Valdoxan Dosage/Direction for Use

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 generalized 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 3X 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 3X 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 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.
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. No effect is documented in depressed patients ≥75 years nor in elderly patients suffering from generalized anxiety disorder. Therefore, agomelatine should not be used in these patients.
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 (Valdoxan) in depressed patients with severe or moderate renal impairment with major depressive episodes is available. Therefore, caution should be exercised when prescribing Agomelatine (Valdoxan) to these patients.
Hepatic impairment: Agomelatine (Valdoxan) is contraindicated in patients with hepatic impairment.
Pediatric population: The safety and efficacy of Agomelatine (Valdoxan) in children from 2 years onwards have not been established. No data are available. There is no relevant use of Agomelatine (Valdoxan) in children from birth to 2 years.
Method of administration: For oral use.
Agomelatine (Valdoxan) film-coated tablets may be taken with or without food.
Missed Dose: Do not take a double dose to make up for a forgotten dose. Just carry on with the next dose at the usual time.
The calendar printed on the blister containing the tablets should help the patient remember when the last tablet intake of Agomelatine (Valdoxan).
Discontinuation of Treatment: The patient should not stop taking this medicine without the advice of the doctor even if he/she feels better.
The patient should discuss with the doctor before stopping this medicine.
If the patient thinks that the effect of Agomelatine (Valdoxan) is too strong or too weak, talk to the doctor or pharmacist.
If the patient has any further questions on the use of this product, ask the doctor or pharmacist.