Product Dossier
GABAPENTIN-WGR
Product Dossier for GABAPENTIN-WGR (gabapentin, GM Pharma). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: GM Pharma
- Active ingredient: gabapentin
- Therapeutic area: Neurology
- Related brand: NEURONTIN
- Related brand: GABACOR
- Related brand: GAPENTIN
- Same area: GILENYA
- Same area: RIVOTRIL
What it is
GABAPENTIN-WGR is a registered Australian medicine containing gabapentin, available in strengths of 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 who have not achieved adequate control with standard antiepileptic drugs. — Treatment of neuropathic pain.
Dosing overview
Dosage adjustment is recommended in patients with neuropathic pain or epilepsy who have compromised renal function or who are undergoing haemodialysis.
Key safety warnings
GABAPENTIN-WGR is a potential drug of abuse and dependence, posing risks of abuse and dependence which can lead to overdose and death especially when used concomitantly with opioids and other central nervous system depressants. The patient's risk of abuse or dependence should be assessed before prescribing and the patient should be monitored regularly during treatment, particularly amongst patients with current or past abuse or dependence of opioids and/or benzodiazepines.
Regulatory history
GABAPENTIN-WGR was first listed on the ARTG on 2 July 2020, with three registered capsule strengths: 100 mg, 300 mg, and 400 mg.