Active Ingredient: Agomelatine
Agomelatine is indicated for the treatment of major depressive episodes in adults.
For this indication, competent medicine agencies globally authorize below treatments:
Oral
25 - 50 mg
From 25 To 50 mg once every day for 180 day(s)
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.
Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free of symptoms.
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.
No dosage tapering is needed on treatment discontinuation.
Taken orally at bedtime.
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