Pimecrolimus cream 1%
پیمکرولیموس کرم ۱٪
🧴 DermatologicalsTopical calcineurin inhibitor
Market / country: 🇺🇸 USA
Elidel (US)
🧮 Dose calculator
Atopic dermatitis (eczema) · Regimen source: FDA Pimecrolimus · 2FDA Pimecrolimus · 1
🛡️ Safety & information
Contraindications
- ⛔ Hypersensitivity to pimecrolimus. FDA Pimecrolimus · 4
Warnings
- • Boxed warning: long-term safety not established; rare malignancy (skin, lymphoma). Not for immunocompromised patients or under 2 years. FDA Pimecrolimus · Boxed Warning
Formulations
- Pimecrolimus 1% cream — cream 🇺🇸 USA FDA Pimecrolimus · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Pimecrolimus · 8.1
“Pregnancy Category C There are no adequate and well-controlled studies with Pimecrolimus Cream, 1% in pregnant women.”
- 🤱 BreastfeedingDangerous / avoid
Label: breastfeeding not recommended, or choose between the drug and breastfeeding. FDA Pimecrolimus · 8.3
“Because of the potential for serious adverse reactions in nursing infants from pimecrolimus, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.”
- 👶 ChildrenUse with caution
Label: only ≥2 years and second line; not indicated under 2 years. FDA Pimecrolimus · 8.4
“Pimecrolimus Cream, 1% is not indicated for use in children less than 2 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 Pimecrolimus · 8.5
“Nine (9) subjects ≥65 years old received Pimecrolimus Cream, 1% in Phase 3 trials.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)NDA021302
- DailyMed (FDA label)FDA Pimecrolimus
- MedlinePlus (NIH)❌ None
- WHO ATC/DDDD11AH02
- Darooyab (Iran)Pimecrolimus
🇮🇷 Registered in Iran Darooyab · G-2308/Pimecrolimus
Dosage forms with Iranian generic codes, per Darooyab.
- 07760 · PIMECROLIMUS 1% 15G CREAM · کرم پیمکرولیموس ۱ درصد ۱۵ گرم
- 05421 · PIMECROLIMUS 1% 30G CREAM · کرم پیمکرولیموس ۱ درصد ۳۰ گرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Pimecrolimus · 3FDA Pimecrolimus · 2FDA Pimecrolimus · 1FDA Pimecrolimus · 4FDA Pimecrolimus · Boxed WarningFDA Pimecrolimus · 8.1FDA Pimecrolimus · 8.3FDA Pimecrolimus · 8.4FDA Pimecrolimus · 8.5FDA Pimecrolimus · 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-2308/Pimecrolimus
- Clinical review⚠ Unverified