APO-SERTRALINE

What it is

APO-SERTRALINE is available in 50 mg and 100 mg tablet strengths, each containing sertraline as the active ingredient in the form of sertraline hydrochloride. 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 aged 6 years and older and adolescents with obsessive compulsive disorder — Adults with major depression — Adults with obsessive compulsive disorder — Adults with panic disorder — Adults with social phobia (social anxiety disorder) and prevention of its relapse — Adults with premenstrual dysphoric disorder as defined by DSM-IV criteria

Dosing overview

For children aged 6–12 years with obsessive compulsive disorder, treatment commences at 25 mg per day for the first week then increases 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 adults with panic disorder, therapy should commence at 25 mg per day, increasing to 50 mg per day after one week, a dosage regimen designed to reduce early treatment-emergent side effects. For adults with 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 a dose of 50 mg per day either continuously or intermittently. Patients not responding may benefit from dose increases up to 150 mg per day with daily dosing or 100 mg per day with luteal phase dosing. The maximum recommended dose of sertraline is 200 mg per day. APO-SERTRALINE 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 selective serotonin reuptake inhibitors including sertraline. The risk is increased with concomitant use of serotonergic drugs, drugs that impair serotonin metabolism including monoamine oxidase inhibitors, and antipsychotics. The risk of suicide attempt is inherent in depression and may persist until significant remission occurs. Patients with depression may experience worsening of 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 treatment or at the time of dose changes. Bleeding abnormalities have been reported with selective serotonin reuptake inhibitors including APO-SERTRALINE. This risk may be potentiated by concurrent use of atypical antipsychotics, phenothiazines, most tricyclic antidepressants, non-steroidal anti-inflammatory drugs, aspirin or other medicines that affect coagulation. APO-SERTRALINE should be used with caution in patients concomitantly treated with medicines that increase the risk of bleeding or in patients with a past history of abnormal bleeding. Hyponatraemia may occur as a result of treatment with sertraline. In many cases, hyponatraemia appears to be the result of a syndrome of inappropriate antidiuretic hormone secretion. Elderly patients may be at greater risk of developing hyponatraemia.

Contraindications

APO-SERTRALINE is contraindicated in patients with known hypersensitivity to sertraline. Concomitant use in patients taking pimozide is contraindicated due to the narrow therapeutic index of pimozide. APO-SERTRALINE 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 APO-SERTRALINE before starting a monoamine oxidase inhibitor.

Regulatory history

APO-SERTRALINE 50 mg and 100 mg tablet strengths were first listed on the ARTG on 27 September 2013.