英文药名: PENTASA Enema(Mesalamine，5-Aminosalicylic acid)

中文药名: 美沙拉嗪，5-氨基水杨酸灌肠剂

生产厂家: 杏林药业

ペンタサ注腸1g

治疗类别名称
溃疡性结肠炎的治疗剂
欧文商標名
PENTASA Enema 1g
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）
用法用量
通常，成人：1G则在直肠注射。应当指出的是，这取决于患者的年龄和症状减肥。
包装规格
灌肠剂：1克
100毫升×7本

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/2399715X1023_3_09/
PENTASA Enema 1g（Mesalamine，5-Aminosalicylic acid）美沙拉嗪，颇得斯安，5-氨基水杨酸灌肠剂
PENTASA Enema 1g（ペンタサ注腸1g）
Brand name : PENTASA Enema 1g
　Active ingredient: Mesalazine
　Dosage form: white to pale yellow suspension enema
　Print on wrapping: ペンタサ注腸1g 1本 (100mL) KP-008
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.
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 have 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>>
•In general, for adults, instill a pack of enema (1 g of the active ingredient) into the rectum daily. The dosage may be decreased according to the age or symptoms. Strictly follow the instructions of your doctor and pharmacist.
•Take out from the package immediately before using, and shake the container well.
•If you miss a dose, use a dose as soon as possible when you remember that you missed a rectal instillation. However, if it is almost time for the next dose, consult with your doctor or pharmacist.
•If you accidentally use more than your prescribed dose, consult with your doctor or pharmacist.
•Do not stop using this medicine unless your doctor instructs you to do so.
Precautions while taking this medicine
•Possible adverse reactions to this medicine
The most commonly reported adverse reactions include rash, hives, erythema, diarrhea, abdominal pain, nausea, vomiting, headache, discomfort and defecation urgency. 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, breathing difficulty, dry cough  [interstitial lung disease]
•chest pain, fever, breathing difficulty  [myocarditis, pericarditis, pleuritis]
•fever, decreased urine output, breathing difficulty  [interstitial nephritis, nephrotic syndrome, deteriorated renal function, acute renal failure]
•anemic tendency, bleeding tendency, fever  [aplastic anemia, pancytopenia, agranulocytosis, thrombocytopenia]
•general fatigue, 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.
•Use the pack immediately after opening. Discard the remainder. Do not store them.
Kyorin Pharmacetical Co.,LtdExternal
Revised: 1/2015
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.