Sertraline-TIH

What it is

Sertraline-TIH is a tablet formulation containing sertraline hydrochloride as the active ingredient, available in 50 mg and 100 mg strengths. Sertraline is an antidepressant whose mechanism of action is presumed to be linked to its inhibition of central nervous system neuronal uptake of serotonin.

Approved indications

**Children and adolescents** — Treatment of obsessive compulsive disorder in children aged 6 years of age and older and adolescents. **Adults** — Treatment of major depression, obsessive compulsive disorder and panic disorder. — Treatment of social phobia (social anxiety disorder) and the prevention of its relapse. — Treatment of premenstrual dysphoric disorder as defined by DSM-IV criteria.

Dosing overview

For children with obsessive compulsive disorder aged 6–12 years, treatment should commence at 25 mg per day for the first week then increase to 50 mg per day; adolescents aged 13–18 years may commence at 50 mg per day. In children, a dose of 200 mg per day should not be exceeded. For adults with major depression or obsessive compulsive disorder, treatment should be initiated with a dose of 50 mg once daily, which is the usual therapeutic dose. Patients not responding to a 50 mg per day dose may benefit from dose increases up to a maximum of 200 mg per day. For panic disorder, therapy should commence at 25 mg per day, increasing to 50 mg per day after one week. For social phobia, therapy should commence at 25 mg per day, increasing to 50 mg per day after one week. For premenstrual dysphoric disorder, treatment should be initiated with a dose of 50 mg per day either continuously or intermittently depending on physician assessment. Sertraline-TIH should be administered once daily, either in the morning or evening, and may be administered with or without food.

Key safety warnings

Potentially life-threatening serotonin syndrome or neuroleptic malignant syndrome has been reported with sertraline, with increased risk when used concomitantly with serotonergic drugs, drugs that impair metabolism of serotonin, antipsychotics and other dopamine antagonists. Cases of QTc prolongation and torsade de pointes have been reported during post-marketing use of sertraline, with the majority of reports occurring in patients with other risk factors for QTc prolongation; sertraline should be used with caution in patients with risk factors for QTc prolongation. The risk of suicide is inherent in depression and must be considered in all depressed patients; patients may experience worsening of depressive symptoms and emergence of suicidal ideation and behaviours, and 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 short-term placebo-controlled trials in children and adolescents with major depressive disorder, obsessive compulsive disorder, or other psychiatric disorders revealed a greater risk of suicidal behaviour or thinking during the initial treatment period, with an average risk of 4% in those receiving antidepressants compared with 2% of patients treated with placebo. Bleeding abnormalities have been reported with sertraline use, with risk potentially potentiated by concurrent use of certain medications; sertraline should be used with caution in patients concomitantly treated with medicines that increase the risk of bleeding or in patients with a history of abnormal bleeding. Hyponatraemia may occur as a result of treatment with sertraline, often as a result of syndrome of inappropriate antidiuretic hormone secretion, with elderly patients at greater risk. Upon discontinuation of sertraline, particularly when abrupt, adverse events have been reported including dysphoric mood, irritability, agitation, dizziness, sensory disturbances, anxiety, confusion, headache and insomnia; patients should be monitored for these symptoms and a gradual reduction in dose rather than abrupt cessation is recommended.

Contraindications

Sertraline-TIH is contraindicated in patients with known hypersensitivity to sertraline. Concomitant use in patients taking pimozide is contraindicated. Sertraline-TIH should not be used in combination with a monoamine oxidase inhibitor, or within 14 days of discontinuing treatment with a monoamine oxidase inhibitor.

Regulatory history

Sertraline-TIH was first registered on the Australian Register of Therapeutic Goods on 27 September 2013, with two registrations for 50 mg and 100 mg tablet formulations under licence category RE.