Neoral: Advanced Immunosuppression for Transplant Success
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Synonyms | |||
Neoral (cyclosporine, modified) is a critical immunosuppressive agent formulated to prevent organ rejection in transplant recipients. Its advanced microemulsion technology ensures more consistent and predictable absorption than previous formulations, allowing for precise therapeutic management. Trusted by specialists worldwide, Neoral plays an indispensable role in long-term graft survival and patient outcomes, offering a tailored approach to immunosuppressive therapy.
Features
- Microemulsion formulation for improved bioavailability
- Consistent and predictable pharmacokinetic profile
- Available in 25 mg and 100 mg soft gelatin capsules
- Oral solution formulation for flexible dosing
- Hydrophilic matrix design for reduced food effect variability
- Precisely calibrated release mechanism
Benefits
- Significantly reduces risk of acute and chronic organ rejection
- Provides stable drug exposure with reduced peak-trough fluctuations
- Enables more precise therapeutic drug monitoring
- Supports long-term graft function and survival
- Minimizes dosage adjustments through predictable absorption
- Facilitates personalized immunosuppressive regimens
Common use
Neoral is primarily indicated for the prophylaxis of organ rejection in patients receiving allogeneic kidney, liver, and heart 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.
Dosage and direction
Initial dosing must be individualized based on patient weight, transplant type, and concomitant immunosuppressive therapy. For transplant patients, the initial oral dose typically ranges from 8-15 mg/kg/day, administered in two divided doses, beginning 4-12 hours prior to transplantation. Subsequent dosing should be adjusted based on cyclosporine blood concentration monitoring, clinical assessment, and laboratory parameters. The dosage should be gradually reduced to maintenance levels of 3-10 mg/kg/day over time. Always administer at consistent times relative to meals to maintain stable absorption patterns. Regular therapeutic drug monitoring is essential throughout treatment.
Precautions
Patients require continuous medical supervision during Neoral therapy. Regular monitoring of blood pressure, renal function, liver enzymes, and cyclosporine blood levels is mandatory. Hypertension may develop and require antihypertensive therapy. Nephrotoxicity can occur at any dose and may be progressive. Hepatotoxicity has been reported, particularly with high doses. Hyperlipidemia may develop and require treatment. Patients should be monitored for neurological complications, including tremor, headache, and rarely, seizures. Increased susceptibility to infection and possible development of lymphoma and other malignancies may occur. Potassium levels should be monitored due to risk of hyperkalemia.
Contraindications
Neoral is contraindicated in patients with hypersensitivity to cyclosporine or any component of the formulation. It should not be used concurrently with PUVA or UVB therapy in psoriasis patients due to increased risk of skin malignancies. Concomitant administration with potassium-sparing diuretics is contraindicated due to hyperkalemia risk. Use is contraindicated with live vaccines during treatment. Patients with uncontrolled hypertension, significant renal impairment, or uncontrolled infections should not receive Neoral unless potential benefits outweigh risks.
Possible side effects
Common adverse reactions include renal dysfunction (25-38%), hypertension (13-53%), tremor (12-55%), headache (15-27%), hirsutism (21-45%), gum hyperplasia (4-16%), and gastrointestinal disturbances (4-16%). Less frequent but serious side effects may include nephrotoxicity, hepatotoxicity, neurotoxicity, thrombocytopenia, microangiopathic hemolytic anemia, and anaphylactic reactions. Metabolic abnormalities including hyperkalemia, hypomagnesemia, hyperuricemia, and glucose intolerance may occur. Malignancies, particularly skin cancer and lymphoma, have been reported with long-term therapy.
Drug interaction
Neoral interacts significantly with numerous medications. Strong CYP3A4 inhibitors (ketoconazole, fluconazole, clarithromycin) increase cyclosporine levels. CYP3A4 inducers (rifampin, phenytoin, St. John’s wort) decrease levels. Nephrotoxic drugs (aminoglycosides, amphotericin B, NSAIDs) increase renal toxicity risk. Potassium-sparing diuretics and ACE inhibitors increase hyperkalemia risk. Statins may have increased myopathy risk. Grapefruit juice inhibits metabolism and increases bioavailability. Always review complete medication profile before initiation and during therapy.
Missed dose
If a dose is missed, administer it as soon as possible within the same dosing interval. If it is near the time for the next dose, skip the missed dose and resume the regular dosing schedule. Do not double the dose to make up for a missed administration. Consistent timing is crucial for maintaining therapeutic drug levels. Patients should maintain a dosing diary and contact their transplant team for specific guidance if multiple doses are missed.
Overdose
Symptoms of overdose include nausea, vomiting, lethargy, headache, tachycardia, and potentially severe renal and hepatic impairment. Management involves immediate gastric lavage if ingestion was recent, followed by supportive measures. Hemodialysis is not effective due to high protein binding and extensive distribution. Charcoal hemoperfusion may enhance elimination. Specific monitoring of renal and hepatic function, cyclosporine levels, and electrolyte status is essential. Maintain adequate hydration while monitoring for fluid overload in renal impairment.
Storage
Store at room temperature (15-30°C/59-86°F) in original container. Protect from light and moisture. Keep bottle tightly closed. Do not freeze. Oral solution remains stable for two months after opening when stored at room temperature. Do not transfer capsules or solution to other containers. Keep out of reach of children and pets. Do not use beyond expiration date printed on packaging.
Disclaimer
This information does not replace professional medical advice. Treatment decisions must be made by qualified healthcare providers based on individual patient circumstances. Dosage and administration must be supervised by physicians experienced in immunosuppressive therapy. Regular monitoring is essential throughout treatment duration. Patients should report any adverse effects immediately to their healthcare provider.
Reviews
Clinical studies demonstrate Neoral’s efficacy in preventing rejection, with one-year kidney graft survival rates exceeding 90% in combination therapy. Transplant specialists note its predictable pharmacokinetics allow for better management than previous formulations. Patients report improved quality of life despite necessary monitoring requirements. Long-term data supports maintained efficacy with proper therapeutic drug monitoring. Some clinicians note the need for careful management of metabolic side effects. Overall, it remains a cornerstone therapy in transplant medicine with decades of clinical experience supporting its use.