Cyclast-50 Capsule

Ciclosporin (Cyclosporine) Capsules IP 50 mg

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About Cyclast-50 Capsule

Cyclast-50 Capsule contains Ciclosporin (Cyclosporine) IP 50 mg — a calcineurin-inhibitor immunosuppressant indicated for the management of severe, treatment-resistant autoimmune and inflammatory conditions, and for prophylaxis of organ rejection following transplantation. Manufactured by Trumac Healthcare under WHO-GMP certified conditions and supplied in moisture-resistant Alu-Alu blisters that protect the capsule from humidity during Indian climatic transit.

Ciclosporin is a cyclic polypeptide of 11 amino acids that selectively and reversibly inhibits calcineurin, blocking T-lymphocyte activation at the transcriptional level. Unlike broad cytotoxic immunosuppressants, it targets the immune-mediated inflammatory cascade at its source without significant myelosuppression — which is why it remains a mainstay in severe plaque psoriasis, severe atopic dermatitis, refractory urticaria, pyoderma gangrenosum, active rheumatoid arthritis inadequately controlled by DMARDs, steroid-dependent and steroid-resistant nephrotic syndrome, ulcerative colitis and uveitis.

The 50 mg strength allows finer dose titration — essential because ciclosporin is dosed on a mg/kg basis. It is used for lower total daily doses, for stepwise dose escalation and tapering, and in smaller-bodyweight and paediatric patients. It is frequently combined with the 100 mg strength to achieve an exact daily dose. Ciclosporin is a specialist-initiated therapy requiring regular blood pressure and renal function monitoring. Cyclast-50 is available for pan-India monopoly PCD franchise and third-party manufacturing under your own brand.

Indications

• Severe plaque psoriasis unresponsive to conventional systemic therapy
• Severe atopic dermatitis (eczema) refractory to topical and conventional treatment
• Chronic refractory urticaria not controlled by antihistamines
• Pyoderma gangrenosum
• Active rheumatoid arthritis inadequately controlled by conventional DMARDs
• Nephrotic syndrome — steroid-dependent and steroid-resistant (minimal change disease, FSGS, membranous nephropathy)
• Ulcerative colitis — severe steroid-refractory disease
• Non-infectious intermediate and posterior uveitis, and Behçet's uveitis
• Prophylaxis of organ rejection following kidney, liver and heart transplantation
• Prophylaxis and treatment of graft-versus-host disease (GVHD) after bone marrow transplantation

Mechanism of Action

Ciclosporin is a lipophilic cyclic polypeptide comprising 11 amino acids, originally isolated from the fungus Tolypocladium inflatum. After absorption it binds to the cytosolic immunophilin cyclophilin-A within T-lymphocytes. The resulting ciclosporin–cyclophilin complex binds to and inhibits calcineurin, a calcium- and calmodulin-dependent serine/threonine phosphatase. Calcineurin normally dephosphorylates the Nuclear Factor of Activated T-cells (NFAT), allowing it to translocate into the nucleus and drive transcription of interleukin-2 (IL-2) and other pro-inflammatory cytokines (IL-3, IL-4, IFN-γ, TNF-α). By blocking calcineurin, ciclosporin prevents NFAT dephosphorylation and nuclear entry — shutting down IL-2 gene transcription and thereby preventing clonal expansion and activation of helper and cytotoxic T-cells. The immunosuppression is selective for T-lymphocyte-mediated immunity and is fully reversible on withdrawal, with little effect on haematopoiesis or phagocyte function — a key advantage over cytotoxic immunosuppressants. In dermatology this translates into rapid suppression of the Th1/Th17-driven inflammatory cascade underlying psoriasis and atopic dermatitis. Ciclosporin is extensively metabolised by hepatic CYP3A4 and is a substrate and inhibitor of P-glycoprotein, which underlies its extensive drug- and food-interaction profile.

Dosage & Administration

STRICTLY SPECIALIST-INITIATED — dosing is weight-based and must be individualised by the treating dermatologist, rheumatologist, nephrologist or transplant physician.
Severe psoriasis / atopic dermatitis: initial 2.5 mg/kg/day in two divided doses; may be increased gradually to a maximum of 5 mg/kg/day if inadequate response after 4 weeks. Treatment courses are usually limited to 8–16 weeks; continuous therapy beyond 1–2 years is generally avoided.
Rheumatoid arthritis: initial 2.5 mg/kg/day in two divided doses; maximum 4 mg/kg/day.
Nephrotic syndrome: 5 mg/kg/day (adults) or 6 mg/kg/day (children) in two divided doses, tapered per response and trough levels.
Transplantation: 10–15 mg/kg/day starting 4–12 hours pre-operatively, tapered to a maintenance of 2–6 mg/kg/day guided by whole-blood trough levels.
The 50 mg strength is particularly useful for fine dose adjustment and for tapering. Swallow capsules whole; do not chew. Take at the same times each day, consistently either with or without food. AVOID grapefruit and grapefruit juice — it markedly raises ciclosporin levels. Mandatory monitoring: blood pressure and serum creatinine at baseline, then every 2 weeks for the first 3 months and monthly thereafter; plus serum potassium, magnesium, uric acid, lipids and liver function.

Side Effects

Nephrotoxicity — dose-dependent rise in serum creatinine and reduction in GFR; the most important dose-limiting toxicity, and may become chronic/structural with prolonged therapy. Hypertension — very common, often requiring antihypertensive therapy (dihydropyridine calcium channel blockers preferred). Other common effects: tremor, headache, paraesthesia; hirsutism and gingival hyperplasia; nausea, vomiting, diarrhoea, abdominal discomfort; hyperkalaemia, hypomagnesaemia, hyperuricaemia and gout; hyperlipidaemia; fatigue. Less common but important: hepatotoxicity, seizures and posterior reversible encephalopathy syndrome (PRES), thrombotic microangiopathy / haemolytic uraemic syndrome, and increased susceptibility to bacterial, viral, fungal and opportunistic infections. Long-term immunosuppression carries an increased risk of lymphoma, other lymphoproliferative disorders and skin malignancies — patients must use strict photoprotection and avoid PUVA/UVB phototherapy concurrently.

Contraindications & Precautions

Known hypersensitivity to ciclosporin, polyoxyl castor oil or any capsule excipient. Uncontrolled hypertension. Abnormal renal function (except in nephrotic syndrome, where use is under strict nephrology supervision). Uncontrolled infections. Current or past malignancy — especially lymphoproliferative disease or skin cancer. Concurrent PUVA or UVB phototherapy, coal tar or radiotherapy in psoriasis patients (markedly raises skin cancer risk). Concurrent use of tacrolimus. Live vaccines must be avoided during therapy. CRITICAL DRUG INTERACTIONS — ciclosporin is a CYP3A4 substrate and P-gp inhibitor: levels are RAISED by ketoconazole, itraconazole, voriconazole, clarithromycin, erythromycin, diltiazem, verapamil, amiodarone and grapefruit juice; levels are LOWERED by rifampicin, phenytoin, carbamazepine, phenobarbital and St John's Wort. Ciclosporin raises statin levels (risk of rhabdomyolysis — avoid or use minimal statin doses), raises digoxin and colchicine levels, and its nephrotoxicity is potentiated by NSAIDs, aminoglycosides, amphotericin B, ACE inhibitors and ARBs. Potassium-sparing diuretics and potassium supplements increase hyperkalaemia risk. Pregnancy — use only if the potential benefit clearly outweighs the risk (crosses placenta; associated with prematurity and low birth weight). Lactation — ciclosporin is excreted in breast milk; breastfeeding is not recommended. IMPORTANT: different oral ciclosporin formulations are NOT bioequivalent — do not switch brands without specialist supervision and blood-level re-monitoring.

Storage

Store below 30 °C in a dry place, protected from light and moisture. Do not refrigerate. Keep the capsule in its original blister until use. Keep out of reach of children.

Frequently Asked Questions

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