近日，美国食品药品监督管理局（FDA）已批准ASACOL HD(mesalamina delayed-release tablets)，用于治疗溃疡性结肠炎（UC）。
溃疡性结肠炎是一种大肠（结肠）和背道（直肠）疾病，其中肠黏膜发炎（红肿）。症状可能包括直肠出血、频繁腹泻和腹痛。灌肠剂局部作用于结肠下部以减少炎症。
溃疡性结肠炎（UC）是一种病因及发病机制尚不完全清楚的慢性非特异性炎症性疾病，主要累及结直肠，临床主要表现为腹泻、腹痛、黏液脓血便，约90%的患者在发病后25年内至少复发1次。
批准日期：2008年05月28日 公司：Warner Chilcott (US), LLC
ASACOL HD（美沙拉敏[mesalamine]）缓释片，口服
美国初次批准：1987年
作用机理
美沙拉敏的作用机理尚不清楚，但似乎是局部的而不是全身的。在慢性炎症性肠病患者中，通过环加氧酶途径（即前列腺素）和通过脂氧合酶途径（即白三烯和羟基二十碳四烯酸）的花生四烯酸代谢产物的粘膜产生均增加，美沙拉酮有可能减轻炎症 通过阻断环氧合酶并抑制结肠中前列腺素的产生。
适应症和用途
Asacol HD是一种氨基水杨酸盐​​，适用于治疗成人中度活动性溃疡性结肠炎。
使用限制：
尚未确定超过6周的Asacol HD的安全性和有效性。
剂量和给药
重要管理说明：
不要用两种美沙拉敏400mg口服缓释片代替一种Asacol HD 800片剂。
在开始使用Asacol HD之前评估肾功能。
饭前至少1小时和饭后2小时空腹
吞下整个；请勿切割，破碎或咀嚼药片。
中度活动性溃疡性结肠炎的治疗：
推荐剂量为1600毫克（两片800毫克片剂），每天3次，共6周。
剂量形式和强度
延迟释放片：800mg
禁忌症
已知或怀疑对水杨酸酯或氨基水杨酸酯或Asacol HD片剂的任何成分过敏。
警告和注意事项
肾功能不全：评估已知肾功能不全或服用肾毒性药物的患者的风险和获益；监测肾功能。
美沙拉敏诱发的急性不耐受症候群：症状可能难以与溃疡性结肠炎加重区分开；监测症状恶化；如果怀疑是急性不耐受综合征，则停止使用。
超敏反应，包括心肌炎和心包炎：立即评估患者，如果怀疑有超敏反应，则中止治疗。
肝衰竭：评估已知肝功能不全患者的风险和收益。
不良反应
最常见的不良反应（≥2％）是头痛，恶心，鼻咽炎，腹痛和溃疡性结肠炎的恶化。
要报告可疑的不良反应，请致电1-800-678-1605与Allergan联系，或致电1-800-FDA-1088与FDA联系或访问www.fda.gov/medwatch
药物相互作用
肾毒性药物，包括非甾体抗炎药：肾毒性的风险增加；监测肾功能的变化以及与美沙拉敏有关的不良反应。
硫唑嘌呤或6-巯基嘌呤：血液疾病的风险增加；监测全血细胞计数和血小板计数。
在特定人群中的使用
老年患者：发生血液异常的风险增加；监测全血细胞计数和血小板计数。
包装供应/存储和处理方式
Asacol HD（美沙拉敏）缓释片可作为红褐色胶囊状片剂，包含800毫克美沙拉敏，并印有“ WC 800”的黑色字样。
NDC 0023-5901-18瓶180片
防潮。 无需干燥剂即可分配药片长达6周。
存放在20°至25°C（68°至77°F）的受控室温下; 允许在15°至30°C（59°至86°F）的范围内偏移。[请参阅USP控制的室温]
完整资料附件：
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2f68f68c-58d2-4575-b573-f2e62f95d7e3
ASACOL HD(mesalamine)delayed-release tablets, for oral use
Initial U.S. Approval: 1987
IMPORTANT RISK INFORMATION
Do not take ASACOL HD if you are:
allergic to salicylates, such as aspirin or medications that contain aspirin
allergic to aminosalicylates
allergic to any of the ingredients of ASACOL HD
Before taking ASACOL HD tell your doctor if you:
have or have had kidney problems
are allergic to sulfasalazine
have or have had heart-related allergic reactions, such as inflammation of the heart muscle (myocarditis) or inflammation of the lining of the heart (pericarditis)
have or have had liver problems
are pregnant, nursing, or are planning to become pregnant or to breastfeed
have any other medical conditions
What are the possible side effects of ASACOL HD?
ASACOL HD may cause serious side effects, including:
Kidney problems: Reports of problems with kidney function have been associated with mesalamine-containing products like ASACOL HD. Your doctor may check to see how your kidneys are working before starting and periodically while taking ASACOL HD.
Acute Intolerance Syndrome: Products that contain mesalamine, like ASACOL HD, have been associated with a condition, Mesalamine-Induced Acute Intolerance Syndrome, that may be difficult to distinguish from an ulcerative colitis flare-up. Symptoms include cramping, stomach-area (abdominal) pain, bloody diarrhea, and occasionally fever, headache, tiredness, itching, rash, and conjunctivitis. If you experience any of these symptoms while on treatment, call your doctor right away. He or she may tell you to stop taking ASACOL HD.
Allergic reactions, including inflammation of the heart muscle or lining: Allergic reactions may involve internal organs, including inflammation of the heart muscle (myocarditis), inflammation of the lining of the heart (pericarditis), inflammation of the kidneys (nephritis), inflammation of the liver (hepatitis), inflammation of the lungs (pneumonitis), and blood abnormalities. If you experience any allergic reaction symptoms, call your doctor right away. He or she may tell you to stop taking ASACOL HD.
Liver failure: Reports of liver failure have been associated with mesalamine-containing products like ASACOL HD in patients that have or have had liver disease. Tell your doctor if you have a problem with your liver.
The most common side effects of ASACOL HD include:
Headache, nausea, nasopharyngitis (common cold), stomach-area (abdominal) pain, and worsening of UC.
Tell your doctor if you have any side effect that bothers you or does not go away. These are not all the possible side effects of ASACOL HD.
Before starting ASACOL HD, tell your doctor about all medications you are taking, including:
Nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen and naproxen. Taking these medications with ASACOL HD may increase your risk of kidney problems.
Azathioprine or 6-mercaptopurine. Taking these medications with ASACOL HD may increase your risk of blood disorders.
What is ASACOL HD?
ASACOL HD (mesalamine) delayed-release tablets is a prescription medication used to treat moderately active ulcerative colitis (UC) in adults. Safety and effectiveness of ASACOL HD beyond 6 weeks has not been established.
Please see full Prescribing Information for ASACOL HD.
The product information provided on this page is intended only for residents of the United States. The products discussed on this page may have different product labeling outside of the United States.
The health information described on this page is provided for educational purposes only and is not intended to substitute for discussions with a healthcare provider.