Lotilaner eye drops (Demodex blepharitis)
قطره چشمی لوتیلانر (بلفاریت دمودکسی)
👁️ Sensory OrgansOphthalmic antiparasitic
Market / country: 🇺🇸 USA
Xdemvy (US)
🧮 Dose calculator
Blepharitis · Regimen source: FDA Xdemvy · 2
- • About 12 h apart; 5 min from other drops. Remove contact lenses and reinsert after 15 min. FDA Xdemvy · 2FDA Xdemvy · 5.2
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Formulations
- Lotilaner 0.25% eye drops — eye drops 🇺🇸 USA FDA Xdemvy · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Xdemvy · 8.1
“Risk Summary There are no available data on XDEMVY use in pregnant women to inform any drug associated risk; however, systemic exposure to lotilaner from ocular administration is low [see Clinical Pharmacology (12.3) ] .”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Xdemvy · 8.2
“Risk Summary There are no data on the presence of XDEMVY 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 Xdemvy · 8.4
“Safety and effectiveness in pediatric patients below the age of 18 years have not been established.”
- 👴 Older adultsNo specific problem stated
Label: no specific difference or dose adjustment stated for older adults. FDA Xdemvy · 8.5
“No overall differences in safety or effectiveness have been observed between elderly and other adult patients.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)NDA217603
- DailyMed (FDA label)FDA Xdemvy
- MedlinePlus (NIH)❌ None
- WHO ATC/DDDS01AX25
- 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 Xdemvy · 3FDA Xdemvy · 2FDA Xdemvy · 5.2FDA Xdemvy · SPL approval / marketing categoryFDA Xdemvy · 8.1FDA Xdemvy · 8.2FDA Xdemvy · 8.4FDA Xdemvy · 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