Tacrolimus (oral)
تاکرولیموس خوراکی
🎗️ Antineoplastic And Immunomodulating AgentsCalcineurin inhibitor
Market / country: 🇺🇸 USA
Prograf (US)
🧮 Dose calculator
Prevention of organ transplant rejection · Regimen source: FDA Prograf · 2.2, Table 1
- • Initial dose; then adjust by whole-blood trough levels per the table. First dose for liver/heart/lung no sooner than 6 h after transplant. Avoid grapefruit. FDA Prograf · 2.2, Table 1FDA Prograf · 2.2FDA Prograf · 2.1
Enter age and weight.
🛡️ Safety & information
Contraindications
- ⛔ Hypersensitivity to tacrolimus; injection: hypersensitivity to HCO-60 (polyoxyl 60 hydrogenated castor oil). FDA Prograf · 4
Warnings
- • Boxed warning: malignancy and serious infections. Nephrotoxicity, neurotoxicity, post-transplant diabetes, QT prolongation; many CYP3A interactions. FDA Prograf · Boxed WarningFDA Prograf · 5
Formulations
- 0.5 mg capsule — capsule 🇺🇸 USA FDA Prograf · 3
- 1 mg capsule — capsule 🇺🇸 USA FDA Prograf · 3
- 5 mg capsule — capsule 🇺🇸 USA FDA Prograf · 3
👥 Special populations
- 🤰 PregnancyDangerous / avoid
Label: can cause fetal harm. Dangerous in pregnancy. FDA Prograf · 8.1
“Risk Summary Tacrolimus can cause fetal harm when administered to a pregnant woman.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Prograf · 8.2
“Risk Summary Controlled lactation studies have not been conducted in humans; however, tacrolimus has been reported to be present in human milk.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Prograf · 8.4
“Safety and effectiveness have been established in pediatric liver, kidney, heart, and lung transplant patients.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Prograf · 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 potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Prograf · 8.3
“Contraception PROGRAF can cause fetal harm when administered to pregnant women.”
🔗 Reference links
- FDA (approval record)NDA050708
- DailyMed (FDA label)FDA Prograf
- MedlinePlus (NIH)TacrolimusTacrolimus Injection
- WHO ATC/DDDL04AD02
- Darooyab (Iran)Tacrolimus
🇮🇷 Registered in Iran Darooyab · G-2744/Tacrolimus
Dosage forms with Iranian generic codes, per Darooyab.
- 18952 · TACROLIMUS 0.03% 10G OINT · پماد تاکرولیموس ۰٫۰۳ درصد ۱۰ گرم
- 11622 · TACROLIMUS 0.03% 30G OINT · پماد تاکرولیموس ۰٫۰۳ درصد ۳۰ گرم
- 08131 · TACROLIMUS 0.03% 60G OINT · پماد تاکرولیموس ۰٫۰۳ درصد ۶۰ گرم
- 08187 · TACROLIMUS 0.1% 10G OINT · پماد تاکرولیموس ۰٫۱ درصد ۱۰ گرم
- 06599 · TACROLIMUS 0.1% 30G OINT · پماد تاکرولیموس ۰٫۱ درصد ۳۰ گرم
- 05804 · TACROLIMUS 0.5MG CAP · کپسول تاکرولیموس ۰٫۵ میلیگرم
- 02083 · TACROLIMUS 1MG CAP · کپسول تاکرولیموس ۱ میلیگرم
- 02084 · TACROLIMUS 5MG CAP · کپسول تاکرولیموس ۵ میلیگرم
- 02087 · TACROLIMUS 5MG/ML FOR INFU · محلول انفوزیون تاکرولیموس ۵ میلیگرم / میلیلیتر
- 50539 · TACROLIMUS 3MG CAP · کپسول تاکرولیموس ۳ میلیگرم
- 52291 · TACROLIMUS CAPSULE, EXTENDED RELEASE ORAL 0.5 mg · کپسول آهستهرهش تاکرولیموس ۰٫۵ میلیگرم
- 52332 · TACROLIMUS CAPSULE, EXTENDED RELEASE ORAL 1 mg · کپسول آهستهرهش تاکرولیموس ۱ میلیگرم
- 52333 · TACROLIMUS CAPSULE, EXTENDED RELEASE ORAL 5 mg · کپسول آهستهرهش تاکرولیموس ۵ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Prograf · 3FDA Prograf · 2.2, Table 1FDA Prograf · 2.2FDA Prograf · 2.1FDA Prograf · 4FDA Prograf · Boxed WarningFDA Prograf · 5FDA Prograf · SPL approval / marketing categoryFDA Prograf · 8.1FDA Prograf · 8.2FDA Prograf · 8.4FDA Prograf · 8.5FDA Prograf · 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-2744/Tacrolimus
- Clinical review⚠ Unverified