Sandimmun/Sandimmun Neoral新山地明

Sandimmun/Sandimmun Neoral

ciclosporin

Manufacturer:

Novartis

Distributor:

Zuellig
/
Four Star
Concise Prescribing Info
Contents
Ciclosporin
Indications/Uses
Prevention of rejection of kidney, liver, heart, combined heart-lung, lung & pancreas allografts. Treatment of transplant rejection in patients previously treated w/ other immunosuppressive agents. Prevention of bone marrow graft rejection. Prevention & treatment of graft-versus-host disease (GVHD). Sandimmun Neoral Non-transplantation indications: Endogenous uveitis; severe psoriasis, atopic dermatitis, & RA; nephrotic syndrome (induction or maintenance of remission).
Dosage/Direction for Use
Sandimmun Organ transplantation 3-5 mg/kg. In conjunction w/ other immunosuppressants: Lower doses (eg, 1-2 mg/kg/day IV followed initially by 3-6 mg/kg/day orally) may be given. Bone marrow transplantation Starting dose should be given on the day before transplantation. 3-5 mg/kg/day IV infusion, repeated daily in the immediate post-op period for a max of 2 wk before switching to oral maintenance. Sandimmun Neoral Organ transplantation Initially 10-15 mg/kg in 2 divided doses 12 hr pre-op, maintained for 1-2 wk post-op, then gradually reduced to maintenance dose of 2-6 mg/kg/day in 2 divided doses. In conjunction w/ other immunosuppressants: Lower doses (eg, 3-6 mg/kg/day orally) may be given. Bone marrow transplantation Starting dose should be given on the day before transplantation. Oral therapy: Initially 12.5-15 mg/kg/day. Maintenance: Approx 12.5 mg/kg/day in 2 divided doses for at least 3-6 mth. GVHD Reinstitution therapy: Initially 10-12.5 mg/kg, followed by daily oral maintenance dose. Endogenous uveitis Initially 5 mg/kg/day in 2 divided doses, may be temporarily increased up to 7 mg/kg/day. Maintenance: Gradually reduce to lowest effective dose, ≤5 mg/kg/day, during remission period. Psoriasis Induction of remission: Initially 2.5 mg/kg/day in 2 divided doses. If no improvement after 1 mth, may be gradually increased by 0.5-1 mg/kg/mth up to max 5 mg/kg/day. Maintenance: Adjust to lowest effective dose, ≤5 mg/kg/day. If rapid improvement is required: Initially 5 mg/kg/day. Atopic dermatitis Adult & adolescent >16 yr 2.5-5 mg/kg/day in 2 divided doses. May be rapidly increased to max of 5 mg/kg/day after 2 wk of unsatisfactory response. Severe cases: Initially 5 mg/kg/day. RA 3 mg/kg/day in 2 divided doses for 1st 6 wk. May be increased gradually to max 5 mg/kg/day. Nephrotic syndrome Induction of remission: Adult 5 mg/kg/day in 2 divided doses. Childn 6 mg/kg/day in 2 divided doses.
Administration
May be taken with or without food: Cap: Swallow whole. Oral soln: Dilute w/ orange/apple juice. Other drinks (eg, soft drinks) may be used according to individual taste. Stir soln well & drink immediately. Do not use grapefruit juice.
Contraindications
Sandimmun Hypersensitivity to ciclosporin & polyoxyethylated castor oil. Sandimmun Neoral Hypersensitivity. Renal impairment, except in patients w/ nephrotic syndrome & moderately increased baseline serum creatinine values of max 200 micromol/L in adults & 140 micromol/L in childn. Inadequately controlled HTN &/or infection. History of known or diagnosed malignancy of any kind, except premalignant or malignant skin lesions following curative treatment.
Special Precautions
Risk of lymphomas & other malignancies. W/draw treatment if premalignancy or malignancy is determined. Avoid excessive sun exposure w/o adequate protection; patients should not receive concomitant UVB irradiation or PUVA photochemotherapy. Susceptibility to several bacterial, fungal, parasitic & viral infections, often w/ opportunistic pathogens. Activation of latent polyomavirus. Increases in serum creatinine & urea levels; serum bilirubin & liver enzyme levels. Regularly monitor appropriate hepatic & renal parameters. Closely monitor renal function of elderly patients. Monitor ciclosporin blood levels preferably by measuring the proportion of parent drug using a specific monoclonal Ab or a HPLC-based analysis method. Regularly check BP. Measure blood lipid levels prior & 1 mth after the start of treatment. Increased risk of hyperkalaemia. Enhanced clearance of Mg. Caution in treating patients w/ hyperuricaemia. Concomitant use w/ K-sparing drugs (eg, K-sparing diuretics, ACE inhibitors, AIIAs) or medicines containing K; lercanidipine; P-glycoprotein or organic anion transporter protein substrates (eg, aliskiren, dabigatran, or bosentan). Psoriatic patients should not be concomitantly given w/ β-blockers or diuretics. Vaccines may be less effective. Avoid live vaccines. Contains polyoxyethylated castor oil (Sandimmun). Contains ethanol (Sandimmun Neoral oral soln). Pregnancy & lactation.
Adverse Reactions
Hyperlipidaemia; tremor, headache including migraine; HTN; nausea, vomiting, abdominal pain, diarrhoea, gingival hyperplasia; hypertrichosis; renal dysfunction. Leukopenia; anorexia, hyperuricaemia, hyperkalaemia, hypomagnesaemia; paraesthesia; peptic ulcer; liver injury; acne, rash; muscle cramps, myalgia; fatigue, pyrexia, oedema.
Drug Interactions
Increased bioavailability w/ grapefruit juice. Reduced ciclosporin levels w/ barbiturates, carbamazepine, oxcarbazepine, phenytoin, nafcillin, sulfadimidine IV, rifampicin, octreotide, probucol, orlistat, Hypericum (St. John's wort) prep, ticlopidine, sulfinpyrazone, terbinafine, bosentan. Increased ciclosporin levels w/ chloroquine, macrolide antibiotics (erythromycin, azithromycin & clarithromycin), ketoconazole, fluconazole, itraconazole, voriconazole, diltiazem, nicardipine, verapamil, metoclopramide, OCs, danazol, high-dose methylprednisolone, allopurinol, amiodarone, cholic acid & derivatives, PIs, imatinib, colchicine, nefazodone. Use w/ caution w/ other medicines causing nephrotoxicity like aminoglycosides (eg, gentamicin & tobramycin), amphotericin B, ciprofloxacin, vancomycin, trimethoprim (+ sulfamethoxazole), NSAIDs (including diclofenac, indometacin, naproxen, sulindac), melphalan, histamine H2-receptor antagonists (eg, cimetidine, ranitidine), methotrexate, tacrolimus. Increased incidence of gingival hyperplasia w/ nifedipine. Increased AUC of ciclosporin & lercanidipine following co-administration. Increased bioavailability of diclofenac. May reduce clearance of digoxin, colchicine, prednisolone, HMG-CoA reductase inhibitors (statins), etoposide, aliskiren, bosentan or dabigatran. Potentiated toxic effects of digoxin & colchicine. Increased exposure to anthracycline antibiotics (eg, doxorubicine, mitoxanthrone, daunorubicine). Cases of myotoxicity, myositis & rhabdomyolysis w/ lovastatin, simvastatin, atorvastatin, pravastatin & fluvastatin. Elevated serum creatinine w/ everolimus or sirolimus. Significantly increased blood levels of everolimus & sirolimus. Significantly increased serum K w/ K-sparing drugs (eg, K-sparing diuretics, ACE inhibitors, AIIAs). Raised repaglinide plasma levels. Decreased levels w/ bosentan. Increased exposure of bosentan. Increased Cmax conc & AUC of aliskiren. Increased plasma conc of dabigatran. Increased exposure of ciclosporin & ambrisentan following co-administration.
ATC Classification
L04AD01 - ciclosporin ; Belongs to the class of calcineurin inhibitors. Used as immunosuppressants.
Presentation/Packing
Form
Sandimmun Neoral cap 100 mg
Packing/Price
50's
Form
Sandimmun Neoral oral soln 100 mg/mL
Packing/Price
50 mL x 1's
Form
Sandimmun Neoral cap 10 mg
Packing/Price
60's
Form
Sandimmun inj 250 mg/5 mL
Packing/Price
1's
Form
Sandimmun Neoral cap 25 mg
Packing/Price
50's
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