Product Name :
Sirolimus
Strength :
0.5mg
Dosage Form :
Tablets
Size :
100
NDC :
67877074601
UPC :
367877746012
OTC/RX :
Rx
Reference Brand :
Rapamune
Case Qty :
24
Case Weight (lbs) :
12
Case Dimentions (inches) :
9.64x6.49x4.52
Bottle Size(inches) :
2.93x1.56
Bottle Weight(lbs) :
0.075
Product Shelf Life :
24 months
Shape :
Round Biconvex
Color :
Tan
Imprint/Markings :
Debossed with "S" on one side and plain on the other
Therapeutic Class :
Immunosuppressants
Indications for Use :
1.1 Prophylaxis of Organ Rejection in Renal Transplantation Sirolimus is indicated for the prophylaxis of organ rejection in patients aged 13 years or older receiving renal transplants.In patients at low-to moderate-immunologic risk, it is recommended that sirolimus tablets be used initially in a regimen with cyclosporine and corticosteroids; cyclosporine should be withdrawn 2 to 4 months after transplantation In patients at high-immunologic risk (defined as Black recipients and/or repeat renal transplant recipients who lost a previous allograft for immunologic reason and/or patients with high panel-reactive antibodies [PRA; peak PRA level > 80%]), it is recommended that sirolimus tablets be used in combination with cyclosporine and corticosteroids for the first year following transplantation 1.2 Limitations of Use in Renal Transplantation Cyclosporine withdrawal has not been studied in patients with Banff Grade 3 acute rejection or vascular rejection prior to cyclosporine withdrawal, those who are dialysis-dependent, those with serum creatinine >4.5 mg/dL, Black patients, patients of multi-organ transplants, secondary transplants, or those with high levels of panel-reactive antibodies In patients at high-immunologic risk, the safety and efficacy of sirolimus tablets used in combination with cyclosporine and corticosteroids has not been studied beyond one year; therefore after the first 12 months following transplantation, any adjustments to the immunosuppressive regimen should be considered on the basis of the clinical status of the patient.In pediatric patients, the safety and efficacy of sirolimus tablets have not been established in patients <13 years old, or in pediatric (<18 years) renal transplant patients considered at high-immunologic risk. The safety and efficacy of de novo use of sirolimus tablets without cyclosporine have not been established in renal transplant patients). The safety and efficacy of conversion from calcineurin inhibitors to sirolimus tablets in maintenance renal transplant patients have not been established.
Inactive Ingrediant :
EDETATE DISODIUM, POLOXAMER 188, HYPROMELLOSE 2910 (5 MPA.S), SUCROSE , ALPHA.-TOCOPHEROL, DL, MICROCRYSTALLINE CELLULOSE, CROSCARMELLOSE SODIUM, LACTOSE MONOHYDRATE, GLYCERYL DIBEHENATE, POLYETHYLENE GLYCOL, UNSPECIFIED, POLYVINYL ALCOHOL, UNSPECIFIED, TITANIUM DIOXIDE, GLYCERYL MONOCAPRYLOCAPRATE, SODIUM LAURYL SULFATE,FERRIC OXIDE YELLOW,FERROSOFERRIC OXIDE,FERRIC OXIDE RED, TALC
Contains Gluten :
No
Contains Lactose :
Yes
Contains DYE :
Yes
