SETRONA

What it is

SETRONA is a tablet formulation containing sertraline hydrochloride as the active ingredient, available in 50 mg and 100 mg strengths. Sertraline is an antidepressant that works by inhibiting the reuptake of serotonin in the central nervous system.

Approved indications

— Treatment of children aged 6 years and older and adolescents with obsessive compulsive disorder (OCD) — Treatment of major depression in adults — Treatment of obsessive compulsive disorder (OCD) in adults — Treatment of panic disorder in adults — Treatment of social phobia (social anxiety disorder) in adults and prevention of its relapse — Treatment of premenstrual dysphoric disorder (PMDD) in adults as defined by DSM-IV criteria

Dosing overview

For children aged 6–12 years with OCD, treatment should commence at 25 mg/day for the first week, then increase to 50 mg/day. Adolescents aged 13–18 years may commence at 50 mg/day. In children, a dose of 200 mg/day should not be exceeded. For adults, SETRONA treatment for major depression and OCD should be initiated with a dose of 50 mg once daily, which is also the usual therapeutic dose. For panic disorder, therapy should commence at 25 mg/day, increasing to 50 mg/day after one week to reduce early treatment-emergent side effects. For social phobia (social anxiety disorder), therapy should commence at 25 mg/day, increasing to 50 mg/day after one week. For premenstrual dysphoric disorder, treatment should be initiated with 50 mg/day either continuously or intermittently during the luteal phase, with dose increases up to 150 mg/day (daily dosing) or 100 mg/day (luteal phase dosing) if needed. The maximum recommended dose of sertraline is 200 mg/day. SETRONA should be administered once daily, either in the morning or evening.

Key safety warnings

The development of potentially life-threatening serotonin syndrome or neuroleptic malignant syndrome has been reported with SETRONA, with increased risk when used concomitantly with serotonergic drugs, drugs that impair serotonin metabolism (including MAOIs), antipsychotics, or other dopamine antagonists. SETRONA should not be used in combination with a monoamine oxidase inhibitor, or within 14 days of discontinuing such treatment. Similarly, at least 14 days should be allowed after stopping SETRONA before starting a MAOI. The risk of suicide attempt is inherent in depression and may persist until significant remission occurs. This risk must be considered in all depressed patients, and patients should be closely monitored for clinical worsening and suicidality, especially at the beginning of treatment or at the time of dose changes. Pooled analyses of placebo-controlled trials in 4400 children and adolescents revealed a greater risk of adverse events representing suicidal behaviour or thinking during the initial treatment period in those receiving antidepressants, with an average risk of 4% compared with 2% for placebo. Bleeding abnormalities including purpura, haematoma, epistaxis, and gastrointestinal bleeding have been reported with SSRIs, with increased risk when used concurrently with atypical antipsychotics, phenothiazines, tricyclic antidepressants, NSAIDs, aspirin, or other medicines affecting coagulation. SETRONA should be used with caution in patients concomitantly treated with medicines that increase bleeding risk. Hyponatraemia may occur as a result of SETRONA treatment, often secondary to syndrome of inappropriate antidiuretic hormone secretion. Elderly patients may be at greater risk. Signs and symptoms include headache, difficulty concentrating, memory impairment, confusion, weakness and unsteadiness, and in severe cases hallucination, syncope, seizure, coma, and respiratory arrest. Upon discontinuation of SETRONA, spontaneous reports of adverse events have occurred, particularly with abrupt cessation, including dysphoric mood, irritability, agitation, dizziness, sensory disturbances, anxiety, confusion, headache, lethargy, emotional lability, insomnia, and hypomania. While generally self-limiting, some have been reported as severe. Gradual dose reduction rather than abrupt cessation is recommended.

Contraindications

SETRONA is contraindicated in patients with known hypersensitivity to sertraline. Concomitant use with pimozide is contraindicated due to the narrow therapeutic index of pimozide.

Regulatory history

SETRONA 50 mg and 100 mg tablet formulations were first registered on the ARTG on 22 June 2006.