Safinamide
سافینامید
🧠 Nervous SystemMAO-B inhibitor
Market / country: 🇺🇸 USA
Xadago (US)
🧮 Dose calculator
Parkinson's disease · Regimen source: FDA Xadago · 2.1
- • Moderate hepatic impairment: max 50 mg; severe: contraindicated. FDA Xadago · 2.2
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Other MAOIs or potent MAO inhibitors (including linezolid); opioids (meperidine, methadone, tramadol), SNRIs, tri-/tetracyclic antidepressants, cyclobenzaprine, methylphenidate and amphetamines, St John’s wort; dextromethorphan; severe hepatic impairment. FDA Xadago · 4
Formulations
- 50 mg tablet — tablet 🇺🇸 USA FDA Xadago · 3
- 100 mg tablet — tablet 🇺🇸 USA FDA Xadago · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Xadago · 8.1
“Risk Summary There are no adequate data on the developmental risk associated with the use of XADAGO in pregnant women.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Xadago · 8.2
“Risk Summary There is no information regarding the presence of XADAGO or its metabolites 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 Xadago · 8.4
“Safety and effectiveness in pediatric patients have not been established.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Xadago · 8.5
“Of the 1516 subjects exposed to XADAGO in clinical studies, 38% were 65 and over, while 4% were 75 and over.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)NDA207145
- DailyMed (FDA label)FDA Xadago
- MedlinePlus (NIH)Safinamide
- WHO ATC/DDDN04BD03
- 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 Xadago · 3FDA Xadago · 2.1FDA Xadago · 2.2FDA Xadago · 4FDA Xadago · SPL approval / marketing categoryFDA Xadago · 8.1FDA Xadago · 8.2FDA Xadago · 8.4FDA Xadago · 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