Product Dossier
Pregabalin-WGR
Product Dossier for Pregabalin-WGR (pregabalin, GM Pharma). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: GM Pharma
- 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
Pregabalin-WGR is a capsule formulation containing pregabalin 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
Pregabalin-WGR may be taken with or without food. If Pregabalin-WGR has to be discontinued, it is recommended to withdraw it gradually over a minimum of one week. Patients with diabetic neuropathy should be assessed for renal impairment prior to commencing Pregabalin-WGR and dosage adjusted appropriately. In patients with compromised renal function, dosage reduction must be individualised according to creatinine clearance.
Key safety warnings
Pregabalin-WGR is a potential drug of misuse, abuse, and dependence, with risks that can lead to overdose and death, especially when used concomitantly with opioids and other CNS 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/or benzodiazepines.
Regulatory history
Pregabalin-WGR was first listed on the ARTG on 5 February 2024 across 16 registered variants in strengths of 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg, supplied in blister and bottle pack formats.