Major depressive episodes

Active Ingredient: Agomelatine

Indication for Agomelatine

Population group: only adults (18 - 65 years old)

Agomelatine is indicated for the treatment of major depressive episodes in adults.

For this indication, competent medicine agencies globally authorize below treatments:

25 - 50 mg once daily

Route of admnistration

Oral

Defined daily dose

25 - 50 mg

Dosage regimen

From 25 To 50 mg once every day for 180 day(s)

Detailed description

The recommended dose is 25 mg once daily taken orally at bedtime. After two weeks of treatment, if there is no improvement of symptoms, the dose may be increased to 50 mg once daily, i.e. two 25 mg tablets, taken together at bedtime.

Decision of dose increase has to be balanced with a higher risk of transaminases elevation. Any dose increase to 50 mg should be made on an individual patient benefit/risk basis and with strict respect of LFT monitoring.

Liver function tests should be performed in all patients before starting treatment. Treatment should not be initiated if transaminases exceed 3 X upper limit of normal.

During treatment transaminases should be monitored periodically after around three weeks, six weeks (end of acute phase), twelve weeks and twenty four weeks (end of maintenance phase) and thereafter when clinically indicated. Treatment should be discontinued if transaminases exceed 3 X upper limit of normal.

When increasing the dosage, liver function tests should again be performed at the same frequency as when initiating treatment.

Treatment duration

Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free of symptoms.

Switching therapy from SSRI/SNRI antidepressant to agomelatine

Patients may experience discontinuation symptoms after cessation from an SSRI/SNRI antidepressant.

The SmPC of the actual SSRI/SNRI should be consulted on how to withdraw the treatment to avoid this. Agomelatine can be started immediately while tapering the dosage of a SSRI//SNRI.

Treatment discontinuation

No dosage tapering is needed on treatment discontinuation.

Dosage considerations

Taken orally at bedtime.

Active ingredient

Agomelatine

Agomelatine is a melatonergic agonist (MT1 and MT2 receptors) and 5-HT2C antagonist. In humans, agomelatine has positive phase shifting properties; it induces a phase advance of sleep, body temperature decline and melatonin onset.

Read more about Agomelatine

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