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Treprostinil

ترپروستینیل

⚠ Unverified

🩸 Blood And Blood Forming OrgansProstacyclin analogue

🤰 Pregnancy:Use with caution 🤱 Breastfeeding:Use with caution 👶 Children:Safety not established 👴 Older adults:Use with caution 🇮🇷 Registered in Iran 🇺🇸 FDA approved (NDA) NDA021272 ATC B01AC21

Market / country: 🇺🇸 USA

Remodulin (US)

🧮 Dose calculator

Disease / regimen

Pulmonary arterial hypertension (PAH) · Regimen source: FDA Remodulin · 2.2 FDA Remodulin · 2.4 FDA Remodulin · 2.5 FDA Remodulin · 2.7

⛔ Dosed in ng/kg/min by pump: increase 1.25 per week for the first 4 weeks, then 2.5 per week. Not tolerated: 0.625. Mild–moderate hepatic impairment: start 0.625. Avoid abrupt cessation. Transition from epoprostenol in hospital. FDA Remodulin · 2.2 FDA Remodulin · 2.4 FDA Remodulin · 2.5 FDA Remodulin · 2.7

🛡️ Safety & information

Warnings

• Catheter-related bloodstream infection with IV use; worsening PAH on abrupt withdrawal; hypotension; bleeding. FDA Remodulin · 5

Formulations

1 mg/mL, 20 mL vial (also 0.1–20 mg/mL) — injection 🇺🇸 USA FDA Remodulin · 3

👥 Special populations

🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Remodulin · 8.1
“Risk Summary Limited case reports of treprostinil use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes.”
🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Remodulin · 8.2
“Risk Summary There are no data on the presence of treprostinil 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 Remodulin · 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 Remodulin · 8.5
“In general, dose selection for an elderly patient should be cautious, 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)NDA021272
DailyMed (FDA label)FDA Remodulin
MedlinePlus (NIH)Treprostinil Treprostinil Injection
WHO ATC/DDDB01AC21
Darooyab (Iran)Treprostinil

🇮🇷 Registered in Iran Darooyab · G-3195/Treprostinil

Dosage forms with Iranian generic codes, per Darooyab.

53085 · TREPROSTINIL (AS SODIUM) INJECTION PARENTERAL 5 mg/1mL 10 mL · فرآورده تزریقی ترپروستینیل (معادل سدیم) ۵ میلی‌گرم / ۱ میلی‌لیتر ۱۰ میلی‌لیتر
53084 · TREPROSTINIL (AS SODIUM) INJECTION PARENTERAL 2.5 mg/1mL 10 mL · فرآورده تزریقی ترپروستینیل (معادل سدیم) ۲٫۵ میلی‌گرم / ۱ میلی‌لیتر ۱۰ میلی‌لیتر
53083 · TREPROSTINIL (AS SODIUM) INJECTION PARENTERAL 1 mg/1mL 10 mL · فرآورده تزریقی ترپروستینیل (معادل سدیم) ۱ میلی‌گرم / ۱ میلی‌لیتر ۱۰ میلی‌لیتر

📚 Reference status for this drug

Shows which sources have references recorded for this drug and which do not.

FDA label (DailyMed)✅ Present
FDA Remodulin · 3 FDA Remodulin · 2.2 FDA Remodulin · 2.4 FDA Remodulin · 2.5 FDA Remodulin · 2.7 FDA Remodulin · 5 FDA Remodulin · SPL approval / marketing category FDA Remodulin · 8.1 FDA Remodulin · 8.2 FDA Remodulin · 8.4 FDA Remodulin · 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)✅ Present
Darooyab · G-3195/Treprostinil
Clinical review⚠ Unverified

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