部份中文琥珀酸西苯唑啉处方资料（仅供参考）
商品名：Cibenol Tablets
英文名：Cibenzoline Succinate
中文名：琥珀酸西苯唑啉片
生产商：安斯泰来制药
药品简介
Cibenol（Cibenzoline Succinate）为咪唑类衍生物，具有抗心律失常作用，既具Ⅰa类抗心律常药的作用，又有Ⅲ类和Ⅴ类者的特点，用于防治室性或室上性心律失常，尤多在新发生的心肌梗塞时应用。也用于心房颤动、心房扑动恢复节律后的维持治疗。
シベノール錠50mg/シベノール錠100mg
药用类别名称
心律失常治疗剂
批准日期：1990年11月
欧文商標名
Cibenol Tablets 50mg
Cibenol Tablets 100mg
一般名：シベンゾリンコハク酸塩（Cibenzoline Succinate）
化学名：2-［（1RS）-2,2-Diphenylcyclopropan-1-yl］-4,5-dihydro-1H -imidazole monosuccinate
分子式：C18H18N2・C4H6O4
分子量：380.44
融　点：163〜167℃
分配係数：1.26×10-1 （1-オクタノール／水系）
構造式：
性　状：
氰基琥珀酸盐是一种白色结晶性粉末。溶于甲醇或醋酸 (100), 几乎不溶于水或乙醇 (99.5)。 本产品 (1→10) 的甲醇溶液不显示光学旋转。
药用药理学
1. 对心律失常模型的影响
(1) 电刺激引起的心律失常
在麻醉猫中, 增加电刺激阈值, 导致心室纤颤。此外, 在通过冠状动脉结扎造成心肌梗死的狗, 通过电刺激抑制室颤。
(2) 药品监督管理局的心律失常
在麻醉过的大鼠或麻醉狗中, 抑制由乌头碱、欧阿班和肾上腺素引起的室性心律失常。
(3) 冠状动脉结扎术后心律失常
在犬中, 抑制冠状动脉两阶段结扎引起的室性心律失常, 其效果强于二异吡胺, 是持续的。
2. 电生理作用
家兔、狗、豚鼠和青蛙在不同切除心肌标本中的作用, 显示了I类类型(心肌活动电位最大去极化速率的抑制) 在Vaughan Williams分类中的作用, 抑制启动速度的动力学是温和的。 此外, 我还显示了内CA2+电流在延长和高浓度的作用电位持续时间中的抑制作用。 也抑制缩短的持续时间的心房活动潜力引起的缺氧。
3. 对心肌代谢的影响
麻醉犬心肌缺血引起心肌ATP含量下降, 对乳酸含量的增加和心肌酸中毒有改善作用。
4. 对抗心血管的作用
(1)在抗心律失常作用表达水平不不利地影响特别受损的血液行为。 麻醉犬或冠状动脉狭窄犬的心肌收缩力、对心输出量和左心室工作的抑制作用弱于二异吡胺, 也不影响左心室压力最大 dp/dt。
(2) 在室性心律失常患者中, 在给药2-4时, 剂300~450mg"天, 左心室功能, 特别是血压和心率无明显变化。
5. 肾动脉和冠状动脉血流量的影响
它对肾动脉和冠状动脉血流量(犬)没有特别明显的影响。
适应症
如果在下列情况下没有其他抗心律失常药物或禁用:
心动过速心律失常
用法与用量
通常情况下, 作为西本菌素琥珀酸盐在成年期, 包括给药从 1天 300mg, 当效果不足增加到450毫克, 口服分为三次, 每天。
应该注意的是, 年龄, 根据症状增加或减少。
临床结果
对275例室性心律失常进行的临床试验概况如下。
1. 通过多设施双盲交叉组比较试验观察到这种药物的效用。
2. 疗效判决病例共234例, 效率为62.0%), 对室期外收缩有效。
3. 在室期外收缩患者的试验中, 确定该制剂的最低有效血浆浓度为277~329ngl。
此外, 对上室性心律失常461例进行的临床试验概述如下。
1. 通过多设施双盲跨群上心室收缩比较试验, 观察到这种药物的效用。
2. 280例(效率为68.6%)的疗效判断共408例, 上室性心律失常(上室期收缩、癫痫上室性心动过速、阵发性心房颤动)疗效408例有效。
包装
片剂
50mg  100片(PTP)，500片(PTP) 1000片(PTP, Rose)
100mg  100片 (PTP)，500片(PTP)，1000片(PTP, Rose)
制造供应商
安斯泰来制药公司
注：以上中文处方资料不够完整，使用者以原处方资料为准。
完整资料附件：http://www.info.pmda.go.jp/go/pack/6119001F1025_1_02/
Cibenol Tablets 100mg（Cibenzoline succinate シベノール錠）
Brand name:Cibenol Tablets 100mg
Active ingredient:Cibenzoline succinate
Dosage form:white tablet (φ: 7.1 mm, thickness: 3.6 mm)
Print on wrapping:(face) シベノール 100mg, (back) シベノール 100, 100mg, シベンゾリン(Cibenzoline)
Effects of this medicine
This medicine works to normalize the pulse by blocking the sodium channel (membrane-stabilizing action) of cardiacmuscle as well as prolonging the action potential duration.It is usually used for the treatment of arrhythmia.
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 heart disease, glaucoma or difficulty in urination.
・If you are on dialysis.
・If you are pregnant or breastfeeding.
・If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinaleffects. 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, start at a dose of 100 mg as the active ingredient at a time, 3 times a day. If it is ineffective,the dose may be increased up to 150 mg at a time, 3 times a day. The dosage may be adjusted according to thepatient's age and symptoms.Each tablet contains 100 mg of the active ingredient. Use this tablet when you takethe medicine 100 mg at a time according to your dosage described above. Strictly follow the instructions.
・If you miss a dose, take the dose as soon as you realize you have missed a dose. However, if it is almost time for thenext dose, skip the missed dose and continue your regular dosing schedule from the next dose onwards. Youshould 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
・Dizziness or swaying feeling may occur after taking this medicine. Avoid driving a car, operating machinery orworking at heights.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include rash, erythema, feeling of itching, dry mouth, stomachdiscomfort, and swaying feeling. 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 indicatedin brackets. If any of these symptoms occur, stop taking this medicine and see your doctorimmediately.
・dizziness, chest pain, palpitation [arrhythmogenic activity]
・facial pallor, cold sweat, dizziness on standing up [shock, anaphylaxis]
・shortness of breath, whole-body edema, cough [cardiac failure]
・sweat, chills, palpitation [hypoglycemia]
・general malaise, loss of appetite, yellowing of the skin and the whites of the eyes [liver disorder due to circulatory
failure, hepatic function disorder, jaundice]
・fever, dry cough, dyspnoea [interstitial pneumonia]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 infants and young children. Store away from direct sunlight, heat and humidity.
・Discard the remainder. Do not store them. Consult with your dispensing pharmacy when you discard the medicine.
Internal
Revised: 09/2012
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approvaldetails may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It isimportant to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response,patients should understand their medication and cooperate with the treatment.