SERTRALINE GENERICHEALTH

What it is

SERTRALINE GENERICHEALTH is available in tablet form containing either 50 mg or 100 mg of sertraline as the active ingredient (as hydrochloride). The mechanism of action is presumed to be linked to 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 for prevention of its relapse. — Adults with premenstrual dysphoric disorder as defined by DSM-IV criteria.

Dosing overview

For children with obsessive compulsive disorder aged 6 to 12 years, administration should commence at 25 mg per day for the first week, then increase to 50 mg per day. Adolescents aged 13 to 18 years may commence at 50 mg per day. In children, a dose of 200 mg per day should not be exceeded. SERTRALINE GENERICHEALTH should be administered once daily, either in the morning or evening, and may be taken with or without food.

Key safety warnings

Potentially life-threatening serotonin syndrome or neuroleptic malignant syndrome has been reported with sertraline. The risk is increased with concomitant use of serotonergic drugs, drugs that impair serotonin metabolism, and antipsychotics. Symptoms may include mental status changes, autonomic instability, neuromuscular abnormalities, and gastrointestinal symptoms. The risk of suicide is inherent in depression and may persist until significant remission occurs. Depressed patients may experience worsening of depressive symptoms and emergence of suicidal ideation, and this risk may persist until significant remission occurs. Patients should be closely monitored for clinical worsening and suicidality, especially at the beginning of treatment or at times of dose changes. Pooled analyses of 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% in placebo-treated patients. Bleeding abnormalities including purpura, haematoma, epistaxis, and gastrointestinal bleeding have been reported. This risk may be potentiated by concurrent use of atypical antipsychotics, phenothiazines, tricyclic antidepressants, NSAIDs, aspirin, or other medicines affecting coagulation. SERTRALINE GENERICHEALTH should be used with caution in patients receiving medicines that increase bleeding risk or with a history of abnormal bleeding. Hyponatraemia may occur, often due to syndrome of inappropriate antidiuretic hormone secretion. Elderly patients may be at greater risk. Signs and symptoms of hyponatraemia include headache, difficulty concentrating, memory impairment, confusion, weakness and unsteadiness. Severe cases may include hallucination, syncope, seizure, coma, and respiratory arrest.

Contraindications

SERTRALINE GENERICHEALTH is contraindicated in patients with known hypersensitivity to sertraline. Concomitant use in patients taking pimozide is contraindicated. SERTRALINE GENERICHEALTH 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 SERTRALINE GENERICHEALTH before starting a MAOI.

Regulatory history

SERTRALINE GENERICHEALTH 50 mg tablets were first listed on the Australian Register of Therapeutic Goods on 6 September 2007, and SERTRALINE GENERICHEALTH 100 mg tablets were first listed on the same date.