Valdoxan Dosage/Direction for Use

Adults: Recommended Dose: 25 mg once daily taken orally at bedtime.
After 2 weeks of treatment, if there is no improvement of symptoms, the dose may be increased to 50 mg once daily ie, 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 liver function test (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 (ULN).
During treatment, transaminases should be monitored periodically after around 3 weeks, 6 weeks (end of acute phase), 12 weeks and 24 weeks (end of maintenance phase) and thereafter, when clinically indicated. Treatment should be discontinued if transaminases exceed 3 x ULN.
When increasing the dosage, LFT should again be performed at the same frequency as when initiating treatment.
Duration of Treatment: 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 summary of product characteristics (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.
Discontinuation of Treatment: No dosage tapering is needed on treatment discontinuation.
Elderly: The efficacy and safety of agomelatine (25-50 mg/day) have been established in elderly depressed patients (<75 years). No effect is documented in patients ≥75 years. Therefore, agomelatine should not be used by patients in this age group. No dose adjustment is required in relation to age.
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 Valdoxan in depressed patients with severe or moderate renal impairment with major depressive episodes is available. Therefore, caution should be exercised when prescribing Valdoxan to these patients.
Administration: For oral use. May be taken with or without food.