Dosage Forms
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)
Pharmacology
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/Pharmacodynamics
Onset of Action
15-60 minutes
Duration of Action
4-12 hours
Use: Labeled Indications
Mydriasis: For the production of mydriasis.
Contraindications
Hypersensitivity to any component of the formulation; untreated narrow-angle glaucoma; untreated anatomically narrow angles.
Dosage and Administration
Dosing: Adult
Mydriasis: Ophthalmic: Instill 1 drop into the eye every 5 to 10 minutes.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
Mydriasis: Ophthalmic: Infants, Children, and Adolescents: Instill 1 drop into eye(s) at least 15 minutes prior to the examination (AAP 2008); may repeat every 5 to 10 minutes if needed
Administration
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.
Storage
Store at 8°C to 25°C (46°F to 77°F).
Drug Interactions
Alpha1-Blockers: May diminish the vasoconstricting effect of Alpha1-Agonists. Similarly, Alpha1-Agonists may antagonize Alpha1-Blocker vasodilation. Monitor therapy
AtoMOXetine: May enhance the hypertensive effect of Sympathomimetics. AtoMOXetine may enhance the tachycardic effect of Sympathomimetics. Monitor therapy
Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Exceptions: Cannabidiol. Monitor therapy
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. Consider therapy modification
Doxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline. Monitor therapy
Ergot Derivatives: May enhance the hypertensive effect of Alpha1-Agonists. Ergot Derivatives may enhance the vasoconstricting effect of Alpha1-Agonists. Exceptions: Ergoloid Mesylates; Nicergoline. Avoid combination
Guanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. 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. Avoid combination
Linezolid: May enhance the hypertensive effect of Sympathomimetics. Management: Reduce initial doses of sympathomimetic agents, and closely monitor for enhanced pressor response, in patients receiving linezolid. Specific dose adjustment recommendations are not presently available. Consider therapy modification
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. Exceptions: Linezolid. Avoid combination
Solriamfetol: Sympathomimetics may enhance the hypertensive effect of Solriamfetol. Monitor therapy
Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Monitor therapy
Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Monitor therapy
Tricyclic Antidepressants: May enhance the therapeutic effect of Alpha1-Agonists. Tricyclic Antidepressants may diminish the therapeutic effect of Alpha1-Agonists. Monitor therapy
Adverse Reactions
See individual agents.
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.
Monitoring Parameters
Infants should be monitored for at least 30 minutes following application.
Pregnancy
Pregnancy Considerations
Animal reproduction studies have not been conducted with this combination.
Patient Education
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience ocular burning sensation, blurred vision, or sensitivity to lights. Have patient report immediately to prescriber vision changes, eye pain, severe eye irritation, fast heartbeat, severe headache, flushing, difficult urination, confusion, sensing things that seem real but are not, seizures, change in balance, abnormal gait, slurred speech, or agitation (HCAHPS).
- Educate patient about signs of a significant reaction (eg, 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. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.
