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Cyclopentolate and phenylephrine: Drug information

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

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

Mydriasis: Ophthalmic: Instill 1 drop into the 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: Hepatic 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): $19.96

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

None known.

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 Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

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

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

Alpha1-Blockers: May diminish the vasoconstricting effect of Alpha1-Agonists. Similarly, Alpha1-Agonists may antagonize Alpha1-Blocker vasodilation. Risk C: Monitor therapy

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

Atomoxetine: May enhance the hypertensive effect of Sympathomimetics. Atomoxetine may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy

Atropine (Systemic): May enhance the hypertensive effect of Alpha1-Agonists. Risk C: Monitor therapy

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

Bromocriptine: May enhance the hypertensive effect 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 enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy

Cannabinoid-Containing Products: Anticholinergic Agents may enhance the tachycardic effect of Cannabinoid-Containing Products. 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

Chlorprothixene: Anticholinergic Agents may enhance the anticholinergic effect of Chlorprothixene. 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

Cocaine (Topical): May enhance the hypertensive effect 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

Doxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline. Risk C: Monitor therapy

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

Ergot Derivatives (Vasoconstrictive CYP3A4 Substrates): May enhance the vasoconstricting effect of Alpha1-Agonists. 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

Guanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. Risk C: Monitor therapy

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

Iobenguane Radiopharmaceutical Products: Alpha1-Agonists may diminish the therapeutic effect 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 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

Kratom: May enhance the adverse/toxic effect of Sympathomimetics. Risk X: Avoid combination

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

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

Linezolid: May enhance the hypertensive effect 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 enhance the hypertensive effect of Alpha1-Agonists. 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

Monoamine Oxidase Inhibitors: May enhance the hypertensive effect 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 combination

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

Ozanimod: May enhance the hypertensive effect of Sympathomimetics. Risk C: Monitor therapy

Pergolide: May enhance the hypertensive effect of Alpha1-Agonists. Risk C: Monitor therapy

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. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form 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 X: Avoid combination

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

Rivastigmine: Anticholinergic Agents may diminish the therapeutic effect of Rivastigmine. Rivastigmine may diminish the therapeutic effect of Anticholinergic Agents. Management: Use of rivastigmine with an anticholinergic agent is not recommended unless clinically necessary. If the combination is necessary, monitor for reduced anticholinergic effects. Risk D: Consider therapy modification

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

Solriamfetol: Sympathomimetics may enhance the hypertensive effect of Solriamfetol. Sympathomimetics may enhance the tachycardic effect of Solriamfetol. Risk C: Monitor therapy

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

Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy

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

Tricyclic Antidepressants: May enhance the therapeutic effect of Alpha1-Agonists. Tricyclic Antidepressants may diminish the therapeutic effect of Alpha1-Agonists. Risk C: Monitor therapy

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

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: 15-60 minutes

Duration of action: 4-12 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;
  • (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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