Neoral: Advanced Immunosuppression for Transplant Success
Neoral
| Product dosage: 100mg | |||
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| Product dosage: 25mg | |||
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Synonyms | |||
Neoral (cyclosporine, modified) is a critical immunosuppressive agent specifically engineered to prevent organ rejection in transplant recipients. As a microemulsion formulation, it offers improved and more consistent bioavailability compared to earlier cyclosporine preparations, allowing for more predictable blood levels and enhanced therapeutic outcomes. This advanced formulation supports long-term graft survival while maintaining a manageable safety profile under appropriate medical supervision. Its role remains foundational in modern transplant protocols, providing clinicians with a reliable tool for immunosuppression management.
Features
- Microemulsion formulation for enhanced bioavailability
- Consistent and predictable pharmacokinetic profile
- Available in 25 mg and 100 mg soft gelatin capsules
- Oral solution formulation (100 mg/mL) for dosing flexibility
- Temperature-stable composition within recommended storage conditions
- Precise blood level monitoring through cyclosporine assays
Benefits
- Significantly reduces risk of acute and chronic organ rejection
- Provides stable immunosuppression with reduced dosing variability
- Enables personalized therapy through therapeutic drug monitoring
- Supports long-term graft survival and patient outcomes
- Flexible dosing options accommodate individual patient needs
- Established safety profile with decades of clinical experience
Common use
Neoral is primarily indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. It is typically used as part of a comprehensive immunosuppressive regimen that may include corticosteroids and other immunosuppressive agents. The medication may also be prescribed for severe, active rheumatoid arthritis where conventional therapy has proven inadequate, and for severe psoriasis in adult non-immunocompromised patients when other systemic therapies have failed or are contraindicated. In transplant medicine, initiation usually occurs immediately pre-transplant or peri-operatively, with maintenance therapy continuing indefinitely under careful medical supervision.
Dosage and direction
Dosing must be highly individualized based on transplant type, concomitant immunosuppression, and therapeutic drug monitoring. For renal transplantation: initial dose of 9 ± 3 mg/kg/day divided into two doses, beginning 4-12 hours before transplantation. For liver transplantation: initial dose of 8 ± 4 mg/kg/day in two divided doses, beginning 4-12 hours pre-transplant. For cardiac transplantation: initial dose of 7 ± 3 mg/kg/day in two divided doses. Subsequent dosing adjustments should be based on cyclosporine blood trough levels, with target ranges typically between 100-400 ng/mL depending on time post-transplant and institutional protocols. All doses should be administered consistently with regard to meals at approximately 12-hour intervals. The oral solution should be diluted with room temperature orange or apple juice immediately before administration to improve palatability.
Precautions
Patients require comprehensive education regarding infection risks and the importance of avoiding live vaccines. Regular monitoring of blood pressure, renal function, liver enzymes, and cyclosporine levels is mandatory. Healthcare providers should exercise caution in patients with hypertension, renal impairment, or hepatic dysfunction. Patients must be advised to avoid grapefruit and grapefruit juice, which can significantly increase cyclosporine bioavailability. Sun protection measures are essential due to increased photosensitivity risk. Regular dermatological examinations are recommended for early detection of malignancies. Blood lipid levels should be monitored periodically due to potential hyperlipidemic effects.
Contraindications
Neoral is contraindicated in patients with hypersensitivity to cyclosporine or any component of the formulation. It should not be administered concurrently with PUVA or UVB therapy in psoriasis patients. Concomitant use with strong CYP3A4 inhibitors or inducers that cannot be discontinued is contraindicated. The medication is contraindicated in patients with abnormal renal function, uncontrolled hypertension, or malignancies except skin cancer, unless the benefits outweigh the risks. Live vaccines should not be administered during therapy.
Possible side effects
- Nephrotoxicity: elevated serum creatinine and BUN
- Hypertension: requiring antihypertensive management
- Neurological: tremor, headache, paresthesia, rarely seizures
- Gastrointestinal: nausea, vomiting, diarrhea, abdominal discomfort
- Metabolic: hyperkalemia, hypomagnesemia, hyperuricemia
- Hepatic: elevated bilirubin and liver enzymes
- Dermatological: hirsutism, gingival hyperplasia
- Infectious: increased susceptibility to opportunistic infections
- Malignancies: increased risk of lymphoma and skin cancers
Drug interaction
Cyclosporine interacts significantly with medications metabolized by CYP3A4. Strong inhibitors (ketoconazole, clarithromycin) increase cyclosporine levels, while inducers (rifampin, phenytoin) decrease levels. Concurrent use with nephrotoxic agents (aminoglycosides, NSAIDs) increases renal toxicity risk. Potassium-sparing diuretics and potassium supplements may cause dangerous hyperkalemia. Statins may have increased myopathy risk when combined with cyclosporine. Monitoring and dose adjustments are essential when adding or discontinuing interacting medications.
Missed dose
If a dose is missed, the patient should take it as soon as remembered unless it is nearly time for the next dose. In that case, the missed dose should be skipped and the regular dosing schedule resumed. Patients should never double the dose to make up for a missed administration. Consistent timing is critical for maintaining therapeutic drug levels, so patients should be instructed to maintain strict adherence to the prescribed schedule and contact their healthcare provider if multiple doses are missed.
Overdose
Cyclosporine overdose may manifest as elevated serum creatinine, hepatotoxicity, nausea, vomiting, lethargy, and in severe cases, seizures. Management involves immediate gastric lavage if ingestion was recent, followed by activated charcoal administration. Supportive care includes maintenance of renal perfusion and electrolyte balance. Hemodialysis is not effective due to high protein binding, though charcoal hemoperfusion may provide some clearance. Serum cyclosporine levels should be monitored frequently until concentrations return to therapeutic range.
Storage
Store at room temperature between 15-30°C (59-86°F). Protect from light and excessive moisture. Keep the oral solution in the original container and do not transfer to other containers. Once opened, the oral solution should be used within two months. Keep all formulations out of reach of children and pets. Do not freeze the medication. Always keep the container tightly closed when not in use to prevent evaporation and contamination.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. Neoral should only be used under the supervision of a qualified healthcare professional experienced in immunosuppressive therapy. Treatment decisions must be based on individual patient characteristics and current clinical guidelines. Patients should not adjust their dosage or discontinue therapy without consulting their healthcare provider. The prescribing physician should be consulted for complete prescribing information.
Reviews
Clinical studies demonstrate Neoral’s efficacy in preventing rejection, with one-year kidney graft survival rates exceeding 90% in controlled trials. Rheumatologists report significant improvement in disease activity scores in rheumatoid arthritis patients refractory to other therapies. Dermatologists note substantial clearing of psoriatic lesions in appropriate patients. The consistent bioavailability of the microemulsion formulation receives particular praise from transplant specialists for reducing intra-patient variability and simplifying therapeutic drug monitoring. Long-term follow-up studies confirm maintained efficacy with appropriate management of side effects.