英文药名:HERBESSER R Capsules(Diltiazem Hydrochloride)
中文药名:盐酸地尔硫R胶囊
生产厂家:田边三菱制药
ヘルベッサーRカプセル100mg/ヘルベッサーRカプセル200mg
治疗类别名称 持续钙拮抗剂 商標名 HERBESSER R Capsules 100mg HERBESSER R Capsules 200mg ○一般名 ジルチアゼム塩酸塩(Diltiazem Hydrochloride)(JAN) ○化学名 (2S , 3S )-5-[2-(Dimethylamino)ethyl]-2-(4-methoxyphenyl)-4-oxo-2,3,4,5-tetrahydro-1,5-benzothiazepin-3-yl acetate monohydrochloride ○構造式
○分子式 C22H26N2O4S・HCl ○分子量 450.98 ○性状 体状粉末或白色晶体,无异味。 ·易溶于甲酸,易溶于氯仿中的水,或甲醇,难溶于乙腈,微溶于乙醇或乙酸酐(99.5),和几乎不溶于乙醚。 ·[α] 20D旋光:+115〜+120°(干燥后,0.20克,水20mL,100毫米) 熔点:210〜215℃(分解) 适应病症 ○心绞痛,变异型心绞痛 ○原发性高血压(轻度至中度疾病) 用法与用量 ○心绞痛,变异型心绞痛 成人每天三次口服一次30毫克。如果的不足,可以增加到每天三次,一次60毫克。 ○原发性高血压(轻度至中度疾病) 成人每天三次口服一次30-60毫克。另外,也将增加或减少取决于病人的年龄和症状。 药效药理 通过抑制钙流入血管平滑肌细胞,如冠状动脉和外周血管,扩张血管,表示心肌缺血改善作用和降血压作用硫氮酮盐酸盐。 (1) 对心肌缺血的影响 1) 供氧的需平衡改善心脏肌肉的作用 1. 为延长厚的冠状血管及侧支循环,增加血液流向心脏肌肉缺血部分(狗)。 2. 压制冠状动脉痉挛(猴,人)。 3. 外周血管扩张后负荷减少,和心脏速率降低,抑制心肌耗氧量不减少心输出量(狗)。 2) 心肌保护作用 心肌缺血,通过抑制钙过度流入细胞,保持心脏功能和心肌能量代谢,减少梗死(大鼠)的蔓延。 (2) 对血压的影响 1) 几乎不影响正常血压,慢慢降低高血压(大鼠,人),血压升高抑制因运动负荷(人)。 2) 脑,而不会降低肾的血流量,降低血压(狗,人)。 3) 与血压,心肌肥大的减少,抑制血管肥大(鼠)。 (3) 对心脏的刺激产生和心脏传导系统的影响 虽然略微延伸的窦房结(AH)的时间导通的自愿周期和房室结,嘶嘶声-它不影响浦肯野系统传导(HV)时间(狗,人)。 包装规格 R胶囊 100毫克:100胶囊(10粒×10)500胶囊(10粒×50) 1000粒胶囊(10粒×100) 1,400胶囊(14粒×100)700胶囊(14粒×50)500粒(瓶装)
200毫克: 100胶囊(10粒×10)
*制造商 田边三菱制药株式会社
完整资料附件:http://www.info.pmda.go.jp/go/pack/2171006N1105_1_07/ HERBESSER R Capsules(Diltiazem hydrochloride) HERBESSER R Capsules 100 mg(ヘルベッサーRカプセル100mg) Brand name : HERBESSER R Capsules 100 mg Active ingredient: Diltiazem hydrochloride Dosage form: white capsule, major axis: 14.2 mm, minor axis: 5.4 mm Print on wrapping: ヘルベッサーR100mg, HerbesserR100, TA303 HERBESSER R Capsules 200 mg(ヘルベッサーRカプセル200mg) Brand name : HERBESSER R Capsules 200 mg Active ingredient: Diltiazem hydrochloride Dosage form: red/white capsule, major axis: 17.7 mm, minor axis: 6.4 mm Print on wrapping: ヘルベッサーR200mg, HerbesserR200, TA304 Effects of this medicine This medicine has calcium antagonistic action to inhibit calcium ion influx of extracellular fluid into cells, and thereby dilates coronary artery and peripheral blood vessels, reduces blood pressure and the frequency of angina attacks. It is usually used to treat hypertension and angina pectoris. 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 congestive cardiac failure, second-degree or higher atrioventricular (AV) block, or sick sinus syndrome (with persistent sinus bradycardia at less than 50 beats/minute, sinus arrest, sinoatrial block, etc.) •If you are pregnant, possibly 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>> •Essential hypertension (mild to moderate) : In general, for adults, take 100 to 200 mg of the active ingredient at a time, once a day. It should be adjusted according to your age and symptoms. Angina pectoris, variant angina : In general, for adults, take 100 mg at a time, once a day. If the effect is insufficient, the dose may be increased to 200 mg at a time, once a day. This preparation contains 200 mg of the active ingredient in a capsule. In any case, strictly follow the instructions. •Take the capsules without opening or chewing them. •If you miss a dose, take a dose as soon as possible. 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 •This medicine may cause dizziness due to decreased blood pressure. Avoid performing dangerous operations such as driving a car, operating machinery or working at heights. Possible adverse reactions to this medicine The most commonly reported adverse reactions include bradycardia, AV block (skipped pulse beats), facial flushing, constipation, nausea, stomach discomfort, headache, dull headache and hypersensitivity (rash, itch, hives, photosensitivity). 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. •slow pulse, general malaise/shortness of breath, dizziness/syncope [complete AV block, severe bradycardia] •respiratory distress, general edema, fatiguability [congestive cardiac failure] •high fever over 38 degrees Celsius, bloodshot eyes, erosion of lip, rash and blister on skin and mucous membranes, red skin in vast area, pus filled blister [oculomucocutaneous syndrome, toxic epidermal necrolysis, erythroderma (exfoliative dermatitis), acute generalised exanthematous pustulosis] •general malaise, loss of appetite, yellowing of the skin and the whites of eyes [hepatic function disorder, jaundice] 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 reach of children. Store away from direct sunlight, heat and moisture. •Discard the remainder. Do not store them. Mitsubishi Tanabe Pharma CorporationInternal Revised: 11/2013 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.
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