Product Dossier
NEURONTIN
Product Dossier for NEURONTIN (gabapentin, Viatris). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: Viatris
- Active ingredient: gabapentin
- Therapeutic area: Neurology
- Related brand: GABACOR
- Related brand: GAPENTIN
- Related brand: APX-GABAPENTIN
- Same area: GILENYA
- Same area: RIVOTRIL
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 .