Drug Interaction:
Live vaccines ketoconazole,voroconazole, itraconazole telithromycin, clarithromycin,erythromycin, diltiazem, verapramil, grape fruit juice rifampicin, rifabutin other inhibitors of CYP3A4 cyclosporin, drugs affecting renal function or the multidrug efflux pump P-glycoprotein statins, fibrates
Indication:
New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Sirolimus 15-07-2002
Immunosuppressant
To prevent organ rejection in renal transplant patients
Adverse Reaction:
Lynphocyte, abnormal healing, odema, angioedema lymphodema lever , concomittant infections increased risk of opputunistic infections such as TB , sepsis etc. tachycardia g i upset, stomatitis blood dyscrasis thrombocytopenia thromboembolism increased LDH
Contra-Indications:
High immunological eisk Pregnancy, ensure adequate contraception during and for 12 weeks after therapy Lactation
Special Precaution-
Use under specialist supervision
Hepatic impairment Monitor whole blood conc. and renal function
Hyperlipidaemia Skin cancer risk Elderly
Dosages/ Overdosage Etc:
To prevent organ rejection in renal transplant patients
Dosage-
Initially 6mg loading dose as soon as possible after transplant,
Then 2mg daily for 2-3 months Individualise treatment to obtain whole blood through levels of 12 to 20 nanogram/ ml given with corticosteroids
Discontinue if cyclosporin cannot be withdrawn
Pregnancy and lactation:
Use contraindicated. Observe caution Pregnancy, ensure adequate contraception during and for 12 weeks after therapy Lactation