Active Ingredient: Fluoxetine
Moderate to severe major depressive episode, if depression is unresponsive to psychological therapy after 4-6 sessions. Antidepressant medication should be offered to a child or young person with moderate to severe depression only in combination with a concurrent psychological therapy.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 10 milligrams fluoxetine, once daily, over the duration of 1 to 2 weeks. Afterwards, oral, between 10 milligrams fluoxetine and 20 milligrams fluoxetine, once daily, over the duration of 6 months.
Treatment should be initiated and monitored under specialist supervision. The starting dose is 10mg/day. Dose adjustments should be made carefully, on an individual basis, to maintain the patient at the lowest effective dose.
After one to two weeks, the dose may be increased to 20mg/day. Clinical trial experience with daily doses greater than 20mg is minimal. There is only limited data on treatment beyond 9 weeks.
Lower-weight children: Due to higher plasma levels in lower-weight children, the therapeutic effect may be achieved with lower doses.
For paediatric patients who respond to treatment, the need for continued treatment after 6 months should be reviewed. If no clinical benefit is achieved within 9 weeks, treatment should be reconsidered.
Abrupt discontinuation should be avoided. When stopping treatment with fluoxetine the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of withdrawal reactions. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose, but at a more gradual rate.
Fluoxetine may be administered as a single or divided dose, during or between meals.
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