Product Dossier
ADIMEDI
Product Dossier for ADIMEDI (pregabalin, AdiraMedica). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: AdiraMedica
- Active ingredient: pregabalin
- Therapeutic area: Neurology
- Related brand: LYZALON
- Related brand: Pregabalin-AFT
- Related brand: LYRICA
- Same area: GILENYA
- Same area: RIVOTRIL
What it is
ADIMEDI contains the active ingredient pregabalin, available in capsule strengths of 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg or 300 mg. Not all strengths or pack sizes are being distributed in Australia.
Approved indications
— Treatment of neuropathic pain in adults. — Adjunctive therapy in adults with partial seizures with or without secondary generalisation.
Dosing overview
ADIMEDI may be taken with or without food. If ADIMEDI 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 ADIMEDI and dosage adjusted appropriately.
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 CNS depressants. Assess the patient's risk of misuse, abuse or dependence before prescribing and monitor the patient regularly during treatment, particularly amongst patients with current or past misuse, abuse or dependence of opioids and/or benzodiazepines.
Regulatory history
ADIMEDI pregabalin was registered on the ARTG on 28 March 2022, with four strengths listed: 25 mg, 75 mg, 150 mg and 300 mg capsules.