Zuellig Pharma
Concise Prescribing Info
Prevention of graft rejection in kidney, liver, heart, combined heart-lung, bone marrow, lung or pancreas allogenic transplants. Treatment of transplant rejection in patients previously receiving other immunosuppressives. Prevention or treatment of graft-vs-host disease (GVHD).
Dosage/Direction for Use
Solid organ transplantation Initially 3-5 mg/kg/day w/in 12 hr before surgery. Maintain dose for 1-2 wk post-op, then reduce to 0.7-2 mg/kg in 2 divided doses. Solid organ transplantation w/ other immunosuppressants Initially 1-2 mg/kg in 2 divided doses. Bone marrow transplantation Initially 3-5 mg/kg/day by IV infusion on the day before transplantation. Continue for 2 wk post-op, then change to 12.5 mg/kg/day orally in 2 divided doses. Maintenance therapy: 3 mth then gradually decrease to 0 by 1 yr after transplantation.
Hypersensitivity to ciclosporin & polyoxyl castor oil (for soln for infusion).
Special Precautions
Increased risk of developing skin malignancies, lymphoproliferative disorders & solid organ tumours. Avoid excessive UV light exposure. Predisposed to opportunistic infections. Activation of latent polyomavirus infections. Closely monitor kidney & liver function, BP & ciclosporin blood levels. Patients on K rich diet, K-sparing drugs. Monitor serum Mg levels. Hyperuricemia, impaired renal function, HTN. Avoid live-attenuated vaccines. Pregnancy & lactation. Elderly.
Adverse Reactions
Anaphylactoid reactions after IV administration. Hyperlipidaemia; tremor, headache including migraine; HTN; renal dysfunction. Anorexia, hyperuricaemia, hyperkalaemia, hypomagnesaemia; paresthesia; nausea, vomiting, abdominal pain, diarrhoea, gingival hyperplasia; abnormal hepatic function; hypertrichosis; muscle cramps, myalgia; fatigue.
Drug Interactions
Decreases ciclosporin levels: Barbiturates, carbamazepine, oxcarbazepine, phenytoin; nafcillin, sulfadimidine IV, rifampicin, octreotide, probucol, orlistat, St. John's wort, ticlopidine, sulfinpyrazone, terbinafine, bosentan. Increases ciclosporin levels: Macrolides (eg, erythromycin, azithromycin & clarithromycin), ketoconazole, fluconazole, itraconazole, voriconazole; diltiazem, nicardipine, verapamil; metoclopramide, OC, danazol, high-dose methylprednisolone, allopurinol, amiodarone, cholic acid & derivatives, protease inhibitors, imatinib, colchicine, nefazodone. Exhibits nephrotoxic synergy: Aminoglycosides (including gentamicin, tobramycin), amphotericin B, ciprofloxacin, vancomycin, trimethoprim (+ sulfamethoxazole), NSAIDs (including diclofenac, naproxen, sulindac), melphalan, histamine H2-receptor antagonist (eg, cimetidine, ranitidine), methotrexate, tacrolimus. May increase levels of drugs that are substrates of P-glycoprotein: Digoxin, colchicine, prednisolone, statins, etoposide, aliskiren, bosentan dabigatran, everolimus, sirolimus. May increase level of both drugs: Lercanidipine. May significantly increase serum K. May increase rate of gingival hyperplasia w/ nifedipine.
MIMS Class
ATC Classification
L04AD01 - ciclosporin ; Belongs to the class of calcineurin inhibitors. Used as immunosuppressants.
Sandimmun inj 50 mg/mL
1 mL x 10 × 1's
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