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Posology: The recommended dose is 25 mg once daily taken orally at bedtime.
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: 2 weeks after treatment initiation in major depressive episode; 4 weeks after treatment initiation in generalised anxiety disorder.
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 Liver Function Test 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 (see Contraindications and Precautions).
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 (see also Precautions). Treatment should be discontinued if transaminases exceed 3 X upper limit of normal (see Contraindications and Precautions).
When increasing the dosage, liver function tests should again be performed at the same frequency as when initiating treatment.
Treatment duration: Patients 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 package insert 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 (see Pharmacology: Pharmacodynamics under Actions).
Treatment discontinuation: No dosage tapering is needed on treatment discontinuation.
Special populations: Elderly: The efficacy and safety of agomelatine (25 to 50 mg/day) have been established in elderly depressed patients (< 75 years). No dose adjustment is required in relation to age (see Pharmacology: Pharmacokinetics under Actions).
No effect is documented in depressed patients ≥75 years nor in elderly patient suffering from generalised anxiety disorder. Therefore agomelatine should not be used by patients in this age group (see Precautions and Pharmacology: Pharmacodynamics under Actions).
Renal impairment: No relevant modification in agomelatine pharmacokinetic parameters in patients with severe renal impairment has been observed. However, only limited clinical data on the use of agomelatine in depressed patients with severe or moderate renal impairment with major depressive episodes is available. Therefore, caution should be exercised when prescribing agomelatine to these patients.
Hepatic impairment: Agomelatine is contraindicated in patients with hepatic impairment (see Contraindications, Precautions and Pharmacology: Pharmacokinetics under Actions).
Paediatric population: The safety and efficacy of agomelatine in children from 2 years onwards have not been established.
No data are available (see Precautions).
There is no relevant use of agomelatine in children from birth to 2 years.
Method of administration: For oral use.
Valdoxan film-coated tablets may be taken with or without food.
