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Fentanyl transdermal patch
چسب پوستی فنتانیل
🧠 Nervous SystemLong-acting opioid agonist
🤰 Pregnancy:Dangerous / avoid🤱 Breastfeeding:Dangerous / avoid👶 Children:Use with caution👴 Older adults:Use with caution⚥ Females & males of reproductive potential:Use with caution 🇮🇷 Registered in Iran⛔ 1 contraindications 🇺🇸 FDA approved generic (ANDA) ANDA077154ATC N02AB03
Market / country: 🇺🇸 USA
Duragesic (US)
🧮 Dose calculator
Severe pain requiring an opioid · Regimen source: FDA Fentanyl patch · 2.1FDA Fentanyl patch · 2.3FDA Fentanyl patch · 2.5FDA Fentanyl patch · 2.6FDA Fentanyl patch · 2.8
⛔ Opioid-tolerant patients only (≥60 mg oral morphine/day or equivalent for ≥1 week). Starting dose by conversion from the current opioid per label; underestimating is safer. Every 72 h; fold used patches and dispose. Mild/moderate hepatic or renal impairment: half the dose. FDA Fentanyl patch · 2.1FDA Fentanyl patch · 2.3FDA Fentanyl patch · 2.5FDA Fentanyl patch · 2.6FDA Fentanyl patch · 2.8
🛡️ Safety & information
Contraindications
- ⛔ Not opioid-tolerant; acute, intermittent, postoperative or mild pain; respiratory depression; severe asthma without monitoring; GI obstruction; hypersensitivity. FDA Fentanyl patch · 4
Warnings
- • Boxed warning: fatal respiratory depression (especially if not opioid-tolerant), accidental exposure in children is fatal, heat (fever, heating pads, saunas) raises absorption, interactions with benzodiazepines and CYP3A4 inhibitors. FDA Fentanyl patch · Boxed Warning
Formulations
- Patches 12 / 25 / 37.5 / 50 / 62.5 / 75 / 87.5 / 100 mcg/hour — transdermal patch 🇺🇸 USA FDA Fentanyl patch · 3
👥 Special populations
- 🤰 PregnancyDangerous / avoid
Label: can cause fetal harm. Dangerous in pregnancy. FDA Fentanyl patch · Boxed Warning
“Neonatal Opioid Withdrawal Syndrome (NOWS) Advise pregnant women using opioids for an extended period of time of the risk of Neonatal Opioid Withdrawal Syndrome, which may be life-threatening if not recognized and treated.”
- 🤱 BreastfeedingDangerous / avoid
Label: breastfeeding not recommended, or choose between the drug and breastfeeding. FDA Fentanyl patch · 8.2
“Because of the potential for serious adverse reactions, including excess sedation and respiratory depression in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with fentanyl transdermal system.”
- 👶 ChildrenUse with caution
Label: children ≥2 y only if opioid-tolerant. Accidental exposure to even one patch is fatal in children. FDA Fentanyl patch · 8.4
“The safety of fentanyl transdermal system was evaluated in three open-label trials in 289 pediatric patients with chronic pain, 2 years of age through 18 years of age.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Fentanyl patch · 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 Fentanyl patch · 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)ANDA077154
- DailyMed (FDA label)FDA Fentanyl patch
- MedlinePlus (NIH)❌ None
- WHO ATC/DDDN02AB03
- Darooyab (Iran)Fentanyl
🇮🇷 Registered in Iran Darooyab · G-82/Fentanyl
Dosage forms with Iranian generic codes, per Darooyab.
- 02545 · FENTANYLE 100MCG/H PATCH · پچ پوستی فنتانیل ۱۰۰ میکروگرم / H
- 01987 · FENTANYLE 25MCG/H PATCH · پچ پوستی فنتانیل ۲۵ میکروگرم / H
- 01988 · FENTANYLE 50MCG/H PATCH · پچ پوستی فنتانیل ۵۰ میکروگرم / H
- 02546 · FENTANYLE 75MCG/H PATCH · پچ پوستی فنتانیل ۷۵ میکروگرم / H
- 01359 · FENTANYLE CITRATE 50MCG/ML 10ML AMP · آمپول فنتانیل سیترات ۵۰ میکروگرم / میلی‌لیتر ۱۰ میلی‌لیتر
- 07830 · FENTANYLE CITRATE 50MCG/ML 2ML AMP · آمپول فنتانیل سیترات ۵۰ میکروگرم / میلی‌لیتر ۲ میلی‌لیتر
- 10376 · FENTANYLE CITRATE 50MCG/ML 5ML AMP · آمپول فنتانیل سیترات ۵۰ میکروگرم / میلی‌لیتر ۵ میلی‌لیتر
- 52261 · FENTANYL (AS CITRATE) INJECTION PARENTERAL 50 ug/1mL 5 mL · فرآورده تزریقی فنتانیل (معادل سیترات) ۵۰ میکروگرم / ۱ میلی‌لیتر ۵ میلی‌لیتر
- 51007 · FENTANYL CITRATE TABLET SUBLINGUAL 100 ug · قرص زیرزبانی فنتانیل سیترات ۱۰۰ میکروگرم
- 51013 · FENTANYL CITRATE TABLET SUBLINGUAL 200 ug · قرص زیرزبانی فنتانیل سیترات ۲۰۰ میکروگرم
- 51014 · FENTANYL CITRATE TABLET SUBLINGUAL 300 ug · قرص زیرزبانی فنتانیل سیترات ۳۰۰ میکروگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Fentanyl patch · 3FDA Fentanyl patch · 2.1FDA Fentanyl patch · 2.3FDA Fentanyl patch · 2.5FDA Fentanyl patch · 2.6FDA Fentanyl patch · 2.8FDA Fentanyl patch · 4FDA Fentanyl patch · Boxed WarningFDA Fentanyl patch · 8.2FDA Fentanyl patch · 8.4FDA Fentanyl patch · 8.5FDA Fentanyl patch · 8.3FDA Fentanyl patch · SPL approval / marketing category
- 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-82/Fentanyl
- Clinical review⚠ Unverified