Cyclosporine (oral, modified)
سیکلوسپورین خوراکی (Neoral)
🎗️ Antineoplastic And Immunomodulating AgentsCalcineurin inhibitor
Market / country: 🇺🇸 USA
Neoral (US)
🧮 Dose calculator
Rheumatoid arthritis · Regimen source: FDA Neoral · Dosage and Administration
- • Neoral and Sandimmune are not bioequivalent and must not be interchanged without physician supervision. Always in two doses. Monitor BP and creatinine. FDA Neoral · Dosage and Administration
- • Onset 4–8 weeks. Increase by 0.5–0.75 mg/kg/day after 8 and 12 weeks up to 4 mg/kg/day. FDA Neoral · Dosage and Administration
Enter age and weight.
🛡️ Safety & information
Contraindications
- ⛔ Hypersensitivity to cyclosporine. RA and psoriasis: abnormal renal function, uncontrolled hypertension or malignancy. Psoriasis: not with PUVA or UVB, methotrexate or other immunosuppressants, coal tar or radiation. FDA Neoral · Contraindications
Warnings
- • Boxed warning: only by physicians experienced in immunosuppression; infection and lymphoma; nephrotoxicity and hypertension; psoriasis after PUVA — skin cancer risk. FDA Neoral · Boxed Warning
Formulations
- 100 mg/mL oral solution — solution 🇺🇸 USA FDA Neoral · How Supplied
- 25 mg capsule — capsule 🇺🇸 USA FDA Neoral · How Supplied
- 100 mg capsule — capsule 🇺🇸 USA FDA Neoral · How Supplied
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Neoral · Pregnancy
“Risk Summary Available data from published literature, including the Transplant Pregnancy Registry International, observational cohort studies, case-controlled studies, meta-analysis, case series, and case reports, over decades of use with cyclosporine in pregnancy have not identified a drug associated risk of major …”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Neoral · Nursing Mothers
“Risk Summary Cyclosporine and its metabolites are present in human milk following oral and intravenous administration.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Neoral · Pediatric Use
“The safety and efficacy of Neoral treatment in children with juvenile rheumatoid arthritis or psoriasis below the age of 18 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 Neoral · Geriatric Use
“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 potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)NDA050715
- DailyMed (FDA label)FDA Neoral
- MedlinePlus (NIH)CyclosporineCyclosporine Injection
- WHO ATC/DDDL04AD01
- Darooyab (Iran)Ciclosporin
🇮🇷 Registered in Iran Darooyab · G-2733/Ciclosporin
Dosage forms with Iranian generic codes, per Darooyab.
- 06815 · CICLOSPORIN 0.05% OPH DROP · قطره چشمی سیکلوسپورین ۰٫۰۵ درصد
- 00287 · CICLOSPORIN 100MG CAP · کپسول سیکلوسپورین ۱۰۰ میلیگرم
- 06685 · CICLOSPORIN 250MG/5ML AMP · آمپول سیکلوسپورین ۲۵۰ میلیگرم / ۵ میلیلیتر
- 00288 · CICLOSPORIN 25MG CAP · کپسول سیکلوسپورین ۲۵ میلیگرم
- 01758 · CICLOSPORIN 50MG CAP · کپسول سیکلوسپورین ۵۰ میلیگرم
- 01452 · CICLOSPORIN 50MG/1ML AMP · آمپول سیکلوسپورین ۵۰ میلیگرم / ۱ میلیلیتر
- 00289 · CICLOSPORIN I00MG/ML 50ML ORAL SOL · محلول سیکلوسپورین ید ۰۰ میلیگرم / میلیلیتر ۵۰ میلیلیتر
- 52168 · CYCLOSPORIN SOLUTION, DROPS OPHTHALMIC 0.05 % 0.4 mL · قطره چشمی سیکلوسپورین ۰٫۰۵ درصد ۰٫۴ میلیلیتر
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Neoral · How SuppliedFDA Neoral · Dosage and AdministrationFDA Neoral · ContraindicationsFDA Neoral · Boxed WarningFDA Neoral · PregnancyFDA Neoral · Nursing MothersFDA Neoral · Pediatric UseFDA Neoral · Geriatric UseFDA Neoral · 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-2733/Ciclosporin
- Clinical review⚠ Unverified