Sandimmun Neoral

Sandimmun Neoral

ciclosporin

Manufacturer:

Novartis

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Ciclosporin A microemulsion
Indications/Uses
Severe psoriasis in whom conventional therapy is ineffective or inappropriate.
Dosage/Direction for Use
Individualized dosage. Recommended initial dose: 2.5 mg/kg/day in 2 divided doses. If there is no improvement after 1 mth, dose may be gradually increased. Max: 5 mg/kg/day.
Administration
May be taken with or without food: Take consistently w/ regards to time of day & relation to meals. Avoid grapefruit juice. Cap: Swallow whole. Oral soln: Dilute preferably w/ orange/apple juice. Other drinks (eg, soft drinks) can also be used according to individual taste. Stir well & drink immediately.
Contraindications
Special Precautions
Increased risk of developing skin malignancies, lymphoproliferative disorders & solid organ tumours. Avoid excess 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, uncontrolled HTN/infections, any kind of malignancy. Avoid live-attenuated vaccines & concomitant UV B irradiation or PUVA photochemotherapy. Pregnancy & lactation. Elderly.
Adverse Reactions
Hyperlipidaemia, anorexia, hyperuricemia, hyperkalaemia, hypomagnesaemia, tremor, headache, migraine, paraesthesia, HTN, nausea, vomiting, abdominal pain, diarrhoea, gingival hyperplasia, abnormal hepatic function, hypertrichosis, muscle cramps, myalgia, renal dysfunction, 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, ketoconazole, fluconazole, itraconazole, voriconazole; diltiazem, nicardipine, verapamil; metoclopramide, OC, danazol, high-dose methylprednisolone, allopurinol, amiodarone, cholic acid & derivatives, PIs, imatinib, colchicine, nefazodone. Exhibits nephrotoxic synergy: Aminoglycosides, amphotericin B, ciprofloxacin, vancomycin, trimethoprim (+ sulfamethoxazole), NSAIDs (including diclofenac, naproxen, sulindac), melphalan, H2-blockers, MTX, tacrolimus. May increase levels of drugs that are substrates of P-gp: 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: Nifedipine.
MIMS Class
Psoriasis, Seborrhea & Ichthyosis Preparations
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 cap 25 mg
Packing/Price
50's
Form
Sandimmun Neoral oral soln 100 mg/mL
Packing/Price
50 mL x 1's
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