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Pronunciation
(sye kloe PEN toe late)
Generic Available (U.S.)
Yes
Index Terms
Brand Names: U.S.
Brand Names: Canada
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Diagnostic procedures requiring mydriasis and cycloplegia
Pregnancy Risk Factor
C
Pregnancy Considerations
Animal reproduction studies have not been conducted.
Lactation
Excretion in breast milk unknown/use caution
Contraindications
Hypersensitivity to cyclopentolate or any component of the formulation; untreated narrow-angle glaucoma; presence of untreated anatomically narrow angles
Warnings/Precautions
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.
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.
• Elderly: Use with caution in the elderly; may be predisposed to increased intraocular pressure.
• Pediatrics: May result in psychotic reactions and behavioral disturbances in children, especially with the 2% solution; effects usually occur ~30-45 minutes after instillation; observe infants for at least 30 minutes following instillation. 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, use only 1 drop of solution per eye, followed by pressure applied over the nasolacrimal sac for 2-3 minutes.
Adverse Reactions
1% to 10%:
Cardiovascular: Tachycardia
Central nervous system: Ataxia, hallucinations, hyperactivity, incoherent speech, psychosis, restlessness, seizure
Dermatologic: Burning sensation
Ocular: Intraocular pressure increased, loss of visual accommodation
Miscellaneous: Allergic reaction
Metabolism/Transport Effects
None known.
Drug Interactions
AbobotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of AbobotulinumtoxinA. Risk C: Monitor therapy
Acetylcholinesterase Inhibitors (Central): Anticholinergics may diminish the therapeutic effect of Acetylcholinesterase Inhibitors (Central). Acetylcholinesterase Inhibitors (Central) may diminish the therapeutic effect of Anticholinergics. If the anticholinergic action is a side effect of the agent, the result may be beneficial. Risk C: Monitor therapy
Anticholinergics: May enhance the adverse/toxic effect of other Anticholinergics. Exceptions: Levocabastine (Nasal); Paliperidone. Risk C: Monitor therapy
Cannabinoids: Anticholinergic Agents may enhance the tachycardic effect of Cannabinoids. Risk C: Monitor therapy
OnabotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of OnabotulinumtoxinA. Risk C: Monitor therapy
Potassium Chloride: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Chloride. Risk D: Consider therapy modification
Pramlintide: May enhance the anticholinergic effect of Anticholinergics. These effects are specific to the GI tract. Risk D: Consider therapy modification
RimabotulinumtoxinB: Anticholinergic Agents may enhance the anticholinergic effect of RimabotulinumtoxinB. Risk C: Monitor therapy
Secretin: Anticholinergic Agents may diminish the therapeutic effect of Secretin. Risk D: Consider therapy modification
Storage
Store in tight containers.
Mechanism of Action
Prevents the muscle of the ciliary body and the sphincter muscle of the iris from responding to cholinergic stimulation, causing mydriasis and cycloplegia
Pharmacodynamics/Kinetics
Onset of action: Peak effect: Cycloplegia: 25-75 minutes; Mydriasis: 30-60 minutes
Duration: ≤24 hours
Absorption: Systemic absorption poor (Haaga, 1998)
Dosage
Ophthalmic:
Infants: Note: Cyclopentolate and phenylephrine combination formulation is the preferred agent for use in infants due to lower cyclopentolate concentration and reduced risk for systemic reactions
Children: Instill 1 drop of 0.5%, 1%, or 2% in eye followed by 1 drop of 0.5% or 1% in 5 minutes, if necessary
Adults: Instill 1 drop of 1% followed by another drop in 5 minutes; 2% solution in heavily pigmented iris
Administration: Other
Ophthalmic: To avoid excessive systemic absorption, finger pressure should be applied on the lacrimal sac during and for 1-2 minutes following application
Dental Health: Effects on Dental Treatment
No significant effects or complications reported
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
Cyclopentolate may cause restlessness, hallucinations, psychosis, hyperactivity, seizures, incoherent speech, or ataxia. The 2% solution may result in psychotic reactions and behavioral disturbances in children, usually occurring approximately 30-45 minutes after instillation.
Mental Health: Effects on Psychiatric Treatment
None reported; may counteract the effects of antipsychotics, especially in children; monitor
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, ophthalmic, as hydrochloride [drops]: 1% (2 mL, 15 mL)
AK-Pentolate™: 1% (2 mL, 15 mL) [contains benzalkonium chloride]
Cyclogyl®: 0.5% (15 mL); 1% (2 mL, 5 mL, 15 mL); 2% (2 mL, 5 mL, 15 mL) [contains benzalkonium chloride]
Cylate™: 1% (2 mL, 15 mL) [contains benzalkonium chloride]
Pricing: U.S. (www.drugstore.com)
Solution (Cyclopentolate HCl)
1% (15): $40.99
References
Haaga M, Kaila T, Salminen L, et al, "Systemic and Ocular Absorption and Antagonist Activity of Topically Applied Cyclopentolate in Man," Pharmacol Toxicol, 1998, 82(1):19-22.
International Brand Names
Lexi-Comp.com
Last full review/revision February 2012
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