英文药名: Neoral(Cyclosporine Capsules) 中文药名: 环孢素胶囊 生产厂家: Novartis 药品名称 【药品名称】新山地明胶囊, Sandimmun, Neoral 环孢素胶囊 10mg; 25mg; 50mg; 100mg 环孢素(又称环孢素A)系含11个氨基酸的环状多肽,是一种作用很强的免疫抑制剂。它可抑制细胞介导的反应发生,包括同种异体免疫、迟发性皮肤过敏、实验性过敏性脑脊髓炎、Freund 氏佐剂性关节炎、移植物抗宿主疾病(GVHD)以及T细胞依赖性抗体的产生。在细胞水平,环孢素抑制包括白细胞介素2[T细胞生长因子(TCGF)]在内的淋巴因子的生成和释放。它可阻断细胞周期G0或G1期的休止淋巴细胞,并通过激活的T细胞来抑制抗原触发的淋巴因子的释放。 若患者的血清肌酐值持续超过治疗开始前基线值的30%,则应将剂量减少25-50%。在山地明治疗的银屑病患者中,也有报道癌变的发生(特别是皮肤方面)。极少数患者可发生淋巴组织增生失调。 NEORAL® (cyclosporine) Soft Gelatin Capsules, USP MODIFIED NEORAL® (cyclosporine) Oral Solution, USP MODIFIED WARNING Only physicians experienced in management of systemic immunosuppressive therapy for the indicated disease should prescribe Neoral®. At doses used in solid organ transplantation, only physicians experienced in immunosuppressive therapy and management of organ transplant recipients should prescribe Neoral®. 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. Neoral®, a systemic immunosuppressant, may increase the susceptibility to infection and the development of neoplasia. In kidney, liver, and heart transplant patients Neoral® 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. Neoral® Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED and Neoral® Oral Solution (cyclosporine oral solution, USP) MODIFIED have increased bioavailability in comparison to Sandimmune® Soft Gelatin Capsules (cyclosporine capsules, USP) and Sandimmune® Oral Solution (cyclosporine oral solution, USP). Neoral® and Sandimmune® are not bioequivalent and cannot be used interchangeably without physician supervision. For a given trough concentration, cyclosporine exposure will be greater with Neoral® than with Sandimmune®. If a patient who is receiving exceptionally high doses of Sandimmune® is converted to Neoral®, particular caution should be exercised. Cyclosporine blood concentrations should be monitored in transplant and rheumatoid arthritis patients taking Neoral® to avoid toxicity due to high concentrations. Dose adjustments should be made in transplant patients to minimize possible organ rejection due to low concentrations. Comparison of blood concentrations in the published literature with blood concentrations obtained using current assays must be done with detailed knowledge of the assay methods employed. For Psoriasis Patients (See also Boxed WARNINGS above) Psoriasis patients previously treated with PUVA and to a lesser extent, methotrexate or other immunosuppressive agents, UVB, coal tar, or radiation therapy, are at an increased risk of developing skin malignancies when taking Neoral®. Cyclosporine, the active ingredient in Neoral®, in recommended dosages, can cause systemic hypertension and nephrotoxicity. The risk increases with increasing dose and duration of cyclosporine therapy. Renal dysfunction, including structural kidney damage, is a potential consequence of cyclosporine, and therefore, renal function must be monitored during therapy. DRUG DESCRIPTION Neoral® is an oral formulation of cyclosporine that immediately forms a microemulsion in an aqueous environment. Cyclosporine, the active principle in Neoral®, is a cyclic polypeptide immunosuppressant agent consisting of 11 amino acids. It is produced as a metabolite by the fungus species Beauveria nivea. Neoral® Soft Gelatin Capsules (cyclosporine) Capsules, USP MODIFIED are available in 25 mg and 100 mg strengths. Each 25 mg capsule contains: cyclosporine.............................................................25 mg alcohol, USP dehydrated.............................................................11.9% v/v (9.5% wt/vol.) Each 100 mg capsule contains: cyclosporine.............................................................100 mg alcohol, USP dehydrated.............................................................11.9% v/v (9.5% wt/vol.) Inactive Ingredients: Corn oil-mono-di-triglycerides, polyoxyl 40 hydrogenated castor oil NF, DL-α tocopherol USP, gelatin NF, glycerol, iron oxide black, propylene glycol USP, titanium dioxide USP, carmine, and other ingredients. Neoral® Oral Solution (cyclosporine) Oral Solution, USP MODIFIED is available in 50 mL bottles. Each mL contains: cyclosporine......................................100 mg/mL alcohol, USP dehydrated...............................11.9% v/v (9.5% wt/vol.) Inactive Ingredients: Corn oil-mono-di-triglycerides, polyoxyl 40 hydrogenated castor oil NF, DL-α tocopherol USP, propylene glycol USP. INDICATIONS Kidney, Liver, and Heart Transplantation Neoral® is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Neoral® has been used in combination with azathioprine and corticosteroids. Rheumatoid Arthritis Neoral® is indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate. Neoral® can be used in combination with methotrexate in rheumatoid arthritis patients who 。 |
环孢素胶囊|Neoral(Cyclosporine Capsules)简介:
英文药名: Neoral(Cyclosporine Capsules)
中文药名: 环孢素胶囊
生产厂家: Novartis
药品名称
【药品名称】新山地明胶囊, Sandimmun, Neoral 【制造商】诺华-品牌药 规格
环孢素胶囊 10mg; 25m ... 责任编辑:admin |
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