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Sandimmun Neoral-25mg

Active Ingredient:
Ciclosporin
Form:
Capsule

Sandimmun Neoral-25mg (Ciclosporin Capsule) 25MG

Sandimmun Neoral-25mg is an oral capsule that contains 25 mg of the immunosuppressant ciclosporin. It belongs to the calcineurin inhibitor class and is prescribed by healthcare professionals to modulate the immune system in specific medical conditions. The product is available by prescription only and is administered orally. It is formulated for consistent absorption and is marketed under the Sandimmun Neoral brand name in many countries worldwide.

Strength

25MG

1
Pack/s
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Indications & Clinical Uses

Sandimmun Neoral-25mg is used in clinical practice to prevent immune-mediated rejection and to treat certain autoimmune skin and kidney disorders.

  • Prevention of acute and chronic organ transplant rejection, particularly kidney, liver, and heart transplants.
  • Management of severe plaque psoriasis that has not responded to conventional therapy.
  • Treatment of nephrotic syndrome associated with primary glomerular diseases.
  • Off‑label use for rheumatoid arthritis in patients who require additional immunosuppression.
  • Adjunct therapy in certain dermatologic conditions such as atopic dermatitis when other options are insufficient.

How It Works

  • Ciclosporin binds to the intracellular protein cyclophilin, forming a complex that inhibits the phosphatase activity of calcineurin. This inhibition prevents dephosphorylation of the nuclear factor of activated T‑cells (NF‑AT), reducing transcription of interleukin‑2 and other cytokines essential for T‑cell activation and proliferation. By suppressing this pathway, the drug diminishes the immune response that contributes to graft rejection and inflammatory skin disease.

Side Effects

Ciclosporin may cause a range of adverse reactions, varying from mild to potentially life‑threatening.

Common

  • Headache, tremor, or dizziness.
  • Gastrointestinal discomfort such as nausea, vomiting, or diarrhea.
  • Elevated blood pressure (hypertension).
  • Increased hair growth (hypertrichosis) or gum overgrowth (gingival hyperplasia).

Serious

  • Nephrotoxicity leading to reduced kidney function.
  • Hepatotoxicity presenting as elevated liver enzymes.
  • Severe infections due to immunosuppression.
  • Malignancies, particularly skin cancers and lymphomas.

Precautions & Warnings

Before initiating Sandimmun Neoral-25mg, clinicians should evaluate several safety considerations to minimize risk.

  • Assess baseline renal and hepatic function; adjust dose if impairment is present.
  • Monitor blood pressure regularly, as hypertension is a frequent effect.
  • Perform periodic complete blood counts and lipid profiles during therapy.
  • Avoid use in pregnant women unless benefits outweigh risks; the drug is category C.
  • Counsel patients on the importance of consistent dosing and avoiding missed doses.
  • Review vaccination status; live vaccines are contraindicated while immunosuppressed.
  • Evaluate for potential drug‑induced diabetes, especially in patients with metabolic risk factors.

Avoid Interactions

Ciclosporin interacts with many medicines; recognizing these interactions helps prevent toxicity or loss of efficacy.

Avoid

  • Strong CYP3A4 inhibitors such as ketoconazole, itraconazole, and clarithromycin, which can markedly increase ciclosporin levels.
  • Nephrotoxic agents like aminoglycosides or non‑steroidal anti‑inflammatory drugs (NSAIDs) that may exacerbate kidney injury.
  • Live vaccines, because immunosuppression can lead to uncontrolled infection.

Use with caution

  • CYP3A4 inducers (e.g., rifampin, carbamazepine, St. John’s wort) that may reduce drug concentrations.
  • Other immunosuppressants (e.g., azathioprine, mycophenolate) increasing infection risk.
  • Diuretics and antihypertensives, which may affect blood pressure control.

Frequently Asked Questions

Sandimmun Neoral-25mg is an oral capsule that contains 25 mg of ciclosporin.

It is commonly prescribed to prevent organ transplant rejection, to treat severe plaque psoriasis, and to manage nephrotic syndrome.

Ciclosporin binds cyclophilin, inhibiting calcineurin, which prevents activation of NF‑AT and reduces interleukin‑2 transcription, thereby decreasing T‑cell activation.

The drug is classified as pregnancy category C; it should be used only if the potential benefits justify the potential risks to the fetus.

Regular monitoring of renal and hepatic function, blood pressure, complete blood count, lipid profile, and liver enzymes is recommended.

Common side effects include headache, tremor, gastrointestinal upset, hypertension, and increased hair or gum growth.

Serious reactions may include nephrotoxicity, hepatotoxicity, severe infections, and an increased risk of certain cancers such as skin cancer and lymphoma.

Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin), nephrotoxic agents (e.g., aminoglycosides, NSAIDs), and live vaccines should be avoided.

CYP3A4 inducers, other immunosuppressants, and certain antihypertensive or diuretic medications should be used with caution.

No, Sandimmun Neoral-25mg is a prescription‑only medication.

The ATC code for ciclosporin is L04AD01.

The capsule can be taken with or without food, but consistent administration with respect to meals helps maintain stable blood levels.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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