【通用名称】盐酸环喷托酯滴眼液
【商品名称】赛飞杰
【成份】
Each ml contains：
Cyclopentolate Hydrochloride,………………………………………… 10.0 mg
Boric Acid, …………………………………………………………… 12.0 mg
Potassium Chloride,………………………………………………… 1.2 mg
Benzalkonium Chloride,……………………………………………… 0.1 mg
Disodium Edetate,…………………………………………………… 0.1 mg
Purified Water, q.s. add to…………………………………………… 1.0 ml
Adjust pH to 4.5 with Sodium Carbonate, and/or Hydrochloric Acid,as needed
【藥效】
本品為抗副交感神經藥劑，可阻斷虹彩括約肌及睫狀體調節肌對於副交感神經的刺激反應，而產生瞳孔放大(散瞳)及調節機能的麻痺(睫狀肌麻痺)。 本品較ATROPINE作用時間快且短，睫狀肌麻痺反應在使用後25 - 75分鐘內達最大作用；通常完全恢復調節機能需6 - 24小時。有些病人可能需幾天的時間以恢復散瞳作用。
【適應症】
1. 瞳孔放大。
2. 睫狀肌麻痺。
【禁忌】
勿用於房角狹窄性青光眼，房角狹窄病人及對本藥劑過敏患者。
【警告】
[1] 只可作為外用，不可注射。
[2] 可能引起中樞神經系統障礙，尤其是年輕患者。但若使用較強的濃度時也可能發生於任何年齡患者。對於Cyclopentolate的全身吸收，在早產兒及嬰兒特別有中樞神經及心肺副作用之傾向。為減少全身吸收，每眼只能使用1滴0.5％Cyclogyl，使用後將鼻頭淚囊指壓2-3分鐘。嬰兒點用後需嚴密觀察30分鐘以上。
【注意事項】
一般： 為避免引起房角閉鎖性青光眼，應作房前角深度檢查。
為減少全身吸收，使用後將鼻頭淚囊指壓2-3分鐘。
Down‘s Syndrom 及易罹患閉鎖性青光眼患者，使用本劑應小心觀察。
病人： 勿碰觸滴管頂端以免污染。
使用時可能會有短暫性灼熱感。
於瞳孔放大期間，應建議患者勿開車或操作其他危險工作。
由於對光過敏，患者應於強光照射下保護眼睛。
應警告患者勿將本藥接觸口腔,使用後應立即將自己及小孩之雙手洗淨。
藥物交互作用：本品會干擾Carbachol 或Pilocarpine之抗青光眼作用。併用時會拮抗眼用膽素酯酵素抑制劑之抗青光眼及縮瞳反應。
致癌性、突變性、生殖力傷害性：尚未有研究報告出現。孕　　婦
(分類C)： 動物實驗中，Cyclopentolate對生殖的影響未知。使用Cyclopentolate之孕
婦是否會影響胎兒及生殖能力仍未知。若非必需，孕婦應避免使用本品。
哺乳婦女： 目前尚未證實本品是否會分泌於乳汁，因大部份藥品都會排泄在乳汁中，故哺乳婦女應小心使用。
兒　　童： 曾有報告指出Cyclopentolate對新生兒、幼童、兒童可能造成麻痺或腦損傷。這些病人必須謹慎使用Cyclopentolate。
新生兒使用本品後可能不能忍受餵食，建議檢查後至少四小時暫不餵食。不可使用濃度0.5 %以上於幼小的嬰兒。
老年人：對老年人及眼壓高之患者，須特別小心使用散瞳劑及睫狀肌麻痺劑。
【不良反應】眼睛： 眼壓增高，圴熱感、畏光，視力模糊、刺激感、充血、結膜炎、瞼結膜炎、點狀角膜炎、虹膜黏連。
全身： 睫狀肌麻痺劑 -特別是2％濃度者，可能引起小孩精神上困擾及行為障礙等，包括失調、出言矛盾、運動失調、幻覺、對人、時間及場所之辨認喪失、脈博加速等情況。
本藥可能引起類似之其他Anticholinergic作用，但如上所述之中樞神經系統反常見， Anticholinergic作用之其他毒性為皮膚發疹、嬰兒腹脹、不正常嗜眠、心悸、高熱，血管擴張、尿滯留、胃腸蠕動減少，唾液、汗腺、咽喉、支氣管及鼻道分泌減少；嚴重毒性包括昏迷、骨髓麻痺、死亡。
【藥物過量】 可能有上述<不良反應>之症狀出現，停藥後，病人通常會自動恢復正常。若超量使用而嚴重中毒時，選擇Physostigmine Salicylate作解毒。
小孩用量：緩慢靜脈注射0.5mg，若中毒症狀持續，但無副交感神經作用症狀產生時，每隔五分鐘再注射，最大總劑量為2.0mg。
少年及成人：緩慢靜脈注射2.0mg，若無反轉性中毒症狀產生，在20分鐘後注射第二次劑量1-2mg。
【用法及用量】
成人： 點一或二滴，若有需要可在5至10分鐘後再點一或二滴，平常需要24小時才能完全恢復。
小孩： 點一或二滴於每只眼睛若有需要可在5至10分鐘後再點一或二滴即可。
本藥限由醫師使用。
【貯存】攝氏8-27度貯存。
【规  格】1ml:10mg
【注册证号】H20070213
【生产厂】S.A.ALCON-COUVREUR N.V.,比利时

注册证号 H20070213
原注册证号 
产品名称（中文） 盐酸环喷托酯滴眼液
产品名称（英文） Cyclopentolate Hydrochloride Eye Drops
商品名（中文） 赛飞杰
商品名（英文） CYCLOGYL
剂型（中文） 滴眼剂
规格（中文） 1ml：10mg
注册证号备注 
包装规格（中文） 15ml/支/盒
生产厂商（中文） 
生产厂商（英文） s.a. ALCON-COUVREUR n.v.
厂商地址（中文） 
厂商地址（英文） Rijksweg 14，2870 Puurs
厂商国家（中文） 比利时
厂商国家（英文） Belgium
分包装批准文号 
发证日期 2007-07-23
有效期截止日 2012-07-22
分包装企业名称 
分包装企业地址 
分包装文号批准日期 
分包装文号有效期截止日 
产品类别 化学药品
药品本位码 86978802000160
药品本位码备注 
公司名称（中文） 
公司名称（英文） s.a. ALCON-COUVREUR n.v.
地址（中文） 
地址（英文） Rijksweg 14，2870 Puurs
国家（中文） 比利时
国家（英文） Belgium

DESCRIPTION

CYCLOGYL® (cyclopentolate hydrochloride ophthalmic solution ,USP) is an anticholinergic prepared as a sterile, borate buffered, solution for topical ocular use. It is supplied in three strengths. The active ingredient is represented by the structural formula:

Each mL contains: Active: cyclopentolate hydrochloride 0.5%, 1% or 2%. Preservative: benzalkonium chloride 0.01%. Inactives: boric acid, edetate disodium, potassium chloride (except 2% strength), sodium carbonate and/or hydrochloric acid (to adjust pH), purified water. The pH range is between 3.0 and 5.5.

CLINICAL PHARMACOLOGY

This anticholinergic preparation blocks the responses of the sphincter muscle of the iris and the accommodative muscle of the ciliary body to cholinergic stimulation, producing papillary dilation (mydriasis) and paralysis of accommodation (cycloplegia). It acts rapidly, but has a shorter duration than atropine. Maximal cycloplegia occurs within 25 to 75 minutes after instillation. Complete recovery of accommodation usually takes 6 to 24 hours. Complete recovery from mydriasis in some individuals may require several days. Heavily pigmented irides may require more doses than lightly pigmented irides.

INDICATIONS AND USAGE

Cyclopentolate hydrochloride is used to produce mydriasis and cycloplegia.

CONTRAINDICATIONS

Should not be used when untreated narrow-angle glaucoma, or untreated anatomically narrow angles are present, or if the patient is hypersensitive to any component of this preparation.

WARNINGS

FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION. This preparation may cause CNS disturbances. This is especially true in younger age groups, but may occur at any age, especially with the stronger solutions. Infants are especially prone to CNS and cardiopulmonary side effects from cyclopentolate. To minimize absorption, use only 1 drop of 0.5% CYCLOGYL solution per eye, followed by pressure applied over the nasolacrimal sac for two to three minutes. Observe infants closely for at least 30 minutes following instillation.

Mydriatics may produce a transient elevation of intraocular pressure.

PRECAUTIONS

General

The lacrimal sac should be compressed by digital pressure for two to three minutes after instillation to reduce excessive systemic absorption. Caution should be observed when considering use of this medication in the presence of Down’s syndrome and in those predisposed to angle-closure glaucoma.

Information for Patients

Do not touch dropper tip to any surface, as this may contaminate the solution. A transient burning sensation may occur upon instillation. Patients should be advised not to drive or engage in other hazardous activities while pupils are dilated. Patients 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. Feeding intolerance may follow ophthalmic use of this product in infants. It is recommended that feeding be withheld for four (4) hours after examination.

Drug Interactions

Cyclopentolate may interfere with the ocular anti-hypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies in animals or humans have not been conducted to evaluate the carcinogenic potential of CYCLOGYL® (cyclopentolate hydrochloride ophthalmic solution, USP).

Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted with cyclopentolate. It is also not known whether cyclopentolate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Cyclopentolate should be administered 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 cyclopentolate hydrochloride is administered to a nursing woman.

Pediatric Use

Use of cyclopentolate has been associated with psychotic reactions and behavioral disturbances in pediatric patients. Increased susceptibility to cyclopentolate has been reported in infants, young children, and in children with spastic paralysis or brain damage. These disturbances include ataxia, incoherent speech, restlessness, hallucinations, hyperactivity, seizures, disorientation as to time and place, and failure to recognize people. Feeding intolerance may follow ophthalmic use of this product in infants. It is recommended that feeding be withheld for four (4) hours after examination. Observe infants closely for at least 30 minutes (See WARNINGS).

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

ADVERSE REACTIONS

Ocular: Increased intraocular pressure, burning, photophobia, blurred vision, irritation, hyperemia, conjunctivitis, blepharoconjunctivitis, punctate keratitis, synechiae have been reported.

Non-ocular: Use of cyclopentolate has been associated with psychotic reactions and behavioral disturbances, usually in children, especially with 2% concentration. These disturbances include ataxia, incoherent speech, restlessness, hallucinations, hyperactivity, seizures, disorientation as to time and place, and failure to recognize people. This drug produces reactions similar to those of other anticholinergic drugs, but the central nervous system manifestations as noted above are more common. Other toxic manifestations of anticholinergic drugs are skin rash, abdominal distention in infants, unusual drowsiness, tachycardia, hyperpyrexia, vasodilation, urinary retention, diminished gastrointestinal motility and decreased secretion in salivary and sweat glands, pharynx, bronchi and nasal passages. Severe manifestations of toxicity include coma, medullary paralysis and death.

OVERDOSAGE

Excessive dosage may produce behavioral disturbances, tachycardia, hyperpyrexia, hypertension, elevated intraocular pressure, vasodilation, urinary retention, diminished gastrointestinal motility and decreased secretion in salivary and sweat glands, pharynx, bronchi and nasal passages. Patients exhibiting signs of overdosage should receive supportive care and monitoring.

DOSAGE AND ADMINISTRATION

Adults: Instill one or two drops of 0.5%, 1% or 2% solution in the eye which may be repeated in five to ten minutes if necessary. Complete recovery usually occurs in 24 hours. Complete recovery from mydriasis in some individuals may require several days.

Children: Instill one or two drops of 0.5%, 1% or 2% solution in the eye which may be repeated five to ten minutes later by a second application of 0.5% or 1% solution if necessary.

Small Infants: A single instillation of one drop of 0.5% in the eye. To minimize absorption, apply pressure over the nasolacrimal sac for two to three minutes. Observe infant closely for at least 30 minutes following instillation. Individuals with heavily pigmented irides may require higher strengths.

HOW SUPPLIED

In multiple-dose plastic DROP-TAINER® dispensers:

            0.5% CYCLOGYL                   1% CYCLOGYL                   2% CYCLOGYL

15 mL NDC 0065-0395-15       2 mL   NDC 0065-0396-02     2 mL   NDC 0065-0397-02

                                                  5 mL   NDC 0065-0396-05      5 mL   NDC 0065-0397-05

                                                15 mL   NDC 0065-0396-15   15 mL   NDC 0065-0397-15

Storage: Store at 8° - 27°C (46° - 80°F).