Opicapone
اوپیکاپون
🧠 Nervous SystemCOMT inhibitor
Market / country: 🇺🇸 USA
Ongentys (US)
🧮 Dose calculator
Parkinson's disease · Regimen source: FDA Ongentys · 2.1
- • No food 1 h before and at least 1 h after. Moderate hepatic impairment: 25 mg; severe: avoid. FDA Ongentys · 2.1FDA Ongentys · 2.2
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Concomitant non-selective MAOIs; phaeochromocytoma, paraganglioma or other catecholamine-secreting tumours. FDA Ongentys · 4
Formulations
- 25 mg capsule — capsule 🇺🇸 USA FDA Ongentys · 3
- 50 mg capsule — capsule 🇺🇸 USA FDA Ongentys · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Ongentys · 8.1
“Risk Summary There are no adequate data on the developmental risk associated with use of ONGENTYS in pregnant women.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Ongentys · 8.2
“Risk Summary There are no data on the presence of opicapone in human milk, the effects on the breastfed infant, or the effects on milk production.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Ongentys · 8.4
“Safety and effectiveness in pediatric patients have not been established.”
- 👴 Older adultsNo specific problem stated
Label: no specific difference or dose adjustment stated for older adults. FDA Ongentys · 8.5
“No dose adjustment is required for elderly patients.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)NDA212489
- DailyMed (FDA label)FDA Ongentys
- MedlinePlus (NIH)Opicapone
- WHO ATC/DDDN04BX04
- Darooyab (Iran)❌ None
🇮🇷 Not found in Iran list Darooyab · search
Darooyab lists no registered dosage form or brand for this drug. This does not prove it is unavailable.
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Ongentys · 3FDA Ongentys · 2.1FDA Ongentys · 2.2FDA Ongentys · 4FDA Ongentys · SPL approval / marketing categoryFDA Ongentys · 8.1FDA Ongentys · 8.2FDA Ongentys · 8.4FDA Ongentys · 8.5
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · search
- Clinical review⚠ Unverified