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Cyclopentolate and phenylephrine: Drug information

Cyclopentolate and phenylephrine: Drug information
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For additional information see "Cyclopentolate and phenylephrine: Pediatric drug information" and "Cyclopentolate and phenylephrine: Patient drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Cyclomydril
Pharmacologic Category
  • Ophthalmic Agent, Mydriatic
Dosing: Adult
Mydriasis

Mydriasis: Ophthalmic: Instill 1 drop into each eye every 5 to 10 minutes.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Cyclopentolate and phenylephrine: Pediatric drug information")

Mydriasis

Mydriasis: Ophthalmic: Infants, Children, and Adolescents: Instill 1 drop into eye(s) at least 15 minutes prior to the examination (Ref); may repeat every 5 to 10 minutes if needed

Dosing: Kidney Impairment: Pediatric

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

Dosing: Liver Impairment: Pediatric

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

Adverse Reactions

See individual agents.

Contraindications

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

Warnings/Precautions

Concerns related to adverse effects:

• CNS effects: May cause CNS disturbances. Patients must be cautioned about performing hazardous activities (eg, operating machinery or driving) while pupils are dilated.

• Intraocular pressure: May cause a transient elevation in intraocular pressure.

Disease-related concerns:

• Cardiovascular effects: Use caution in patients with cardiovascular disease or hypertension.

• Down syndrome: Use caution in patients with Down syndrome.

• Glaucoma: Use caution in patients predisposed to angle-closure glaucoma.

• Hyperthyroidism: Use caution in patients with hyperthyroidism.

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.

• Pediatric: May result in psychotic reactions and behavioral disturbances in children; risk may be increased with brain damage or spastic paralysis. Observe infants for at least 30 minutes following instillation. Feeding intolerance may occur in infants; withhold feeding for 4 hours after examination.

Other warnings/precautions:

• Appropriate use: For topical ophthalmic use and short term administration only. To minimize systemic absorption, apply pressure over the lacrimal sac for 2 to 3 minutes after application.

Warnings: Additional Pediatric Considerations

Use of cyclopentolate has been associated with psychotic reactions and behavioral disturbances in pediatric patients; increased susceptibility to these effects has been reported in young infants, young children, and children with spastic paralysis or brain damage, particularly with concentrations >1%; observe neonates and infants closely for at least 30 minutes after administration. May cause transient elevation of intraocular pressure. Feeding intolerance may follow ophthalmic use of this product in neonates and infants; withhold feedings for 4 hours after examination.

Dosage Forms: US

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

Solution, Ophthalmic:

Cyclomydril: Cyclopentolate hydrochloride 0.2% and phenylephrine hydrochloride 1% (2 mL, 5 mL)

Generic Equivalent Available: US

No

Pricing: US

Solution (Cyclomydril Ophthalmic)

0.2-1% (per mL): $22.21

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.

Administration: Adult

Finger pressure should be applied to lacrimal sac for 2 to 3 minutes after instillation to decrease risk of absorption and systemic reactions. Do not touch dropper to eye. Wash hands following administration. Contains benzalkonium chloride, which may be adsorbed by contact lenses; remove contacts prior to administration and wait 15 minutes before reinserting.

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; preservative absorbed by soft contact lenses; wait at least 15 minutes before reinserting

Use: Labeled Indications

Mydriasis: For the production of mydriasis.

Metabolism/Transport Effects

Refer to individual components.

Drug Interactions

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.

Atomoxetine: May increase hypertensive effects of Sympathomimetics. Atomoxetine may increase tachycardic effects of Sympathomimetics. Risk C: Monitor

Atropine (Systemic): May increase hypertensive effects of Alpha1-Agonists. Risk C: Monitor

Bornaprine: Sympathomimetics may increase anticholinergic effects of Bornaprine. Risk C: Monitor

Bromocriptine: May increase hypertensive effects of Alpha1-Agonists. Management: Consider alternatives to this combination when possible. If combined, monitor for hypertension and tachycardia, and do not coadminister these agents for more than 10 days. Risk D: Consider Therapy Modification

Cannabinoid-Containing Products: May increase tachycardic effects of Sympathomimetics. Risk C: Monitor

Carbachol: Cyclopentolate may decrease therapeutic effects of Carbachol. Risk C: Monitor

Cocaine (Topical): May increase hypertensive effects of Sympathomimetics. Management: Consider alternatives to use of this combination when possible. Monitor closely for substantially increased blood pressure or heart rate and for any evidence of myocardial ischemia with concurrent use. Risk D: Consider Therapy Modification

Dihydralazine: Sympathomimetics may decrease therapeutic effects of Dihydralazine. Risk C: Monitor

Doxofylline: Sympathomimetics may increase adverse/toxic effects of Doxofylline. Risk C: Monitor

Echothiophate Iodide: Cyclopentolate may decrease therapeutic effects of Echothiophate Iodide. Risk C: Monitor

Ergot Derivatives (Vasoconstrictive CYP3A4 Substrates): May increase vasoconstricting effects of Alpha1-Agonists. Risk X: Avoid

Esketamine (Injection): May increase adverse/toxic effects of Sympathomimetics. Specifically, the risk for elevated heart rate, hypertension, and arrhythmias may be increased. Risk C: Monitor

Guanethidine: May increase hypertensive effects of Sympathomimetics. Guanethidine may increase arrhythmogenic effects of Sympathomimetics. Risk C: Monitor

Inhalational Anesthetics: Phenylephrine (Ophthalmic) may increase adverse/toxic effects of Inhalational Anesthetics. Specifically, the cardiovascular depressant effects of inhalational anesthetics may be increased. Risk C: Monitor

Iobenguane Radiopharmaceutical Products: Alpha1-Agonists may decrease therapeutic effects of Iobenguane Radiopharmaceutical Products. Management: Discontinue all drugs that may inhibit or interfere with catecholamine transport or uptake for at least 5 biological half-lives before iobenguane administration. Do not administer these drugs until at least 7 days after each iobenguane dose. Risk X: Avoid

Kratom: May increase adverse/toxic effects of Sympathomimetics. Risk X: Avoid

Levothyroxine: May increase therapeutic effects of Sympathomimetics. Sympathomimetics may increase therapeutic effects of Levothyroxine. Levothyroxine may increase adverse/toxic effects of Sympathomimetics. Specifically, the risk of coronary insufficiency may be increased in patients with coronary artery disease. Risk C: Monitor

Linezolid: May increase hypertensive effects of Sympathomimetics. Management: Consider initial dose reductions of sympathomimetic agents, and closely monitor for enhanced blood pressure elevations, in patients receiving linezolid. Risk D: Consider Therapy Modification

Lisuride: May increase hypertensive effects of Alpha1-Agonists. Risk X: Avoid

Monoamine Oxidase Inhibitors: May increase hypertensive effects of Alpha1-Agonists. While linezolid is expected to interact via this mechanism, management recommendations differ from other monoamine oxidase inhibitors. Refer to linezolid specific monographs for details. Risk X: Avoid

Pergolide: May increase hypertensive effects of Alpha1-Agonists. Risk C: Monitor

Pilocarpine (Ophthalmic): Cyclopentolate may decrease therapeutic effects of Pilocarpine (Ophthalmic). Risk C: Monitor

Solriamfetol: Sympathomimetics may increase hypertensive effects of Solriamfetol. Sympathomimetics may increase tachycardic effects of Solriamfetol. Risk C: Monitor

Sympathomimetics: May increase adverse/toxic effects of Sympathomimetics. Risk C: Monitor

Tedizolid: May increase adverse/toxic effects of Sympathomimetics. Specifically, the risk for increased blood pressure and heart rate may be increased. Risk C: Monitor

Tricyclic Antidepressants: May increase therapeutic effects of Alpha1-Agonists. Tricyclic Antidepressants may decrease therapeutic effects of Alpha1-Agonists. Risk C: Monitor

Pregnancy Considerations

Animal reproduction studies have not been conducted with this combination.

Breastfeeding Considerations

It is not known if cyclopentolate or phenylephrine is excreted into breast milk. The manufacturer recommends that caution be exercised when administering to breast-feeding women.

Monitoring Parameters

Infants should be monitored for at least 30 minutes following application.

Mechanism of Action

The anticholinergic effects of cyclopentolate and the adrenergic effects of phenylephrine cause a greater mydriasis than produced by either agent alone, and cause little cycloplegia.

Pharmacokinetics (Adult Data Unless Noted)

Note: Also see individual agents. Onset of action and duration of effect are partially dependent upon eye pigment; dark eyes have a prolonged onset of action and shorter duration than blue eyes.

Onset of action: 15 to 60 minutes.

Duration of action: 4 to 12 hours.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (EG) Egypt: Cyclophrine;
  • (IN) India: Cyclopent plus;
  • (MY) Malaysia: Cyclomydril;
  • (PR) Puerto Rico: Cyclomydril;
  • (QA) Qatar: Cyclomydril;
  • (SE) Sweden: Cyklopentolat fenylefrin;
  • (SG) Singapore: Cyclomydril;
  • (TW) Taiwan: Cycldmydril;
  • (ZA) South Africa: Cyclomydril
  1. American Academy of Pediatrics (AAP); Section on Ophthalmology; American Association for Pediatric Ophthalmology And Strabismus; American Academy of Ophthalmology; American Association of Certified Orthoptists. Red reflex examination in neonates, infants, and children [published correction appears in Pediatrics. 2009;123(4):1254]. Pediatrics. 2008;122(6):1401-1404. doi:10.1542/peds.2008-2624. [PubMed 19047263]
  2. 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):166-73. [PubMed 15977870]
  3. Cyclomydril (cyclopentolate hydrochloride/phenylephrine hydrochloride) [prescribing information]. Fort Worth, TX: Alcon Laboratories Inc; June 2018.
  4. Visser L, Singh R, Young M, et al. Guideline for the prevention, screening and treatment of retinopathy of prematurity (ROP). S Afr Med J. 2013;103(2):116-125. doi: 10.7196/samj.6305. [PubMed 23374306]
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