Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
CYCLOSPORINE (UNII: 83HN0GTJ6D) (CYCLOSPORINE - UNII:83HN0GTJ6D)
Apotex Corp.
ORAL
PRESCRIPTION DRUG
Kidney, Liver, and Heart Transplantation Cyclosporine capsules (modified) is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Cyclosporine capsules (modified) has been used in combination with azathioprine and corticosteroids. Rheumatoid Arthritis Cyclosporine capsules (modified) is indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate. Cyclosporine capsules (modified) can be used in combination with methotrexate in rheumatoid arthritis patients who do not respond adequately to methotrexate alone. Psoriasis Cyclosporine capsules (modified) is indicated for the treatment of adult, nonimmunocompromised patients with severe (i.e., extensive and/or disabling), recalcitrant, plaque psoriasis who have failed to respond to at least one systemic therapy (e.g., PUVA, retinoids, or methotrexate) or in patients for whom other systemic therapies are contraindicated or cannot be tol
Cyclosporine capsules, USP (modified) (Soft Gelatin Capsules) 25 mg An oval, opaque grey colored soft gel capsule filled with liquid, printed with "C25" in black ink across one side. Packages of 30 unit-dose blisters (NDC 60505-4630-3). 50 mg An oblong, opaque off-white colored soft gel capsule filled with liquid, printed with "C50" in black ink across one side. Packages of 30 unit-dose blisters (NDC 60505-4631-3). 100 mg An oblong opaque grey colored soft gel capsule filled with liquid, printed with "C100" in black ink across one side. Packages of 30 unit-dose blisters (NDC 60505-4632-3). Store and Dispense Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in original unit-dose container. Cyclosporine Capsules, USP (MODIFIED) (Soft Gelatin Capsules) All registered trademarks in this document are the property of their respective owners. Revised: November 2023 Revision: 4
Abbreviated New Drug Application
CYCLOSPORINE, MODFIED- CYCLOSPORINE CAPSULE, LIQUID FILLED APOTEX CORP. ---------- CYCLOSPORINE CAPSULES, USP (MODIFIED) (SOFT GELATIN CAPSULES) RX ONLY PRESCRIBING INFORMATION WARNING Only physicians experienced in management of systemic immunosuppressive therapy for the indicated disease should prescribe cyclosporine capsules (modified). At doses used in solid organ transplantation, only physicians experienced in immunosuppressive therapy and management of organ transplant recipients should prescribe cyclosporine capsules (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 capsules (modified), a systemic immunosuppressant, may increase the susceptibility to infection and the development of neoplasia. In kidney, liver, and heart transplant patients cyclosporine capsules (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) have increased bioavailability in comparison to Sandimmune Soft Gelatin Capsules (cyclosporine capsules, USP) [NON- MODIFIED]. Cyclosporine capsules (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 capsules (modified) than with Sandimmune . If a patient who is receiving exceptionally high doses of Sandimmune is converted to cyclosporine capsules (modified), particular caution should be exercised. Cyclosporine blood concentrations should be monitored in transplant and rheumatoid arthritis patients taking cyclosporine capsules (modified) to avoid toxicity due to high concentrati Διαβάστε το πλήρες έγγραφο