Product Dossier
MIPENTINE
Product Dossier for MIPENTINE (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
MIPENTINE is a gabapentin medicine registered on the ARTG in 600 mg and 800 mg film coated tablet formulations. The 600 mg tablets contain 600 mg of gabapentin, and the 800 mg tablets contain 800 mg of 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
MIPENTINE tablets are unscored and should not be broken; they can only be used in stabilised patients. Alternative brands of gabapentin must be used for initiation of treatment. Dosage adjustment is recommended in patients with neuropathic pain or epilepsy who have compromised renal function or who are undergoing haemodialysis.
Key safety warnings
MIPENTINE 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
MIPENTINE gabapentin 600 mg and 800 mg film coated tablets were first registered on the ARTG on 5 December 2017.