部份中文普仑司特处方资料（仅供参考） 药品英文名 Pranlukast 药品别名 奥农、哌鲁司特、普兰流卡斯特、普鲁司特、Onon 药物剂型 普鲁司特片剂：225mg/片。 普鲁司特胶囊剂：112.5mg/粒。室温、密闭、避光、干燥处保存。 药理作用 本品是白三烯受体拮抗剂(LTRA)，对LTC4、LTD4、LTE4均有显著抑制，特别是对LTD4(引起人体气管平滑肌收缩的主要成分)有抑制作用。本品可减轻淋巴细泡在支气管黏膜的浸润，在吸人LTD4前2h从胃管灌入本品，不但使支气管肺泡灌洗液(BALF)中细胞数减少，也使LTD4所致BALF中嗜酸性粒细胞比例增多的作用减少60%。此外，尚可降低支气管的高反应性，但稍逊于氟替卡松。 本品尚可预防高剂量吸入糖皮质激素减量时哮喘的恶化，对吸入二丙酸倍氯米松1600μg/天和并服泼尼松20mg/天治疗无效的哮喘者，应用本品每次225mg，每日2次，连续8周后，患者的临床症状评分、紧急的β受体激动剂吸入次数得到明显改善。 药动学 本品口服吸收良好，生物利用度为60%，血浆药物浓度达峰时间为2.5～3.8h，血药峰浓度为O.3～0.7μg/ml，夜间服用的血药浓度高于日间，提示适合睡前给药，随剂量的增加最大血药峰浓度及药时曲线下面积增大，超过450mg时其增加的幅度减小，消除半衰期为6.7～7h，重复剂量比单一剂量的半衰期延长。急性哮喘口服本品1h起效，慢性哮喘用药后1～2周症状可得到显著改善。空腹口服达峰时间3h，与食物同服达峰时间可延至4～5h。 本品代谢完全，由粪便排出剂量的90%，血浆蛋白结合率达90%。青年与老年的药代动力学参数无性别、年龄差异。本品不影响P450酶。 适应证 适用于各种哮喘，包括特应型、混合型、感染型、发作型、慢性型和非季节的支气管哮喘。还可用于变应性鼻炎(过敏性鼻炎)。临床上合用肾上腺皮质激素以减少肾上腺皮质激素用量。 禁忌证 1.对本品过敏者禁用。 2.颅内出血尚未完全控制者禁用。 3.儿童应用本品的安全性尚未确定，儿童不宜使用。 注意事项 1.对其他白三烯受体拮抗剂如扎鲁司特、孟鲁司特、泊比司特等有过敏史者慎用。 2.肝脏疾病患者尚缺乏相关药代动力学研究，应慎用。 3.严重哮喘患者慎用。 4.孕妇应用本品的安全性尚未确定，孕妇慎用。 5.在治疗急性哮喘上，白三烯受体拮抗剂的疗效尚未确定，暂对不宜应用于急性发作的治疗，不宜突然代替肾上腺皮质激素，也不宜用于解除哮喘急性发作时的支气管痉挛。为增加药物的吸收，本品宜餐后口服给药。 7.支气管哮喘患者服用本品期间，若出现急性发作的情况时必须使用其他支气管扩张药或肾上腺皮质激素。 8.长期接受肾上腺皮质激素治疗的患者，因服用本品而减量服用肾上腺皮质激素时，应逐渐减量，一旦中止服用本品，哮喘可能再度发作。 9.发生Churg-Strauss综合征时，通常需要联合应用减量的口服糖皮质激素。 10.应用本品治疗时需进行常规血液生化及肝功能监测。 不良反应 本品耐受性良好。 1.主要不良反应 皮疹、瘙痒、腹痛、胃部不适、腹泻、便秘、恶心、呕吐及血清氨基转移酶或胆红素升高等肝功能异常。 2.较严重的不良反应 偶见白细胞减少(初期症状：发热、咽喉痛、全身倦怠感等)、血小板减少(初期症状：紫斑、鼻出血、牙龈出血等出血倾向)，若出现这类症状，应终止服用并采取适当措施。 3.其他 偶见麻木、震颤、失眠、嗜睡、头痛、关节痛、倦怠感、发热、浮肿等。 用法用量 口服：成人与12岁以上儿童，每次225～450mg，每日2次，早晚餐后服用。 老年患者因其肝肾功能多有减退应酌情减量。 药物相应作用 本品与华法林合用，可增加华法林的血药浓度。特非那定可降低本品的血药浓度。 包装规格（普仑司特干糖浆10％，胶囊） 干糖浆10％： 100g、500g、0.5g×200包、0.7g×200包、1g×200包 胶囊剂：112.5mg 100胶囊（瓶） 140胶囊（PTP） 420胶囊（PTP）700胶囊（瓶）1400胶囊（PTP） Brand name : PRANLUKAST CAPSULES 112.5 mg "TOWA" 　Active ingredient: Pranlukast hydrate 　Dosage form: white to yellowish white cupsule, total length 14.2mm 　Print on wrapping: Tw429, プランルカスト「トーワ」, 112.5mg Effects of this medicine This medicine suppresses by antagonizing leukotriene receptors, leading to improvements in asthmatic symptoms, such as cough, difficulty breathing and allergic reactions such as rhinitis. It is usually used to allergic rhinitis. This medicine is not intended to stop asthmatic attacks that have already started, but used to prevent these attacks. 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 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, take 2 capsules (225 mg of the active ingredient) twice a day, after breakfast and dinner. Strictly follow the instructions of your doctor or pharmacist. •If you miss a dose, take a dose as soon as possible. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. You should never take two doses at one time. •If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist. •Do not stop taking 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 nausea, diarrhea, abdomen pain, stomach discomfort, headache, sleepiness, dizziness, rash, itch, hives, erythema multiforme exudativum. 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. •decreased blood pressure, breathing difficulty, rash[shock, anaphylactoid symptoms] •bleeding tendency such as purpura, nasal bleeding, gum bleeding[thrombocytopenia] •general malaise, loss of appetite, yellow discoloration of the skin and the conjunctiva[hepatic dysfunction] •fever, dry cough, breathing difficulty[leukopenia, interstitial pneumonia, eosinophilic pneumonia] •muscle pain, feeling of weakness, reddish brown urine[rhabdomyolysis] 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 out of the reach of children. Store away from direct sunlight, heat and moisture. •Discard the remainder. Do not store them. Revised: 9/2009 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.