Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
Cyclosporine (UNII: 83HN0GTJ6D) (Cyclosporine - UNII:83HN0GTJ6D)
Morton Grove Pharmaceuticals, Inc.
Cyclosporine
Cyclosporine 100 mg in 1 mL
PRESCRIPTION DRUG
Abbreviated New Drug Application
CYCLOSPORINE- CYCLOSPORINE SOLUTION MORTON GROVE PHARMACEUTICALS, INC. ---------- CYCLOSPORINE ORAL SOLUTION, USP 100 MG/ML RX ONLY PRESCRIBING INFORMATION WARNING Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe cyclosporine. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient. Cyclosporine should be administered with adrenal corticosteroids but not with other immunosuppressive agents. Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression. Cyclosporine Oral Solution, USP has decreased bioavailability in comparison to Neoral soft gelatin capsules (cyclosporine capsules, USP) MODIFIED and Neoral oral solution (cyclosporine oral solution, USP) MODIFIED. Cyclosporine and Neoral (cyclosporine [MODIFIED]) are not bioequivalent and cannot be used interchangeably without physician supervision. The absorption of cyclosporine during chronic administration of oral solution was found to be erratic. It is recommended that patients taking the oral solution over a period of time be monitored at repeated intervals for cyclosporine blood levels and subsequent dose adjustments be made in order to avoid toxicity due to high levels and possible organ rejection due to low absorption of cyclosporine. This is of special importance in liver transplants. Numerous assays are being developed to measure blood levels of cyclosporine. Comparison of levels in published literature to patient levels using current assays must be done with detailed knowledge of the assay methods employed. (See BLOOD LEVEL MONITORING under DOSAGE AND ADMINISTRATION.) 1 DESCRIPTION Cyclosporine, the active principle in Cyclosporine Oral Solution, USP is a cyclic polypeptide immunosuppressant agent consisting of 11 amino acids. It Olvassa el a teljes dokumentumot