ARTG Entry
GAPENTIN
ARTG entry for GAPENTIN (gabapentin), ARTG 107498 — Product Information, dosage form, registration history. Compiled by arcimedes.
- Sponsor: Arrotex Pharmaceuticals
- Active ingredient: gabapentin
- Therapeutic area: Neurology
What it is
GAPENTIN is a gabapentin tablet medicine available in 600 mg and 800 mg strengths.
Approved indications
— Treatment of partial seizures, including secondarily generalised tonic-clonic seizures, as add-on therapy in adults who have not achieved adequate control with standard antiepileptic drugs. — Treatment of neuropathic pain.
Dosing overview
GAPENTIN is available as 600 mg and 800 mg unscored tablets and should not be broken into half; it can only be used in stabilised patients. Gabapentin can be given orally with or without food.
Key safety warnings
GAPENTIN is a potential drug of abuse and dependence, and poses risks 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 monitored regularly during treatment, particularly amongst patients with current or past abuse or dependence of opioids and/or benzodiazepines.
Regulatory history
GAPENTIN was first registered on the ARTG on 4 July 2005 with gabapentin capsule formulations in 100 mg, 300 mg and 400 mg strengths. GAPENTIN tablet formulations in 600 mg and 800 mg strengths were added to the ARTG on 3 June 2010.