Sufentanil
سوفنتانیل
🧠 Nervous SystemPotent opioid (anaesthesia)
Market / country: 🇺🇸 USA
Sufenta (US)
🧮 Dose calculator
General anaesthesia and premedication (adjunct) · Regimen source: FDA Sufentanil · 2, Table 1
- • About 75% or more before intubation; then 10–25 mcg increments as needed. Total requirements of ≤1 mcg/kg/h recommended. Individualise by age, weight and status. FDA Sufentanil · 2, Table 1FDA Sufentanil · 2
- • Only by personnel trained in anaesthesia, with airway, ventilation and resuscitation equipment at hand. FDA Sufentanil · 2
Enter age and weight.
🛡️ Safety & information
Contraindications
- ⛔ Hypersensitivity to sufentanil. FDA Sufentanil · 4
Warnings
- • Boxed warning: addiction and misuse; life-threatening respiratory depression; risks with benzodiazepines and other CNS depressants. FDA Sufentanil · Boxed Warning
- • Muscle rigidity; severe cardiovascular depression; improper epidural injection; raised intracranial pressure. FDA Sufentanil · 5
Formulations
- 50 mcg/mL (1 mL vial) — injection 🇺🇸 USA FDA Sufentanil · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Sufentanil · 8.1
“Risk Summary Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Sufentanil · 8.2
“Risk Summary The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Sufentanil Citrate Injection and any potential adverse effects on the breastfed infant from Sufentanil Citrate Injection or from the underlying maternal condition.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Sufentanil · 8.4
“The safety and efficacy of intravenous sufentanil in pediatric patients as young as 1 day old undergoing cardiovascular surgery have been documented in a limited number of cases.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Sufentanil · 8.5
“In general, use caution when selecting a dosage for an elderly patient, 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 potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Sufentanil · 8.3
“Infertility Use of opioids for an extended period of time may cause reduced fertility in females and males of reproductive potential.”
🔗 Reference links
- FDA (approval record)ANDA074534
- DailyMed (FDA label)FDA Sufentanil
- MedlinePlus (NIH)❌ None
- WHO ATC/DDDN01AH03
- Darooyab (Iran)Sufentanil
🇮🇷 Registered in Iran Darooyab · G-192/Sufentanil
Dosage forms with Iranian generic codes, per Darooyab.
- 10214 · SUFENTANIL 10MCG/2ML AMP · آمپول سوفنتانیل ۱۰ میکروگرم / ۲ میلیلیتر
- 21744 · SUFENTANIL 250MCG/5ML AMP · آمپول سوفنتانیل ۲۵۰ میکروگرم / ۵ میلیلیتر
- 10216 · SUFENTANIL 25MCG/5ML AMP · آمپول سوفنتانیل ۲۵ میکروگرم / ۵ میلیلیتر
- 01366 · SUFENTANIL 50MCG/10ML AMP · آمپول سوفنتانیل ۵۰ میکروگرم / ۱۰ میلیلیتر
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Sufentanil · 3FDA Sufentanil · 2, Table 1FDA Sufentanil · 2FDA Sufentanil · 4FDA Sufentanil · Boxed WarningFDA Sufentanil · 5FDA Sufentanil · SPL approval / marketing categoryFDA Sufentanil · 8.1FDA Sufentanil · 8.2FDA Sufentanil · 8.4FDA Sufentanil · 8.5FDA Sufentanil · 8.3
- 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-192/Sufentanil
- Clinical review⚠ Unverified