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MYDRIACYL 0.5%(tropicamide ophthalmic solution, USP)
药店国别  
产地国家 美国 
处 方 药: 是 
所属类别 15毫升/瓶 
包装规格 15毫升/瓶 
计价单位: 瓶 
生产厂家中文参考译名:
爱尔康制药
生产厂家英文名:
Alcon Laboratories, Inc.
该药品相关信息网址1:
http://www.drugs.com/cons/mydriacyl-ophthalmic.html
该药品相关信息网址2:
该药品相关信息网址3:
原产地英文商品名:
MYDRIACYL ophthalmic solution 0.5% 15ml/Vial
原产地英文药品名:
tropicamide solution
中文参考商品译名:
MYDRIACYL0.5%滴眼液 15毫升/瓶
中文参考药品译名:
托吡卡胺
曾用名:
简介:

 

部份中文托吡卡胺处方资料(仅供参考)
药品英文名
Tropicamide
药品别名
托品酰胺、托品卡胺、米杜林-M、Tropicamidum、Mydriacyl
药物剂型
滴眼剂:15mg(6ml),30mg(6ml)。
药理作用
本品为抗胆碱药,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%溶液3.17屈光度、1%溶液1.30屈光度。残余调节度数能保持在20屈光度或以下者,0.75%和1%溶液可维持40min,0.5%约为15min。1%溶液1滴滴眼后隔5~25min再滴第2次,能获得更满意的睫状肌麻痹作用20~30min。经2~6h能阅读书报,调节功能于6h内恢复至滴药前水平。本品能阻滞乙酰胆碱引起的虹膜、括约肌及睫状肌兴奋作用。
药动学
本品0.5%、1%溶液滴眼后20~30min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)2~6h。散瞳(残余的)约7h。
适应证
1.主要用于眼底检查、成人验光时散瞳及睫状肌麻痹剂。
2.用于青少年假性近视、中间性近视及预防青少年近视。
禁忌证
1.闭角型青光眼者禁用;婴幼儿有脑损伤、痉挛性麻痹及唐氏综合征者反应强烈应禁用。
2.考虑到残余调节力的存在,本品不适合少年儿童扩瞳验光。
注意事项
1.为避免药物经鼻黏膜吸收,滴眼后应压迫泪囊部2~3min。
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。
3.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。
4.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。
5.孕妇及哺乳期妇女用药反应:(尚不明确)
不良反应
本品0.5%溶液滴眼1~2次,每次1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。本品全身不良反应罕见。
用法用量
1.屈光检查:滴眼剂0.5%~1%溶液滴眼,每次1滴,间隔5min滴第2次,连续4次,20min后行屈光检查。
2.扩瞳检查:0.5%~1%溶液滴眼,常与肾上腺素类扩瞳药合用,以增强作用,减少用药浓度。
药物相应作用
1.本品散瞳作用可被1%毛果芸香碱抵消。
2.与1%羟基苯丙胺合用有协同作用。
MYDRIACYL- tropicamide solution 
Alcon Laboratories, Inc.
Mydriacyl®
(tropicamide ophthalmic solution, USP)
DESCRIPTION
MYDRIACYL® (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:
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 range 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 eva luate 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 punctuate 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 cardiorespiratory 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
3 mL and 15 mL in plastic DROP-TAINER® dispensers.

0.5% - 15 mL: NDC 0998-0354-15

1% -   3 mL: NDC 0065-0355-03

       15 mL: NDC 0998-0355-15
STORAGE: Store at 8°-27°C (46°-80°F). Do not refrigerate or store at high temperatures. Keep container tightly closed.

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