* Composition: Each tablet contains:
& & sertraline hydrochloride equivalent to 50 mg sertraline.
* Therapeutic indications:
& & – Lustral is indicated for the treatment of symptoms of depressive illness including accompanied symptoms of anxiety.
& & – Following satisfactory response, continuation with Lustral therapy is effective in preventing relapse of the initial episode
& & of depression or recurrence of further depressive episodes, including accompanied symptoms of anxiety.
& & – Lustral is also indicated for the treatment of obsessive compulsive disorders (OCD).
& following initial response, Lustral has been associated with sustained efficacy,
& & safety and tolerability in up to 2 years treatment of OCD.
& & – Lustral is also indicated for the treatment of paediatric patients with OCD.
& & – Clinical trials in PTSD demonstrated efficacy in female patients but no evidence of
& & efficacy was seen in males.Treatment with Lustral cannot normally therefore be
& & recommended for male patients with PTSD. A therapeutic trial in males might on occasion
& & be justified, but treatment should be withdrawn unless there is clear
& & evidence of therapeutic benefit.
& & – Lustral is not indicated for use in children and adolescents under the age of 18 years
& & with Major Depressive Disorder: In particular, controlled clinical studies failed to
& & demonstrate efficacy and do not support the use of Lustral in the treatment of
& & children and adolescents with Major Depressive Disorder.
*Psology and method of administration:
& & – Lustral should be given as a single daily dose. Lustral tablets can be administered
& & with or without food. Lustral tablets are for oral administration only.
& & . Adults:
& & # Depression (including accompanying symptoms of anxiety): The starting dose is 50mg
& & daily and the usual antidepressant dose is 50mg daily. In some patients, doses higher
& & than 50mg may be required.
& & # Obsessive Compulsive Disorder: The starting dose is 50mg daily, and the therapeutic dose
& & range is 50-200mg daily.
& & # Post-Traumatic Stress Disorder: Treatment for PTSD should be initiated at 25mg/day.
& & After one week, the dose should be increased to 50mg once daily. PTSD is a heterogeneous
& & illness and some patient groups fulfiling the criteria for PTSD do not appear to be responsive
& & to treatment with Lustral. Dosing should be reviewed periodically by the prescribing
& & physician to determine response to therapy and treatment should be withdrawn if there is
& & no clear evidence of efficacy.
& & # Depression (including accompanying symptoms of anxiety), OCD, and PTSD: In some patients
& & doses higher than 50mg daily may be required. In patients with incomplete response but good
& & therapy at lower doses, dosage adjustments should be made in 50mg increments over a period
& & of weeks to a maximum of 200mg daily. Once an optimal therapeutic response is achieved, the dose
& should be reduced, depending on therapeutic response, to the lowest effective level. Dosage
& & during prolonged maintenance therapy should be kept at the lowest effective level, with resulting
& & adjustments depending on the therapeutic response. The onset of therapeutic effect may be seen within
& & 7 days, although 2-4 weeks (and even longer in OCD) are usually necessay for full activity.
& & A longer treatment period, even beyond 12 weeks in some cases, may be required in the case
& & of therapeutic trial in PTSD.
& & . Use in children aged 6-17 years:
& & – Treatment should only be initiated by specialists. The safety and efficacy of Lustral has been
& & established in paediatric OCD patients (aged 6-17). The administration of Lustral to OCD patients
& & (aged 13-17) should commence at 50mg/day. Therapy for pediatric OCD patients (aged 6-12)
& should commence at 25mg/day increasing to 50mg/day after 1 week. Subsequent doses may
& & be increased in case of lack of response in 50mg/day increments up to 200mg/day as needed.
& & However, the generally lower body weights of children compared to adults should be taken into
& & Consideration in advancing the dose from 50mg, in order to avoid excessive dosing. Given the 24
& & hour elimination half-life of sertraline, dose changes should not occur at intervals of less than
& & 1 week.
& & – The efficacy and safety of Lustral in children and adolscents under the age of 18 years with
& & Major Depressive Disorder have not been established. Controlled clinical studies failed to
& & demonstrate efficacy and do not support the use of Lustral in the treatment of children and
& & adolescents with Major Depressive Disorder.
& & . Children aged less than six years: Lustral is not recommended in children under 6 years of
& & age since safety and efficacy have not been established.
& & . Use in the elderly: No special precautions are required. The usual adult dose is recommended.
& & Several hundred elderly patients have participated in clinical studies with Lustral. The pattern
& & and incidence of adverse reactions in the elderly are similar to that in younger patients.
* Precautions:
& & – Lustral should not be used in combination with MAO inhibitors, Lustral may be started 14 days
& & after discontinuing treatment with an irreversible MAOI and at least one day after discontinuing
& & treatment with reversible MAOI (RIMA), moclobemide. At least 14 days should elapse after
& & discontinuing Lustral treatment before starting an MAOI or RIMA
& & – In patients with renal or hepatic impairment, sertraline should be used with caution.
& & – Seizure disorders.
& & – Lustral should be used with caution in patients with a history of mania/hypomania. Lustral should
& & be discontinued in any patient entering a manic phase.
* Store below 30 degrees C.
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