The active pharmaceutical ingredient is Agomelatine

Chemical Name：N-[2- (7-methoxy-1- naphthyl) ethyl] acetamide

Chemical Structure：

Molecular Formula：C₁₅H₁₇NO₂

Molecular Weight：243.3

This product is a film-coated tablet, presenting white or off-white after removal of the coating.

Adult depression treatment.

Agomelatine is indicated for adults.

Dosage

The recommended dose is 25 mg once daily taken orally at bedtime.

If there is no improvement of symptoms after two weeks of treatment, the dose may be increased the dose to 50 mg once daily, i.e. two 25 mg tablets, taken together before 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 strict respect of LFT monitoring..

Liver fuction tests should be performed in all patients before starting treatment. During treatment LFTshould be monitored periodicallyafter around 3 weeks, 6 weeks (end of the acute phase), 12 weeks, and 24 weeks (end of the maintenance phase). Thereafter, liver function could be tested according to clinical needs (see [Precautions]).

When increasing the dosage, the liver function tests should be performed again at the same frequency as when initiating treatment.
Treatment duration

Patients with depression should be treated for a sufficient period (at least 6 months) to ensure they are free of symptoms.

Treatment Discontinuation

No dosage tapering is needed on treatment discontinuation.

Method of Administration

For oral use

Agomelatine tablets may be taken with food or on an empty stomach.

Special populations

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 moderate/severe renal impairment is available. Therefore, caution should be exercised when prescribing agomelatin to thes patients.

Liver function impairment:

Agomelatine is contraindicated in hepatitis B virus carriers/patients, hepatitis C virus carriers/patients, and liver function impairment patients (see [Contraindications] [Precautions] and [Pharmacokinetics]).