Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
CYCLOSPORINE (UNII: 83HN0GTJ6D) (CYCLOSPORINE - UNII:83HN0GTJ6D)
Actavis Pharma, Inc.
CYCLOSPORINE
CYCLOSPORINE 25 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
CYCLOSPORINE- CYCLOSPORINE CAPSULE, LIQUID FILLED CYCLOSPORINE- CYCLOSPORINE SOLUTION ACTAVIS PHARMA, INC. ---------- CYCLOSPORINE CAPSULES, USP [MODIFIED] (SOFT GELATIN) CYCLOSPORINE ORAL SOLUTION, USP [MODIFIED] REVISED: JANUARY 2015 RX ONLY PRESCRIBING INFORMATION WARNING Only physicians experienced in management of systemic immunosuppressive therapy for the indicated disease should prescribe cyclosporine [MODIFIED]. At doses used in solid organ transplantation, only physicians experienced in immunosuppressive therapy and management of organ transplant recipients should prescribe cyclosporine [MODIFIED]. 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 [MODIFIED], a systemic immunosuppressant, may increase the susceptibility to infection and the development of neoplasia. In kidney, liver, and heart transplant patients, cyclosporine [MODIFIED] may be administered with other immunosuppressive agents. Increased susceptibility to infection and the possible development of lymphoma and other neoplasms may result from the increase in the degree of immunosuppression in transplant patients. Cyclosporine capsules [MODIFIED] and cyclosporine oral solution [MODIFIED] have increased bioavailability in comparison to Sandimmune®* soft gelatin capsules (cyclosporine capsules) and Sandimmune®* oral solution (cyclosporine oral solution). Cyclosporine [MODIFIED] and Sandimmune®* are not bioequivalent and cannot be used interchangeably without physician supervision. For a given trough concentration, cyclosporine exposure will be greater with cyclosporine [MODIFIED] than with Sandimmune®*. If a patient who is receiving exceptionally high doses of Sandimmune®* is converted to cyclosporine [MODIFIED], particular caution should be exercised. Cyclosporine blood concentrations should be monitored in tran Les hele dokumentet