Agomelatine

Treatment of major depressive disorder in adults

Take this medication by mouth, regardless of mealtimes. Swallow the tablet whole without chewing.

The recommended daily dose is 25 mg (1 tablet) in the evening (before bedtime).

If there is no improvement after two weeks of treatment, your doctor may increase the dose to 50 mg (two 25-mg tablets) taken once daily at bedtime. The decision to increase the dose is made by the doctor, taking into account the risk of elevated liver enzyme levels and under close monitoring of liver function tests.

Use with caution in patients with moderate to severe renal impairment;
when agomelatine is co-administered with the following medications: propranolol, gatifloxacin, enoxacin; patients with a history of manic or hypomanic episodes;
if symptoms of mania appear, agomelatine should be discontinued; in patients with a history of suicide-related events, as well as in patients who had suicidal intentions before the start of therapy;
in elderly patients (65 years of age and older), especially when treating major depressive episodes with dementia;

The efficacy of use in elderly patients has not been established. Patients who abuse alcohol or take medications that may cause liver dysfunction. During treatment, patients—especially those in high-risk groups—should be under close medical supervision, particularly at the start of therapy and when the dose is adjusted. Patients (and their caregivers) should be informed of the need to seek immediate medical attention if their condition worsens, if they exhibit suicidal or unusual behavior, or if they experience suicidal thoughts.

It is recommended to monitor liver function at the start of therapy and every 6 weeks thereafter. If serum transaminase levels rise, repeat testing should be performed within 48 hours. If transaminase levels exceed UNL by more than threefold, agomelatine should be discontinued. Thereafter, liver function should be monitored regularly until transaminase levels return to normal.

Liver failure, cirrhosis, active liver disease; concomitant use of potent CYP1A2 inhibitors (such as fluvoxamine, ciprofloxacin); age under 18; hypersensitivity to agomelatine.

2 years