Cyclopentolate (Monograph)

Brand names: AK-Pentolate, Cyclogyl, Cylate
Drug class: Mydriatics
ATC class: S01FA04
VA class: OP600
CAS number: 5870-29-1

Introduction

Mydriatic and cycloplegic; tertiary amine antimuscarinic.

Uses for Cyclopentolate

Ophthalmologic Examination

Produces mydriasis and cycloplegia for refraction (e.g., retina and optic disc examination, measurement of refractive error).

Cyclopentolate may be preferred over atropine because of shorter duration of mydriasis and cycloplegia when used for opthalmologic examination.

Fixed-combination preparation containing cyclopentolate hydrochloride 0.2% and phenylephrine hydrochloride 1% is used to produce pronounced mydriasis with little accompanying cycloplegia for ophthalmologic examination (e.g., patients with retinal detachment; dilation for screening for retinopathy of prematurity).

Cyclopentolate Dosage and Administration

General

• To avoid induction of angle-closure glaucoma in susceptible patients, estimate the depth of the angle of the anterior chamber before administering cyclopentolate.

Administration

Apply topically to the eye(s) as an ophthalmic solution. Not for injection.

Apply finger pressure on the lacrimal sac during and for 2–3 minutes following topical instillation to avoid excessive systemic absorption, particularly if the 2% solution is used and especially in children (see Pediatric Use under Cautions).

Avoid contamination of the solution container.

Dosage

Available as cyclopentolate hydrochloride; dosage expressed in terms of the salt.

In patients with darkly pigmented irides, more doses or higher solution concentrations (e.g., 2% solution) may be required.

Pediatric Patients

Mydriasis and Cycloplegia

Ophthalmic

Select concentration of cyclopentolate hydrochloride for pediatric use based on the patient’s weight, iris coloration, and dilation history. (See Pediatric Use under Cautions.)

Small infants: 1 drop of 0.5% solution into eye(s). Following instillation, observe closely for at least 30 minutes.

Children: 1 drop of 0.5, 1, or 2% solution into eye(s); if necessary, administer a second drop of a 0.5 or 1% solution in 5–10 minutes.

Cyclopentolate hydrochloride 0.2% in fixed combination with phenylephrine hydrochloride 1%: 1 drop into eye(s); may repeat every 5–10 minutes. Administer 30 minutes before examination for retinopathy of prematurity. Following instillation, observe infants closely for at least 30 minutes.

Adults

Mydriasis and Cycloplegia

Ophthalmic

1 drop of 0.5, 1, or 2% solution into eye(s); if necessary, administer a second drop of a 0.5 or 1% solution in 5–10 minutes.

Recovery usually occurs within 24 hours. To reduce recovery time to 3–6 hours, instill 1 or 2 drops of a 1 or 2% pilocarpine solution into the eye(s).

Cyclopentolate hydrochloride 0.2% in fixed combination with phenylephrine hydrochloride 1%: 1 drop instilled into eye(s); may repeat every 5–10 minutes.

Special Populations

No special population dosage recommendations at this time.

Cautions for Cyclopentolate

Contraindications

• Untreated angle-closure (narrow-angle) glaucoma or untreated anatomically narrow angles.

• Known hypersensitivity to cyclopentolate or any component of the preparation.

Warnings/Precautions

Warnings

CNS Effects

CNS disturbances, including psychotic reactions and behavioral disturbances (e.g., ataxia, incoherent speech, restlessness, hallucinations, hyperactivity, seizures, disorientation as to time and place, failure to recognize people), have been reported; more common in younger patients (see Pediatric Use under Cautions), but may occur at any age especially with more concentrated preparations.

Intraocular Pressure

Mydriatics may cause a transient increase in IOP. Use with caution in patients who may be predisposed to increased IOP. (See Contraindications.)

Sensitivity Reactions

Allergic Reactions

Risk of allergic reaction following repeated use. Characterized by persistent irritation (developing within minutes of instillation), blurred vision, diffuse redness; itching eyes not common.

Following repeated reactions, corneal surface may become uniformly covered with tiny, superficial epithelial lesions, and lacrimal drainage system may become occluded.

General Precautions

Use of Fixed Combination

When cyclopentolate is use in fixed combination with phenylephrine, consider cautions, precautions, and contraindications associated with phenylephrine.

Concomitant Illnesses

Use with caution in patients with Down’s syndrome and those predisposed to angle-closure glaucoma.

Specific Populations

Pregnancy

Cyclopentolate: Category C.

Cyclopentolate/phenylephrine: Category C.

Lactation

Not known whether cyclopentolate is distributed into human milk. Exercise caution if used in nursing women.

Pediatric Use

Increased susceptibility to adverse CNS and cardiopulmonary effects has been reported in infants.

Psychotic reactions and behavioral disturbances reported in children; risk of these effects is greatest with 2% solution. Increased susceptibility to cyclopentolate reported in infants, young children, and children with spastic paralysis or brain damage. Symptoms may include ataxia, incoherent speech, restlessness, hallucinations, hyperactivity, seizures, disorientation as to time and place, and failure to recognize people. (See CNS Effects under Cautions and also see Pediatric Patients under Dosage and Administration.)

Feeding intolerance may occur in infants. Following administration, observe infants closely for at least 30 minutes and withhold feeding for 4 hours.

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.

Common Adverse Effects

Elevation of IOP, burning, irritation, photophobia, blurred vision, superficial punctate keratitis.

Drug Interactions

Specific Drugs

Cyclopentolate Pharmacokinetics

Absorption

Onset

Maximum mydriatic effect occurs 30–60 minutes following topical application to the eye.

Maximum cycloplegia occurs within about 25–75 minutes after topical instillation.

Duration

Recovery from mydriasis generally occurs within 24 hours, but may take several days.

Cycloplegia generally lasts 6–24 hours.

Stability

Storage

Ophthalmic

Solution

Tight containers at 8–27°C.

Cyclopentolate in fixed combination with phenylephrine: 8–27°C.

Actions

• Mydriatic and cycloplegic; shares the pharmacologic effects of atropine on the eye but has a shorter duration of action compared with atropine.

• Blocks the responses of the sphincter muscle of the iris and the accommodative muscle of the ciliary body to cholinergic stimulation, producing pupillary dilation (mydriasis) and paralysis of accommodation (cycloplegia).

Advice to Patients

• Advise patients not to drive or engage in other hazardous activities while pupils are dilated.

• Importance of protecting eyes in bright illumination during dilation since sensitivity to light may occur.

• Advise parents to prevent the child from getting the solution into his or her mouth and to wash their own hands and the child’s hands following administration.

• Inform parents that feeding should be withheld for 4 hours after use of the drug in ophthalmic examination of an infant because feeding intolerance may occur.

• Importance of learning and adhering to proper administration techniques to avoid contamination of the product.

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.

• Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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