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Medicine information : SangCyA
 
Drug class description :  Immunosuppressants.
Generic Name :  Cyclosporin - rheumatoid arthritis Imtix Sangstat has withdrawn SangCyA from the UK market. It remains available on a named patient basis for patients who were receiving the product before it was withdrawn in July 2000.
Drug description :  Solution for oral administration.
Presentation :  Oral solution, cyclosporin Ph Eur 100mg per mL.
Indications :  Treatment of severe, active rheumatoid arthritis in patients in whom classical, slow-acting antirheumatic agents are inappropriate or ineffective.
Adult Dosage :  2.5mg/kg daily given orally in two divided doses for the first six weeks, increased gradually to a maximum of 4mg/kg/day. Discontinue if inadequate response after three months. See Summary of Product Characteristics. If converting patients from other proprietary oral formulations of cyclosporin, refer to SPC.
Child Dosage :  Not recommended. See Summary of Product Characteristics. Product Characteristics.
Contra Indications :  Known hypersensitivity to cyclosporin or to one of the excipients. Abnormal renal function, uncontrolled hypertension, uncontrolled infections or any kind of malignancy. Children under 18 years. Lactation.
Special Precautions :  May impair renal function; monitor serum creatinine at two- weekly intervals during first three months of treatment, and four-weekly thereafter. May affect liver function; monitor bilirubin and hepatic enzymes. Monitor serum potassium. Hyperuricaemia. Monitor blood pressure regularly - discontinue treatment if hypertension develops that cannot be controlled. Monitor blood lipid levels. Caution if using in combination with NSAIDs. See Summary of Product Characteristics. Pregnancy.
Interactions :  Systemic antibiotics or other compounds known to have nephrotoxic effects, eg, amphotericin B, aminoglycosides, ciprofloxacin, melphalan, trimethoprim. Ketoconazole, erythromycin, oral contraceptives, danazol, some calcium channel blockers including diltiazem, nicardipine and verapamil. Doxycycline, fluconazole, itraconazole, propafenone, lipid solutions. Phenytoin, carbamazepine, barbiturates, rifampicin. Sulphadiazine. Intravenous sulphadimidine. Prednisolone, methylprednisolone. NSAIDs. Lovastatin. Colchicine. Nifedipine. Potassium supplements, potassium-sparing diuretics. Grapefruit juice. Live attenuated vaccines.
Adverse Reactions :  Reversible and dose-dependent increase in serum creatinine and urea. Renal structural changes. Hypertrichosis, tremor, hyperrension, hepatic dysfunction, fatigue, gingival hypertrophy, gastrointestinal sensations of the hands and feet. Occasionally, headaches, rash, mild anaemia, hyperkalaemia, hyperuricaemia, gout, hypomagnesaemia, hypercholesterolaemia, weight increase, oedema, pancreatitis, neuropathy, confusion, paraesthesia, convulsions, reversible dysmenorrhoea or amenorrhoea may develop. Muscle weakness, muscle cramps and myopathy. Rarely, a syndrome of thrombocytopenia, sometimes in combination with microangiopathic haemolytic anaemia and renal failure has been observed. Rarely, gynaecomastia.
Manufacturer :  Imtix Sangstat
Drug Availability :  (POM)
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