PREGABALIN SANDOZ

What it is

Pregabalin Lupin is available as capsules containing 25, 50, 75, 100, 150, 200, 225 or 300 mg of pregabalin.

Approved indications

— Treatment of neuropathic pain in adults. — Adjunctive therapy in adults with partial seizures with or without secondary generalisation.

Dosing overview

The dose range is 150 to 600 mg per day given in two divided doses. Pregabalin Lupin capsules may be taken with or without food. For neuropathic pain, treatment can be started at 150 mg per day given as two divided doses, increased to 300 mg per day after 3 to 7 days, and if needed, to a maximum of 600 mg per day after an additional 7-day interval, based on individual patient response and tolerability. Patients with diabetic neuropathy should be assessed for renal impairment prior to commencing pregabalin and dosage adjusted appropriately. For epilepsy, treatment can be started with 150 mg per day given as two divided doses, increased to 300 mg per day after one week, and to a maximum of 600 mg per day after an additional week, based on individual patient response and tolerability. Dosage adjustment is required for patients with renal impairment, with daily doses ranging from 25 mg to 600 mg depending on creatinine clearance. No dosage adjustment is necessary for elderly patients unless their renal function is compromised. If pregabalin has to be discontinued, it is recommended to withdraw it gradually over a minimum of one week.

Key safety warnings

Pregabalin Lupin 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. 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. Antiepileptic drugs, including pregabalin, increase the risk of suicidal thoughts or behaviour in patients taking these drugs for any indication, and patients should be monitored for the emergence or worsening of depression, suicidal thoughts or behaviour, and/or any unusual changes in mood or behaviour. Pregabalin causes dizziness and somnolence, which generally begin shortly after initiation and occur more frequently at higher doses; these were the adverse events most frequently leading to withdrawal (4% each) from controlled studies. Hypersensitivity reactions, including cases of angioedema, have been reported in post-marketing experience; pregabalin should be discontinued immediately if symptoms of angioedema such as facial, perioral, or upper airway swelling occur. Severe cutaneous adverse reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, which can be life-threatening or fatal, have been reported rarely; patients should be advised of the signs and symptoms and monitored closely, and pregabalin should be withdrawn immediately if these reactions appear. Concomitant use of opioids may result in severe sedation, respiratory depression, coma, and death; dosages and durations of pregabalin should be limited to the minimum required and patients monitored for signs and symptoms of respiratory depression and sedation. Pregabalin use in the first trimester of pregnancy may cause major birth defects in the unborn child and should not be used during pregnancy unless the benefit to the mother clearly outweighs the potential risk to the fetus.

Contraindications

Pregabalin Lupin is contraindicated in patients who have demonstrated hypersensitivity to pregabalin or to any of the excipients.

Regulatory history

Pregabalin Lupin was first registered on the Australian Register of Therapeutic Goods on 14 February 2017, with twelve variants approved across strengths of 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg in capsule blister pack formulations.