Ciclosporin-Teva

Ciclosporin-Teva

ciclosporin

Manufacturer:

Teva

Distributor:

Zuellig
Concise Prescribing Info
Contents
Ciclosporin
Indications/Uses
Prevents rejection of transplanted organs in organ transplant, bone marrow & stem cell transplantation. Stops immune reaction in endogenous uveitis, including Behçet's uveitis; atopic dermatitis, or eczema & psoriasis, severe RA; nephrotic syndrome.
Dosage/Direction for Use
Adult Organ, bone marrow & stem cell transplantation 2-15 mg/kg daily divided in 2 doses. Endogenous uveitis 5-7 mg/kg daily divided in 2 doses. Nephrotic syndrome 5 mg/kg daily divided in 2 doses. Severe RA 3-5 mg/kg daily divided in 2 doses. Psoriasis & atopic dermatitis 2.5-5 mg/kg daily divided in 2 doses. Childn Nephrotic syndrome 6 mg/kg daily divided in 2 doses. Adult & childn w/ kidney problems Nephrotic syndrome 1st dose taken each day should not be >2.5 mg/kg.
Administration
May be taken with or without food: Take consistently w/ regards to time of day & relation to meals. Avoid grapefruit juice.
Contraindications
Hypersensitivity. Concomitant use w/ products containing Hypericum perforatum (St. John's Wort); dabigatran etexilate or bosentan & aliskiren. Non-transplant disease indication: Kidney problems (except nephrotic syndrome), uncontrolled infection, cancer, inadequately controlled HTN.
Special Precautions
Patients w/ any signs of infection eg, fever or sore throat; liver or kidney problems; high BP; low Mg levels; high K blood levels; gout; alcohol-related problems; epilepsy; patients undergoing vaccination. Limit exposure to sunlight & UV light. Monitor blood levels of ciclosporin, BP, liver & kidney function, & blood lipids during treatment. Monitor neurological symptoms in patients w/ Behçet's uveitis. Closely monitor elderly patients being treated for psoriasis or atopic dermatitis. Should not be given to childn for non-transplant disease (except nephrotic syndrome). Sugar intolerance (for soft gelatin cap). Contains ethanol & castor oil. May affect ability to drive & use machines. Should not be taken during pregnancy. Breast-feeding is not recommended during treatment. Childn. Elderly ≥65 yr.
Adverse Reactions
Kidney problems, high BP, headache, tremors, excessive growth of body & facial hair, hyperlipidaemia. Seizures, liver problems, high level of sugar in the blood, tiredness, loss of appetite, nausea, vomiting, abdominal pain, constipation, diarrhoea, excessive hair growth, acne, hot flushes, fever, leukopenia, feeling numb or tingling, muscle pain, muscle spasm, stomach ulcer, gingival hyperplasia, hyperuricaemia, hyperkalaemia, hypomagnesaemia.
Drug Interactions
Increased risk of hyperkalaemia w/ medicines containing K, K supplements, K-sparing diuretics & certain antihypertensives. Increased blood ciclosporin levels w/ antibiotics (eg, erythromycin or azythromycin), anti-fungals (voriconazole, itraconazole), diltiazem, nicardipine, verapamil, amiodarone, metoclopramide, OCs, danazol, allopurinol, cholic acid & derivatives, HIV PIs, imatinib, colchicine, telaprevir. Decreased blood ciclosporin levels w/ barbiturates, carbamazepine or phenytoin, octreotide, anti-TB, orlistat, herbal medicines containing St. John's wort, ticlopidine, bosentan, terbinafine. Additive effect on kidneys w/ gentamycin, tobramycin, ciprofloxacin, amphotericin B, trimethoprim, melphalan, H2-receptor antagonists, tacrolimus, NSAIDs eg, diclofenac, fibric acid medicines. Increased risk of gingival hyperplasia w/ nifedipine. Potential interaction w/ MTX, digoxin, HMG-CoA reductase inhibitors, prednisolone, etoposide, repaglinide, immunosuppressives (everolimus, sirolimus), ambrisentan, anthracyclines (eg, doxorubicin). Do not take w/ grapefruit or grapefruit juice.
MIMS Class
Disease-Modifying Anti-Rheumatic Drugs (DMARDs) / Immunosuppressants
ATC Classification
L04AD01 - ciclosporin ; Belongs to the class of calcineurin inhibitors. Used as immunosuppressants.
Presentation/Packing
Form
Ciclosporin-Teva oral soln 100 mg/mL
Packing/Price
50 mL x 1's
Form
Ciclosporin-Teva soft-gelatin cap 100 mg
Packing/Price
50's
Form
Ciclosporin-Teva soft-gelatin cap 25 mg
Packing/Price
50's
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