Mydriasis, cycloplegia: Ophthalmic: See Cyclopentolate and Phenylephrine monograph. The combination product is the preferred agent for use in neonates and infants due to lower cyclopentolate concentration and reduced risk for systemic reactions. If the combination product is not available, 0.5% cyclopentolate may be used in combination with the lowest ophthalmic phenylephrine concentration available. A combination of 1 drop of 0.5% cyclopentolate and 1 drop of phenylephrine 2.5% for 3 doses 5 minutes apart was found to be effective and well-tolerated in a large cohort study of use prior to 1,246 retinopathy of prematurity screenings (n=138 infants, 24 to 36 weeks gestation) (Ref).
Mydriasis, cycloplegia:
Infants: Ophthalmic: Instill 1 drop of 0.5% solution as a single dose. Note: The cyclopentolate and phenylephrine combination formulation may be preferred for use in infants due to lower cyclopentolate concentration (0.2%) and potentially reduced risk for systemic adverse reactions.
Children and Adolescents: Ophthalmic: Instill 1 or 2 drops of 0.5%, 1%, or 2% solution; may repeat with 0.5% or 1% solution in 5 to 10 minutes; heavy pigmented irides may require use of higher strengths
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
(For additional information see "Cyclopentolate: Drug information")
Mydriasis, cycloplegia: Ophthalmic: Instill 1 or 2 drops of 0.5%, 1%, or 2% solution; may repeat in 5 to 10 minutes; heavily pigmented irides may require use of higher strengths.
Anterior uveitis (off-label use): Ophthalmic: Instill 1 drop of 1% solution 3 times daily (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined.
1% to 10%:
Cardiovascular: Tachycardia
Central nervous system: Ataxia, hallucination, hyperactivity, incoherent speech, psychosis, restlessness, seizure
Dermatologic: Burning sensation of skin
Hypersensitivity: Hypersensitivity reaction
Ophthalmic: Accommodation disturbance (loss), increased intraocular pressure
Hypersensitivity to cyclopentolate or any component of the formulation.
Canadian labeling: Additional contraindication (not in US labeling): Known or suspected angle-closure glaucoma; use in pediatric patients <6 years of age.
Concerns related to adverse effects:
• CNS effects: May cause CNS disturbances, especially with the higher concentrations. May occur with any age group, although children are more susceptible.
• Intraocular pressure: May cause a transient elevation in intraocular pressure; use with caution in patients with untreated narrow-angle glaucoma or anatomically narrow angles.
Disease-related concerns:
• Down syndrome: Patients with Down syndrome are predisposed to angle-closure glaucoma; use with caution.
Special populations:
• Contact lens wearers: Contains benzalkonium chloride which may be adsorbed by contact lenses; remove contacts prior to administration and wait 15 minutes before reinserting.
• Older adult: Use with caution in elderly patients; may be predisposed to increased intraocular pressure.
• Pediatric: May result in psychotic reactions and behavioral disturbances (disorientation, transient psychosis, seizures, incoherent speech, or visual disturbances) in pediatric patients, especially with the 2% solution; increased susceptibility to these effects has been reported in young infants, young children, and in children with preexisting behavioral/neurologic deficit, spastic paralysis, or brain damage; effects usually occur ~30 to 45 minutes after instillation; observe infants for at least 30 minutes following instillation. Effects are reversible and usually last 6 to 8 hours following the last dose; if these effects occur, monitor blood pressure and pulse closely (Pooniya 2012; Rajeev 2010). Severe cases have also been reported (Rajeev 2010); use of punctal occlusion and lowest dosage possible are recommended to reduce risk of systemic toxicity (Adcock 1971). Anticholinesterases (physostigmine) may be administered in severe life-threatening cases of systemic toxicity (Pooniya 2012). Feeding intolerance may occur in infants; withhold feeding for 4 hours after examination.
Other warnings and precautions:
• Appropriate use: For topical ophthalmic use only. To minimize absorption, apply pressure over the nasolacrimal sac for 2 to 3 minutes after instillation.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution, Ophthalmic, as hydrochloride:
Cyclogyl: 0.5% (15 mL); 1% (2 mL, 5 mL); 2% (2 mL, 5 mL, 15 mL)
Generic: 0.5% (15 mL [DSC]); 1% (2 mL, 15 mL); 2% (2 mL [DSC], 5 mL [DSC], 15 mL [DSC])
Yes
Solution (Cyclogyl Ophthalmic)
0.5% (per mL): $7.71
1% (per mL): $20.25
2% (per mL): $17.52
Solution (Cyclopentolate HCl Ophthalmic)
1% (per mL): $8.17 - $8.40
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Ophthalmic:
Generic: 0.5% (0.5 mL); 1% (0.5 mL)
Solution, Ophthalmic, as hydrochloride:
Cyclogyl: 1% (15 mL) [contains benzalkonium chloride, edetate (edta) disodium]
Generic: 1% (15 mL)
Ophthalmic: Instill drops into conjunctival sac of affected eye(s); avoid contact of bottle tip with skin or eye; to avoid excessive systemic absorption, finger pressure should be applied on the lacrimal sac during and for 2 to 3 minutes following application
Ophthalmic: To avoid excessive systemic absorption, finger pressure should be applied on the lacrimal sac during and for 2 to 3 minutes following application; monitor infants closely for at least 30 minutes after instillation.
Store at 8°C to 25°C (46°F to 77°F).
Mydriasis and cycloplegia for diagnostic procedures (FDA approved in pediatric patients [age not specified] and adults)
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program
Carbachol: Cyclopentolate may diminish the therapeutic effect of Carbachol. Risk C: Monitor therapy
Echothiophate Iodide: Cyclopentolate may diminish the therapeutic effect of Echothiophate Iodide. Risk C: Monitor therapy
Pilocarpine (Ophthalmic): Cyclopentolate may diminish the therapeutic effect of Pilocarpine (Ophthalmic). Risk C: Monitor therapy
Animal reproduction studies have not been conducted.
CNS effects, vital signs; observe neonates and infants closely for at least 30 minutes after instillation.
Prevents the muscle of the ciliary body and the sphincter muscle of the iris from responding to cholinergic stimulation, causing mydriasis and cycloplegia
Onset of action: Peak effect: Cycloplegia: 25 to 75 minutes; Mydriasis: Within 15-60 minutes, with recovery taking up to 24 hours
Duration: Cycloplegia: 6 to 24 hours; Mydriasis: ≤24 hours (Frazier 2008)
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