Cyclogyl®

Cyclopentolate 0.5%, 1%, 2% · ophthalmic solution

Mydriatics/Cycloplegics

Approved uses

Mydriasis and cycloplegia

Adults 1 to 2 drops of 0.5%, 1%, or 2%, repeated in 5 to 10 minutes if necessary; children the same with a second application of 0.5% or 1%; small infants a single drop of 0.5% with nasolacrimal pressure for 2 to 3 minutes.

FDA label, Clinical Pharmacology and Dosage and Administration; Singh RP, et al. Indian J Ophthalmol. 2023;71(12):3633-3636, interventional comparison with a masked observer, PMID 37991295

Contraindications

Hypersensitivity to any component of this preparation.

Available Forms

Ophthalmic solution, 0.5% (15 mL), 1% (2 mL, 5 mL, 15 mL), 2% (2 mL, 5 mL, 15 mL)

Mechanism of Action

Anticholinergic that blocks the response of the iris sphincter and of the ciliary body accommodative muscle to cholinergic stimulation, producing pupillary dilation and paralysis of accommodation. Onset is rapid and duration shorter than atropine, with maximal cycloplegia 25 to 75 minutes after instillation.

Warnings & Precautions

CNS disturbances: Especially likely in younger age groups and with the stronger solutions, but possible at any age.
Concentration-dependent CNS risk: Psychotic and behavioral reactions occur mainly in children and especially with 2%; a 2022 mini review recommends avoiding 2% and pairing a lower strength with phenylephrine instead.
Infant systemic absorption: Infants are especially prone to CNS and cardiopulmonary effects; use one drop of 0.5% per eye, apply pressure over the nasolacrimal sac for two to three minutes, and observe for at least 30 minutes.
IOP and angle closure: Mydriatics may transiently raise intraocular pressure, and untreated narrow angle glaucoma or anatomically narrow angles may be susceptible to angle closure after instillation.
Down syndrome: Caution when considering use.
Preterm infant feeding: Feeding intolerance and necrotizing enterocolitis have been reported after ophthalmic use, causality not established; withhold feeding for 4 hours after examination.
Cholinergic drug interaction: May interfere with the ocular antihypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.
Route restriction: Topical ophthalmic use only, not for injection.

Common Side Effects

Ocular: Increased intraocular pressure, burning, photophobia, blurred vision, irritation, hyperemia, conjunctivitis, blepharoconjunctivitis, punctate keratitis, synechiae.
Systemic, CNS: Psychotic reactions and behavioral disturbances, usually in children and especially with the 2% concentration, including ataxia, incoherent speech, restlessness, hallucinations, hyperactivity, seizures, disorientation as to time and place, and failure to recognize people.
Systemic, anticholinergic: Skin rash, abdominal distention in infants, unusual drowsiness, tachycardia, hyperpyrexia, vasodilation, urinary retention, diminished gastrointestinal motility, decreased salivary and sweat secretion.
Systemic, severe: Coma, medullary paralysis, and death.
Preterm infants: Feeding intolerance, and necrotizing enterocolitis reported after ophthalmic use with causality not established.

Pregnancy & Lactation

Pregnancy: No animal reproduction studies have been conducted; whether fetal harm or an effect on reproductive capacity can occur is unknown, so administer only if clearly needed.

Lactation: Excretion in human milk is unknown; exercise caution in a nursing woman.

Pediatric Use

Psychotic and behavioral reactions reported; infants and young children are most susceptible.