Product Dossier
PHARMAGABAPENTIN
Product Dossier for PHARMAGABAPENTIN (gabapentin, Pharmacor). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: Pharmacor
- Active ingredient: gabapentin
- Therapeutic area: Neurology
- Related brand: NEURONTIN
- Related brand: GABACOR
- Related brand: GAPENTIN
- Same area: GILENYA
- Same area: RIVOTRIL
What it is
PHARMAGABAPENTIN is available as 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
Gabapentin can be given orally with or without food. Dosage adjustment is recommended in patients with neuropathic pain or epilepsy who have compromised renal function or who are undergoing haemodialysis.
Key safety warnings
PHARMAGABAPENTIN is a potential drug of abuse and dependence, and poses risks of abuse and dependence which can lead to overdose and death, especially when used concomitantly with opioids and other CNS 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
PHARMAGABAPENTIN was first registered on the ARTG on 6 February 2014, with registrations for 100 mg, 300 mg and 400 mg capsule formulations.