Neoral Oral Solution (Cyclosporine)
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Fact Table
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| Formula | C62H111N11O12 (cyclosporine A, cyclic?peptide of 11 amino acids) |
| License | Prescription only (Rx; immunosuppressant for transplant rejection prophylaxis, RA, psoriasis) |
| Bioavailability | Moderate, variable; Neoral formulations (microemulsion) have increased bioavailability compared to original formulations (Sandimmune), leading to more consistent and higher systemic exposure |
| Legal status | Rx-only (US, CA, EU, NZ, etc.) |
| Chemical Name | Cyclosporin?A (cyclic peptide antibiotic produced by *Beauveria nivea*) |
| Elimination half-life | Terminal half-life ~8.4?hours (range 5–18?h); overall variable, sometimes reported up to ~19–24?h depending on context and population |
| Dosage (Strength) | Oral solution: 100?mg/mL in 50?mL bottles; dosing individualized (e.g., 1.25–4?mg/kg/day divided BID in RA or psoriasis; transplant induction 15?mg/kg/day then taper) per TDM |
| Pregnancy | Use only if clearly needed—risk of immunosuppression; consult specialist |
| Brands | Neoral?Oral Solution (soln, modified microemulsion)—brand equivalent to Neoral capsules; Gengraf (capsules), original Sandimmune (oily solution) |
| Protein binding | High (approx.?90% to plasma proteins and red blood cells—not directly in sources here, but known classically) |
| PubChem CID | 5284373 |
| MedlinePlus | a601207 |
| ChEBI | 4031 |
| ATC code | L04AD01 |
| DrugBank | DB00091 |
| KEGG | D00184 |
| Routes of administration | Oral (solution, capsules); also IV (other formulations) |
Neoral Oral Solution is an immunosuppressant medication containing cyclosporine as the active ingredient. It is primarily indicated for the prevention of organ transplant rejection and for the treatment of certain autoimmune disorders, such as severe psoriasis and rheumatoid arthritis. The formulation is designed to provide consistent bioavailability and is distinct from other cyclosporine products due to its microemulsion delivery system, which ensures more predictable absorption.
Neoral works by selectively inhibiting the activity of calcineurin, a protein involved in the activation of T-lymphocytes. By modulating immune responses, Neoral helps reduce the risk of organ rejection in transplant patients and manages immune-mediated inflammatory conditions. This product is available as an oral solution and is generally used in patients who require a flexible dosage form or have difficulty swallowing capsules.
Directions
Neoral Oral Solution should be taken exactly as prescribed by a healthcare professional. It should be diluted before administration using an appropriate beverage, such as orange juice or apple juice, but not grapefruit juice due to its interaction with cyclosporine metabolism. The solution must be measured using the supplied dosing syringe to ensure accuracy.
It is important to maintain consistent timing and dietary habits when taking Neoral to optimize absorption. Patients should not switch between different cyclosporine formulations without medical supervision, as differences in bioavailability may affect drug levels and therapeutic outcomes.
Dosage will vary depending on the indication, patient body weight, and individual response to treatment. Therapeutic drug monitoring is often required to maintain appropriate blood cyclosporine concentrations.
Ingredients
Active Ingredient: Cyclosporine (as cyclosporine USP)
Cautions
Use of Neoral requires careful monitoring by a healthcare professional due to its narrow therapeutic index. Regular assessment of kidney function, liver enzymes, and cyclosporine blood levels is recommended to avoid toxicity. Patients with pre-existing renal impairment, liver dysfunction, or hypertension should be monitored closely.
Neoral may increase the risk of infections and malignancies, especially lymphoproliferative disorders and skin cancers. Sun exposure should be minimized, and appropriate protective measures taken. Concomitant use with potassium-sparing diuretics, NSAIDs, or other nephrotoxic agents should be approached with caution due to the potential for renal damage.
The product should not be administered with grapefruit juice, which can interfere with cyclosporine metabolism and increase systemic exposure.
Contraindications
Neoral is contraindicated in patients with known hypersensitivity to cyclosporine or to any component of the formulation. It should not be used in patients with uncontrolled hypertension or malignancies, particularly those related to immunosuppression.
The product is not indicated for use in patients with rheumatoid arthritis or psoriasis who also have abnormal renal function, uncontrolled hypertension, or malignancies. Concomitant use with other nephrotoxic or hepatotoxic agents may also be contraindicated unless closely monitored.
Side Effects
Common side effects associated with Neoral Oral Solution include:
- Tremor
- Hypertension
- Headache
- Gingival hyperplasia
- Hypertrichosis
- Nausea
- Renal dysfunction
- Elevated liver enzymes
Serious adverse effects may include nephrotoxicity, hepatotoxicity, increased risk of infections, and lymphoma. All side effects should be reported to a healthcare provider promptly, especially those that are severe or persistent.
Frequently Asked Questions about Neoral Oral Solution (Cyclosporine)
What is Neoral Oral Solution used for?
Neoral (cyclosporine) is an immunosuppressant used to prevent organ transplant rejection and to treat certain autoimmune conditions such as severe psoriasis or rheumatoid arthritis. It helps reduce immune system activity to prevent it from attacking transplanted organs or the body’s own tissues.
How does Neoral differ from other cyclosporine products?
Neoral is a modified cyclosporine formulation with improved absorption compared to older versions like Sandimmune. It is not interchangeable with non-modified cyclosporine products, and dosing should only be adjusted under medical supervision.
How should Neoral Oral Solution be taken?
Neoral Oral Solution should be measured precisely with the provided dosing syringe and taken consistently with regard to meals. It can be diluted with room temperature orange juice or apple juice (not grapefruit juice) to improve taste and absorption.
What are the common side effects of Neoral?
Common side effects include high blood pressure, kidney dysfunction, increased hair growth, gum swelling, tremors, and elevated cholesterol levels. Regular monitoring is essential to manage potential complications.
Can Neoral affect kidney or liver function?
Yes, Neoral can cause nephrotoxicity and, less commonly, liver dysfunction. Kidney and liver function should be monitored regularly through blood tests to detect any early signs of toxicity.
Are there any food or drink restrictions with Neoral?
Grapefruit and grapefruit juice must be avoided as they can interfere with cyclosporine metabolism and raise drug levels, increasing the risk of side effects. Consistent intake relative to meals is also important for stable absorption.
Can Neoral be used during pregnancy or breastfeeding?
Neoral may pose risks during pregnancy and should be used only if clearly needed under specialist supervision. It is excreted in breast milk, so breastfeeding is generally not recommended while on this medication.
What drug interactions are important with Neoral?
Neoral interacts with many medications, including NSAIDs, antibiotics (like erythromycin), antifungals, and certain blood pressure or cholesterol drugs. These interactions may increase toxicity or reduce effectiveness, so all medications should be reviewed by a healthcare provider.
What monitoring is required while taking Neoral?
Frequent monitoring of cyclosporine blood levels, kidney and liver function, blood pressure, and electrolytes is necessary to ensure the drug is working safely. Dose adjustments are often based on these results.
What should I do if I miss a dose of Neoral?
If you miss a dose, take it as soon as you remember unless it's nearly time for your next dose. Do not double up doses. Consistency is critical with immunosuppressants, so notify your healthcare provider if multiple doses are missed.
