTIN 800 mg tablets are listed on the PBS as 2 items with streamlined and authority required restrictions, with an ex-manufacturer price of A$25.88 .

Regulatory history

NEURONTIN gabapentin 600 mg and 800 mg tablets were first listed on the ARTG on 29 February 2000 .