| 简介：
部份中文盐酸加兰他敏氢溴处方资料（仅供参考）
英文名:Galantamine Hydrobromide
商品名:Reminyl
中文名:盐酸加兰他敏氢溴口腔崩解片
生产商:杨森制药
药品简介
Reminyl(galantamine，レミニール)是一种由Janssen制药公司发现并开发的治疗轻度至中度阿滋海默氏病的药物，它可以用来减缓老年痴呆症进展。该药物的主要药理作用是间接地使乙醯胆硷不被分解而维持脑部一定的浓度，达到使智能改善或减缓记忆恶化的速度。
レミニール錠4mg,8mg,12mg/OD錠4mg,8mg,12mg 内用液4mg/mL
药效分类名称
阿尔茨海默氏型痴呆治疗剂
批准日期：2011年3月
商標名
REMINYL Tablets
REMINYL OD Tablets
REMINYL Oral Solution
一般名
ガランタミン臭化水素酸塩（JAN）、Galantamine Hydrobromide（JAN）
化学名
（4aS,6R,8aS）-4a,5,9,10,11,12-Hexahydro-3-methoxy-11-methyl-6H-benzofuro［3a,3,2-ef］［2］benzazepin-6-ol monohydrobromide
分子式
C17H21NO3・HBr
分子量
368.27
化学構造式
性状
色粉末
溶解度（20°C）
水：33毫克/毫升
甲醇：5.3mg/mL
乙醇：0.52mg/mL
熔点
257℃（分解）
分配系数
logP = -0.44（1-辛醇/pH 7.0磷酸盐缓冲液）
处理注意事项
放在儿童接触不到的地方。
OD片剂：远离高温高湿存放。
内部液体：存放时不要冻结。
药效药理
药理作用
1. 药理作用
(1) 乙酰胆碱酯酶（AChE）抑制作用
乙酰胆碱酯酶选择性和可逆地竞争性地抑制由口服给药增加了大鼠脑乙酰胆碱的浓度。
(2) 对烟碱乙酰胆碱受体的变构促进作用（胆碱受体）
比乙酰胆碱受体的乙酰胆碱结合位点，我们被允许提高对乙酰胆碱的胆碱受体（变构促进作用：APL动作）的动作。
(3) 神经细胞保护作用
针对由β淀粉样蛋白的神经细胞损伤展出细胞保护作用。
(4) 记忆障碍改善作用
在沙鼠脑缺血模型，通过口服给药观察到的记忆障碍的改善。
2. 作用机序
在阿尔茨海默型痴呆，脑胆碱能功能的降低被认为导致所观察到的记忆障碍。加兰他敏，乙酰胆碱酯酶竞争性抑制东西增加脑胆碱浓度，并达到提高通过对胆碱受体的APL作用脑胆碱能功能。另外，为了抑制由神经细胞保护作用的神经细胞的功能降低。
适应症
本品用于治疗轻度到中度阿尔茨海默型痴呆症状。
用法与用量
成人剂量通常为每天8mg（每天4mg，每天两次），并在4周后将剂量增加到每天16mg（每天8mg，每天两次）并口服。 取决于症状，剂量可以增加至每天24mg（每天两次，两次12mg），但是如果要增加剂量，则应在更改前4周或更长时间增加剂量。
关用法和剂量的注意事项
通常，请勿每天服用8毫克超过4周的剂量，因为这不是有效剂量，并且意在抑制胃肠道副作用的发生。
对于中度肝损伤患者（注），从每天4mg开始至少1周，然后每天给药8mg（每天4mg两次）至少4周并增加剂量。但是，每天不要超过16毫克.
注）使用Child-Pugh分类作为肝功能指标的中度（B）肝损伤患者
期望饭后服用以减少副作用。
在医务人员，家庭成员等的监督下进行管理
口腔崩解片
由于该药物在口腔中迅速崩解，因此可以单独使用唾液服用（不用水）。 另外，由于预计该药物不会通过口腔粘膜吸收而发挥作用，因此崩解后请用唾液或水吞咽。
包装
片
4mg：56片（14片x 4），140片（14片x 10），100片（松散）
8mg：56片（14片x 4），140片（14片x 10），100片（松散）
12mg：56片（14片x 4），140片（14片x 10），100片（松散）
口腔速崩解
4mg：56片（14片x 4），140片（14片x 10）
8mg：56片（14片x 4），140片（14片x 10）
12mg：56片（14片x 4），140片（14片x 10）
溶液
4mg/mL：
包装产品
1mLx56包，2mLx56包，3mLx56包
制造商和分销商
杨森制药有限公司
销售
武田制药工业有限公司
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：
http://www.info.pmda.go.jp/go/pack/1190019F1028_1_10/
REMINYL OD Tablets（Galantamine hydrobromide）
REMINYL OD Tablets 8mg（レミニールOD錠8mg）
Brand name : REMINYL OD Tablets 8mg
Active ingredient: Galantamine hydrobromide
Dosage form: slightly red tablets, diameter: 7mm, thickness: 2.9mm
Print on wrapping: (Face) レミニールOD8mg, JP111, (Back) ReminylOD 8mg, レミニールOD8mg
Effects of this medicine
This medicine delays the progression of symptoms of dementia such as memory impairment (forgetfulness), disorientation (problems in cognition of time and place) and difficulty in making judgments, by preventing decrease of acetylcholine, a neurotransmitter in brain, via inhibition of the action of an enzyme catalyzing acetylcholine degradation and by facilitating nerve signaling.
It is usually used for inhibiting progression of symptoms of dementia of the Alzheimer type.
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 sick sinus syndrome, heart diseases such as sinoatrial block and atrioventricular block, a history of gastric ulcer or duodenal ulcer, gastrointestinal obstruction, lower urinary tract obstruction, Parkinsons disease or Parkinson syndrome.
If you are in a condition just after an operation on the digestive tract or on the urinary bladder.
If you have convulsive disorders such as epilepsy or a history of such disorders, a history of bronchial asthma or obstructive lung disease, liver disorder or renal disorder.
•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, start taking this medicine at dosage of 4 mg of galantamine at a time, twice a day, and 4 weeks later, the dosage will be increased up to 8 mg at a time, twice a day. The dosage may be increased up to 12 mg at a time, twice a day, according to symptoms, however, in the case of dosage increase, the increase will be made only after this medicine has been administered for 4 weeks or longer at the preceding dose level. This preparation contains 12 mg of galantamine in a tablet. Strictly follow the instructions.
•This medicine should be taken after a meal wherever possible in order to lessen adverse reactions.
•If you miss giving a dose, give the missed dose as soon as possible. However, if several hours has already passed since the scheduled time, skip the missed dose and follow your regular dosing schedule. You should never give two doses at one time.
•If you accidentally give more than your prescribed dose, consult with your doctor or pharmacist.
•Do not stop giving this medicine unless your doctor instructs you to do so.
Precautions while taking this medicine
•In patients with dementia of the Alzheimer type, the ability to drive a car and to operate machinery diminishes gradually and the use of this medicine may cause dizziness and sleepiness. Therefore, pay attention when operating dangerous machinery such as driving a car.
•As weight loss may occur, be attentive to your body weight changes.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include nausea, vomiting, loss of appetite, diarrhea, decreased appetite and headache. 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.
•fainting, shortness of breath, dizziness [syncope, bradycardia, heart block, QT prolonged]
•fever, red skin rash, small rash resulting from blister containing pus [acute generalized exanthematous pustulosis]
•loss of appetite, malaise, nausea [hepatitis]
•pain of the limb muscle, stiffness, numbness [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 reach of children. Store away from direct sunlight, heat and moisture.
•Discard the remainder. Do not store them. Seek advice of your pharmacy or medical institutions about proper disposal of the unused medicines.
Takeda Chemical Industries, Ltd.Internal
JANSSEN PHARMACEUTICAL K.K
Revised: 10/2015
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. |
