| Common Brand | Company | Unit Dose | Price |
| Valdoxan | Servier | 25mg Tabs | 28’S=KSh. 7,590.00 |
Dose:
25mg OD orally or food at bedtime. The dose may be increased to 50 mg OD if there is no improvement of symptoms after 2 wks. Treatment needs to proceed for at least 6 months.
Indication:
Major depressive episodes in adults.
Mode of Action:
It is a melatonergic agonist (MT1 and MT2 receptors) and 5-HT2C antagonist.
Precautions:
Liver function tests should be performed in all patients at initiation of treatment and then periodically after around 6 wks, 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 65 yrs and those with renal impairment due to the unavailability of adequate clinical data on these patient groups.
Extra caution should also be taken in patients with a 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 the upper limit of normal and liver function tests should be performed regularly until serum transaminases return to normal.
The drug may affect the ability to drive or operate a machine as it causes drowsiness.
Contraindications:
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.
Drug Interactions:
CYP1A2 inhibitors may result in increased blood levels of agomelatine as it is metabolized mainly by cytochrome P4501A2.
Pregnancy Risk Category:
No clinical data on exposure in pregnancy and lactation are available hence caution should be exercised when prescribing to pregnant and breastfeeding women.
Side Effects:
Common: Headache; dizziness; somnolence; insomnia; migraine; nausea; diarrhea; constipation; upper abdominal pain; hyperhidrosis; back pain; fatigue; increased serum transaminases.
Uncommon: Paraesthesia; blurred vision; erythematous rash; hepatitis (rare).
