EDRONAX

What it is

Edronax tablets contain 5.2 mg reboxetine mesilate corresponding to 4 mg reboxetine free base. Reboxetine is a highly selective and potent inhibitor of noradrenaline reuptake, with only a weak effect on the serotonin reuptake and no effect on the uptake of dopamine.

Approved indications

— Treatment of major depression and prevention of the relapse of depressive symptoms.

Dosing overview

The recommended therapeutic dose in adults is 4 mg twice daily (8 mg/day) administered orally, and after 3 weeks the dose can be increased up to 10 mg/day in case of incomplete clinical response. In the elderly (more than 65 years), the recommended dose is 2 mg twice daily (4 mg/day), which can be increased to 6 mg/day after 3 weeks if needed. In patients with renal or moderate to severe hepatic insufficiency, the starting dose should be 2 mg twice daily, increased according to patient tolerance. The onset of clinical effect is usually seen after 14 days of treatment.

Key safety warnings

Since rare cases of seizures have been reported in clinical studies, Edronax should be given under close supervision to subjects with a history of convulsive disorder and should be discontinued if the patient develops seizures. 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 emergence of suicidal ideation and behaviours whether or not they are taking antidepressant medications. As improvement may not occur during the first few weeks or more of treatment, 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 about the need to monitor for any worsening of condition and emergence of suicidal ideation or behaviour and to seek medical advice immediately if these symptoms present. Potentially life-threatening serotonin syndrome has been reported with reboxetine alone and with concomitant use of other serotonergic drugs including selective serotonin reuptake inhibitors, other serotonin-norepinephrine reuptake inhibitors, triptans, tricyclic and tetracyclic antidepressants, lithium, opioids, tryptophan, buspiron, monoamine oxidase inhibitors and St. John's Wort. Serotonin syndrome may include mental status changes, autonomic instability, neuromuscular abnormalities and gastrointestinal signs and symptoms. Patients should be monitored for the emergence of serotonin syndrome. Patients particularly aged more than 65 years with a history of cardiac disease, including hypertension, should be closely supervised when being treated with reboxetine. Orthostatic hypotension has been observed with greater frequency at doses higher than the maximum recommended. Close supervision is recommended when administering Edronax with other drugs known to lower blood pressure.

Contraindications

Hypersensitivity to reboxetine or any of the excipients. Concomitant use in patients taking monoamine oxidase inhibitors is contraindicated. Since reboxetine has a weak mydriatic effect, its use is not recommended in patients with narrow angle glaucoma.

Regulatory history

Edronax reboxetine 4 mg tablet blister pack was first listed on the Australian Register of Therapeutic Goods on 24 August 2001. Edronax reboxetine 4 mg tablet bottle was first listed on the Australian Register of Therapeutic Goods on 10 February 2026.