Deximune

Deximune

ciclosporin

Manufacturer:

Dexcel Pharma/AmediusTec

Distributor:

Apex Pharma Marketing
Concise Prescribing Info
Contents
Ciclosporin
Indications/Uses
Dosage/Direction for Use
The daily doses of Deximune should always be given in 2 divided doses. Transplantation: Solid organ transplantation Initiate w/in 12 hr before surgery at a dose of 10-15 mg/kg. This should be maintained as the daily dose for 1-2 wk post-op before gradual reduction in accordance w/ blood levels until a maintenance dose of about 2-6 mg/kg. Concomitant use w/ other immunosuppressants (eg corticosteroids or as part of a triple or quadruple drug therapy) Lower doses (eg 3-6 mg/kg for the initial treatment) may be used. Bone marrow transplantation Initiate therapy w/ 12.5-15 mg/kg daily starting on the day before transplantation. Non-transplantation: Endogenous uveitis Induction of remission: Initially 5 mg/kg/day. Dose can be increased to 7 mg/kg/day for a limited period in refractory cases. To achieve initial remission or counteract inflammatory ocular attacks, systemic corticosteroid treatment w/ daily doses of prednisone 0.2-0.6 mg/kg or an equivalent may be added if Deximune alone does not control the situation sufficiently. Maintenance treatment: Slowly reduce dose to the lowest effective level, which during the remission phases should not exceed 5 mg/kg/day. Discontinue treatment if no improvement after 3 mth. Nephrotic syndrome Induction of remission if, except for proteinuria, renal function is normal: Adult 5 mg/kg daily. Childn 6 mg/kg daily. Discontinue treatement if no improvement after 3 mth. Maintenance: Dose should be slowly reduced to the lowest effective level. RA 3 mg/kg/day for the 1st 6 wk of treatment. May gradually increase up to max of 5 mg/kg as tolerability permits. Duration of therapy to achieve full effectiveness: Up to 12 wk. Maintenance: Titrate dose individually. May be given in combination w/ low-dose corticosteroids &/or NSAIDs. Discontinue treatment if no response after 3 mth. Psoriasis Individualized dosage. Induction of remission: Initially 2.5 mg/kg/day. May gradually increase up to a max of 5 mg/kg/day if no improvement after 1 mth. Discontinue treatment in patients in whom sufficient response of psoriatic lesions is not achieved w/in 6 wk on 5 mg/kg/day. Maintenance treatment: Titrate dose individually to the lowest effective level up to a max of 5 mg/kg/day. Atopic dermatitis Individualized dosage. Adult & adolescent >16 yr 2.5-5 mg/kg/day. Reduced gradually & if possible, discontinue treatment once satisfactory response is achieved. Max recommended individual treatment cycles: 8 wk. Discontinue treatment in patients who do not respond adequately after 1 mth of treatment at 5 mg/kg/day.
Administration
May be taken with or without food: Swallow whole. Avoid grapefruit juice.
Contraindications
Hypersensitivity. Non-transplant indications: Kidney failure [except in patients w/ nephrotic syndrome in whom disease-related moderate increases in baseline serum creatinine values (max 200 micromol/L in adults & 140 micromol/L in childn) improve & cautious therapy (max 2.5 mg/kg/day) is permitted]; uncontrolled HTN or infection; history of known or diagnosed malignancy (any kind except premalignant or malignant skin changes). Lactation.
Special Precautions
Increases the risk of infections & developing lymphomas & other malignancies. Treatment regimen containing multiple immunosuppressants. UV exposure. Consider polyomavirus-associated nephropathy, BK virus nephropathy or JC virus-associated progressive multifocal leukoencephalopathy in the differential diagnosis in immunosuppressed patients w/ deteriorating renal function or neurological symptoms. Closely monitor parameters that assess renal & hepatic function. Concomitant use w/ P-gp substrates (eg aliskiren); K-sparing (eg K-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists), K-containing drugs & K rich diet; vaccination, live-attenuated vaccines; lercanidipine. Regularly monitor BP. Perform lipid determinations before & after the 1st mth of therapy. Control serum Mg levels in the peri-transplant period particularly in the presence of neurological symptoms/signs. Patients w/ hyperuricaemia. Concomitant use w/ methotrexate in patients w/ RA. Malignant or pre-malignant skin lesions. Monitor regularly for lymphadenopathy during treatment; active herpes simplex; Staphylococcus aureus-infected skin. Pregnancy. Patients <16 yr (in non-transplantation indications except nephrotic syndrome). Elderly.
Adverse Reactions
Renal dysfunction. HTN. Tremor, headache; paraesthesia. Anorexia, nausea, vomiting, abdominal pain, diarrhoea, gingival hyperplasia, hepatic dysfunction. Hyperlipidaemia; hyperuricaemia, hyperkalaemia, hypomagnesaemia. Muscle cramps, myalgia. Hypertrichosis. Fatigue.
Drug Interactions
Barbiturates, carbamazepine, oxcarbazepine, phenytoin, nafcillin, sulfadimidine IV, rifampicin, octreotide, probucol, orlistat, St. John's wort, ticlopidine, sulfinpyrazone, terbinafine, bosentan, macrolide antibiotics, ketoconazole, fluconazole, itraconazole, voriconazole, diltiazem, nicardipine, verapamil, metoclopramide, OCs, danazol, methylprednisolone, allopurinol, amiodarone, cholic acid & derivatives, PIs, imatinib; colchicines, nefazodone, substrates of Pgp (eg aliskiren), everolimus, sirolimus, aminoglycosides (including gentamycin, tobramycin), amphotericin B, ciprofloxacin, vancomycin, trimethoprim (+ sulfamethoxazole), NSAIDs (including naproxen, sulindac), melphalan, histamine H2-receptor antagonists, methotrexate, tacrolimus, nifedipine, lercanidipine, diclofenac, digoxin, colchicines, prednisolone & HMG-CoA reductase inhibitors, etoposide, K-sparing drugs (eg K-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists or K-containing drugs, repaglinide, fibric acid derivatives.
ATC Classification
L04AD01 - ciclosporin ; Belongs to the class of calcineurin inhibitors. Used as immunosuppressants.
Presentation/Packing
Form
Deximune cap 25 mg
Packing/Price
50's
Form
Deximune cap 50 mg
Packing/Price
50's
Form
Deximune cap 100 mg
Packing/Price
50's
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