Product Dossier
PREBALIN
Product Dossier for PREBALIN (pregabalin, Arrotex Pharmaceuticals). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: Arrotex Pharmaceuticals
- Active ingredient: pregabalin
- Therapeutic area: Neurology
- Related brand: LYZALON
- Related brand: ADIMEDI
- Related brand: Pregabalin-AFT
- Same area: GILENYA
- Same area: RIVOTRIL
What it is
PREBALIN is a capsule containing the active ingredient pregabalin, available in strengths of 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg or 300 mg.
Approved indications
— Treatment of neuropathic pain in adults. — Adjunctive therapy in adults with partial seizures with or without secondary generalisation.
Dosing overview
PREBALIN may be taken with or without food. Patients with diabetic neuropathy should be assessed for renal impairment prior to commencing treatment and dosage adjusted appropriately. If PREBALIN has to be discontinued, it is recommended to withdraw it gradually over a minimum of one week.
Key safety warnings
Pregabalin is a potential drug of misuse, abuse and dependence, and poses risks which can lead to overdose and death especially when used concomitantly with opioids and other central nervous system depressants. The patient's risk of misuse, abuse or dependence should be assessed before prescribing and the patient monitored regularly during treatment, particularly amongst patients with current or past misuse, abuse or dependence of opioids and benzodiazepines.
Regulatory history
PREBALIN pregabalin capsules in strengths of 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg were first listed on the ARTG on 23 July 2019.