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| Drug class description : | Immunosuppressants. |
| Generic Name : | Cyclosporin - nephrotic syndrome Imtix Sangstat has withdrawn SangCyA from the UK market. It remains available on a named patient basis for patients who were receiving the product before it was withdrawn in July 2000.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 steroid dependent or steroid resistant nephrotic syndrome (associated with adverse prognostic features) due to minimal change glomerulonephritis, focal segmental glomerulosclerosis or membranous glomerulonephritis in both adults and children. |
| Adult Dosage : | To induce remission, 5mg/kg per day given orally in two divided doses, if, with the exception of proteinuria, the renal function is normal. In impaired renal function, 2.5mg/kg per day. Maintenance treatment, maximum recommended dose is 5mg/kg per day orally. |
| Child Dosage : | To induce remission, 6mg/kg per To induce remission, 6mg/kg per day given orally in two divided doses, if, with the exception of proteinuria, the renal function is normal. In impaired renal function, 2.5mg/kg per day. Maintenance treatment, maximum recommended dose is 6mg/kg per day orally. |
| Contra Indications : | Known hypersensitivity to cyclosporin or to one of the excipients. Uncontrolled hypertension, uncontrolled infections or any kind of malignancy. Lactation. |
| Special Precautions : | May impair renal function; monitor serum creatinine and urea. May affect liver function; monitor bilirubin and hepatic enzymes. Monitor serum potassium. Hyperuricaemia. Monitor blood pressure regularly. Monitor blood lipid levels. 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 disturbances, and burning 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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