Product Dossier
ADRABALIN
Product Dossier for ADRABALIN (pregabalin, AdiraMedica). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: AdiraMedica
- 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
ADRABALIN 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
— Neuropathic pain in adults. — Adjunctive therapy in adults with partial seizures with or without secondary generalisation.
Dosing overview
ADRABALIN may be taken with or without food. If ADRABALIN 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 that can lead to overdose and death especially when used concomitantly with opioids and other central nervous system 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
ADRABALIN received ARTG registration on 28 March 2022 in four strengths: 25 mg, 75 mg, 150 mg, and 300 mg capsules.