英文药名: Mydriacyl(tropicamide Opthalmic drops) 中文药名: 托品酰胺滴眼剂 品牌药生产厂家: Alcon Labratories Inc. 药品名称 通用名: 托吡卡胺滴眼液 英文名: TROPICAMIDE EYE DROPS 药品类别: 眼科用药 性状: 本品为无色澄明液体。 生产厂家 Alcon Labratories Inc. 爱尔康 药理毒理 本品为抗胆碱药，能阻滞乙酰胆碱引起的虹膜括约肌及睫状肌兴奋作用。其0.5%溶液可引起瞳孔散大;1%溶液可引起睫状肌麻痹及瞳孔散大。 药代动力学 本品系托品酸的合成衍生物。具有较低的解离常数，眼内通透性良好，组织扩散力强，可能是其起始迅速，维持时间短的原因。本品0.5%、１％溶液滴眼后２０－３０分钟内散瞳及调节麻痹作用达高峰。随后作用逐渐降低，调节麻痹（残余的）２～６小时。散瞳（残余的）约7小时。本品的睫状肌调节麻痹作用强度与剂量密切相关，其0.25、0.5、0.75和1%四种浓度均有调节麻痹作用。滴眼后，最大残余调节度数分别为0.25% 3.17屈光度、1% 1.30屈光度。残余调节度数能保持在2.0屈光度或以下者，0.75%和1%溶液可维持40分钟，0.5%约为15分钟。1%溶液一滴滴眼后隔5~25分钟再滴第二次，能获得更满意的睫状肌麻痹作用约20~30分钟。经2~6小时能阅读书报，调节功能于6小时内恢复至滴药前水平。 适应症 用于滴眼散瞳和调节麻痹。 用法用量 滴眼剂0.5%~1%溶液滴眼，一次一滴，间隔5分钟滴第二次。 任何疑问，请遵医嘱！ 不良反应 本品0.5%溶液滴眼1~2次，每次一滴的不良反应罕见，1%溶液可能产生暂时的刺激症状。因本品为类似阿托品的药物，故可使闭角型青光眼眼压急剧升高，也可能激发未被诊断的闭角型青光眼。 禁忌症 闭角型青光眼者禁用；婴幼儿有脑损伤、痉挛性麻痹及先天愚型综合征者反应强烈应禁用。 注意事项 1.为避免药物经鼻粘膜吸收，滴眼后应压迫泪囊部2~3分钟。 2.如出现口干、颜面潮红等阿托品样毒性反应应即停用，必要时予拟胆碱类药物解毒。 儿童用药 婴幼儿对本品的不良反应极为敏感，药物吸收后可引起眼局部皮肤潮红、口干等。 老年患者用药 高龄者容易产生类阿托品样毒性反应，也有可能诱发未经诊断的闭角型青光眼，一经发现应即停药。 包装规格： 0.50% 3支 x 5ml  1% 3支 x 5ml  Tropicamide Dosage Form: ophthalmic solution Tropicamide Ophthalmic Solution, USP DESCRIPTION Tropicamide Ophthalmic Solution, USP is an anticholinergic prepared as a sterile topical ophthalmic solution in two strengths. The active ingredient is represented by the chemical structure: Established name: Tropicamide ophthalmic solution Chemical name: Benzeneacetamide, N-ethyl-α-(hydroxymethyl)-N-(4-pyridinylmethyl)-. Each mL contains: Active: Tropicamide 0.5% or 1%. Preservative: benzalkonium chloride 0.01%. Inactives: sodium chloride, edetate disodium, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water. pH 4.0 - 5.8. CLINICAL PHARMACOLOGY This anticholinergic preparation blocks the responses of the sphincter muscle of the iris and the ciliary muscle to cholinergic stimulation, dilating the pupil (mydriasis). The stronger preparation (1%) also paralyzes accommodation. This preparation acts in 15-30 minutes, and the duration of activity is approximately 3-8 hours. Complete recovery from mydriasis in some individuals may require 24 hours. The weaker strength may be useful in producing mydriasis with only slight cycloplegia. Heavily pigmented irides may require more doses than lightly pigmented irides. INDICATIONS AND USAGE For mydriasis and cycloplegia for diagnostic procedures. CONTRAINDICATIONS Contraindicated in persons showing hypersensitivity to any component of this preparation. WARNINGS For topical ophthalmic use only. Not for injection. This preparation may cause CNS disturbances which may be dangerous in pediatric patients. The possibility of psychotic reactions and behavioral disturbances due to hypersensitivity to anticholinergic drugs should be considered. Mydriatics may produce a transient elevation of intraocular pressure. Remove contact lenses before using. PRECAUTIONS General The lacrimal sac should be compressed by digital pressure for two to three minutes after instillation to reduce excessive systemic absorption. Information for Patients Do not touch dropper tip to any surface, as this may contaminate the solution. Patient should be advised not to drive or engage in potentially hazardous activities while pupils are dilated. Patient may experience sensitivity to light and should protect eyes in bright illumination during dilation. Parents should be warned not to get this preparation in their child's mouth and to wash their own hands and the child's hands following administration. Drug Interactions Tropicamide may interfere with the antihypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors. Carcinogenesis, Mutagenesis, Impairment of Fertility There have been no long-term studies done using Tropicamide in animals to evaluate carcinogenic potential. Pregnancy Pregnancy Category C. Animal reproduction studies have not been conducted with Tropicamide. It is also not known whether Tropicamide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Tropicamide should be given to a pregnant woman only if clearly needed. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Tropicamide is administered to a nursing woman. Pediatric Use Tropicamide may rarely cause CNS disturbances which may be dangerous in pediatric patients. Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse in children have been reported with the use of anticholinergic drugs (See WARNINGS). Keep this and all medications out of the reach of children. Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients. ADVERSE REACTIONS Ocular: Transient stinging, blurred vision, photophobia and superficial punctate keratitis have been reported with the use of Tropicamide. Increased intraocular pressure has been reported following the use of mydriatics. Non-Ocular: Dryness of the mouth, tachycardia, headache, allergic reactions, nausea, vomiting, pallor, central nervous system disturbances and muscle rigidity have been reported with the use of Tropicamide. Psychotic reactions, behavioral disturbances, and vasomotor or cardio-respiratory collapse in children have been reported with the use of anticholinergic drugs. DOSAGE AND ADMINISTRATION For refraction, instill one or two drops of 1% solution in the eye(s), repeated in five minutes. If patient is not seen within 20 to 30 minutes, an additional drop may be instilled to prolong mydriatic effect. For examination of fundus, instill one or two drops of 0.5% solution 15 or 20 minutes prior to examination. Individuals with heavily pigmented irides may require higher strength or more doses. Mydriasis will reverse spontaneously with time, typically in 4 to 8 hours. However, in some cases, complete recovery may take up to 24 hours. HOW SUPPLIED 3mL and 15mL in plastic DROP-TAINER* dispensers. 0.5% - 15 mL:       NDC 61314-354-01 1% - 3 mL:            NDC 61314-355-01 1% - 15 mL:          NDC 61314-355-02 STORAGE: Store at 8°-27°C (46°-80°F). Do not refrigerate or store at high temperatures. Keep container tightly closed.