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
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.
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