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| Drug class description : | Immunosuppressants. |
| Generic Name : | Cyclosporin - immunosuppression Imtix Sangstat has withdrawn SangCyA from the UK market. It remains available on a named patient basis for patients who were receiving the product before it was withdrawn in July 2000.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 : | Prevention of graft rejection following kidney, liver, heart, combined heart-lung, lung or pancreas transplants. Treatment of transplant rejection in patients previously receiving other immunosuppressive agents. Prevention of graft rejection following bone marrow transplantation and prophylaxis of graft versus host disease (GVHD). Treatment of established GVHD. |
| Adult Dosage : | Organ transplantation: Initiate within 12 hours before transplantation at a dose of 10 - 15mg/kg body weight per day given in two divided doses. As a general rule, treatment should continue at 10 - 15mg/kg daily, continue at 10 - 15mg/kg daily, given in two divided doses, for one to two weeks postoperatively. Then reduce dosage gradually until a maintenance of 2 - 6mg/kg per day is reached. See Summary of Product Characteristics. Bone marrow transplantation/ prevention and treatment of GVHD: initiation of therapy usually given by the intravenous route using intravenous preparations. Treatment should continue orally at 12.5mg/kg/day in two divided doses for at least three, preferably six months before tailing off to zero. See Summary of Product Characteristics. If converting patients from other proprietary oral formulations of cyclosporin, refer to SPC. |
| Child Dosage : | Refer to Summary of Product Characteristics. |
| Contra Indications : | Known hypersensitivity to cyclosporin or to one of the excipients. 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. Should preferably not be administered with other immunosuppressive agents except corticosteroids. 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, 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, hypertension, hepatic dysfunction, fatigue, gingival hypertrophy, gastrointestinal disturbances, and burning 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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