25 mg OD orally before or food at bed-time. The dose may be increased to 50mg OD if there is no improvement of symptoms after 2wks. Treatment needs to proceed for at least 6 months.
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It is a melatonergic agonist [MT1 and MT2 receptors] and 5-HT2C antagonist.
Liver function tests should be performed in all patients at initiation of treatment and then periodically after around 6wks, 12 wks, and 24 wks and thereafter when clinically indicated. Agomelatine is not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy. Caution should be exercised when prescribing agomelatine to patients above 65yrs and those with renal impairment due to unavailability of adequate clinical data on these patient groups. Extra cautions should also be taken in patients with history of mania or hypomania [discontinued if a patient develops manic symptoms]. Therapy should be discontinued if the increase in serum transaminases exceeds 3 times upper limit of normal and liver function tests should be per-formed regularly until serum transaminases return to normal. The drug may affect ability to drive or operate a machine as it causes drowsiness.
Patients with hepatic impairment; hypersensitivity to the active substance or to any of the excipients; concomitant use of potent CYP1A2 inhibitors such as fluvoxamine and ciprofloxacin.