سعر اكسوميلاتين 25 مجم 10 اقراص 2026

Agomelatine 25 mg film-coated tablets, 10 tablets per pack (Horus for Pharmaceutical Products, Egypt); melatonergic antidepressant.

• Treatment of major depressive episodes in adults.Population: AdultsEuropean Medicines Agency (EMA) - EPAR

• Usually mild or moderate, within the first two weeks: most common headache, nausea and dizziness; common anxiety and abnormal dreams; uncommon suicidal thoughts or behaviour, agitation, aggression, nightmares, mania/hypomania, confusion; rare hallucinations.International label, same formulation · European Medicines Agency (EMA) - EPAR

• Hypersensitivity to agomelatine or excipients; hepatic impairment (cirrhosis or active liver disease) or transaminases >3 x ULN; concomitant potent CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin).International label, same formulation · European Medicines Agency (EMA) - EPAR

• Liver injury including hepatic failure (rarely fatal or requiring transplantation), hepatitis and jaundice have been reported, mostly in the first months; prescribe after careful benefit-risk assessment in patients with hepatic risk factors and discontinue if transaminases exceed 3 x ULN or signs of liver injury occur.International label, same formulation · European Medicines Agency (EMA) - EPAR

• Potent CYP1A2 inhibitors (fluvoxamine, ciprofloxacin)Contraindicated: fluvoxamine increased agomelatine exposure about 60-fold.European Medicines Agency (EMA) - EPAR
• Oestrogens and moderate CYP1A2 inhibitors (e.g. propranolol, enoxacin)Several-fold increased agomelatine exposure; use with caution.European Medicines Agency (EMA) - EPAR
• Rifampicin; smoking (CYP1A2 induction)May decrease agomelatine bioavailability, especially in heavy smokers.European Medicines Agency (EMA) - EPAR

• Limited human data (<300 pregnancy outcomes); animal studies show no direct or indirect harm; as a precaution, preferably avoid during pregnancy.International label, same formulation · European Medicines Agency (EMA) - EPAR
• Unknown whether excreted in human milk; excreted in animal milk; a risk to the infant cannot be excluded: decide whether to stop breastfeeding or therapy.International label, same formulation · European Medicines Agency (EMA) - EPAR

• Agomelatine: Melatonergic agonist at MT1 and MT2 receptors and 5-HT2C antagonist, with no effect on monoamine uptake; resynchronises circadian rhythms in animal models (EU SmPC).