Cyclopentolate

CYCLOGYL

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Pronunciation: sye-kloe-PEN-toe-layt

Cyclopentolate ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Cyclopentolate ballicule

What it isAntimuscarinic cycloplegic eye drop; refraction and uveitis.

Why this oneFaster onset and shorter duration than atropine, which suits office cycloplegic refraction.

What limits itSystemic anticholinergic effects in children, including hallucinations and seizures. It precipitates angle closure.

Cyclopentolate molecular structure (skeletal formula) — Molecular structure: Cyclopentolate

FDA-approved for

cycloplegia and mydriasis for eye examination

FDA label

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FDA dosing	Population	Start	Max
Mydriasis/cycloplegia for diagnostic procedures	Adults	1–2 drops (0.5%, 1%, or 2%) in eye; may repeat in 5–10 min PRN
Mydriasis/cycloplegia for diagnostic procedures	Children	1–2 drops (0.5%, 1%, or 2%) in eye; may repeat with 0.5% or 1% in 5–10 min PRN
Mydriasis/cycloplegia for diagnostic procedures	Small infants	Single drop of 0.5% in eye (one instillation only)	1 drop 0.5%

Renal Undefined

Hepatic Undefined

Complete recovery of accommodation usually 6–24 h; recovery from mydriasis may take several days in some individuals

Instructions

Topical ophthalmic use only — not for injection
Apply pressure over nasolacrimal sac 2–3 min after instillation to minimize systemic absorption
Observe infants closely for at least 30 min after instillation; withhold feeding 4 h after examination in infants
Heavily pigmented irides may require higher strengths
Do not touch dropper tip to any surface; advise against driving/hazardous activities and to protect eyes from bright light while dilated

Available strengths

drops 0.5, 1, 2 %
sol 10 mg/mL

Cautions

CNS disturbances, especially in younger patients and with stronger (2%) solutions
Infants especially prone to CNS and cardiopulmonary side effects — use only 1 drop of 0.5% per eye
Transient IOP elevation — risk of angle closure in untreated narrow-angle glaucoma or anatomically narrow angles
Psychotic reactions/behavioral disturbances in pediatrics (ataxia, incoherent speech, hallucinations, seizures); increased susceptibility in infants and children with spastic paralysis or brain damage
Feeding intolerance and necrotizing enterocolitis reported in preterm infants
Caution in Down's syndrome

Adverse reactions

Ocular: increased IOP, burning, photophobia, blurred vision, irritation, hyperemia, conjunctivitis, blepharoconjunctivitis, punctate keratitis, synechiae
CNS: psychotic reactions and behavioral disturbances (usually children): ataxia, restlessness, hallucinations, hyperactivity, seizures, disorientation
Systemic anticholinergic effects: tachycardia, hyperpyrexia, vasodilation, urinary retention, decreased GI motility and secretions, abdominal distention in infants, drowsiness, rash
Severe toxicity: coma, medullary paralysis, death

Pregnancy Animal reproduction studies not conducted; unknown fetal risk — give to pregnant women only if clearly needed

Lactation Unknown whether excreted in human milk — use caution in nursing women

Cost

Cyclopentolate (CYCLOGYL)

Strength		#/mo	CostPlus
0.5 %	drops	per unit	not offered
1 %	drops	per unit	not offered
2 %	drops	per unit	not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Cyclopentolate is dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

Generic entry1983

NO BOXED WARNINGS

Principal riskSystemic anticholinergic effects in children

Classes and tags

Clinical profile

Therapeutic safety burden0 / 4

Overdose danger0 / 4

Weight-gain liability0 / 4

Sedation liability0 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism4 / 4

Embryofetal risk0 / 4

Legacy pregnancy categoryC

Defining liabilityLocal irritation, sensitization or administration-site injury; negligible systemic toxicity at usual use.

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