

SALAGEN 盐酸毛果芸香碱片

通用中文 | 盐酸毛果芸香碱片 | 通用外文 | Pilocarpine hydrochloride |
品牌中文 | 品牌外文 | SALAGEN | |
其他名称 | |||
公司 | 诺华(Novartis) | 产地 | 加拿大(Canada) |
含量 | 5mg | 包装 | 84片/盒 |
剂型给药 | 片剂 口服 | 储存 | 室温 |
适用范围 | 与头部和颈部的放射治疗相关的口干症状 干燥综合征患者的口干 |
通用中文 | 盐酸毛果芸香碱片 |
通用外文 | Pilocarpine hydrochloride |
品牌中文 | |
品牌外文 | SALAGEN |
其他名称 | |
公司 | 诺华(Novartis) |
产地 | 加拿大(Canada) |
含量 | 5mg |
包装 | 84片/盒 |
剂型给药 | 片剂 口服 |
储存 | 室温 |
适用范围 | 与头部和颈部的放射治疗相关的口干症状 干燥综合征患者的口干 |
SALAGEN 5MG
Pilocarpine
結構式 |
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藥理作用 |
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本品為膽鹼性擬副交感神經製劑,能表現出廣泛的藥理作用,特別是muscarinic作用。適當劑量的pilocarpine能增加外分泌腺的分泌。汗腺、唾腺、淚腺、胃腺、腸腺及呼吸道的黏膜細胞都能被刺激。當局部使用單劑量於眼部時會造成瞳孔縮小、痙攣及產生暫時性眼內壓上升接著有較持續性的降低。對腸道平滑肌的刺激是與劑量多寡有關,可能造成緊張度及活動力的增加、痙攣和裡急後重。 支氣管平滑肌的緊張度會增加。尿道、膽囊、膽管平滑肌的緊張度及活動力亦會增加。Pilocarpine對心血管系統的影響尚不明確。Muscarinic agonist的作用應是血管擴張,但服用pilocarpine會在產生高血壓前先發生短暫的低血壓。使用pilocarpine可能會心跳緩慢或心跳加快,都曾有過報告。 |
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適應症 |
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1. 因頭頸部癌放射線治療造成唾腺功能減低而引起的口乾燥症。 2. SJOGREN'S SYNDROME 所引起的口乾燥症。 |
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用法用量 |
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1. 頭頸癌病患:Salagen tablets的建議起始劑量為5mg,一天三次。劑量可依治療反應及忍受度做調整。一般劑量為每日3~6錠或15~30mg (每次劑量不可超過2錠)。雖然服用初期即有進步,但在治療上服滿12周更有益 常見的副作用發生率會隨著劑量增高而增大。應以能忍受及有效的最低劑量做為維持劑量。 2. Sjogren's Syndrome病患:Salagen tablets的建議劑量為一次一錠5mg,一天四次。 至多6周後即可建立明確之效果。 |
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藥動力學 |
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在一多劑量給藥的藥動試驗中,男性自願者分別在早(8a.m.)、中、晚(6p.m.)服用5mg或10mg的pilocarpine hydrochloride 2天,其平均半衰期在5mg劑量時為0.76小時,10mg為1.35小時, Tmax分別為1.25小時和0.85小時, Cmax分別為15 ng/ml和41 ng/ml。 服用6小時後AUC值分別為33 ng x h/ml(5mg)和108 ng x h/ml(10mg)。 |
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副作用 |
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睫狀肌痙攣,頭痛,難以集中視力,暗處視力降低,局部刺激作用,唾液分泌,增加水汗。 |
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交互作用 |
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本品與β-腎上腺素拮抗劑併用會減低pilocarpine的效果。與其他副交感神經製劑併用會加成pilocarpine的效果。pilocarpine會與抗膽鹼製劑有拮抗作用,可能會影響這些藥物(atropine, inhaled ipratropium)的治療效果,併用時應注意。 |
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禁忌 |
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對有未控制之氣喘、pilocarpine過敏、病變性的縮瞳(如急性虹膜炎和閉角性青光眼)等患者,本品為禁忌。 |
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給付規定 |
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1.5.Parasympathomimetic (Cholinergic) Agents(93/8/1、94/2/1、96/7/1、97/5/1、102/2/1) |
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注意事項 |
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1. 支氣管氣喘病的患者使用宜小心,特別是做全身性使用時,因為本品會造成支氣管收縮作用。 2. 勸告病人若有發汗、流涎、強直和噁心的症狀立刻要報告,因為這是全身性中毒發作的徵兆。 3. 本品要避光,因為它很不穩定。 4. 勿將滴管與眼瞼接觸,以免發生污染的情形。 |
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過量處理 |
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曾有2名病患因服用pilocarpine超過100mg而產生毒性,造成pilocarpine服用過量致死。100mg的pilocarpine被視為可能之致死劑量。若過量服用時,應以atropine滴定法(0.5mg至1mg皮下或皮內靜脈注射)來處理,並支持療法維持呼吸和循環的穩定。epinephine(0.3mg至1mg皮下或皮內肌肉注射)可使用於嚴重的心血管衰竭或支氣管收縮。pilocarpine是否可以透析處理尚未知。 |
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藥品保存方式 |
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藥品應置於攝氏 15 ~ 25 度乾燥處所;如發生變質或過期,不可再食用。 |
产品 资料 SALAGEN Tab(Pilocarpine hydrochloride)
简介: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(Pi ...
关键字:盐酸毛果芸香碱片 Pilocarpine hydrochloride 药品商标名SALAGEN 口干症状改善药物
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
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.