英文药名：SALAGEN Tab(Pilocarpine hydrochloride)
中文药名：盐酸毛果芸香碱片
生产厂家：KISSEI药品
サラジェン錠5mg
治疗类别名称
口干症状改善药物
商標名
SALAGEN Tab.
一般名：ピロカルピン塩酸塩（Pilocarpine Hydrochloride）
分子式：C11H16N2O2・HCl
分子量：244.72
構造式：
化学名：
(3S,4R)-3-Ethyl-4-(1-methyl-1H-imidazol-5-ylmethyl)-4,5-dihydrofuran-2(3H)-one monohydrochloride
性状：
本产品为无色结晶或白色粉末，没有气味，味道微苦。
它是在乙酸（100），水，易溶于甲醇或乙醇（95），在乙酸酐中微溶，并在乙醚中几乎不溶于非常可溶的。
解决这个品1.0g溶解在水10ml的pH为3.5至4.5。
本产品是吸湿。
它是由光的影响。
适应病症
1. 与头部和颈部的放射治疗相关的口干症状的改善
2. 干燥综合征患者的口干症状的改善
用法用量
成人；每天三次，每次口吸取5毫克，盐酸饭后口服给药。
药效药理
本剂药品，正常动物（小鼠，大鼠，狗），唾液分泌衰竭模型大鼠和由X射线照射干燥综合征小鼠模型，表现出通过十二指肠给药剂量依赖性唾液分泌促进作用。唾液分泌促进按照本剂作用显着选择性毒蕈碱M3受体拮抗剂抑制。这种药物显示了几乎为人类和大鼠毒蕈碱性受体亚型（M1，M2和M3）相同的亲和力，通过该药物的刺激大鼠腮腺细胞的细胞内钙浓度增加。
包装规格
片剂
5mg：100片（PTP），210片（PTP），500片（PTP）
制造厂商
KISSEI药品有限公司
SALAGEN Tab（Pilocarpine hydrochloride）
SALAGEN Tab. 5mg（サラジェン錠5mg）
Brand name : SALAGEN Tab. 5mg
Active ingredient: Pilocarpine hydrochloride
Dosage form: white tablet, diameter: 6.4 mm, thickness: 3.3 mm
Print on wrapping: サラジェン5mg, 口腔乾燥症状改善薬, S5, SALAGEN5mg
Effects of this medicine
This medicine directly acts on muscarinic M3 receptors in salivary gland to prompt saliva secretion. It consequently improves symptoms of dry mouth and also improves symptoms such as difficulty in talking or swallowing.
It is usually used to improve dry mouth symptoms associated with radiation therapy to the head and neck and in patients with Sjogren's syndrome.
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: heart disease, bronchial asthma, chronic obstructive pulmonary disease, gastrointestinal obstruction or obstruction of the urinary bladder, epilepsy, parkinsonism or Parkinson's disease, iritis, edema or pain in salivary gland, interstitial pneumonia, pancreatitis, hypersensitive enteropathy, peptic ulcer, gallbladder disorder or gallstone, stone formation (in urinary tract, kidney), prostatic hyperplasia or hyperthyroidism.
•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, take 1 tablet (5 mg of the active ingredient) at a time, three times daily, after meal (avoid taking on an empty stomach, take within 30 minutes after meal). Strictly follow the instructions.
•If you miss a dose and realize that over 30 minutes after meal, skip the missed dose and follow 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 visual impairment due to constricted pupil. Pay close attention in driving a car during the night and operating dangerous machinery in a dark place.
•This medicine may cause excess sweating. Be sure to intake enough water to avoid dehydration.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include excess sweating, rhinitis, diarrhea, urinary frequency, headache, flush, nausea, chill, dizziness, abdominal pain, cough and malaise. 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.
•fever, cough, phlegm, breathing difficulty [interstitial pneumonia]
•fainting, loss of consciousness [syncope, loss of consciousness]
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 the reach of children. Store away from heat and moisture.
•Discard the remainder. Do not store them. Ask the pharmacist or medical facility how to discard.
Kissei Pharmaceutical Co., Ltd.Internal
Revised: 2/2013
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.
http://www.info.pmda.go.jp/go/pack/2399013F1021_1_09/