Monograph Details
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Musculoskeletal Disorders
> Arthritis/rheumatic disorders
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NEORAL |
| Manufacturer |
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Novartis Pharmaceuticals Corp |
| Legal Classification |
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Rx
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| Pharmacological Class |
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DMARD (immunosuppressant). |
| Generic Name |
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Cyclosporine (modified) 25mg, 100mg; caps; contains alcohol. |
| Also |
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• NEORAL ORAL SOLUTION
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| Indications |
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Severe, active rheumatoid arthritis unresponsive to methotrexate alone. |
| Children |
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<18 years: not recommended. |
| Adults |
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Give consistently with regard to meals, diluent, and time of day. ≥18 years: 1.25mg/kg twice daily; may increase by 0.5–0.75mg/kg per day after 8 weeks and again after 12 weeks; max 4mg/kg per day (many patients on concomitant methotrexate can be treated with doses of 3mg/kg per day or less). Dilute soln in a glass of room temp orange or apple juice. Reduce dose by 25–50% if adverse events (eg, hypertension or serum creatinine increases ≥30% above baseline) occur. Discontinue if adverse events are severe or persistent, or if no benefit by week 16. |
| Contraindications |
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Renal impairment. Uncontrolled hypertension. Malignancies. |
| Precautions |
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Be fully familar with immunosuppressive therapy before prescribing. Monitor renal and hepatic (if given with methotrexate) function, BP, CBC, serum magnesium, potassium, uric acid, lipids, cyclosporine levels (see literature for monitoring frequency). Not bioequivalent to all other forms of cyclosporine. Reduce dose if hypertension occurs; may medically manage hypertension. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended. |
| Interactions |
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Avoid other nephrotoxic drugs (eg, gentamicin, tobramycin, vancomycin, SMX/TMP, melphalan, amphotericin B, ketoconazole, cimetidine, ranitidine, tacrolimus, NSAIDs, colchicine), orlistat, St. John's wort. Cyclosporine levels increased by CYP3A inhibitors (eg, calcium channel blockers, amiodarone, azole antifungals, erythromycin, clarithromycin, quinupristin/dalfopristin, methylprednisolone, allopurinol, colchicine, bromocriptine, danazol, metoclopramide; probably indinavir, saquinavir, nelfinavir, ritonavir). Avoid grapefruit juice. Cyclosporine levels decreased by CYP3A inducers (eg, nafcillin, rifampin, carbamazepine, phenobarbital, phenytoin, octreotide, ticlopidine, St. John's wort), orlistat. Avoid potassium-sparing diuretics. May decrease effectiveness of vaccines; avoid live attenuated vaccines. May increase levels of digoxin, prednisolone, lovastatin. Myositis with lovastatin. Gingival hyperplasia with nifedipine. Convulsions with high-dose methylprednisolone. May affect methotrexate levels (esp. with diclofenac). |
| Adverse Reactions |
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Renal dysfunction, hypertension, headache, GI disturbances, hirsutism, hypertrichosis, leg cramps, pain, tremor, paresthesia, edema, dizziness, gum hyperplasia, liver dysfunction, increased risk of infections or malignancies, others. |
| How Supplied |
Caps—30
Soln—50mL |
| Additional Resources |
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• Related Prescribing Note |
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