英文药名：REMINYL Oral Solution（Galantamine Hydrobromide） 中文药名：氢溴酸加兰他敏口服溶液 生产厂家：杨森制药/武田薬品 レミニール内用液4mg/mL 治疗类别名称 阿尔茨海默氏病的治疗 商標名 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 白色粉末 溶解度（20℃） 水：33毫克/毫升 甲醇：5.3mg/ mL的 乙醇：0.52mg/ mL的 熔点 257℃（分解） 分配系数 的logP=-0.44（1-辛醇/ pH值7.0的磷酸盐缓冲液） 操作注意事项 放在儿童不能接触的地方。 OD片：从储存的热量和湿气。 口服液：从冻结保持距离 适应症： 本品用于治疗轻度到中度阿尔茨海默型痴呆症状。 用法用量： 口服，建议与早餐及晚餐同服。 起始剂量： 推荐剂量为一次4mg，一日2次，服用4周。治疗过程中保证足够液体摄入。 维持剂量： 初始维持剂量为一次8mg，一日2次，此剂量下，患者至少维持4周。 医师在对患者临床疗效及耐受性进行综合评价后，可以将剂量提高到临床最高推荐剂量，一次12mg，一日2次。 服用本品请参照以上推荐方案或遵医嘱。特殊人群用药注意事项参见说明书相关部分。本品无撤药反应。 药效药理 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。 包装规格 口服液 4mg/mL：1毫升×56包，2毫升×56包，3毫升×56包 [袋装品] 制造厂商 杨森制药有限公司 武田化学工业有限公司 REMINYL Oral Solution（Galantamine hydrobromide） REMINYL Oral Solution 4mg/mL(1mL of divided pack)（レミニール内用液4mg/mL（1mL分包品）） Brand name : REMINYL Oral Solution 4mg/mL(1mL of divided pack) 　Active ingredient: Galantamine hydrobromide 　Dosage form: clear, colorless solution 　Print on wrapping: (Face) レミニール内用液4mg/mL, 4mg/1mL, 1mL, (Back) Reminyl 1mL, JP115 REMINYL Oral Solution 4mg/mL(2mL of divided pack)（レミニール内用液4mg/mL（2mL分包品）） Brand name : REMINYL Oral Solution 4mg/mL(2mL of divided pack) 　Active ingredient: Galantamine hydrobromide 　Dosage form: clear, colorless solution 　Print on wrapping: (Face) レミニール内用液4mg/mL, 8mg/2mL, 2mL, (Back) Reminyl 2mL, JP116 REMINYL Oral Solution 4mg/mL(3mL of divided pack)（レミニール内用液4mg/mL（3mL分包品）） Brand name : REMINYL Oral Solution 4mg/mL(3mL of divided pack) 　Active ingredient: Galantamine hydrobromide 　Dosage form: clear, colorless solution 　Print on wrapping: (Face) レミニール内用液4mg/mL, 12mg/3mL, 3mL, (Back) Reminyl 3mL, JP117 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. http://www.info.pmda.go.jp/go/pack/1190019F1028_1_10/