【活性成分】替米沙坦,氨氯地平
【药理分类】抗高血压药物(血管紧张素Ⅱ受体阻滞剂+钙通道阻滞剂) 【适应症】高血压,作为单一疗法或与其他抗高血压药物共用。作为初期治疗的患者可能需要多种药物,以达到降压目地。 【药理作用】替米沙坦可以阻止血管收缩和醛固酮分泌血管紧张素II,血管紧张素II是肾素血管紧张素系统的主要升压剂。氨氯地平抑制成血管平滑肌钙离子内流,其次,也能抑制心肌钙离子内流。通过抑制,氨氯地平引起外周阻力减少,血压下降。
【用法用量】成人:每天一次。初始治疗:40/5mg或80/5mg;在2周后滴定最大可用80/10mg。附加疗法:可用于单药治疗,如果服用氨氯地平10毫克出现明显不良反应,改用40/5mg。替代疗法:可替换为滴定组件。肾和/或肝功能损害患者,滴定速度应较慢。75岁以上,肝功能不全的患者不适宜作为初次使用。儿童:不建议使用。
【注意事项】治疗开始之前或密切监测血压变化。充血性心力衰竭,胆道梗阻,严重肝或肾功能不全,肾动脉狭窄,严重阻塞性冠状动脉疾病,妊娠期的患者慎用,同时需要在医师指导下才可使用。哺乳期女性,不建议使用。
【药物间相互作用】不宜与雷米普利同时使用。高钾血症时与K+同用加强药效,与钾利尿剂加强药效。与地高辛,锂同时服用加强药效。
【不良反应】可能出现周围水肿,头晕,体位性低血压,背部疼痛等不良反应。
【原产地英文商品名】MICAMLO COMBINATION TABLETS AP(ミカムロ配合錠AP)(40mg+6.93mg)/tab 100tabs/box 【原产地英文药品名】TELMISARTAN/AMLODIPINE BESILATE 【中文参考商品译名】MICAMLO COMBINATION AP片剂(ミカムロ配合錠AP) (40毫克+6.93毫克)/片 100片/盒 【中文参考药品译名】替米沙坦/苯磺酸氨氯地平 【生产厂家中文参考译名】日本勃林格殷格翰 【生产厂家英文名】Boehringer Ingelheim GmbH
Manufacturer's name : Nippon Boehringer Ingelheim Co., Ltd. Information is based on approvals granted in Japan. In some cases, the approved details may vary in countries other than Japan. In deciding to use a medicine, the risk (side effects) of taking the medicine must be weighed against the benefit (effects) it will do. The patient's cooperation is indispensable here.
Brand name : Micamlo Combination Tablets AP
Active ingredient: Telmisartan、Amlodipine besilate
Dosage form: pale red film-coated tablets (diameter: 8.5mm, thickness: 4.0mm)
Printings on wrapping: (Face) Micamlo配合錠AP、AI, (Back) ミカムロ配合錠AP、Boehringer Ingelheim Effects of this medicine Micamlo is a combination drug of an angiotensin receptor blocker (ARB) and calcium blocker: the ARB inhibits vasoconstriction caused by angiotensin II in vascular smooth muscle to lower blood pressure and the calcium blocker enhances the ARB's effect.
Usually, this medicine is used in the treatment of hypertension.
Before using this medicine, tell your doctor/pharmacist •If you have ever had any unusual or allergic reaction (itch, rash etc.) to any medicines. If you have a hepatic disorder, poor bile secretion. •If you are pregnant or breastfeeding. •If you are using any other prescription or nonprescription (OTC) medicine. (It is important to reduce the risk of drug interactions.) Dosage regimen (proper use of this medicine) •General dosage regimen: Usually for adults, one tablet is orally administered once daily. Follow your doctor's instructions. •Missed dose: For patients taking the medicine before meals, take as soon as possible. If it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. For patients taking the medicine after meals, take as soon as possible after taking a snack. DO NOT take double doses to make up for the missed dose. •Overdose: If you took too much of the medicine, check with your doctor/pharmacist. •Others: Do not stop taking the medicine without the instructions of your doctor. Precautions while using this medicine •Use caution when driving, operating machinery, working at high places or engaging in other hazardous activities. This medicine may cause dizziness or light-headedness due to decrease in blood pressure. •Do not take grapefruit juice and the medicine together as it may intensify the effect of the medicine. Side effects of this medicine Common side effects are reported as below. If any of them occur, check with your doctor/pharmacist: dizziness, eczema, rash, etc.
In rare cases, symptoms described below may be the sign of side effects indicated in brackets [ ]. If they occur, stop taking your medicine and check with your doctor immediately. •swelling of the eyelids, lips, tongue, or throat; breathing difficulty, decrease in blood pressure [angioedema, anaphylactoid symptoms] •numbness of the hands and lips, muscle weakness, paralysis of limbs[hyperkalemia] •cold sensation, vomiting, faint[shock, syncope, loss of consciousness] •lassitude, hunger, cold sweat [hypoglycemia] •a decrease in urine volume, edema, general fatigue[renal dysfunction] •dry cough, fever, difficulty breathing (shortness of breath on exertion)[interstitial pneumonia] •lassitude, muscle pain, brown urin[rhabdomyolysis] •bradycardia, dizziness[atrioventricular block]
Other side effects not listed here may occur. Check with your doctor/pharmacist if you have any worrisome symptom.
Storage and other information •Keep out of the reach of children. Store away from heat, moisture and direct sunlight. •Discard unused medicine. Ask the pharmacy how to discard.
ミカムロ配合錠AP
商標名
Micamlo Combination Tablets AP
有効成分に関する理化学的知見
一般名
テルミサルタン(JAN) Telmisartan(JAN,INN)
化学名
4’-{[4-methyl-6-(1-methyl-2-benzimidazolyl)-2-propyl-1-benzimidazolyl]methyl}-2-biphenylcarboxylic acid
化学構造式
分子式
C33H30N4O2
分子量
514.62
性状
・白色~微黄色の粉末である。 ・ギ酸に溶けやすく、メタノール又は無水酢酸に溶けにくく、エタノール(95)に極めて溶けにくく、水にほとんど溶けない。
融点
269℃
分配係数
logP=3.2(n-オクタノール/pH 7.4リン酸緩衝液)
一般名
アムロジピンベシル酸塩(Amlodipine Besilate)
化学名
3-Ethyl 5-methyl(4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate monobenzenesulfonate
化学構造式
分子式
C20H25ClN2O5・C6H6O3S
分子量
567.05
性状
・白色~帯黄白色の結晶性の粉末である。 ・メタノールに溶けやすく、エタノール(99.5)にやや溶けにくく、水に溶けにくい。 ・メタノール溶液(1→100)は旋光性を示さない。
融点
約198℃(分解)
取扱い上の注意
分包後は吸湿して軟化することがあるので、高温・多湿を避けて保存すること。
包装
ミカムロ配合錠AP:100錠(10錠×10)PTP、700錠(14錠×50)PTP
製造販売
日本ベーリンガーインゲルハイム株式会社
处方原文附件:http://www.info.pmda.go.jp/go/pack/2149117F1025_1_03/ |