Finished product reference
Agomelatine
Tablet · Oral · 25 mg
- List code
- 18949
- Pharmacologic class
- Antidepressant; melatonergic MT1/MT2 agonist and 5-HT2C antagonist
What it is and how it works
Agomelatine is an agonist at melatonin MT1 and MT2 receptors and an antagonist at serotonin 5-HT2C receptors. It resynchronises circadian rhythms and increases noradrenaline and dopamine release in the frontal cortex, without affecting extracellular serotonin levels.
Indications
Major depressive episodes in adults.
Dosage and administration (summary)
25 mg orally once daily at bedtime, increased to 50 mg once daily after 2 weeks if response is insufficient.
Contraindications
Hepatic impairment (cirrhosis or active liver disease) or transaminases above 3 times the upper limit of normal; concomitant potent CYP1A2 inhibitors such as fluvoxamine or ciprofloxacin.
Warnings and precautions
Hepatotoxicity including hepatic failure has been reported; liver function tests are required before starting, periodically during treatment and on dose increase, and treatment stopped if transaminases exceed 3 times normal. Monitor for suicidal thoughts and behaviour, particularly early in treatment. Use with caution in patients over 75 years.
Pregnancy
Avoid as a precaution because data are limited.
Storage and supply
No special storage conditions; store below 30 °C.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
Tell us the quantity, the market and the timing.
Send the molecule or ingredient, the specification and the destination. We reply from Tehran with the questions, the documents and the next step.