Cyclopentolate is a cycloplegic, mydriatic ophthalmic agent with anticholinergic effects on the eye that are similar to atropine. It is used for cycloplegic refraction and for dilating the pupil for diagnostic purposes. This drug is useful as an aid to ophthalmic examination in a wide variety of populations, from newborns through the elderly. Cyclopentolate was approved by the FDA in 1953.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Ophthalmic Administration
-Wash hands before and after use. Tilt the head back slightly and pull the lower eyelid down with the index finger to form a pouch. Squeeze the prescribed number of drops into the pouch. To avoid excessive systemic absorption, apply finger pressure on the lacrimal sac for 1-2 minutes (in adults or children) and 2-3 minutes (infants) following topical application to the eye.
-Do not touch dropper tip to any surface to prevent contamination.
-If more than one topical ophthalmic drug product is being used, the drugs should be administered at least 5 minutes apart.
-To avoid contamination or the spread of infection, do not use dropper for more than one person.
Ocular adverse reactions associated with cyclopentolate include ocular pain (burning, stinging), transient increases in intraocular pressure (ocular hypertension), ocular irritation, punctate keratitis, blurred vision, hyperemia, synechiae, conjunctivitis, and photophobia.
Non-ocular adverse reactions that may occur following ophthalmic application of cyclopentolate include flushing. Anticholinergic effects of cyclopentolate include skin rash (unspecified), abdominal distention in infants, sinus tachycardia, vasodilation (hypotension), urinary retention, drowsiness, hyperpyrexia (fever), xerostomia, and feeding intolerance.
Cyclopentolate 2% may cause behavioral and CNS disturbances, including dysarthria (incoherent speech), impaired cognition (disorientation), ataxia, hallucinations, hyperkinesis, psychosis, and seizures. This occurs more frequently in children and infants than in adults. These reactions are more common than the anticholinergic effects of cyclopentolate.
Contact urticaria has been reported following application of cyclopentolate.
Cyclopentolate is contraindicated for use in patients with untreated narrow angle glaucoma (closed-angle glaucoma). Use cautiously in those with Down Syndrome and in those predisposed to increases in intraocular pressure.
Cyclopentolate contains benzalkonium chloride, which may be absorbed by contact lenses. Users of soft contact lenses should not administer cyclopentolate while wearing these lenses.
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 children with spastic paralysis or brain damage. Feeding intolerance may follow ophthalmic use of cyclopentolate in infants; withhold feeding 4 hours after examination. Observe infants closely for at least 30 minutes.
No adequate human or animal studies have examined the effects of cyclopentolate on the fetus or maternal reproduction. Therefore, in making the decision to administer this drug during pregnancy, the potential risks to the fetus must be weighed against the potential benefits to the mother.
Data are limited regarding the use of cyclopentolate during breast feeding and its' excretion in breast milk is unknown. Because of the potential risk for adverse reactions in nursing infants and because anticholinergic medications may interfere with breast-feeding, the manufacturer recommends caution when administering to nursing mothers. However, since cyclopentolate is typically a single dose ophthalmic agent, it is considered unlikely to cause harm to a nursing infant or interfere with lactation. To minimize the amount of drug that reaches systemic circulation and breast milk, apply pressure over the tear duct by the corner of the eye for 1 minute after each administration. If prolonged use is required, health care providers are advised to monitor for signs of decreased lactation. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.
For mydriasis induction and cycloplegia induction:
Ophthalmic dosage (0.5% ophthalmic solution):
Adults: 1 or 2 drops in the affected eye(s); may repeat dose in 5 to 10 minutes if necessary.
Children and Adolescents: 1 or 2 drops in the affected eye(s); may repeat dose in 5 to 10 minutes if necessary.
Infants: 1 drop in the affected eye(s) as a single dose.
Neonates: 1 drop in the affected eye(s) as a single dose.
Ophthalmic dosage (1% ophthalmic solution):
Adults: 1 or 2 drops in the affected eye(s); may repeat dose in 5 to 10 minutes if necessary.
Children and Adolescents: 1 or 2 drops in the affected eye(s); may repeat dose in 5 to 10 minutes if necessary.
Ophthalmic dosage (2% ophthalmic solution):
Adults: 1 or 2 drops in the affected eye(s); may repeat dose in 5 to 10 minutes if necessary.
Children and Adolescents: 1 or 2 drops in the affected eye(s); may repeat dose with 0.5% or 1% solution in 5 to 10 minutes if necessary.
Maximum Dosage Limits:
-Adults
4 drops/eye/day.
-Geriatric
4 drops/eye/day.
-Adolescents
4 drops/eye/day 0.5% or 1% solution; 2 of the 4 drops may be with a 2% solution.
-Children
4 drops/eye/day 0.5% or 1% solution; 2 of the 4 drops may be with a 2% solution.
-Infants
1 drop/eye/day 0.5% solution.
-Neonates
1 drop/eye/day 0.5% solution.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
*non-FDA-approved indication
There are no drug interactions associated with Cyclopentolate products.
Cyclopentolate blocks the action of acetylcholine to produce relaxation of the sphincter muscle of the iris resulting in dilation of the pupil (mydriasis). This agent has an anticholinergic effect similar to atropine. Paralysis of accommodation (cycloplegia) is produced by blocking cholinergic stimulation of the ciliary muscle of the lens.
Cyclopentolate is administered as a topical ophthalmic solution.
-Route-Specific Pharmacokinetics
Other Route(s)
Ophthalmic route
Cyclopentolate has a rapid onset of action producing the maximum mydriatic and cycloplegic effects within 15-60 minutes following topical application to the eye. The duration of both effects is normally 24 hours. However, mydriasis may persist for several days in selected patients.