SERTRA

What it is

Sertraline hydrochloride is an antidepressant for oral administration that is chemically unrelated to tricyclic, tetracyclic, or other available antidepressant agents. The mechanism of action is presumed to be linked to its inhibition of central nervous system neuronal uptake of serotonin. SERTRA is available in 50 mg and 100 mg film-coated tablets.

Approved indications

— Treatment of children aged 6 years and older and adolescents with obsessive compulsive disorder. — Treatment of major depression in adults. — Treatment of obsessive compulsive disorder in adults. — Treatment of panic disorder in adults.

Dosing overview

The maximum recommended dose is 200 mg daily. SERTRA should be administered once daily, either in the morning or evening, and may be administered with or without food. The onset of therapeutic effect may be seen within seven days; however, for full activity two to four weeks are usually necessary for depression, and possibly even longer for OCD.

Key safety warnings

Serotonin syndrome or Neuroleptic Malignant Syndrome has been reported with sertraline. The risk is increased with concomitant use of serotonergic drugs including amphetamines, triptans, and opioids, with drugs that impair metabolism of serotonin including monoamine oxidase inhibitors, and with antipsychotics. The risk of suicide is inherent in depression and may persist until significant remission occurs. Patients may experience worsening of depressive symptoms and emergence of suicidal ideation and behaviours whether or not they are taking antidepressant medications. Patients should be closely monitored for clinical worsening and suicidality, especially at the beginning of treatment or at the time of dose changes. A pooled analysis of 24 short-term placebo-controlled trials in 4400 children and adolescents revealed a greater risk of suicidal behaviour or thinking during the initial treatment period in those receiving antidepressants, with an average risk of 4% compared with 2% with placebo. Bleeding abnormalities have been reported with the use of sertraline. This risk may be potentiated by concurrent use of atypical antipsychotics and phenothiazines, most tricyclic antidepressants, non-steroidal anti-inflammatory drugs, aspirin or other medicines that affect coagulation. Sertraline should be used with caution in patients concomitantly treated with medicines that increase the risk of bleeding. Hyponatremia may occur as a result of treatment with sertraline, often as a result of syndrome of inappropriate antidiuretic hormone secretion. Elderly patients may be at greater risk of developing hyponatremia. Upon discontinuation of sertraline, particularly when abrupt, adverse events have been reported including dysphoric mood, irritability, agitation, dizziness, sensory disturbances, anxiety, confusion, headache, lethargy, emotional lability, insomnia, and hypomania. While these events are generally self-limiting, some have been reported to be severe. A gradual reduction in dose rather than abrupt cessation is recommended whenever possible.

Contraindications

SERTRA is contraindicated in patients with known hypersensitivity to sertraline or any of the components. Concomitant use in patients taking pimozide is contraindicated. Serious reactions, sometimes fatal, have been reported in patients receiving sertraline in combination with monoamine oxidase inhibitors. Sertraline should not be used in combination with a monoamine oxidase inhibitor, or within 14 days of discontinuing treatment with one. Similarly, at least 14 days should be allowed after stopping sertraline before starting a monoamine oxidase inhibitor.

Regulatory history

SERTRA 50 mg and 100 mg tablets were first listed on the ARTG on 4 August 2005.