Epoprostenol
اپوپروستنول
🩸 Blood And Blood Forming OrgansProstacyclin
Market / country: 🇺🇸 USA
Flolan (US) · Veletri (US)
🧮 Dose calculator
Pulmonary arterial hypertension (PAH) · Regimen source: FDA Epoprostenol · 2.1FDA Epoprostenol · 2.2
🛡️ Safety & information
Contraindications
- ⛔ Chronic use in heart failure due to severe left ventricular systolic dysfunction; pulmonary oedema during dose initiation; hypersensitivity. FDA Epoprostenol · 4
Warnings
- • Hypotension and flushing at initiation; rebound symptoms on withdrawal; catheter infection; bleeding (platelet inhibition). FDA Epoprostenol · 5
Formulations
- 1.5 mg vial (also 0.5 mg) — powder for injection 🇺🇸 USA FDA Epoprostenol · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Epoprostenol · 8.1
“Risk Summary Limited published data from case series and case reports with Epoprostenol for Injection have not established a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes when used during pregnancy.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Epoprostenol · 8.2
“Risk Summary There are no data on the presence of epoprostenol in either human or animal milk, the effects on the breastfed infant, or the effect on milk production.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Epoprostenol · 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 Epoprostenol · 8.5
“In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)ANDA219237
- DailyMed (FDA label)FDA Epoprostenol
- MedlinePlus (NIH)Epoprostenol
- WHO ATC/DDDB01AC09
- Darooyab (Iran)Epoprostenol
🇮🇷 Registered in Iran Darooyab · G-3181/Epoprostenol
Dosage forms with Iranian generic codes, per Darooyab.
- 06744 · EPOPROSTENOL 500MCG VIAL · ویال اپوپروستنول ۵۰۰ میکروگرم
- 52165 · EPOPROSTENOL (AS SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION PARENTERAL 0.5 mg · محلول تزریقی اپوپروستنول (معادل سدیم) ۰٫۵ میلیگرم
- 52166 · EPOPROSTENOL (AS SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION PARENTERAL 1.5 mg · محلول تزریقی اپوپروستنول (معادل سدیم) ۱٫۵ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Epoprostenol · 3FDA Epoprostenol · 2.1FDA Epoprostenol · 2.2FDA Epoprostenol · 4FDA Epoprostenol · 5FDA Epoprostenol · SPL approval / marketing categoryFDA Epoprostenol · 8.1FDA Epoprostenol · 8.2FDA Epoprostenol · 8.4FDA Epoprostenol · 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 · G-3181/Epoprostenol
- Clinical review⚠ Unverified