英文药名:DELZICOL(mesalamine delayedrelease capsules)
中文药名:美沙拉嗪缓释胶囊
生产厂家:Warner Chilcott (US) LLC 药品介绍 DELZICOL(mesalamine 美沙拉嗪缓释胶囊)治疗溃疡性结肠炎于2013年获FDA批准上市 美国FDA批准其400毫克美沙拉嗪(mesalamine)缓释胶囊用于治疗溃疡性结肠炎(轻度至中度活动期溃疡性结肠炎和溃疡性结肠炎的缓解维持),该产品商品名为Delzicol。 适用范围及用途 DELZICOL是一种氨基水杨酸盐,用于: 12岁以上患者轻度至中度活动性溃疡性结肠炎的治疗 维持成人溃疡性结肠炎的缓解 包装规格 缓释胶囊 400mg×180粒/瓶
DELZICOL(mesalamine) delayed-release capsules Generic Name and Formulations: Mesalamine 400mg; del-rel caps. Company: Allergan Select therapeutic use: Colorectal disorders Indications for DELZICOL: Mildly to moderately active ulcerative colitis (UC) in patients ≥5 years of age. Maintenance of remission of UC in adults. Adult: Swallow caps whole; if unable to swallow, may open and swallow contents (four 100mg tabs). Treatment: 800mg 3 times daily for 6 weeks. Maintenance: 1.6g/day in 2–4 divided doses. Two Delzicol 400mg caps are not bioequivalent to one mesalamine 800mg del-rel tab. Children: <5yrs: not established. Give twice daily dosing for 6 weeks. ≥5yrs (17–32kg): 36–71mg/kg/day, up to max 1.2g/day (800mg in the AM + 400mg in the afternoon); (33–53kg): 37–61mg/kg/day, up to max 2g/day (1200mg in the AM + 800mg in the afternoon); (54–90kg): 27–44mg/kg/day, up to max 2.4g/day (1200mg in the AM + 1200mg in the afternoon). Warnings/Precautions: Monitor renal function before and during therapy. History of renal disease. Conditions predisposing to myocarditis, pericarditis. Sulfasalazine allergy. Pre-existing liver disease. Upper GI tract obstruction. Reevaluate periodically. Elderly (monitor CBCs). Pregnancy (Cat.B). Nursing mothers. Interactions: Increased risk of renal reactions with nephrotoxic agents (eg, NSAIDs). Increased risk of blood disorders with azathioprine or 6-mercaptopurine. Pharmacological Class: Salicylate. Adverse Reactions: Abdominal pain, eructation, pain, headache, back pain, diarrhea, rash, dyspepsia, rhinitis, flu syndrome, asthenia, flatulence, vomiting, fever, arthralgia, constipation, GI bleeding; acute intolerance syndrome (discontinue if occurs), cardiac hypersensitivity reactions. Pediatrics: also, nasopharyngitis, sinusitis. How Supplied: Caps—180 https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8e6b0544-e75d-463a-bd61-517834b49f53
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