ARTG Entry
GABAPENTIN
ARTG entry for GABAPENTIN (gabapentin), ARTG 284396 — Product Information, dosage form, registration history. Compiled by arcimedes.
- Sponsor: Micro Labs
- Active ingredient: gabapentin
- Therapeutic area: Neurology
What it is
GABAPENTIN is available as 600 mg and 800 mg film coated tablets containing gabapentin.
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 600 mg and 800 mg tablets are unscored and cannot be broken into smaller doses. 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
GABAPENTIN 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 central nervous system 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.
Regulatory history
GABAPENTIN tablets in 600 mg and 800 mg strengths were first registered on the Australian Register of Therapeutic Goods on 5 December 2017.