Sandimmun/Sandimmun Neoral

Sandimmun/Sandimmun Neoral

ciclosporin

Manufacturer:

Novartis

Distributor:

DKSH
Concise Prescribing Info
Contents
Ciclosporin
Indications/Uses
Transplantation: Solid organ transplantation (kidney, liver, heart, combined heart-lung, lung, pancreas); bone marrow transplantation. Non-transplantation: Endogenous uveitis; nephrotic syndrome; severe active RA; severe psoriasis.
Dosage/Direction for Use
Solid organ transplantation Initially 10-15 mg/kg in 2 divided doses w/in 12 hr pre-op & continued daily for 1-2 wk post-op. Maintenance: Gradually reduce to 2-6 mg/kg daily in 2 divided doses. In conjunction w/ other immunosuppressants: 3-6 mg/kg in 2 divided doses may be given. Bone marrow transplantation Initially 3-5 mg/kg daily IV infusion initiated 1 day pre-op & continued during post-op for up to 2 wk before shifting to oral therapy w/ Sandimmun Neoral 12.5 mg/kg daily in 2 divided doses for 3-6 mth before gradually w/drawing therapy 1 yr after transplantation. If Sandimmun Neoral is used to initiate therapy, 12.5-15 mg/kg daily in 2 divided doses is given. Endogenous uveitis Inducing remission: Initially 5 mg/kg daily orally in 2 divided doses, may be increased to 7 mg/kg daily for limited period in refractory cases. Systemic corticosteroid treatment w/ prednisolone 0.2-0.6 mg/kg daily or an equiv may be added if Sandimmun Neoral alone is insufficient to achieve initial remission or to counteract inflammatory ocular attacks. Maintenance: Slowly reduce dose to 5 mg/kg daily. RA 3 mg/kg daily in 2 divided doses for 1st 6 wk, may be increased gradually to max: 5 mg/kg. Up to 12 wk of Sandimmun Neoral treatment may be required to achieve full effectiveness. Psoriasis Inducing remission: Initially 2.5 mg/kg daily orally in 2 divided doses, may be increased up to max: 5 mg/kg daily if no improvement after 1 mth. Discontinue treatment if no improvement is achieved w/in 6 wk on 5 mg/kg daily or if effective dose is incompatible w/ established safety guidelines. Maintenance: Titrate individually to lowest effective level not to exceed 5 mg/kg daily. Nephrotic syndrome Inducing remission: Adult 5 mg/kg daily in 2 divided doses. Childn 6 mg/kg daily in 2 divided doses Renal impairment Not to exceed 2.5 mg/kg daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to ciclosporin, polyoxyl castor oil (for Sandimmun: Cremophor EL).
Special Precautions
Closely monitor renal & hepatic function, serum creatinine, K & Mg levels, BP, ciclosporin & lipid blood levels during therapy. Activation of latent polyomavirus infections. Hyperuricaemia; epilepsy. Avoid excessive unprotected sun & UV light exposure during therapy. Alcoholic patients or on K-rich diet. Long-term immunosuppressive therapy. Avoid use w/ live attenuated vaccines; dabigatran, bosentan. Not recommended in concomitant use w/ aliskiren. Concomitant use w/ K-sparing & -containing drugs; lercanidipine. Acute & chronic nephrotoxicity; hepatotoxicity, liver injury. Renal & severe hepatic impairment. Not to be used during pregnancy & lactation. Not recommended in childn. Elderly. Sandimmun: Anaphylactoid reactions. Non-transplant indications: Discontinue Sandimmun Neoral if HTN develops & cannot be controlled by anti-hypertensives in patients w/ RA & psoriasis. Uncontrolled HTN & infection, history or presence of malignancy. Not to be used concomitantly UVB irradiation or PUVA photochemotherapy in patients w/ psoriasis.
Adverse Reactions
Anorexia, hyperglycaemia; tremor, headache; HTN, nausea, vomiting, abdominal discomfort, diarrhea, gingival hyperplasia; hirsutism; renal dysfunction. Leucopenia; convulsions, paraesthesia; flushing; peptic ulcer; hepatotoxicity; acne, rash; pyrexia, oedema.
Drug Interactions
Not recommended w/ live attenuated vaccines. Increased serum K w/ K-sparing & -containing drugs. Increased AUC w/ lercanidipine. Decreased levels by barbiturates, carbamazepine, oxcarbazepine, phenytoin, nafcillin, sulfadimidine IV, rifampicin, octreotide, probucol, orlistat, Hypericum perforatum (St. John's wort), ticlopidine, sulfinpyrazone, terbinafine, bosentan. Increased levels by macrolides, ketoconazole, fluconazole, itraconazole, voriconazole, diltiazem, nicardipine, verapamil, metoclopramide, OCs, danazol, methylprednisolone (high dose), allopurinol, amiodarone, cholic acid & derivatives, PIs, imatinib, nefazodone. Increased bioavailability w/ grapefruit juice. Potential increased nephrotoxicity w/ aminogylcosides, amphotericin B, ciprofloxacin, vancomycin, trimethoprim + sulfamethoxazole, NSAIDs (including diclofenac, naproxen, sulindac), melphalan, H2-receptor antagonists, methotrexate, tacrolimus, fibric acid derivatives. Increased rate of gingival hyperplasia w/ nifedipine. Increased plasma levels of P-gp substrates. Reduced clearance of digoxin, colchicine, prednisolone, HMG-CoA reductase inhibitors (statins), etoposide, aliskiren, bosentan, dabigatran. Increased blood levels of everolimus, sirolimus. Increased repaglinide plasma conc. Increased exposure of ambrisentan, anthracycline antibiotics eg, doxorubicine, mitoxanthrone, daunorubicine.
MIMS Class
ATC Classification
L04AD01 - ciclosporin ; Belongs to the class of calcineurin inhibitors. Used as immunosuppressants.
Presentation/Packing
Form
Sandimmun Neoral softgel cap 100 mg
Packing/Price
5 × 10's
Form
Sandimmun Neoral softgel cap 25 mg
Packing/Price
5 × 10's
Form
Sandimmun infusion conc 50 mg/mL
Packing/Price
10 × 1's
Form
Sandimmun Neoral oral soln 100 mg/mL
Packing/Price
1's
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