英文药名: PENTASA Granules 94%(Mesalamine，5-Aminosalicylic acid) 中文药名: 美沙拉嗪，5-氨基水杨酸顆粒 94% 生产厂家: 杏林药业 ペンタサ顆粒94％ 治疗类别名称 溃疡性结肠炎的治疗剂 欧文商標名 PENTASA Granules 94% 一般名：メサラジン(JAN)、Mesalazine(JAN, INN) 化学名：5-Aminosalicylic acid 構造式： 分子式：C7H7NO3 分子量：153.14 融点　：270～275℃(分解) 性状 本产品为针状结晶或结晶性粉末灰白色至淡黄色灰，有一种无臭〜异味。该产品有一个略带甜味依然酸酸的。此产品是微溶于水，乙醇（99.5），或在甲醇中极微溶，并在二乙醚或氯仿中几乎不溶。 药效药理 1. 动物模型的效果 在乙酸诱导的溃疡性结肠炎模型和大鼠TNBS诱导结肠炎模型，在前者从6.25mg/kg的抑制显著溃疡面积的效果，后者25.0mg/kg的显著失败美沙拉嗪的灌肠施用观察抑制效果。 2. 作用机序 自由基（DPPHL）在体外，过氧化氢清除活性，离子清除作用次氯酸降低作用，脂质过氧化抑制作用（体外，体内）进行了观察。大鼠嗜中性粒细胞进一步抑制白三烯B4（LTB4）的生物合成（体外）。 因此，擦除从炎性细胞释放这种药物的作用的主要模式的活性氧，抑制进展和组织疾病的炎症，并抑制LTB 4的生物合成，炎性细胞它被认为，以防止该组织的浸润。 另外，作为动作的另一个模式中，组胺释放从肥大细胞抑制作用，生物合成抑制血小板活化因子（PAF），白介素1-β产生抑制作用的作用（IL-1β）是参与部分已推断可能性（体外）。 适应病症 溃疡性结肠炎（不含重度），克罗恩病 用法用量 溃疡性结肠炎： 成年人饭后口服，一日三次，每次服1,500mg，缓解可每日一次。此外，年龄，将根据症状进行调整，到最大1天2,250mg。 然而，活性相可在两部分每日4,000mg如果必要给药。 儿童，饭后它是口服给药，每天为30〜60毫克/公斤的三倍。此外，年龄，将根据症状进行调整，到最大1天2,250mg的。 克罗恩病： 成人，饭后口服给药，一日三次，每次服：1,500mg〜3,000mg。应当指出的是，这取决于患者的年龄和症状减肥。 儿童，饭后它是口服给药，每天为40〜60毫克/公斤的三倍。应当指出的是，增加或减少取决于患者的年龄和症状。 包装规格 顆粒94％ 分包： 250毫克※100包（10包×10） 500毫克※100包（10包×10） 1000毫克※100包（10包×10） 2,000mg※100包（10包×10） 制造厂商 杏林药业有限公司 完整处方资料附件：http://www.info.pmda.go.jp/go/pack/2399009D2020_1_01/ PENTASA Granules(Mesalamine，5-Aminosalicylic acid)美沙拉嗪，5-氨基水杨酸顆粒 94% PENTASA Granules 94%（ペンタサ顆粒94%） Brand name : PENTASA Granules 94% 　Active ingredient: Mesalazine 　Dosage form: grayish-white to pale-grayish-yellow cylindrical granules 　Print on wrapping: ［yellow,250mg］ペンタサ顆粒94%,メサラジン250mg含有,KP-012 ［green,500mg］ペンタサ顆粒94%,メサラジン500mg含有,KP-012 ［blue,1,000mg］ペンタサ顆粒94%,メサラジン1,000mg含有,KP-012 ［orange,2,000mg］ペンタサ顆粒94%,メサラジン2,000mg含有,KP-012 Effects of this medicine This medicine eliminates activated oxygen released from inflammatory cells and inhibits the synthesis of leukotriene. It suppresses development of inflammation and tissue damage, and consequently improves abdominal pain and hematochezia. It is usually used in the treatment of ulcerative colitis and Crohn's disease. Before using this medicine, be sure to tell your doctor and pharmacist •If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines. If you are a patient with renal or hepatic disorder. •If you are pregnant or breastfeeding. •If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.) Dosing schedule (How to take this medicine) •Your dosing schedule prescribed by your doctor is <<to be written by a healthcare professional>> •For ulcerative colitis: In general, for adults, take 1,500 mg of the active ingredient daily in 3 divided doses, after meals. In the remission stage, however, you may be instructed to take the medicine once daily, as necessary. The dosage may be adjusted according to the age or symptoms, and the daily dose is limited to 2,250 mg. In the active stage, however, you may be instructed to take 4,000 mg daily in 2 divided doses, as necessary. For children, take 30 to 60 mg of the active ingredient per kilogram of body weight daily in 3 divided doses, after meals. The dosage may be adjusted according to the age or symptoms, and the daily dose is limited to 2,250 mg. For Crohn's disease: In general, for adults, take 1,500 to 3,000 mg of the active ingredient daily in 3 divided doses, after meals. The dosage may be reduced according to the age or symptoms. For children, take 40 to 60 mg of the active ingredient per kilogram of body weight daily in 3 divided doses, after meals. The dosage may be adjusted according to the age or symptoms. There are four kinds of preparations containing 250 mg, 500mg, 1,000mg,and 2,000mg of the active ingredient in a sachet. Strictly follow the instructions of your doctor/pharmacist. •This medicine is a controlled-active ingredient release preparation and so swallow it without chewing. •If you miss a dose, take a dose as soon as possible when you remember that you missed a dose. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. You should not take two doses at one time. •If you took too much of the medicine (more than prescribed), check with your doctor/pharmacist. •Do not stop taking this medicine unless your doctor instructs you to do so. Precautions while taking this medicine •Sometimes you will find white object in your stool. It is ethylcellulose, the coating agent. Possible adverse reactions to this medicine The most commonly reported adverse reactions include diarrhea, melena, bloody stool, abdominal pain, rash, fever and colored urine. If any of these symptoms occur, consult with your doctor or pharmacist. The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately. •fever, respiratory distress, dry cough [interstitial lung disease] •chest pain, fever, respiratory distress [myocarditis, pericarditis, pleuritis] •fever, decreased urine output, respiratory distress [interstitial nephritis, nephrotic syndrome, deteriorated renal function, acute renal failure] •anemic tendency, bleeding tendency, fever [aplastic anemia, pancytopenia, agranulocytosis, thrombocytopenia] •general malaise, loss of appetite, yellowing of the skin/eyes [hepatitis, liver dysfunction, jaundice] •severe pain in the upper abdomen or lower back, fever, nausea, vomiting [pancreatitis] The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above. Storage conditions and other information •Keep the medicine out of the reach of children. Store it away from light, heat and moisture. The medicine may be colored during storage, however, it does not affect its efficacy. •Discard the remainder. Do not store them.