THE MERCK MANUAL: The Merck Manual of Diagnosis and Therapy
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Cyclopentolate Drug Information Provided by Lexi-Comp

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Pronunciation

(sye kloe PEN toe late)

Generic Available (U.S.)

Yes

Index Terms

  • Cyclopentolate Hydrochloride

Brand Names: U.S.

  • AK-Pentolate™
  • Cyclogyl®
  • Cylate™

Brand Names: Canada

  • Cyclogyl®
  • Diopentolate®

Pharmacologic Category

  • Anticholinergic Agent, Ophthalmic

Pharmacologic Category Synonyms

  • Cholinergic Antagonist, Ophthalmic

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

  • Chlorhydrate de cyclopentolate (LU)
  • Ciclolato (BR)
  • Ciclolux (IT)
  • Ciclopejico (ES)
  • Ciclopenal (AR, PY)
  • Ciclople (ES)
  • Cicloplegic (ES)
  • Cicloplejico Llorens (ES)
  • Colircusi Cicloplejico (ES)
  • Colirio Ocul Cicloplejic (ES)
  • Cyclogyl (AE, AU, BE, BF, BG, BH, BJ, CH, CI, CL, CO, CY, DK, EG, ET, GH, GM, GN, GR, IL, IN, IQ, IR, JO, KE, KP, KW, LB, LR, LY, MA, ML, MR, MU, MW, NE, NG, NL, NZ, OM, PK, QA, SA, SC, SD, SE, SL, SN, SY, TH, TN, TW, TZ, UG, UY, VE, YE, ZA, ZM, ZW)
  • Cyclopent (HU)
  • Cyclopentol (LU)
  • Cyclopentolat (AT, NO)
  • Cyclopentolate (CZ)
  • Cyclopentolate Eye Drops (PH)
  • Cycogyl (CN, HK)
  • Cyplegin (JP)
  • Humapent (HU)
  • Midriodavi (PT)
  • Minims Cyclopentolate Hydrocloride (AE, AU, BH, CY, EG, IL, IQ, IR, JO, KW, LB, LY, NZ, OM, QA, SA, SY, YE)
  • Minims-Cyclopentolate (IE)
  • Mydrilate (GB, IE)
  • Oftan-Syklo (FI, PL)
  • Refractyl Ofteno (CR, DO, GT, HN, PA, SV)
  • Skiacol (FR)
  • Zyklolat EDO (LU)
  • Zyklolat-Edo (DE)

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Last full review/revision February 2012

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