מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
CYCLOSPORINE (UNII: 83HN0GTJ6D) (CYCLOSPORINE - UNII:83HN0GTJ6D)
Physicians Total Care, Inc.
CYCLOSPORINE
CYCLOSPORINE 100 mg
ORAL
PRESCRIPTION DRUG
Cyclosporine Capsules, USP are indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. It is always to be used with adrenal corticosteroids. The drug may also be used in the treatment of chronic rejection in patients previously treated with other immunosuppressive agents. Cyclosporine capsules are contraindicated in patients with a hypersensitivity to cyclosporine or to any of the ingredients of the formulation.
Cyclosporine Capsules, USP NON-MODIFIED 100 mg Hard gelatin capsules with a reddish brown opaque body and a reddish brown opaque cap. "APO" over "134" and "100" are imprinted on each capsule in black ink; supplied in bottles of 30 (NDC 54868-5522-0). Store and Dispense Store at 20° to 25°C (66° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP]. APOTEX INC. CYCLOSPORINE CAPSULES, USP 100 mg Manufactured by: Manufactured for: Apotex Inc. Apotex Corp. Toronto, Ontario Weston, Florida Canada M9L 1T9 33326 Revised: August 2010 Rev. 6 *Neoral® (cyclosporine capsules, USP) MODIFIED manufactured by Novartis. Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, OK 74146
Abbreviated New Drug Application
CYCLOSPORINE - CYCLOSPORINE CAPSULE, LIQUID FILLED PHYSICIANS TOTAL CARE, INC. ---------- CYCLOSPORINE CAPSULES, USP 25 MG AND 100 MG WARNING Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe Cyclosporine Capsules, USP NON-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, USP NON-MODIFIED 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 Soft Gelatin Capsules, USP (NON-MODIFIED) have decreased bioavailability in comparison to Neoral * (cyclosporine capsules, USP) MODIFIED. Cyclosporine Capsules, USP (NON-MODIFIED) and Neoral * (cyclosporine capsules, USP) MODIFIED are not bioequivalent and cannot be used interchangeably without physician supervision. The absorption of cyclosporine during chronic administration of Cyclosporine Capsules, USP NON-MODIFIED was found to be erratic. It is recommended that patients taking Cyclosporine Capsules, USP NON-MODIFIED 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.) DESCRIPTION Cyclosporine, the active principle in Cyclosporine Capsules, USP is a cyclic polypeptide immu קרא את המסמך השלם