ZOLOFT

What it is

ZOLOFT is available in tablet strengths of 50 mg and 100 mg, each containing sertraline hydrochloride as the active ingredient. The 50 mg tablets are white, film-coated, capsular-shaped tablets debossed with "VLE" on one side and "ZLT 50" on the other, whilst the 100 mg tablets are similarly styled with "ZLT 100". ZOLOFT is administered orally once daily, either in the morning or evening, and may be taken with or without food.

Approved indications —

Obsessive compulsive disorder in children aged 6 years and older and adolescents — Major depression in adults — Obsessive compulsive disorder in adults — Panic disorder in adults — Social phobia (social anxiety disorder) in adults and prevention of its relapse — Premenstrual dysphoric disorder in adults as defined by DSM-IV criteria

Dosing overview

**Children and adolescents (6–18 years) with OCD:** For children aged 6–12 years, ZOLOFT is commenced at 25 mg daily for the first week, then increased to 50 mg daily. Adolescents aged 13–18 years may commence at 50 mg daily. Clinical effects may be noted after 2 weeks of treatment, but clinical responses should be monitored for 6 weeks before any dose increase. In children, a dose of 200 mg daily should not be exceeded. **Adults:** For major depression and obsessive compulsive disorder, treatment is initiated with 50 mg once daily, which is the usual therapeutic dose. Patients not responding to 50 mg daily may benefit from dose increases up to a maximum of 200 mg daily. For panic disorder and social phobia, therapy commences at 25 mg daily, increasing to 50 mg daily after one week; this regimen has been demonstrated to reduce early treatment-emergent side effects. For premenstrual dysphoric disorder, treatment is initiated at 50 mg daily, either continuously or intermittently during the luteal phase, with dose increases up to 150 mg daily (continuous dosing) or 100 mg daily (luteal phase dosing) for non-responders.

Key safety warnings

The development of potentially life-threatening syndromes like serotonin syndrome or neuroleptic malignant syndrome has been reported with ZOLOFT, particularly with concomitant use of serotonergic drugs, drugs that impair metabolism of serotonin, antipsychotics and dopamine antagonists. The risk of suicide is inherent in depression and may persist until significant remission occurs. Patients with depression may experience worsening of depressive symptoms and/or emergence of suicidal ideation and behaviours, whether or not taking antidepressants. Patients should be closely monitored for clinical worsening and suicidality, especially at the beginning of treatment or at times of dose changes. Bleeding abnormalities have been reported with ZOLOFT, and this risk may be potentiated by concurrent use of atypical antipsychotics, phenothiazines, tricyclic antidepressants, non-steroidal anti-inflammatory drugs, aspirin or other medicines that affect coagulation. ZOLOFT 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 ZOLOFT, often as a result of syndrome of inappropriate antidiuretic hormone secretion. Elderly patients may be at greater risk of developing hyponatraemia. Adverse events including dysphoric mood, irritability, agitation, dizziness, sensory disturbances, anxiety, confusion, headache, lethargy, emotional lability, insomnia and hypomania have been reported upon discontinuation of ZOLOFT, particularly when abrupt. Patients should be monitored for these symptoms, and a gradual reduction in dose rather than abrupt cessation is recommended whenever possible.

Contraindications

ZOLOFT is contraindicated in patients with known hypersensitivity to sertraline. Concomitant use in patients taking pimozide is contraindicated. ZOLOFT should not be used in combination with a monoamine oxidase inhibitor, or within 14 days of discontinuing treatment with a MAOI. Similarly, at least 14 days should be allowed after stopping ZOLOFT before starting a MAOI.

PBS listing

ZOLOFT tablets of 50 mg and 100 mg strength are listed on the PBS with restriction type. The ex-manufacturer price for each strength is A$8.83.

Regulatory history

ZOLOFT 50 mg and 100 mg tablets were first registered on the Australian Register of Therapeutic Goods on 2 September 2019, sponsored by Viatris.