ARTG Entry
GABACOR
ARTG entry for GABACOR (gabapentin), ARTG 204498 — Product Information, dosage form, registration history. Compiled by arcimedes.
- Sponsor: Pharmacor
- Active ingredient: gabapentin
- Therapeutic area: Neurology
What it is
GABACOR 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
— 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
GABACOR can only be used in stabilised patients, as alternative brands of gabapentin must be used for initiation of treatment and dose titration. Dosage adjustment is recommended in patients with neuropathic pain or epilepsy who have compromised renal function or who are undergoing haemodialysis.
Key safety warnings
GABACOR 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. 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
GABACOR gabapentin 100 mg, 300 mg and 400 mg capsules were first listed on the ARTG on 6 February 2014.