ELEVA

What it is

ELEVA contains sertraline hydrochloride as the active ingredient, available in 50 mg and 100 mg tablet formulations. Sertraline works by inhibiting the uptake of serotonin in the central nervous system.

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 (PMDD) in adults as defined by DSM-IV criteria

Dosing overview

ELEVA should be administered once daily, either in the morning or evening. It may be administered with or without food. During prolonged maintenance therapy, dosage should be kept at the lowest effective level.

Key safety warnings

Potentially life-threatening serotonin syndrome or neuroleptic malignant syndrome may develop with ELEVA, particularly when used with serotonergic drugs, drugs that impair serotonin metabolism, or antipsychotics. Patients should be monitored for signs and symptoms of these syndromes. Suicide risk is inherent in depression and persists until significant remission occurs. Depressed patients may experience worsening of symptoms and emergence of suicidal ideation whether or not taking antidepressants. Patients should be closely monitored for clinical worsening and suicidality, especially at the beginning of treatment or at the time of dose changes. In children and adolescents receiving antidepressants, pooled analyses revealed greater risk of suicidal behaviour or thinking during the initial treatment period, with an average risk of 4% compared with 2% on placebo. Bleeding abnormalities have been reported with ELEVA, and this risk may be potentiated by concurrent use of NSAIDs, aspirin, or other medicines affecting coagulation; ELEVA should be used with caution in such patients. Hyponatraemia may occur as a result of treatment with ELEVA, often due to syndrome of inappropriate antidiuretic hormone secretion. Elderly patients may be at greater risk. Epidemiological studies show an increased risk of bone fractures in patients receiving ELEVA. Upon discontinuation of ELEVA, adverse events including dysphoric mood, irritability, agitation, dizziness, anxiety, and insomnia have been reported, particularly with abrupt cessation. A gradual reduction in dose is recommended.

Contraindications

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

PBS listing

No source documents provide information about PBS listing status or pricing for ELEVA.

Regulatory history

ELEVA 50 mg and 100 mg tablets in both blister pack and bottle presentations were first listed on the ARTG on 29 July 2003.