APX-AMITRIPTYLINE

What it is

APX-AMITRIPTYLINE is a tricyclic antidepressant with sedative properties. It contains amitriptyline hydrochloride in strengths of 10 mg, 25 mg or 50 mg. Amitriptyline inhibits the membrane pump mechanism responsible for uptake of noradrenaline and serotonin in adrenergic and serotonergic neurons.

Approved indications

— Treatment of major depression. — Nocturnal enuresis where organic pathology has been excluded.

Dosing overview

Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerance.

Key safety warnings

The risk of suicide attempt 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 behaviour, whether or not they are taking antidepressant medications. 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 (SCARs), including drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported in association with amitriptyline treatment. Most of these reactions occurred within 2 to 6 weeks. If signs and symptoms suggestive of these reactions appear, APX-AMITRIPTYLINE should be withdrawn immediately and must not be restarted in that patient at any time. Patients with cardiovascular disorders should be watched closely. Tricyclic antidepressant medicines, particularly when given in high doses, have been reported to produce arrhythmias, sinus tachycardia, and prolongation of the conduction time. The 50 mg tablets are indicated only for the maintenance treatment of major depression and should not be used in acutely ill patients where there is a risk of suicide. There is an increased risk of completed suicide by overdose with the 50 mg tablet compared with the 25 mg tablet.

Contraindications

APX-AMITRIPTYLINE is contraindicated in patients who have shown prior hypersensitivity to it. It should not be given concurrently with monoamine oxidase inhibitors, including selegiline. The combination has caused severe convulsions, hyperpyretic crises and death. A minimum of 14 days should be allowed to elapse after the monoamine oxidase inhibitor is discontinued before initiating APX-AMITRIPTYLINE. APX-AMITRIPTYLINE is contraindicated in patients taking cisapride due to the possibility of adverse cardiac interactions including prolongation of the QT interval, cardiac arrhythmias and conduction system disturbances.

PBS listing

Information regarding PBS listing is not available in the provided source documents.

Regulatory history

APX-AMITRIPTYLINE received initial ARTG registration on 18 May 2020, with three strengths registered: 10 mg, 25 mg and 50 mg tablet blister packs.