País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
CYCLOSPORINE (UNII: 83HN0GTJ6D) (CYCLOSPORINE - UNII:83HN0GTJ6D)
Mayne Pharma Inc.
CYCLOSPORINE
CYCLOSPORINE 25 mg
ORAL
PRESCRIPTION DRUG
Cyclosporine capsules, USP [MODIFIED] and cyclosporine oral solution, USP [MODIFIED] are indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Cyclosporine capsules, USP [MODIFIED] and cyclosporine oral solution, USP [MODIFIED] have been used in combination with azathioprine and corticosteroids. Cyclosporine capsules, USP [MODIFIED] and cyclosporine oral solution, USP [MODIFIED] are indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate. Cyclosporine capsules, USP [MODIFIED] and cyclosporine oral solution, USP [MODIFIED] can be used in combination with methotrexate in rheumatoid arthritis patients who do not respond adequately to methotrexate alone. Cyclosporine capsules, USP [MODIFIED] and cyclosporine oral solution, USP [MODIFIED] are indicated for the treatment of adult, nonimmunocompromised patients with severe (i.e., extensive and/or disabling), recalcitrant, plaque pso
A light yellow liquid supplied in 50 mL bottles containing 100 mg/mL and a 4 mL dosing syringe with case. In the original container at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Do not store in the refrigerator. Once opened, the contents must be used within two months. At temperatures below 68°F (20°C) the solution may gel; light flocculation or the formation of a light sediment or flakes may also form. Allow contents to reach room temperature to reverse these effects. There is no impact on product performance or dose.
Abbreviated New Drug Application
CYCLOSPORINE- CYCLOSPORINE CAPSULE, LIQUID FILLED MAYNE PHARMA INC. ---------- CYCLOSPORINE CAPSULES, USP [MODIFIED](SOFT GELATIN) CYCLOSPORINE ORAL SOLUTION, USP [MODIFIED] REVISED: MARCH 2021 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 TRANSPLANT AND RHEUMATOID ARTHRITIS PATIENTS TAKIN Llegiu el document complet