| 简介：
部份中文缬沙坦苯磺酸氨氯地平处方资料（仅供参考）
英文名：Valsartan/Amlodipine Besilate
商品名：Amvalo Combination Tablets
中文名：缬沙坦/苯磺酸氨氯地平复合片
生产商：共创未来制药
アムバロ配合錠「FFP」
药效分类名称
选择性AT1受体阻滞剂/长效Ca拮抗剂组合
批准日期：2015年12月
商標名
Amvalo Combination Tablets「FFP」
一般名
バルサルタン(Valsartan)
化学名
(2S )-3-Methyl-2-(N -｛［2'-(1H -tetrazol-5-yl)biphenyl-4-yl］methyl｝pentanamido)butanoic acid
分子式
C24H29N5O3
分子量
435.52
構造式
性状
它是一种白色粉末。它极易溶于甲醇和乙醇(99.5)，几乎不溶于水。
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
分子式
C20H25ClN2O5・C6H6O3S
分子量
567.05
構造式
性状
它是一种白色至黄白色结晶粉末。易溶于甲醇，微溶于乙醇（99.5），微溶于水。甲醇溶液(1 →100)不显示旋光。
熔点
约198℃（分解）
处理注意事项
稳定性测试
作为使用最终包装产品的加速测试（40°C，75% 相对湿度，6个月）的结果，估计Ambaro组合片剂“FFP”在正常市场分销下可稳定3年。
药效药理
缬沙坦：
它是血管紧张素II受体亚型AT1受体的拮抗剂。它通过在受体水平竞争性拮抗内源性升压物质血管紧张素II来发挥抗高血压作用。
苯磺酸氨氯地平：
它充当二氢吡啶类钙通道阻滞剂，但其特点是起效缓慢且持续。二氢吡啶类钙通道阻滞剂与膜电位依赖性L型钙通道特异性结合，减少钙流入细胞，从而放松冠状动脉和外周血管的平滑肌。
适应症
高血压
用法与用量
成人，每天一次口服1片（80毫克缬沙坦和5毫克氨氯地平）。本药不作为治疗高血压的一线药物。
包装
复方片剂“FFP”
（PTP包装）100片（10片×10）140片（14片×10）
制造商和分销商
共创未来制药有限公司
注：以上中文处方资料不够完整，使用者以原处方资料为准！
完整说明资料附件：
https://www.info.pmda.go.jp/go/pack/2149114F1145_1_07/
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AMVALO Combination Tablets "FFP"（Valsartan/Amlodipine besilate）
Brand name :AMVALO Combination Tablets "FFP"
Active ingredient:Valsartan/Amlodipine besilate
Dosage form:yellowish white tablet, diameter: approx. 8.6 mm, thickness: approx. 4.35 mm Print on wrapping:(Face)アムバロ配合錠「FFP」, アムバロ, 血圧降下剤
(Back)Amvalo Combination Tablets「FFP」, 血圧降下剤, アムバロ配合錠「FFP」, 配合錠
Effects of this medicine
This medicine inhibits vasoconstriction action by antagonizing the receptor for angiotensin II, a pressor substance. It also expands blood vessels by blocking the calcium channel and decreases in blood pressure.
It is usually used to treat hypertension.
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: diabetes mellitus, renal disorder or liver disorder.
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))
In general, for adults, take 1tablet at a time, once a day. Strictly follow the instructions.
If you miss a dose, take the missed 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
This medicine may cause dizziness or light headedness. Be aware of working at heights or operating dangerous machinery such as driving a car.
Do not take grapefruit juice with this medicine, since it may intensify the therapeutic effects of this medicine.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include dizziness and rash. 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.
swelling of face/lip/pharynx/tongue, hives[angioedema]
general malaise, loss of appetite, yellowness in skin or conjunctiva [fulminant hepatitis, hepatitis, liver dysfunction, jaundice]
decrease urine output, edema, headache[renal failure]
numbness of limbs/lips, muscle weakness, paralysed arms/legs[hyperkalemia]
cold sweat, nausea, loss of consciousness[shock, syncope, unconsciousness]
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. Ask your pharmacy or medical institution on how to discard the remainder.
Internal
Published: 2/2019
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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