Agomelatine
آگوملاتین
🧠 Nervous SystemMelatonergic agonist and 5-HT2C antagonist
Market / country: UK
Valdoxan (UK)
🧮 Dose calculator
Major depressive disorder · Regimen source: eMC Valdoxan · 4.2
- • Liver tests before starting and at about 3, 6, 12 and 24 weeks; do not start (and stop) if transaminases exceed 3× ULN. Increase to 50 mg only with strict liver monitoring. eMC Valdoxan · 4.2
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Hepatic impairment (cirrhosis or active liver disease) or transaminases >3× ULN; potent CYP1A2 inhibitors (fluvoxamine, ciprofloxacin); hypersensitivity. eMC Valdoxan · 4.3
Warnings
- • Liver injury (occasionally hepatic failure); monitor liver tests. eMC Valdoxan · 4.4
Formulations
- 25 mg film-coated tablet — tablet UK eMC Valdoxan · 6.5
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. eMC Valdoxan · 4.6
“There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of agomelatine in pregnant women.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. eMC Valdoxan · 4.6
“Available pharmacodynamic/toxicological data in animals have shown excretion of agomelatine/metabolites in milk (see section 5.3).”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. eMC Valdoxan · 4.2
“Children and adolescents from 7 to 17 years The safety and efficacy of agomelatine in children and adolescents aged from 7 to 17 years for treatment of major depressive episodes have not been established.”
- 👴 Older adultsNo specific problem stated
Label: no specific difference or dose adjustment stated for older adults. eMC Valdoxan · 4.2
“No dose adjustment is required in relation to age (see section 5.2).”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)❌ None
- DailyMed (FDA label)❌ None
- MedlinePlus (NIH)❌ None
- WHO ATC/DDDN06AX22
- Darooyab (Iran)Agomelatine
- eMC (UK label)eMC Valdoxan
🇮🇷 Registered in Iran Darooyab · G-5431/Agomelatine
Dosage forms with Iranian generic codes, per Darooyab.
- 18949 · AGOMELATINE 25 mg TABLET · قرص آگوملاتین ۲۵ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)❌ Not present
- UK SmPC (eMC / MHRA)✅ PresenteMC Valdoxan · 6.5eMC Valdoxan · 4.2eMC Valdoxan · 4.3eMC Valdoxan · 4.4eMC Valdoxan · 4.6
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · G-5431/Agomelatine
- Clinical review⚠ Unverified