Product Dossier
APX-GABAPENTIN
Product Dossier for APX-GABAPENTIN (gabapentin, Arrotex Pharmaceuticals). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: Arrotex Pharmaceuticals
- Active ingredient: gabapentin
- Therapeutic area: Neurology
- Related brand: NEURONTIN
- Related brand: GABACOR
- Related brand: GAPENTIN
- Same area: GILENYA
- Same area: RIVOTRIL
What it is
APX-GABAPENTIN is available in 600 mg and 800 mg tablet strengths, containing gabapentin as the active ingredient.
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
APX-GABAPENTIN 600 mg and 800 mg tablets are unscored and cannot be used for initiation of treatment, dose titration or to achieve lower daily dose regimens; APX-GABAPENTIN can only be used in stabilised patients. Dosage adjustment is recommended in patients with neuropathic pain or epilepsy who have compromised renal function or who are undergoing haemodialysis.
Key safety warnings
APX-GABAPENTIN 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 CNS depressants. Patients' risk of abuse or dependence should be assessed before prescribing and patients should be monitored regularly during treatment, particularly amongst patients with current or past abuse or dependence of opioids and/or benzodiazepines.
Regulatory history
APX-GABAPENTIN 600 mg and 800 mg tablets were first listed on the ARTG on 14 September 2018. APX-GABAPENTIN 300 mg and 400 mg capsules, and 100 mg capsules were first listed on the ARTG on 2 July 2020.