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Cyclosporine (oral, modified)

سیکلوسپورین خوراکی (Neoral)

⚠ Unverified

🎗️ Antineoplastic And Immunomodulating AgentsCalcineurin inhibitor

🤰 Pregnancy:Use with caution 🤱 Breastfeeding:Use with caution 👶 Children:Safety not established 👴 Older adults:Use with caution 🇮🇷 Not found in Iran list ⛔ 1 contraindications 🇺🇸 FDA approved (NDA) NDA050715 ATC L04AD01

Market / country: 🇺🇸 USA

Neoral (US)

🧮 Dose calculator

Disease / regimen

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

Formulation

Age *

Weight (kg) *

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🛡️ 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)Cyclosporine Cyclosporine Injection
WHO ATC/DDDL04AD01
Darooyab (Iran)❌ None

🇮🇷 Not found in Iran list Darooyab · search

Darooyab lists no registered dosage form or brand for this drug. This does not prove it is unavailable.

📚 Reference status for this drug

Shows which sources have references recorded for this drug and which do not.

FDA label (DailyMed)✅ Present
FDA Neoral · How Supplied FDA Neoral · Dosage and Administration FDA Neoral · Contraindications FDA Neoral · Boxed Warning FDA Neoral · SPL approval / marketing category FDA Neoral · Pregnancy FDA Neoral · Nursing Mothers FDA Neoral · Pediatric Use FDA Neoral · Geriatric Use
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)✅ Present
Darooyab · search
Clinical review⚠ Unverified