Monograph Details
|
|
Dermatological Disorders
> Psoriasis
|
|
NEORAL ORAL SOLUTION |
| Manufacturer |
|
Novartis Pharmaceuticals Corp |
| Legal Classification |
|
Rx
|
| Pharmacological Class |
|
Immunosuppressant. |
| Generic Name |
|
Cyclosporine (modified) 100mg/mL; contains alcohol. |
| Also |
|
• NEORAL
|
| Indications |
|
Treatment of adult, non-immunocompromised patients with severe, recalcitrant, plaque psoriasis who have failed to respond to at least one systemic therapy or in patients for whom other systemic therapies are contraindicated or intolerable. |
| Children |
|
<18 years: not recommended. |
| Adults |
|
Give consistently with regard to meals, diluent, and time of day. ≥18 years: 1.25mg/kg twice daily; may increase after 4 weeks by 0.5mg/kg per day, then adjust at 2-week intervals; max 4mg/kg per day. Dilute soln in glass of room temp orange or apple juice. Reduce by 25–50% if adverse events (eg, hypertension or serum creatinine increases ≥25% above baseline) occur. Discontinue if adverse events are severe or persistent. |
| Contraindications |
|
Renal impairment. Uncontrolled hypertension. Malignancies. Concurrent PUVA or UVB therapy; methotrexate, other immunosuppressants, coal tar, or radiation therapy. |
| Precautions |
|
Be fully familar with immunosuppressive therapy before prescribing. Do not use if undiagnosed or suspicious lesions are present. Monitor renal function, BP, CBC, serum magnesium, potassium, uric acid, lipids (see literature for monitoring frequency). Not bioequivalent to all other forms of cyclosporine. Avoid excessive exposure to sun. Reduce dose if hypertension occurs; do not attempt to manage medically. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended. |
| Interactions |
|
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. |
| Adverse Reactions |
|
Renal dysfunction, headache, hypertension, hypertriglyceridemia, hirsutism, hypertrichosis, paresthesia, hyperesthesia, flu-like syndrome, GI disturbances, lethargy, musculoskeletal or joint pain, increased risk of infection or malignancy. |
| How Supplied |
Caps—30
Soln—50mL |
|
|
|
|
