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Cipol-N

Cipol-N

ciclosporin

Manufacturer:

Chong Kun Dang

Distributor:

SPS Medical
Concise Prescribing Info
Contents
Cyclosporin
Indications/Uses
Transplant rejection in patients previously receiving other immunosuppressants; active slight-threatening intermediate or posterior uveitis of non-infectious aetiology conventional therapy fails, or cause unacceptable side effects; Behçet uveitis w/ repeated inflammatory attacks involving the retina; severe, active RA; severe psoriasis when conventional therapy is ineffective or inappropriate. Steroid dependent & resistant nephrotic syndrome in adults & childn. Severe atopic dermatitis when systemic therapy is required. Prevention or treatment of graft-versus-host disease (GVHD). Prevention of graft rejection following kidney, liver, heart, combined heart-lung, lung or pancreas allogeneic transplantations & bone marrow transplantation.
Dosage/Direction for Use
Solid organ transplantation Initially 10-15 mg/kg in 2 divided doses 12 hr before surgery & maintain for 1-2 wk post-op prior to gradually reduce. Maintenance dose: 2-6 mg/kg daily in 2 divided doses. Combination w/ other immunosuppressants Initially 3-6 mg/kg in 2 divided doses. Bone marrow transplantation Recommended daily dose: Initially 12.5-15 mg/kg in 2 divided doses, starting on the day before transplantation. Maintenance daily dose: 12.5 mg/kg continued for at least 3 mth (& preferably for 6 mth) before dose is gradually decreased 0 by 1 yr after transplantation. Endogenous uveitis Initially 5 mg/kg daily in 2 divided doses until remission of active uveal inflammation & visual acuity improvement. May be increased to 7 mg/kg daily for a limited period. Initial remission to counteract inflammatory ocular attacks: 0.2-0.6 mg/kg prednisone or equiv. Maintenance: Not to exceed 5 mg/kg daily. Nephrotic syndrome Adult 5 mg/kg daily in 2 divided dose. Childn w/ normal renal function except for proteinuria 6 mg/kg daily in 2 divided dose. Patient w/ impaired renal function Not to exceed 2.5 mg/kg daily. RA Recommended dose: 3 mg/kg daily in 2 divided doses for 1st 6 wk & not to exceed 5 mg/kg daily. Duration: Up to 12 wk. Psoriasis Recommended initial dose: 2.5 mg/kg daily in 2 divided doses, may gradually increased dose but not to exceed 5 mg/kg daily if no improvement after 1 mth. Atopic dermatitis 2.5 mg/kg daily in 2 divided doses, may rapidly increased dose to max of 5 mg/kg daily if does not achieve satisfactory response. Duration of therapy: 8 wk-1 yr.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. RA or psoriasis patients w/ abnormal renal function, uncontrolled HTN or malignancies. Concurrent use w/ PUVA or UVB, MTX or other immunosuppressants, coal tar or RT in psoriasis patients.
Special Precautions
Increased susceptibility to serious infections w/ fatal outcomes; risk for opportunistic infections including reactivation of latent viral infections; risk of neoplasia. Possible development of lymphoma. Routinely monitor in allograft recipients & periodically in patients w/ RA. Limit UV light exposure. Routine lab testing eg, BUN & serum creatinine, bilirubin & liver enzyme conc for the assessment of renal & hepatic function. Carefully monitor renal function. Renal & severe liver impairment. Pregnancy. Avoid during lactation. Not recommended in childn for non-transplant indications other than nephrotic syndrome.
Adverse Reactions
HTN, edema; headache, paresthesia; hypertrichosis; hirsutism, increased serum triglycerides, female genital tract disease; nausea, diarrhea, gingival hyperplasia, abdominal distress, dyspepsia; UTI; increased susceptibility to infection, viral infection; tremor, leg cramps; increased serum creatinine, renal insufficiency; URTI.
Drug Interactions
Potentiated renal dysfunction w/ aminoglycosides, vancomycin, co-trimoxazole, ciprofloxacin, melphalan, amphotericin B, ketoconazole, NSAIDs (eg, azapropazone, diclofenac, naproxen, sulindac), cimetidine, ranitidine, fibric acid derivatives (eg, fenofibrate, bezafibrate), MTX, colchicine, tacrolimus. Increased conc w/ colchicine. Increased risk of lymphoma & other neoplasm w/ immunosuppressive & antineoplastic agents. Increased blood sirolimus conc. Elevated MTX AUC in patients w/ RA. Concomitant use w/ K-sparing drugs (eg, ACE inhibitors, angiotensin II receptor antagonists) & K-containing drugs & K-rich diet. Altered plasma & blood conc w/ drugs or foods affecting hepatic microsomal enzymes eg, cytochrome P450 subfamily CYP3A. Decreased metabolism & increased conc w/ diltiazem, nicardipine, verapamil, mibefradil, fluconazole, itraconazole, ketoconazole, voriconazole, clarithromycin, erythromycin, quinupristin/dalfopristin, methylprednisolone, allopurinol, amiodarone, bromocriptine, colchicine, imatinib, danazol, OCs, metoclopramide. Increased metabolism & decreased conc w/ nafcillin, rifampin, carbamazepine, oxcarbazepine, phenobarb, phenytoin, octreotide, sulfinpyrazone, terbinafine, ticlopidine. Decreased plasma clearance of prednisolone. Increased plasma conc w/ methylprednisolone. Increased bioavailability w/ grapefruit juice. Diminished immune response to live vaccines. Increased AUC & absorption w/ metoclopramide. Decreased absorption w/ orlistat. Decreased plasma conc w/ bosentan. Decreased vol of distribution & serum clearance of digoxin.
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
Cipol-N soft-gelatin cap 100 mg
Packing/Price
10 × 5's
Form
Cipol-N soft-gelatin cap 25 mg
Packing/Price
10 × 5's
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