Generic
Agomelatine
Contraindications
Potential interactions affecting agomelatine: Agomelatine is metabolised mainly by cytochrome P450 1A2 (CYP1A2) (90%) and by CYP2C9 (10%). Medicinal products that interact with these isoenzymes may decrease or increase the bioavailability of agomelatine. Fluvoxamine, a potent CYP1A2 and moderate CYP2C9 inhibitor markedly inhibits the metabolism of agomelatine resulting in a 60-fold (range 12-412) increase of agomelatine exposure. Consequently, co-administration of agomelatine with potent CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin) is contraindicated.
Side Effects
It is contraindicated in patients with hepatic impairment and hypersensitivity to the active substances or any of the excipients.
Pregnancy And Lactation
The commonly reported adverse effects in the clinical trials of agomelatine are headache, nausea and diarrhea.
Therapeutic
Children under 18 years: Should be given only on medical advice. Children and adolescents: Agomelatine is not recommended in the treatment of depression in patients . Use in the elderly: Efficacy has not been clearly demonstrated in the elderly (65 years). Only limited clinical data is available on the use of Agomelatine in elderly patients 65 years with major depressive episodes. Therefore, caution should be exercised when prescribing Agomelatine to these patients.
Storage Conditions
There is limited experience with agomelatine overdose. During the clinical development, there were a few reports of agomelatine overdose, taken alone (up to 450 mg) or in combination (up to 525 mg) with other psychotropic medicinal products. Signs and symptoms of overdose were limited and included drowsiness and epigastralgia. No specific antidotes for agomelatine are known. Management of overdose should consist of treatment of clinical symptoms and routine monitoring. Medical follow-up in a specialised environment is recommended.
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