APO-MIRTAZAPINE

What it is

APO-MIRTAZAPINE contains mirtazapine in orally disintegrating tablet formulations of 15 mg, 30 mg and 45 mg. The tablets contain aspartame as an excipient with known effect. The 15 mg, 30 mg and 45 mg tablets are white, round tablets that disintegrate on the tongue.

Approved indications

— Treatment of major depression including relapse prevention

Dosing overview

Treatment should begin with 15 mg daily in adults. 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 that for adults; dosage increases should be done under close supervision. APO-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 a positive response expected within 2–4 weeks at an adequate dose.

Key safety warnings

The risk of suicidality is inherent in depression and may persist until significant remission occurs. Patients should be closely monitored for clinical worsening and suicidality, especially at the beginning of treatment or at times of dose changes. Patients and caregivers should be alerted to monitor for worsening of condition and the emergence of suicidal ideation or behaviour, and to seek medical advice immediately if these symptoms present. Hyponatremia has been reported very rarely with mirtazapine use, and caution should be exercised in patients at risk, such as elderly patients or those taking medications known to cause hyponatremia. Severe cutaneous adverse reactions including Stevens–Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, bullous dermatitis and erythema multiforme have been reported in association with mirtazapine treatment. If signs and symptoms suggestive of these reactions appear, mirtazapine should be withdrawn immediately.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, with symptoms mostly appearing after 2–6 weeks of treatment. One should be alert for symptoms such as fever, sore throat, stomatitis or other signs of infections, and if such symptoms occur, treatment should be stopped and blood counts taken. Abrupt termination of treatment after long-term administration may result in withdrawal symptoms, which are usually mild and self-limiting; dizziness, agitation, anxiety, headache and nausea are the most frequently reported.

Contraindications

APO-MIRTAZAPINE is contraindicated in patients with hypersensitivity to mirtazapine or to any of the excipients. It is contraindicated with MAO inhibitors as concomitant therapy, and should not be used in combination with MAO inhibitors, or within 14 days of initiating or discontinuing therapy with a MAO inhibitor.

PBS listing

No information on PBS listing is available in the provided documents.

Regulatory history

APO-MIRTAZAPINE mirtazapine 15 mg, 30 mg and 45 mg tablets were first listed on the ARTG on 14 August 2007 (licence category RE).