Sandimmun Neoral

Sandimmun Neoral

ciclosporin

Manufacturer:

Novartis Healthcare

Distributor:

Zuellig
Concise Prescribing Info
Contents
Ciclosporin
Indications/Uses
Prevention of graft rejection in kidney, liver, heart, combined heart-lung, lung or pancreas allogenic transplant. Treatment of transplant rejection in patients previously receiving other immunosuppressive agents. Non-transplantation conditions eg, endogenous uveitis; nephrotic syndrome; severe active RA; severe psoriasis; severe atopic dermatitis. Prevention of graft rejection following bone marrow transplantation. Prevention or treatment of graft-vs-host disease (GVHD).
Dosage/Direction for Use
Transplantation: Solid organ transplantation Initially 10-15 mg/kg in 2 divided doses, w/in 12 hr before surgery. Maintain dose for 1-2 wk post-op before gradually reduced in accordance w/ blood levels. Maintenance: 2-6 mg/kg in 2 divided doses. Bone marrow transplantation 12.5-15 mg/kg in 2 divided doses, starting on the day before transplantation. IV infusion is preferred in most cases. Continue infusion up to 2 wk post-transplant before switching to oral. Maintenance dose: 12.5 mg/kg PO daily in 2 divided doses. Continue for at least 3 mth (& preferably for 6 mth) before the dose is gradually decreased to 0 by 1 yr after transplantation. GVHD after discontinuation Loading dose: Initially 10-12.5 mg/kg followed by daily maintenance dose. Nontransplant: Endogenous uveitis Induce remission: Initially 5 mg/kg/day in 2 divided doses. Refractory cases: May be increased to 7 mg/kg/day for a limited period. Max maintenance: 5 mg/kg/day. Nephrotic syndrome Induce remission: Adult 5 mg/kg/day. Childn 6 mg/kg/day. To be given in 2 divided doses. RA 3 mg/kg/day in 2 divided doses for 1st 6 wk. May be increased gradually to max 5 mg/kg/day & may be extended up to 12 wk. Psoriasis Individualized dose. Induce remission: Initially 2.5 mg/kg/day in 2 divided doses for the 1st mth. May gradually increased to max 5 mg/kg/day. Atopic dermatitis Individualized dose. 2.5-5 mg/kg/day in 2 divided doses. May be rapidly increased to max of 5 mg/kg/day w/in 2 wk. Severe cases 5 mg/kg/day.
Administration
May be taken with or without food: Take consistently w/ regard to time of day & relation to meals. Cap: Swallow whole. Oral soln: Preferably dilute w/ orange or apple juice; however, other drinks such as soft drinks can be used according to individual taste. Avoid grapefruit juice. Stir well immediately before taking the oral soln.
Contraindications
Hypersensitivity to ciclosporin or polyoxyl castor oil (content for oral soln).
Special Precautions
Immunosuppressed patient w/ deteriorating renal function. & patients on multiple long-term immunosuppressive therapy. Hepatoxicity & liver injury. Require routine monitoring of trough blood conc for transplant patients. Discontinue use if anaphylaxis, lymphoproliferative disorders or HTN occur. Risk of developing lymphomas & other malignancies particularly skin; avoid excess UV light exposure. Nontransplant patients w/ impaired renal function (except in nephrotic syndrome), uncontrolled HTN, uncontrolled infections or any kind of malignancy). Hyperkalemia, hypomagnesemia, hyperuricemia. Determine baseline serum creatinine, blood lipids (before & after 1st mth of therapy) & assess regularly for renal function. Observe patient for at least 30 min after the start of treatment & at frequent intervals thereafter. Closely monitor kidney & liver function; BP, blood lipids & ciclosporin blood levels in transplant patients. Patients w/ neurological Behcet's syndrome (in endogenous uveitis). Liver disease or epilepsy & alcoholic patients due to ethanol content. Concomitant use w/ K sparing drugs (eg, K sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists & K containing drugs); live attenuated vaccines; methotrexate (in RA) & erythromycin; UV B irradiation or PUVA photochemotherapy. Pregnancy & lactation. Childn (nontransplantation other than nephrotic syndrome). Elderly.
Adverse Reactions
Anorexia, hyperglycemia, tremor, headache, HTN, nausea, vomiting, abdominal discomfort, diarrhea, gingival hyperplasia, hirsutism, renal dysfunction; leukopenia, convulsions, paresthesia, flushing, peptic ulcer, hepatotoxicity, acne, rash, pyrexia, edema.
Drug Interactions
Avoid use of live attenuated vaccines. May increase serum K w/ K-sparing & K-containing drugs. Increased AUC w/ lercanidipine. Risk of synergy w/ methotrexate. Increased/decreased plasma or whole blood levels w/ CYP3A4. Increased levels w/ macrolides (eg, erythromycin, azithromycin, clarithromycin), ketoconazole, fluconazole, itraconazole, voriconazole, diltiazem, nicardipine, verapamil, metoclopramide, OCs, danazol, methylprednisolone (high dose), allopurinol, amiodarone, cholic acid & derivatives, PIs, imatinib, colchicine, nefazodone. Potential increased nephrotoxicity w/ aminoglycosides (gentamycin, tobramycin), amphotericin B, ciprofloxacin, vancomycin, trimethoprim (sulfamethoxazole), NSAIDs (including diclofenac, naproxen, sulindac), melphalan, H2-receptor antagonists (eg, cimetidine, ranitidine), tacrolimus, methotrexate. Reversible kidney impairment w/ fibric acid derivatives (eg, bezafibrate, fenofibrate). Increased risk of gingival hyperplasia w/ nifedipine. May increase levels of CYP3A4 & multidrug efflux trasporter P-gp. May reduce clearance of digoxin, colchicine, prednisolone, HMG-CoA reductase inhibitors (statins), etoposide, aliskiren, bosentan or dabigatran. Severe digitalis toxicity w/ digoxin. Myotoxicity, myositis & rhabdomyolysis w/ lovastatin, simvastatin, atorvastatin, pravastatin & (rare) fluvastatin. Increased blood levels of everolimus & sirolimus. May increase plasma conc of repaglinide. Increased exposure w/ ambrisentan & anthracyclines (eg, doxorubicin, mitoxanthrone, daunorubicine).
ATC Classification
L04AD01 - ciclosporin ; Belongs to the class of calcineurin inhibitors. Used as immunosuppressants.
Presentation/Packing
Form
Sandimmun Neoral cap 25 mg
Packing/Price
50's
Form
Sandimmun Neoral oral soln 100 mg/mL
Packing/Price
50 mL x 1's
Form
Sandimmun Neoral cap 100 mg
Packing/Price
50's
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