Product Dossier
PREGABALIN-DRLA
Product Dossier for PREGABALIN-DRLA (pregabalin, Dr Reddys Laboratories). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: Dr Reddys Laboratories
- 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-DRLA is a medicine containing the active ingredient pregabalin, available in capsule strengths of 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 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-DRLA may be taken with or without food. If PREGABALIN-DRLA needs to be discontinued, it is recommended to withdraw it gradually over a minimum of one week.
Key safety warnings
PREGABALIN-DRLA 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. Patients' risk of misuse, abuse or dependence should be assessed before prescribing, and patients should be monitored regularly during treatment, particularly those with current or past misuse, abuse or dependence of opioids and benzodiazepines.
Regulatory history
PREGABALIN-DRLA was first registered on the ARTG on 21 December 2016, with eight strength variants (25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg capsules).