Sandimmun Neoral

Sandimmun Neoral

ciclosporin

Manufacturer:

Novartis Indonesia
Concise Prescribing Info
Contents
Ciclosporin
Dosage/Direction for Use
Solid organ transplantation 10-15 mg/kg/day in 2 divided doses, initiated 12 hr pre-op & continued 1-2 wk post-op. Gradually reduce dose to 2-6 mg/kg in 2 divided doses. Bone marrow transplantation Initially 3-5 mg/kg/day IV infusion for up to 2 wk, then shift to oral therapy w/ Sandimmun Neoral 12.5 mg/kg/day in 2 divided doses for 3-6 mth. Endogenous uveitis Initially 5 mg/kg/day orally in 2 divided doses; may be increased to 7 mg/kg/day for a limited period. To achieve initial remission or to counteract inflammatory ocular attacks, systemic corticosteroid treatment w/ prednisolone 0.5-0.6 mg/kg/day or an equivalent may be added if Sandimmun Neoral alone is insufficient to control the situation. Maintenance: Slowly reduce dose to the lowest effective level which, during the remission phases, should not exceed 5 mg/kg/day. Psoriasis Initially 2.5 mg/kg/day given orally in 2 divided doses. If no improvement after 1 mth, the dose may be increased but should not exceed 5 mg/kg/day. RA 2.5 mg/kg/day in 2 divided doses for the 1st 6 wk of treatment. Max: 4 mg/kg. Nephrotic syndrome Adult 5 mg/kg/day in 2 divided doses. Childn 6 mg/kg/day in 2 divided doses. Renal impairment Initial dose should not exceed 2.5 mg/kg.
Administration
May be taken with or without food: Take consistently w/ or w/o meals & at the same time each day.
Contraindications
Hypersensitivity to polyoxyethylated castor oil (for IV infusion); abnormal HTN, uncontrolled infections or malignancies; renal impairment (except nephrotic syndrome patients w/ permissible degree of renal impairment); concomitant PUVA or UVB therapy, MTX or other immunosuppressants, coal tar or radiation therapy.
Special Precautions
Renal & hepatic functions should be monitored closely. Monitor ciclosporin through conc in whole blood, serum creatinine & BP. Avoid high dietary K intake, K-containing medication or K-sparing diuretics, vaccination & excess UV light exposure during therapy. Patients previously treated w/ polyethylated castor oil (IV inj/infusion); hyperuricaemia. Lactation. Childn. Elderly.
Adverse Reactions
Renal dysfunction, HTN, tremor, headache, hyperlipidaemia, paraesthesia, GIT & liver disorder, hyperuricaemia, hyperkalaemia, hypomagnesaemia, muscle cramps, myalgia, hypertrichosis, fatigue.
Drug Interactions
Aminoglycosides, amphotericin B, ciprofloxacin, co-trimoxazole, melphalan; NSAIDs, H2-receptor antagonists, MTX, tacrolimus, nifedipine, lercanidipine, digoxin, colchicine, prednisolone & HMG-CoA reductase inhibitors (statins); live attenuated vaccines, K-sparing or K-containing drugs.
MIMS Class
Immunosuppressants
ATC Classification
L04AD01 - ciclosporin ; Belongs to the class of calcineurin inhibitors. Used as immunosuppressants.
Presentation/Packing
Form
Sandimmun Neoral cap 25 mg
Packing/Price
5 × 10's (Rp763,665/boks)
Form
Sandimmun Neoral cap 50 mg
Packing/Price
5 × 10's (Rp1,373,335/boks)
Form
Sandimmun Neoral cap 100 mg
Packing/Price
5 × 10's (Rp2,573,890/boks)
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