美国FDA批准了Salix Pharmaceuticals, Ltd.公司的美沙拉嗪缓释胶囊(mesalamine extended-release capsules),商品名为Apriso ,该制剂为目前唯一的每日给药1次的24小时缓释制剂。 Apriso的通用名称为 美沙拉嗪0.375克; EXT-REL帽;含有苯丙氨酸0.56mg/cap。 法律分类: 对Apriso的制造商 成人剂量为Apriso的 为Apriso的儿童用药 警告/ Apriso的注意事项 为Apriso的相互作用 Apriso的不良反应 Apriso的是如何提供的? The FDA has approved Apriso (mesalamine extended-release capsules, from Salix) for remission maintenance of ulcerative colitis (UC) in adults. In two randomized, double-blind, placebo-controlled studies involving 562 patients, Apriso was more effective in maintaining long-term UC remission and sustaining improvement of UC symptoms for six months than placebo. Generic Name for APRISOMesalamine 0.375g; ext-rel caps; contains phenylalanine 0.56mg/cap. Legal Classification:Rx Pharmacological Class for APRISOAminosalicylate. Manufacturer of APRISOSalix Pharmaceuticals, Inc. Indications for APRISOMaintenance of remission of ulcerative colitis (UC) in adults. Adult dose for APRISO≥18yrs: 1.5g once daily in the AM. Children's dosing for APRISO<18yrs: not recommended. Warnings/Precautions for APRISOSulfasalazine allergy. Renal dysfunction or history of renal disease; assess renal function at the beginning and periodically during treatment. Hepatic impairment. Elderly (monitor CBCs). Pregnancy (Cat.B). Nursing mothers. Interactions for APRISODo not co-administer with antacids. Adverse Reactions for APRISOHeadache, GI upset, upper abdominal pain, nasopharyngitis, flu-like symptoms, sinusitis; renal impairment, mesalamine-induced acute intolerance syndrome (eg, cramping, abdominal pain, bloody diarrhea, fever, headache, rash); discontinue if occurs. How is APRISO supplied?Caps—120 |
Apriso(美沙拉嗪肠溶缓释微丸胶囊)简介:
美国FDA批准了Salix Pharmaceuticals, Ltd.公司的美沙拉嗪缓释胶囊(mesalamine extended-release capsules),商品名为Apriso ,该制剂为目前唯一的每日给药1次的24小时缓释制剂。
Apriso的通用名称 ... 责任编辑:admin |
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