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Phenylephrine (ophthalmic): Drug information

Phenylephrine (ophthalmic): Drug information
(For additional information see "Phenylephrine (ophthalmic): Patient drug information" and see "Phenylephrine (ophthalmic): Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Altafrin
Brand Names: Canada
  • Minims Phenylephrine HCl
Pharmacologic Category
  • Alpha-Adrenergic Agonist;
  • Ophthalmic Agent, Mydriatic
Dosing: Adult
Mydriasis

Mydriasis: Ophthalmic: 2.5% or 10% solution: Instill 1 drop every 3 to 5 minutes as needed (maximum dose: 3 drops per eye). If necessary, dose may be repeated.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney 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: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Phenylephrine (ophthalmic): Pediatric drug information")

Mydriasis

Mydriasis: Ophthalmic:

2.5% Solution: Infants, Children, and Adolescents: Instill 1 drop 15 to 30 minutes prior to procedure; administer every 3 to 5 minutes; maximum total dose: 3 drops per eye (Ref).

10% Solution: Children and Adolescents: Instill 1 drop 15 to 30 minutes prior to procedure; administer every 3 to 5 minutes as needed; maximum total dose: 3 drops per eye

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

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

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined. Systemic effects are rare at normal dosages.

Ophthalmic: Burning sensation of eyes, eye irritation, miosis (rebound), visual disturbance, vitreous opacity (transient)

<1%, postmarketing, and/or case reports: Cardiac arrhythmia, hypertension, myocardial infarction, subarachnoid hemorrhage, syncope

Contraindications

2.5% solution: There are no contraindications listed in the manufacturer's labeling.

10% solution: Hypertension; thyrotoxicosis; infants younger than 1 year.

Warnings/Precautions

Concerns related to adverse effects:

• Cardiovascular events: Although rare, ventricular arrhythmias and myocardial infarction (including fatalities) have been reported with use of the 10% solution. Patients with preexisting cardiovascular disease may be at increased risk; consider use of 2.5% solution in these patients.

• Hypertension: Significant blood pressure elevation has been reported with the 10% solution; risk is less with 2.5% solution. Use caution when using 10% solution in children <5 years of age, patients with hyperthyroidism or patients with cardiovascular disease. Carefully monitor posttreatment blood pressure in patients with endocrine or cardiac diseases, or any patient who develops symptoms during treatment.

• Rebound miosis: Has been reported 1 day after treatment; reinstallation of the drug produced a lesser mydriatic effect.

Special populations:

• Pediatrics: The 10% should NOT be used in infants <1 year of age (2.5% solution should be used). Use caution when using 10% solution in children <5 years of age.

Other warnings/precautions:

• Appropriate use: For ophthalmic use only; not for injection.

• Driving: Topical ophthalmic phenylephrine may cause blurring of vision. Patients should be cautioned about driving or operating machinery following dosing.

• Sulfites: Some products contain sulfites which may cause allergic reactions in susceptible individuals.

Warnings: Additional Pediatric Considerations

Neonates and young infants are susceptible to systemic blood pressure effects from ophthalmic products; the 2.5% ophthalmic phenylephrine solution has been shown to cause significant increases in blood pressure compared to 1% preparations in neonates (Chew 2005).

Dosage Forms: US

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

Solution, Ophthalmic:

Altafrin: 2.5% (15 mL) [contains benzalkonium chloride]

Generic: 2.5% (2 mL, 10 mL, 15 mL)

Solution, Ophthalmic, as hydrochloride:

Altafrin: 10% (5 mL) [contains benzalkonium chloride]

Generic: 10% (5 mL)

Generic Equivalent Available: US

Yes

Pricing: US

Solution (Altafrin Ophthalmic)

2.5% (per mL): $0.54

10% (per mL): $1.61

Solution (Phenylephrine HCl Ophthalmic)

2.5% (per mL): $7.20

10% (per mL): $9.60 - $10.00

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.

Dosage Forms: Canada

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

Solution, Ophthalmic:

Generic: 10% (0.3 mL)

Administration: Adult

Ophthalmic: Wash hands before and after application. For topical ophthalmic use only; to avoid contamination, do not touch dropper tip to eyelids or other surfaces when placing drops in eyes. Solution should be applied to the conjunctival fornix unless otherwise directed. Protect eyes from bright illumination while pupils are dilated. Use of finger to occlude tear duct following instillation reduces systemic exposure. Topical ophthalmic phenylephrine may contain a preservative that can discolor soft contact lenses. Patients should remove contacts prior to drop instillation and wait at least 15 minutes before reinsertion.

Administration: Pediatric

For topical ophthalmic use only; not for injection. Wash hands before and after application. To avoid contamination, do not touch dropper tip to eyelids or other surfaces when placing drops in eyes. Solution should be applied to the conjunctival fornix unless otherwise directed. Protect eyes from bright illumination while pupils are dilated. To avoid excessive systemic absorption, apply gentle pressure to lacrimal sac during and immediately following instillation (1 minute) or instruct patient to gently close eyelid after administration (Ref).

Use: Labeled Indications

Mydriasis: Pharmacologic dilation of pupils.

Medication Safety Issues
Sound-alike/look-alike issues:

Mydfrin may be confused with Midrin

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.

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

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

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

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

Kratom: May enhance the adverse/toxic effect of Sympathomimetics. 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

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

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

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

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

Pregnancy Considerations

Animal reproduction studies have not been conducted. When administered intravenously, phenylephrine crosses the placenta (refer to the Phenylephrine (Systemic) monograph for details). The amount of phenylephrine available systemically following ophthalmic application is generally less in comparison to oral or IV doses.

Breastfeeding Considerations

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

Mechanism of Action

Potent, direct-acting alpha-adrenergic agonist with virtually no beta-adrenergic activity; produces local vasoconstriction. When applied topically to the eye, phenylephrine stimulates the dilator muscle of the iris, resulting in mydriasis.

Pharmacokinetics (Adult Data Unless Noted)

Onset of action: Mydriasis: 15 minutes; maximal mydriasis: 20 to 90 minutes; time to recovery: 3 to 8 hours

Absorption: Minimal systemic absorption (Kumar 1986)

Time to peak, plasma: ≤20 minutes (Kumar 1986)

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

  • (QA) Qatar: Apifrin | Minims Phenylephrine Hydrochloride
  1. American Academy of Pediatrics (AAP) Section on Ophthalmology. Red reflex examination in neonates, infants, and children. Pediatrics. 2008;122(6):1401-1404. [PubMed 19047263]
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  3. Kumar V, Schoenwald RD, Barcellos WA, et al, “Aqueous vs Viscous Phenylephrine. I. Systemic Absorption and Cardiovascular Effects,” Arch Ophthalm, 1986, 104(8):1189-91. [PubMed 3741249]
  4. Phenylephrine hydrochloride [prescribing information]. Tigard, OR: Paragon BioTeck Inc; March 2013.
  5. Phenylephrine solution/drops [prescribing information]. Lake Forest, IL: Akorn, Inc.; January 2015.
  6. Urtti A, Salminen L. Minimizing systemic absorption of topically administered ophthalmic drugs. Surv Ophthalmol. 1993;37(6):435-456. [PubMed 8100087]
  7. Zimmerman TJ, Kooner KS, Kandarakis AS, Ziegler LP. Improving the therapeutic index of topically applied ocular drugs. Arch Ophthalmol. 1984;102(4):551-553. [PubMed 6704011]
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