Cyclopentolate

Pharmacologic Category

Anticholinergic Agent, Ophthalmic

Dosing: Adult

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 (AOA [Alexander, 2004]).

* See Dosage and Administration in AHFS Essentials for additional information.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Pediatric

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

Dosing: Renal Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Use: Labeled Indications

Mydriasis/Cycloplegia: Produce mydriasis and cycloplegia.

* See Uses in AHFS Essentials for additional information.

Use: Off-Label: Adult

Anterior uveitis (acute)Level of Evidence [G]

Based on the American Optometric Association guidelines for the treatment of anterior uveitis, cyclopentolate is an effective and recommended treatment option for the management of mild acute anterior uveitis.

Level of Evidence Definitions

Level of Evidence Scale

Class and Related Monographs

Cycloplegic Mydriatics

Administration: 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.

Administration: Pediatric

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

Storage/Stability

Store at 8°C to 25°C (46°F to 77°F).

Medication Patient Education with HCAHPS Considerations

What is this drug used for?

• It is used to widen the pupil before an eye exam or eye surgery.

Frequently reported side effects of this drug

• Burning

• Eye irritation

• Blurred vision

• Sensitivity to light

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

• Confusion

• Sensing things that seem real but are not

• Behavioral changes

• Trouble speaking

• Seizures

• Change in balance

• Agitation

• Vision changes

• Eye pain

• Severe eye irritation

• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Contraindications

Hypersensitivity to cyclopentolate or any component of the formulation; untreated narrow-angle glaucoma; presence of untreated anatomically narrow angles.

Canadian labeling: Additional contraindication (not in US labeling): Known or suspected angle-closure glaucoma; use in pediatric patients <6 years of age.

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.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

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.

• 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.

* See Cautions in AHFS Essentials for additional information.

Pregnancy Considerations

Animal reproduction studies have not been conducted.

Breast-Feeding Considerations

It is not known if cyclopentolate is excreted in breast milk. The manufacturer recommends that caution be exercised when administering cyclopentolate to nursing women.

Briggs' Drugs in Pregnancy & Lactation

• Cyclopentolate Ophthalmic

Adverse Reactions

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

* See Cautions in AHFS Essentials for additional information.

Toxicology

• Anticholinergic Agents

Metabolism/Transport Effects

None known.

Drug Interactions Open Interactions

Acetylcholinesterase Inhibitors: Anticholinergic Agents may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Acetylcholinesterase Inhibitors may diminish the therapeutic effect of Anticholinergic Agents. Risk C: Monitor therapy

Aclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Amantadine: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy

Anticholinergic Agents: May enhance the adverse/toxic effect of other Anticholinergic Agents. Risk C: Monitor therapy

Botulinum Toxin-Containing Products: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy

Cannabinoid-Containing Products: Anticholinergic Agents may enhance the tachycardic effect of Cannabinoid-Containing Products. Exceptions: Cannabidiol. Risk C: Monitor therapy

Carbachol: Cyclopentolate may diminish the therapeutic effect of Carbachol. Risk C: Monitor therapy

Chloral Betaine: May enhance the adverse/toxic effect of Anticholinergic Agents. Risk C: Monitor therapy

Cimetropium: Anticholinergic Agents may enhance the anticholinergic effect of Cimetropium. Risk X: Avoid combination

CloZAPine: Anticholinergic Agents may enhance the constipating effect of CloZAPine. Management: Consider alternatives to this combination whenever possible. If combined, monitor closely for signs and symptoms of gastrointestinal hypomotility and consider prophylactic laxative treatment. Risk D: Consider therapy modification

Echothiophate Iodide: Cyclopentolate may diminish the therapeutic effect of Echothiophate Iodide. Risk C: Monitor therapy

Eluxadoline: Anticholinergic Agents may enhance the constipating effect of Eluxadoline. Risk X: Avoid combination

Gastrointestinal Agents (Prokinetic): Anticholinergic Agents may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Risk C: Monitor therapy

Glucagon: Anticholinergic Agents may enhance the adverse/toxic effect of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased. Risk C: Monitor therapy

Glycopyrrolate (Oral Inhalation): Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation). Risk X: Avoid combination

Glycopyrronium (Topical): May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Ipratropium (Oral Inhalation): May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Itopride: Anticholinergic Agents may diminish the therapeutic effect of Itopride. Risk C: Monitor therapy

Levosulpiride: Anticholinergic Agents may diminish the therapeutic effect of Levosulpiride. Risk X: Avoid combination

Mianserin: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy

Mirabegron: Anticholinergic Agents may enhance the adverse/toxic effect of Mirabegron. Risk C: Monitor therapy

Nitroglycerin: Anticholinergic Agents may decrease the absorption of Nitroglycerin. Specifically, anticholinergic agents may decrease the dissolution of sublingual nitroglycerin tablets, possibly impairing or slowing nitroglycerin absorption. Risk C: Monitor therapy

Opioid Agonists: Anticholinergic Agents may enhance the adverse/toxic effect of Opioid Agonists. Specifically, the risk for constipation and urinary retention may be increased with this combination. Risk C: Monitor therapy

Oxatomide: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Pilocarpine (Ophthalmic): Cyclopentolate may diminish the therapeutic effect of Pilocarpine (Ophthalmic). Risk C: Monitor therapy

Potassium Chloride: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Chloride. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium chloride. Risk X: Avoid combination

Potassium Citrate: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Citrate. Risk X: Avoid combination

Pramlintide: May enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Risk D: Consider therapy modification

Ramosetron: Anticholinergic Agents may enhance the constipating effect of Ramosetron. Risk C: Monitor therapy

Revefenacin: Anticholinergic Agents may enhance the anticholinergic effect of Revefenacin. Risk X: Avoid combination

Secretin: Anticholinergic Agents may diminish the therapeutic effect of Secretin. Management: Avoid concomitant use of anticholinergic agents and secretin. Discontinue anticholinergic agents at least 5 half-lives prior to administration of secretin. Risk D: Consider therapy modification

Thiazide and Thiazide-Like Diuretics: Anticholinergic Agents may increase the serum concentration of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor therapy

Tiotropium: Anticholinergic Agents may enhance the anticholinergic effect of Tiotropium. Risk X: Avoid combination

Topiramate: Anticholinergic Agents may enhance the adverse/toxic effect of Topiramate. Risk C: Monitor therapy

Umeclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Advanced Practitioners Physical Assessment/Monitoring

Monitor infants at least 30 minutes following application.

Nursing Physical Assessment/Monitoring

Monitor infants at least 30 minutes following application.

Dosage Forms: US

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, 15 mL [DSC]); 2% (2 mL, 5 mL, 15 mL)

Generic: 0.5% (15 mL); 1% (2 mL, 15 mL); 2% (2 mL, 5 mL, 15 mL)

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Ophthalmic:

Generic: 0.5% (0.3 mL); 1% (0.3 mL, 0.5 mL)

Solution, Ophthalmic, as hydrochloride:

Cyclogyl: 1% (15 mL) [contains benzalkonium chloride, edetate disodium]

Generic: 0.5% (15 mL); 1% (15 mL)

Anatomic Therapeutic Chemical (ATC) Classification

• S01FA04

Generic Available (US)

Yes

Pricing: US

Solution (Cyclogyl Ophthalmic)

0.5% (per mL): $6.09

1% (per mL): $15.97

2% (per mL): $13.82

Solution (Cyclopentolate HCl Ophthalmic)

0.5% (per mL): $5.13

1% (per mL): $7.39 - $8.40

2% (per mL): $9.76

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.

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 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)

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

No significant effects or complications reported

Effects on Bleeding

No information available to require special precautions

Index Terms

Cyclopentolate HCl; Cyclopentolate Hydrochloride

References

Adcock EW 3rd. Cyclopentolate (cyclogyl) toxicity in pediatric patients. J Pediatr. 1971;79(1):127-129.[PubMed 5091252]

Alexander KL, Dul MW, Lalle PA, et al. Care of the patient with anterior uveitis. Optometric Clinical Practice Guideline. 2004. Available at http://www.aoa.org/documents/optometrists/CPG-7.pdf.[PubMed 9527641]

Chew C, Rahman RA, Shafie SM, et al. Comparison of mydriatic regimens used in screening for retinopathy of prematurity in preterm infants with dark irides. J Pediatr Ophthalmol Strabismus. 2005;42(3):166-173.[PubMed 15977870]

Cyclogyl (cyclopentolate ophthalmic solution) [prescribing information]. Fort Worth, TX: Alcon; September 2018.

Cyclogyl (cyclopentolate ophthalmic solution) [product monograph]. Mississauga, Ontario, Canada: Alcon Canada Inc; April 2016.

Frazier M, Jaanus SD. Cycloplegics. In: Bartlett JD, Jaanus SD, eds. Clinical Ocular Pharmacology. 5th ed. St. Louis, MO: Butterworth-Heinemann; 2008:127.

Pooniya V, Pandey N. Systemic toxicity of topical cyclopentolate eyedrops in a child. Eye (Lond). 2012;26(10):1391-1392. doi: 10.1038/eye.2012.149.[PubMed 22814809]

Rajeev A, Gupta G, Adhikari KM, Yadav AK, Sathyamoorthy M. Neurotoxic effects of topical cyclopentolate. Med J Armed Forces India. 2010;66(3):288-289. doi: 10.1016/S0377-1237(10)80069-3.[PubMed 27408323]

Brand Names: International

Auropent (LK); Chlorhydrate de cyclopentolate (LU); Cicloftal (VE); Ciclolato (BR); Ciclolux (IT); Ciclopenal (AR, PY); Cicloplegic (ES); Cicloplegicedol (LB); Colircusi Cicloplejico (ES); Cyclogyl (AE, AU, BE, BF, BG, BH, BJ, CH, CI, CL, CO, CY, CZ, DK, ET, GH, GM, GN, GR, IL, IN, IQ, IR, IS, JO, KE, KR, KW, LR, LT, LV, LY, MA, ML, MR, MU, MW, NE, NG, NL, NZ, OM, PK, SA, SC, SD, SE, SG, SL, SN, SY, TH, TN, TR, TW, TZ, UG, UY, VE, YE, ZA, ZM, ZW); Cyclomed (UA); Cyclopen (TW); Cyclopent (HU); Cyclopentol (LU); Cyclopentolat (AT, NO); Cyclopentolate Eye Drops (PH); Cyclothil (AE); Cycogyl (CN, HK); Cyplegin (JP); Dilate (LK); Midriodavi (PT); Minims Cyclopentolate Hydrocloride (AE, AU, BH, CY, IL, IQ, IR, JO, KW, LY, NZ, OM, SA, SY, YE); Minims-Cyclopentolate (IE); Mydrate (BD); Mydrilate (GB, IE); Oftan-Syklo (FI, PL); Pentolate (JO, SA); Plegica (EG); Refractyl Ofteno (CR, DO, GT, HN, PA, PE, SV); Skiacol (FR, VN); Swixolate (EG); Uccmapentolate (EG); Zyklolat EDO (LU); Zyklolat-Edo (DE)

Last Updated 3/20/20