cyclosporine modfied cyclosporine capsule liquid filled
INDICATIONS AND USAGE 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 tolerated. While rebound rarely occurs, most patients will experience relapse with cyclosporine capsules (modified) as with other therapies upon cessation of treatment.
apotex corp.
CAPSULE WHITE C50
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HOW SUPPLIED
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. Manufactured by Manufactured for Catalent Ontario Limited Apotex Corp. Windsor, Ontorio Weston, Florida Canada N9C 3R5 USA 33326 Revised: November 2023 Revision: 4
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