SERTRALINE-WGR

What it is

SERTRALINE-WGR contains sertraline hydrochloride as the active ingredient, available in 50 mg and 100 mg tablet 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

— 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. — Treatment of social phobia (social anxiety disorder) in adults and prevention of its relapse. — Treatment of premenstrual dysphoric disorder in adults as defined by DSM-IV criteria.

Dosing overview

For children aged 6–12 years with obsessive compulsive disorder, SERTRALINE-WGR 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 50 mg once daily, with the usual therapeutic dose being 50 mg per day. For panic disorder, therapy should commence at 25 mg per day, increasing to 50 mg per day after one week, which has been demonstrated to reduce early treatment-emergent side effects. For social phobia (social anxiety disorder), 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 50 mg per day either continuously or intermittently, with patients not responding to this dose potentially benefiting from increases up to 150 mg per day with continuous dosing or 100 mg per day with luteal phase dosing. The maximum recommended dose of sertraline is 200 mg per day.

Key safety warnings

The development of potentially life-threatening serotonin syndrome or neuroleptic malignant syndrome has been reported with SERTRALINE-WGR, particularly with concomitant use of serotonergic drugs including amphetamines, triptans and certain opioids, drugs that impair serotonin metabolism, and antipsychotics. SERTRALINE-WGR should not be used in combination with a monoamine oxidase inhibitor, or within 14 days of discontinuing treatment with a monoamine oxidase inhibitor. Similarly, at least 14 days should be allowed after stopping SERTRALINE-WGR before starting a monoamine oxidase inhibitor. 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, and this risk may persist until significant remission occurs. 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 a course of treatment or at the time of dose changes. Pooled analyses of short-term placebo-controlled trials of nine antidepressant medicines in children and adolescents revealed a greater risk of adverse events representing suicidal behaviour or thinking during the initial treatment period, with the average risk being 4% for those receiving antidepressants compared with 2% for placebo. Bleeding abnormalities have been reported with use of selective serotonin reuptake inhibitors, and this risk may be potentiated by concurrent use of non-steroidal anti-inflammatory drugs, aspirin or other medicines that affect coagulation. SERTRALINE-WGR should be used with caution in patients concomitantly treated with medicines that increase the risk of bleeding. Hyponatraemia may occur as a result of treatment with SERTRALINE-WGR, often as a result of syndrome of inappropriate antidiuretic hormone secretion. Elderly patients may be at greater risk of developing hyponatraemia.

Contraindications

SERTRALINE-WGR is contraindicated in patients with known hypersensitivity to sertraline. Concomitant use in patients taking pimozide is contraindicated. SERTRALINE-WGR should not be used in combination with a monoamine oxidase inhibitor.

Regulatory history

SERTRALINE-WGR was first registered on the Australian Register of Therapeutic Goods on 12 February 2013, with two registered variants: the 50 mg tablet and 100 mg tablet.