MIRTANZA

What it is

MIRTANZA is an orally disintegrating tablet containing mirtazapine, available in strengths of 15 mg, 30 mg and 45 mg. The tablet rapidly disintegrates 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. The effective daily dose is usually between 30 and 45 mg, but responses have been observed at 60 mg per day. It should be taken preferably as a single night-time dose before going to bed. Mirtazapine begins to exert its effect in general after 1–2 weeks of treatment, and treatment with an adequate dose should result in a positive response within 2–4 weeks. Treatment should preferably be continued until the patient has been completely symptom-free for 4–6 months.

Key safety warnings

The risk of suicidality is inherent in depression and may persist until significant remission occurs. Patients with depression may experience worsening of their depressive symptoms and/or the emergence of suicidal ideation and/or behaviours whether or not they are taking antidepressant medication. Patients should be closely monitored for clinical worsening and suicidality, especially at the beginning of a course of treatment, or at the time of dose changes. Severe cutaneous adverse reactions including Stevens–Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, bullous dermatitis and erythema multiforme, which can be life-threatening or fatal, have been reported. If signs and symptoms suggestive of these reactions appear, mirtazapine should be withdrawn immediately. Bone marrow depression, usually presenting as granulocytopenia or agranulocytosis, has been reported during treatment with mirtazapine. The symptoms mostly appear after 2–6 weeks of treatment. One should be alert for symptoms like fever, sore throat, stomatitis or other signs of infections. If such symptoms occur the treatment should be stopped and blood counts taken. Hyponatremia has been reported very rarely with the use of mirtazapine. Caution should be exercised in patients at risk, such as elderly patients or patients concomitantly treated with medications known to cause hyponatremia. Treatment should be discontinued if jaundice occurs.

Contraindications

Hypersensitivity to mirtazapine or to any of the excipients. Mirtazapine should not be used in combination with MAO inhibitors, or within 14 days of initiating or discontinuing therapy with a MAO inhibitor. Mirtazapine should not be used in children and adolescents under the age of 18 years.

PBS listing

MIRTANZA orally disintegrating tablets are listed on the PBS in strengths of 15 mg, 30 mg and 45 mg with restricted access. The ex-manufacturer prices are A$3.85 for the 15 mg strength, A$4.37 for the 30 mg strength, and A$6.58 for the 45 mg strength, with the latest schedule dated 2026-05-01.

Regulatory history

MIRTANZA orally disintegrating tablets were first listed on the ARTG on 25 January 2012 in strengths of 15 mg, 30 mg and 45 mg.