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The recommended daily dose is one 25 mg tablet taken orally at bedtime for both MDD and GAD.
If there is no improvement in symptoms the dose may be increased to 50 mg once daily, taken as a single dose of two tablets at bedtime: 2 weeks after treatment initiation in patients with MDD; 4 weeks after treatment initiation in patients with GAD.
The maximum recommended dose should not be exceeded.
Dose escalation has been associated with an increased incidence of serum transaminase elevations. Dose increases to 50 mg should only occur following an assessment of the benefits and risk and assessment of liver function.
Liver function tests should be performed in all patients before initiation of treatment and before a dose increase to 50 mg. Treatment with VALDOXAN (agomelatine) should not be initiated if serum transaminase levels are > 3 times the upper limit of normal range (see Contraindications and Precautions).
During treatment transaminases should be monitored periodically after around 3, 6 (end of acute phase), 12, and 24 (end of maintenance phase) weeks with regimen to be repeated following dose increase to 50 mg and thereafter when clinically indicated (see Precautions). Treatment should be discontinued if serum transaminase levels are > 3 times the upper limit of the normal range (see Contraindications and Precautions).
Treatment duration: Both MDD and GAD are diseases with a chronic course and long-term treatments are therefore warranted to consolidate response and prevent relapse.
Patients with MDD and/or GAD should be treated for a period of at least six months following response to ensure that they are free of symptoms.
VALDOXAN (agomelatine) tablets may be taken with or without food.
Switching to agomelatine from other antidepressants (SSRIs) or SNRIs): Patients may experience discontinuation symptoms after cessation from an SSRI/SNRI antidepressant. The product information of the actual SSRI/SNRI should be consulted on how to withdraw the treatment to avoid discontinuation symptoms. VALDOXAN (agomelatine) can be started immediately while tapering the dosage of an SSRI/SNRI (see Contraindications and Pharmacology: Pharmacodynamics under Actions).
Children and adolescents: Safety and efficacy have not been established in this age group. VALDOXAN (agomelatine) is not recommended for use in children and adolescents aged < 18 years (see Precautions).
Elderly Patients: The efficacy and safety of agomelatine (25 to 50 mg/day) have been established in elderly patients with MDD (aged < 75 years). No adjustment in the usual dose is recommended for elderly patients with MDD (aged < 75 years) solely because of their age. As efficacy has not been established in very elderly patients with MDD aged ≥ 75 years VALDOXAN (agomelatine) should not be used in this patient group (see Precautions).
As data on the use of agomelatine (25 to 50mg/day) in elderly patients with GAD are limited, VALDOXAN is not recommended to treat generalised anxiety disorder in the elderly aged > 65 years (see Precautions; Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions).
VALDOXAN (agomelatine) should not be used for the treatment of MDD or GAD in elderly patients with dementia since the safety and efficacy of VALDOXAN (agomelatine) have not been established in these patients.
Patients with renal impairment: No relevant modification in agomelatine pharmacokinetic parameters in patients with severe renal impairment has been observed. However, as only limited clinical data on the use of agomelatine in patients with moderate or severe renal impairment are available, caution should be exercised when prescribing VALDOXAN (agomelatine) to these patients.
Patients with hepatic impairment: VALDOXAN (agomelatine) is contraindicated in patients with hepatic impairment (see Contraindications).
Treatment discontinuation: No dose tapering is needed on treatment discontinuation, as VALDOXAN (agomelatine) does not induce discontinuation symptoms after abrupt treatment cessation.
