【中文通用名称】卡巴胆碱 【英文通用名称】Carbachol 【其 它 名 称】碳酰胆碱,卡米可林,卡巴可,氨甲酸胆碱,氨甲酰碱,Carbach,Carbacholine,Carbamycholine,Carbamylcholine,Doryl,迈斯特,Miostat,匹斯特,卡巴胆碱注射液,Chline Chloride Carbamate,Carbachol Intraocular Solution,卡巴胆碱眼内注射溶液,卡巴胆碱眼内注射液,Carbachol Injection 注意事项 1.本药眼用制剂适用于： (1)注射液(眼用)适用于白内障摘除术、人工晶体植入术、角膜移植术等需要缩瞳的手术。 (2)滴眼液可用于治疗开角型青光眼或单用毛果芸香碱过敏、无效或产生耐受的患者。 2.非眼用制剂可用于手术后腹部胀气、尿潴留及其它原因所致的胃肠或膀胱功能异常，也可用于缓解口干症状。 【注意事项】 1.禁忌症 (1)对本药过敏(国外资料)。 (2)缩瞳功能不良，如急性虹膜炎(国外资料)。 (3)甲状腺功能亢进。 (4)低血压。 (5)消化性溃疡。 (6)支气管哮喘。 (7)心律失常等心脏病。 (8)癫痫。 (9)震颤麻痹。 (10)闭角型青光眼。 (11)机械性肠梗阻。 (12)尿路梗阻、痉挛等。 2.慎用 (1)有视网膜剥离史者(国外资料)。 (2)角膜擦伤者(本药可能被大量吸收)(国外资料)。 (3)近期发生过心肌梗死者(国外资料)。 (4)原发性高血压患者(国外资料)。 (5)胃肠道痉挛(国外资料)。 3.药物对妊娠的影响 尚不清楚本药是否对胎儿有害，妊娠期间使用应权衡利弊。美国药品和食品管理局(FDA)对本药的妊娠安全性分级为C级。 4.药物对哺乳的影响 尚不清楚本药是否分泌入乳汁，哺乳期妇女慎用。 【不良反应】1.可引起较强的调节痉挛及由此引起的暂时性视力下降和头痛等不良反应，还可见结膜充血、泪腺分泌增多以及眼睑瘙痒、抽动，并可增加虹膜及睫状体的血流。以上反应可比使用毛果芸香碱时更严重。另外尚有引起白内障的报道。 2.较少引起全身不良反应，偶可出现皮肤潮红、出汗、上腹部不适、腹部绞痛、呃逆、膀胱紧缩感、头痛和流涎等。 [国外不良反应参考] 1.心血管系统 较少引起全身胆碱样不良反应，但应警惕可能出现的晕厥、心律失常或低血压等。 2.中枢神经系统 有头痛的报道，比使用毛果芸香碱更严重。 3.胃肠道 可见呕吐、腹泻。 4.眼 有引起角膜混浊、大疱性角膜炎和白内障摘除术后角膜水肿及虹膜炎的报道。 【给药说明】 1.本药注射液禁用于静脉或肌内注射。 2.用药过量可引起皮肤潮红、出汗、恶心、呕吐、流涎、腹部不适、哮喘发作、胸骨下压迫感或疼痛，严重者可发生心肌缺氧、短暂的晕厥和心跳暂停、传导阻滞、呼吸困难、低血压、不自主排便和尿急等。 3.用药过量的处理：皮下或静脉注射硫酸阿托品0.5-1mg。如发生严重的心血管反应或支气管收缩反应，也可用肾上腺素0.3-1mg皮下或肌内注射。 【用法与用量】成人 ·常规剂量 ·经眼给药 1.术前用药：前房内注射本药注射液，一次0.02mg。 2.青光眼：0.75%-1.5%的滴眼液滴眼，一日2-3次。 ·口服给药 一次2mg，一日3次。 ·皮下注射 一次0.25mg，必要时间隔30分钟重复1次，共2次。 [国外用法用量参考] 成人 ·常规剂量 ·经眼给药 1.青光眼：(1)原发性开角型青光眼和其它慢性青光眼：推荐的初始剂量为0.75%-3%的滴眼液，一次2滴，一日3次，同时调整使用的频率和浓度以维持眼压，防止视神经进一步损害和视野进一步缺损。(2)鼻泪管阻塞：用1.5%的溶液，每12小时1次。 2.眼科手术缩瞳：推荐在前房注入0.01%的本药注射液，最多不超过0.5ml。 【禁忌】 (1)对本药过敏(国外资料)。 (2)缩瞳功能不良，如急性虹膜炎(国外资料)。 (3)甲状腺功能亢进。 (4)低血压。(5)消化性溃疡。 (6)支气管哮喘。 (7)心律失常等心脏病。 (8)癫痫。(9)震颤麻痹。 (10)闭角型青光眼。 (11)机械性肠梗阻。 (12)尿路梗阻、痉挛等。 【原产地英文商品名】MIOSTAT-1.5mg/Vial 【原产地英文药品名】CARBACHOL 【中文参考商品译名】迈斯特-1.5毫升/瓶 【中文参考药品译名】卡巴胆碱 【生产厂家中文参考译名】爱尔康眼科产品有限公司 【生产厂家英文名】ALCON　LABORATORIES,INC --------------------------------------------------------------- Miostat Generic Name: carbachol Dosage Form: intraocular solution Miostat® (CARBACHOL INTRAOCULAR SOLUTION, USP) 0.01% DESCRIPTION Miostat® (carbachol intraocular solution, USP) is a sterile balanced salt solution of carbachol for intraocular injection. The active ingredient is represented by the chemical structure: Established name: Carbachol Chemical name: Ethanaminium, 2-[(aminocarbonyl)oxy]-N,N,Ntrimethyl-, chloride. Molecular Formula: C6H15CIN2O2 Molecular Weight: 182.65 Each mL contains: Active: carbachol 0.01%. Inactives: sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride dehydrate 0.048%, magnesium chloride hexahydrate 0.03%, sodium acetate trihydrate 0.39%, sodium citrate dihydrate 0.17%, sodium hydroxide and/or hydrochloric acid (to adjust pH) and Water for Injection. pH range is 6.5-7.5. CLINICAL PHARMACOLOGY Carbachol is a potent cholinergic (parasympathomimetic) agent which produces constriction of the iris and ciliary body resulting in reduction in intraocular pressure. The exact mechanism by which carbachol lowers intraocular pressure is not precisely known. INDICATIONS AND USAGE Intraocular use for obtaining miosis during surgery. In addition, Miostat (carbachol intraocular solution, USP) reduces the intensity of intraocular pressure elevation in the first 24 hours after cataract surgery. CONTRAINDICATIONS Should not be used in those persons showing hypersensitivity to any of the components of this preparation. WARNINGS For single-dose intraocular use only. Discard unused portion. Intraocular carbachol 0.01% should be used with caution in patients with acute cardiac failure, bronchial asthma, peptic ulcer, hyperthyroidism, G.I. spasm, urinary tract obstruction and Parkinson's disease. PRECAUTIONS Use only if the container is undamaged. Carcinogenesis Studies in animals to evaluate the carcinogenic potential have not been conducted. Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Miostat® (carbachol intraocular solution, USP) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers It is not known if this medication is excreted in breast milk. Exercise caution when administering to a nursing woman. Pediatric Use Safety and efficacy in pediatric patients have not been established. Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients. ADVERSE REACTIONS Ocular: Corneal clouding, persistent bullous keratopathy, retinal detachment and postoperative iritis following cataract extraction have been reported. Systemic: Side effects such as flushing, sweating, epigastric distress, abdominal cramps, tightness in urinary bladder, and headache have been reported with topical or systemic application of carbachol. DOSAGE AND ADMINISTRATION Aseptically remove the sterile vial from the blister package by peeling the backing paper and dropping the vial onto a sterile tray. Withdraw the contents into a dry sterile syringe, and replace the needle with an atraumatic cannula prior to intraocular instillation. No more than one-half milliliter should be gently instilled into the anterior chamber for the production of satisfactory miosis. It may be instilled before or after securing sutures. Miosis is usually maximal within two to five minutes after application. HOW SUPPLIED In a 2.0 mL glass vial with a 1.5 mL fill, grey butyl stopper and aluminum seal packaged twelve to a carton. NDC 0065-0023-15 STORAGE: Store at 15° - 30°C (59° - 86°F).