CICLOSPORIN SOFT GEL CAP 25 MG 50 UNITS EQUORAL TEVA

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CICLOSPORIN SOFT GEL CAP 25 MG 50 UNITS EQUORAL TEVA

Contents Ciclosporin Indications/Uses Prophylaxis of organ rejection in kidney, liver & heart allogeneic transplants in combination w/ azathioprine & corticosteroids. Patients w/ severe active RA where the disease has not adequately responded to MTX in combination w/ MTX in RA patients who do not respond adequately to MTX alone. Non-immunocompromised adult w/ severe (ie, extensive &/or disabling), recalcitrant, plaque psoriasis who have failed to respond to at least 1 systemic therapy (eg, PUVA, retinoids, or MTX) or in patients for whom other systemic therapies are contraindicated or cannot be tolerated. Dosage/Direction for Use Newly transplanted patients Individualised dose to be given 4-12 hr prior to transplantation or post-op. RA Initially 2.5 mg/kg/day bid as divided dose. Dose may be increased by 0.5-0.75 mg/kg/day after 8 wk & again, after 12 wk to a max of 4 mg/kg/day. In combination w/ MTX: 3 mg/kg/day. Max: 15 mg wkly. Psoriasis Initially 2.5 mg/kg bid as divided dose for at least 4 wk. Increase dose at 2 wk intervals of approx 0.5 mg/kg/day to a max of 4 mg/kg/day. Administration May be taken with or without food: Take consistently w/ regard to time of day & relation to meals. Avoid grapefruit juice. Swallow whole. Contraindications Hypersensitivity. Patients w/ abnormal renal function, uncontrolled HTN or malignancies. Concomitant PUVA or UVB therapy, MTX or other immunosuppressive agents, coal tar or RT in patients w/ psoriasis. Special Precautions Monitor renal function & serum creatinine during therapy. May cause nephrotoxicity & hepatotoxicity. Evaluate patient for malignancies before & after therapy. Abnormal renal function, uncontrolled HTN or malignancies. Not to be treated concurrently w/ cyclosporine, PUVA or UVB, other RT or other immunosuppressives. Avoid excessive sun exposure. Skin lesion not typical of psoriasis should be biopsied before starting treatment. Avoid K-sparing diuretics. Live attenuated vaccines. Perform physical & dermatological exam including BP measurements & 2 creatinine levels before initiating treatment. Evaluate BP, serum creatinine, BUN, CBC, uric acid, K, lipids & Mg every 2 wk during the initial 3 mth & then mthly if stable. Concomitant use w/ nephrotoxic drugs, immunosuppressants, high dose methylprednisolone, NSAIDs, MTX, grapefruit & grapefruit juice. Patients w/ malignant or pre-malignant changes of the skin. Discontinue treatment if reversibility of serum creatinine is not achievable in 2 dose modifications. Pregnancy & lactation. Childn <18 yr. Elderly. Adverse Reactions Renal dysfunction, tremor, hirsutism, HTN & gum hyperplasia. Drug Interactions Renal dysfunction potentiated by gentamicin, tobramycin, vancomycin, trimethoprim w/ sulfamethoxazole, melphalan, amphotericin B, ketoconazole, azapropazon, diclofenac, naproxen, sulindac, colchicine, cimetidine, ranitidine, tacrolimus. Decreased absorption w/ orlistat. Increased conc w/ diltiazem, nicardipine, verapamil, fluconazole, itraconazole, ketoconazole, clarithromycin, erythromycin, quinupristin/daldopristin, methylprednisolone, allopurinol, bromocriptine, danazol, metoclopramide, colchicine, amiodarone. Decreased conc w/ nafcillin, rifampin, carbamazepine, phenobarb, phenytoin, octreotide, ticlopidine, orlistat, St. John's wort. NSAIDs. Reduced clearance of prednisolone, digoxin & lovastin. Hyperkalemia may occur w/ K-sparing diuretics. Live vaccines. Myositis may occur w/ lovastatin. Frequent gingival hyperplasia w/ nifedipine. Convulsions w/ high dose methylprednisolone. Possible excessive immunosuppression w/ other immunosuppressive agents or RT (PUVA & UVB). MIMS Class Immunosuppressants / Disease-Modifying Anti-Rheumatic Drugs (DMARDs) ATC Classification L04AD01 - ciclosporin ; Belongs to the class of calcineurin inhibitors. Used as immunosuppressants. Thai FDA Category S

  • Model: EQUORAL 25

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