APX-MIRTAZAPINE

What it is

APX-MIRTAZAPINE is an orally disintegrating tablet containing 15, 30 or 45 mg mirtazapine. The 15 mg tablet is white and round, debossed with '36' on one side and 'A' on the other; the 30 mg tablet is debossed with '37'; and the 45 mg tablet is debossed with '38'. The tablet disintegrates rapidly on the tongue and can be swallowed with or without water.

Approved indications

— Treatment of major depression including relapse prevention.

Dosing overview

Treatment should begin with 15 mg daily, with dosage generally increased to obtain optimal clinical response; the effective daily dose is usually between 30 and 45 mg, but responses have been observed at 60 mg per day. The recommended dose for elderly patients is the same as for adults, though dosing increases should be done under close supervision to elicit a satisfactory and safe response. Mirtazapine has a half-life of 20–40 hours and is suitable for once-daily administration, preferably as a single night-time dose before going to bed. Mirtazapine begins to exert its effect after 1–2 weeks of treatment, with an adequate dose generally producing a positive response within 2–4 weeks.

Key safety warnings

The risk of suicidality (suicidal ideation and behaviours) is inherent in depression and may persist until significant remission occurs; patients may experience worsening of depressive symptoms and emergence of suicidal ideation whether or not they are taking antidepressants. Patients should be closely monitored for clinical worsening and suicidality, especially at the beginning of treatment or at times of dose changes. Bone marrow depression, usually presenting as granulocytopenia or agranulocytosis, has been reported during treatment; symptoms mostly appear after 2–6 weeks and the depression is generally reversible after termination, though in very rare cases agranulocytosis can be fatal. Patients should be alert for symptoms like fever, sore throat or stomatitis, and if such symptoms occur, treatment should be stopped and blood counts taken. Severe cutaneous adverse reactions including Stevens–Johnson syndrome, toxic epidermal necrolysis and drug reaction with eosinophilia and systemic symptoms, which can be life-threatening or fatal, have been reported; if signs suggestive of these reactions appear, mirtazapine should be withdrawn immediately. Hyponatraemia has been reported very rarely with mirtazapine; caution should be exercised in elderly patients or those concomitantly treated with medications known to cause hyponatraemia.

Contraindications

Mirtazapine is contraindicated in patients with hypersensitivity to mirtazapine or to any of the excipients. Mirtazapine is contraindicated with MAO inhibitors as concomitant therapy, and it is recommended that mirtazapine not be used in combination with MAO inhibitors, or within 14 days of initiating or discontinuing therapy with a MAO inhibitor.

Regulatory history

APX-MIRTAZAPINE was first registered on the ARTG on 25 January 2012 with three entries: the 15 mg tablets (ARTG 183398), 30 mg tablets (ARTG 183399) and 45 mg tablets (ARTG 183400), all in blister pack form.