Professional Drug Information > Ocu-Phrin Sterile Eye Drops

Phenylephrine (Ophthalmic)

VA CLASSIFICATION
Primary: OP600
Secondary: OP802; DX900

Commonly used brand name(s): Ak-Dilate; Ak-Nefrin; Dilatair; Dionephrine; I-Phrine; Isopto Frin; Minims Phenylephrine; Mydfrin; Neo-Synephrine; Neofrin; Ocu-Phrin Sterile Eye Drops; Ocu-Phrin Sterile Ophthalmic Solution; Ocugestrin; Phenoptic; Prefrin Liquifilm; Relief Eye Drops for Red Eyes; Spersaphrine.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Mydriatic—

decongestant (ophthalmic)—

diagnostic aid (mydriatic)—

Indications

Accepted

Note: The 2.5 and 10% phenylephrine ophthalmic solutions are indicated when rapid dilation of the pupil and reduction of congestion in the capillary bed are desired. ^{{17} {18}}

Uveitis with posterior synechiae (treatment) or
Synechiae, posterior (prophylaxis)—The 2.5 and 10% phenylephrine ophthalmic solutions are indicated in patients with uveitis when synechiae are present or may develop. ^{{17} {18}} The formation of synechiae may be prevented by concurrent use of either of these concentrations with atropine to produce wide dilation of the pupil; ^{18} however, the vasoconstrictor effect of phenylephrine may be antagonistic to the increase of local blood flow in uveal inflammation.

Mydriasis, preoperative—The 2.5 and 10% phenylephrine ophthalmic solutions are indicated to produce dilation of the pupil prior to intraocular surgery. ^{{17} {18}}

Mydriasis, in diagnostic procedures—Refraction: ^{18} Prior to determination of refractive errors, the 2.5% phenylephrine ophthalmic solution may be used effectively with homatropine, atropine, cyclopentolate, or tropicamide.
—Ophthalmoscopy: The 2.5% phenylephrine ophthalmic solution is indicated to produce mydriasis for ophthalmoscopic examination. ^{18}
—Retinoscopy (shadow test): The 2.5% phenylephrine ophthalmic solution may be used alone when dilation of the pupil without cycloplegic action is desired for retinoscopy (shadow test). ^{{17} {18}}
—Blanching test: The 2.5% phenylephrine ophthalmic solution is indicated for the blanching test. If blanching occurs, the congestion is superficial and probably does not indicate iritis. ^{18}

Ocular redness^{16} (treatment)—The 0.12% phenylephrine ophthalmic solution is indicated to provide temporary relief of redness ^{16} associated with minor eye irritations, such as those caused by hay fever, colds, dust, wind, swimming, sun, smog, smoke, or wearing contact lenses.


Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    203.67 ^{19}

Mechanism of action/Effect:

Phenylephrine is primarily a direct-acting sympathomimetic amine, which stimulates alpha-adrenergic receptors. ^{17}


Mydriatic ^{18}:

Phenylephrine acts on alpha-adrenergic receptors in the dilator muscle of the pupil, producing contraction.



Decongestant ^{18} (ophthalmic):

Phenylephrine acts on alpha-adrenergic receptors in the arterioles of the conjunctiva, producing constriction.


Time to peak effect:


Mydriasis:

2.5% solution: 15 to 60 minutes.

10% solution: 10 to 90 minutes.


Duration of action:


Mydriasis recovery time:

2.5% solution: 1 to 3 hours. ^{17}

10% solution: 3 to 7 hours.



Precautions to Consider

Carcinogenicity

Long-term studies have not been done. ^{17}

Pregnancy/Reproduction

Pregnancy—
Studies have not been done in humans; however, ophthalmic phenylephrine may be systemically absorbed. ^{17}

Studies have not been done in animals. ^{17}

FDA Pregnancy Category C. ^{17}

Breast-feeding

It is not known whether phenylephrine is distributed into breast milk ^{17} and problems in humans have not been documented; however, ophthalmic phenylephrine may be systemically absorbed.

Pediatrics

The recommended dose should not be exceeded in pediatric patients, especially for the 2.5 and 10% solutions, since high doses of phenylephrine can increase blood pressure ^{17} and cause irregular heartbeat. In addition, repeated use of 2.5 or 10% phenylephrine may result in rebound miosis and a reduced mydriatic effect. ^{{06} {15}} Moreover, the 10% phenylephrine solution is not recommended for use in infants, since a pronounced increase in blood pressure may occur. Also, the 2.5 and 10% concentrations are not recommended for use in low birth weight infants. ^{{17} {18}}


Geriatrics


Cardiovascular reactions, such as marked increase in blood pressure, syncope, myocardial infarction, tachycardia, arrhythmia, and fatal subarachnoid hemorrhage, have occurred primarily in elderly patients. ^{{17} {18}} In addition, repeated use of 2.5 or 10% phenylephrine, especially in older patients, may result in rebound miosis and a reduced mydriatic effect. ^{{06} {15} {17}} Also, older patients may develop transient pigment floaters in the aqueous humor 40 to 45 minutes following administration of the 2.5 or 10% concentrations, ^{{17} {18}} the appearance of which may be similar to anterior uveitis or to a microscopic hyphema. ^{{17} {18}}

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.


For 2.5 or 10% strengths only
Antidepressants, tricyclic or^{17}{18}
Maprotiline or
Monoamine oxidase (MAO) inhibitors,^{17}{18} including furazolidone, procarbazine, and selegiline    (if significant systemic absorption of ophthalmic phenylephrine occurs, concurrent use of these medications may potentiate the pressor effect of phenylephrine; in addition, if ophthalmic phenylephrine is administered during or within 21 days following the administration of MAO inhibitors, careful supervision with possible adjustment of dosage is recommended, since exaggerated adrenergic response may occur ^{{17} {18}})


Guanadrel or
Guanethidine    (if significant systemic absorption of ophthalmic phenylephrine occurs, concurrent use of guanadrel or guanethidine may increase the mydriatic effect of phenylephrine; also, concurrent use may potentiate the pressor effect of phenylephrine, possibly resulting in hypertension and cardiac arrhythmias)


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problems exist

For 2.5 or 10% strengths only:
Arteriosclerotic changes, advanced^{18}
Cardiac disease^{17}{18}
Diabetes mellitus
» Glaucoma, angle-closure, predisposition to^{17}{18}
Hypertension^{18}
Idiopathic orthostatic hypotension^{17}{18}    (a marked increase in blood pressure may occur ^{18})


Sensitivity to phenylephrine or sulfites^{17}


Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence less frequent with 10% solution; incidence rare with 2.5% ^{17} or weaker solution
Signs and symptoms of systemic absorption
    
Dizziness
    
fast, irregular,^{18} or pounding heartbeat
    
increase in blood pressure
    
increase in sweating^{18}
    
paleness^{18}
    
trembling^{18}




Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent with 2.5 or 10% solution
    
Burning or stinging of eyes
    
headache
    
browache
    
sensitivity of eyes to light
    
watering of eyes

Incidence less frequent
    
Eye irritation not present before therapy





Overdose
For specific information on the agents used in the management of phenylephrine ophthalmic overdose, see:
   • Phentolamine (Systemic) monograph.
For more information on the management of overdose or unintentional ingestion, contact a Poison Control Center (see Poison Control Center Listing ).

Treatment of overdose
Specific treatment—The hypertensive effects of phenylephrine may be treated with an alpha-adrenergic blocker, such as phentolamine 5 to 10 mg intravenously, repeated as necessary.


Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Phenylephrine (Ophthalmic).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Sensitivity to phenylephrine or to sulfites ^{17}





Use in children— May be especially sensitive to the effects of phenylephrine; also, the 10% strength is not recommended for use in infants, and the 2.5 and 10% strengths are not recommended for use in low birth weight infants






Use in the elderly— Repeated use of 2.5 or 10% phenylephrine may increase the chance of side/adverse effects; also, cardiovascular reactions have occurred more often in elderly patients
Other medical problems, especially, predisposition to angle-closure glaucoma

Proper use of this medication
Not using if solution turns brown or contains a precipitate

Proper administration technique ^{17}

Preventing contamination: Not touching applicator tip to any surface; keeping container tightly closed

» Proper dosing

» Proper storage

For the 2.5 and 10% solutions
» Importance of not using more medication than the amount prescribed
Missed dose: Applying as soon as possible; not applying if almost time for next dose; applying next dose at regularly scheduled time

Precautions while using this medication
» Stopping medication and checking with physician if eye pain or change in vision occurs or if redness or irritation continues, gets worse, or lasts for more than 72 hours

For the 2.5 and 10% solutions
» Medication may cause increased sensitivity of eyes to light; wearing sunglasses that block ultraviolet light to protect eyes from sunlight and other bright lights; checking with physician if this effect continues longer than 12 hours after discontinuation of medication


Side/adverse effects
Signs of potential side effects, especially systemic absorption


General Dosing Information
Although some manufacturers recommend a dose of 2 drops of an ophthalmic solution at appropriate intervals, the conjunctival sac will usually hold only 1 drop. ^{20}

To avoid excessive systemic absorption, patient should apply digital pressure to the lacrimal sac during and for 2 or 3 minutes following instillation of medication. ^{{17} {18}}

Although some manufacturers recommend that patients not wear soft contact lenses during treatment with phenylephrine ophthalmic solution, USP medical experts do not believe this precaution is necessary unless the patient has corneal epithelial problems and the medication is to be used more often than once every 1 to 2 hours. No significant problems have been documented with ophthalmic solutions containing 0.03% or less of benzalkonium chloride as a preservative that are used in patients with no significant corneal surface problems.

For the 2.5 and 10% solutions
To prevent pain and subsequent lacrimation on administration, a suitable topical anesthetic may be applied a few minutes before use of phenylephrine solution. ^{{17} {18}}

The recommended dose should not be exceeded, especially in children and in individuals with high blood pressure or heart disease, since high doses of phenylephrine can increase blood pressure and cause irregular heartbeat.

Repeated use of phenylephrine, especially in older patients, may result in rebound miosis and a reduced mydriatic effect. ^{17}


Ophthalmic Dosage Forms

PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC SOLUTION USP

Usual adult and adolescent dose
Mydriasis and vasoconstriction
Topical, to the conjunctiva, 1 drop of a 2.5 or 10% solution, repeated in one hour if necessary. ^{17}

Chronic mydriasis
Topical, to the conjunctiva, 1 drop of a 2.5 or 10% solution two or three times a day.

Uveitis with posterior synechiae (treatment) or
Synechiae, posterior (prophylaxis)
Topical, to the conjunctiva, 1 drop of a 2.5 or 10% solution, repeated in one hour if necessary, not to exceed three times a day. Treatment may be continued the following day, if necessary. ^{{17} {18}}

Note: Atropine sulfate and the application of hot compresses should also be used if indicated. ^{{17} {18}}


Mydriasis, preoperative
Topical, to the conjunctiva, 1 drop of a 2.5 or 10% solution thirty to sixty minutes prior to surgery. ^{{17} {18}}

Mydriasis, in diagnostic procedures


Refraction:
Topical, to the conjunctiva, 1 drop of a cycloplegic followed in five minutes by 1 drop of a 2.5% solution of phenylephrine. ^{{17} {18}} The need for additional drops of the cycloplegic, and the waiting period before adequate cycloplegia occurs, depend on the cycloplegic used. ^{17}

Note: For a 'one application method,' the 2.5% solution may be used in combination with a cycloplegic ^{18} for synergistic action.




Ophthalmoscopy:
Topical, to the conjunctiva, 1 drop of a 2.5% solution fifteen to thirty minutes prior to examination. ^{{17} {18}}



Retinoscopy (shadow test):
Topical, to the conjunctiva, as a 2.5% solution. ^{{17} {18}}



Blanching test:
Topical, to the infected eye, 1 drop of a 2.5% solution. ^{{17} {18}}

Note: Eye should be examined for perilimbal blanching 5 minutes after application of phenylephrine. ^{{17} {18}}



Ocular redness (treatment)
Topical, to the conjunctiva, 1 drop of a 0.12% solution every three or four hours as needed.


Usual pediatric dose
Mydriasis and vasoconstriction
Topical, to the conjunctiva, 1 drop of a 2.5% solution, repeated in one hour if necessary.

Chronic mydriasis
Topical, to the conjunctiva, 1 drop of a 2.5% solution two or three times a day.

Uveitis with posterior synechiae (treatment)
Topical, to the conjunctiva, 1 drop of a 2.5% solution, repeated in one hour if necessary. Treatment may be continued the following day, if necessary.

Note: Atropine sulfate and application of hot compresses should also be used if indicated.


Mydriasis, preoperative
Topical, to the conjunctiva, 1 drop of a 2.5% solution thirty to sixty minutes prior to surgery.

Mydriasis, in diagnostic procedures


Refraction:
Topical, to the conjunctiva, 1 drop of a 1% solution of atropine, followed in ten to fifteen minutes by 1 drop of a 2.5% solution of phenylephrine and in five to ten minutes by a second drop of a 1% solution of atropine. In one to two hours, the eyes are ready for refraction.

Note: For a “one application method,” the 2.5% solution of phenylephrine may be used in combination with a cycloplegic ^{18} for synergistic action.




Ophthalmoscopy:
See Usual adult and adolescent dose .



Retinoscopy (shadow test):
See Usual adult and adolescent dose .



Blanching test:
See Usual adult and adolescent dose .


Ocular redness (treatment)
See Usual adult and adolescent dose.


Note: The 10% phenylephrine solution is not recommended for use in infants, since a pronounced increase in blood pressure may occur following instillation. Also, the 2.5 and 10% concentrations are not recommended for use in low birth weight infants. ^{{17} {18}}


Strength(s) usually available
U.S.—


0.12% (OTC) [Ak-Nefrin^{02}] [Isopto Frin^{12}] [Ocu-Phrin Sterile Eye Drops^{13}] [Prefrin Liquifilm^{29} (polyvinyl alcohol 1.4%)] [Relief Eye Drops for Red Eyes^{30} ( polyvinyl alcohol 1.4%)][Generic]


2.5% (Rx) [Ak-Dilate^{16} (sodium bisulfite ) (benzalkonium chloride 0.01%)] [Dilatair] [I-Phrine^{03}] [Mydfrin^{17} (sodium bisulfite) (benzalkonium chloride 0.01%) (boric acid) (edetate disodium) ( sodium hydroxide or hydrochloric acid)] [Neofrin] [Neo-Synephrine] [Ocugestrin] [Ocu-Phrin Sterile Ophthalmic Solution^{15}] [Phenoptic^{01}][Generic]^{19}


10% (Rx) [Ak-Dilate^{16} (sodium bisulfite ) (benzalkonium chloride 0.01%)] [I-Phrine] [Neofrin] [Neo-Synephrine] [Ocu-Phrin Sterile Ophthalmic Solution^{15}][Generic]^{18}

Canada—


0.12% (OTC) [Prefrin Liquifilm^{36} (sodium bisulfite ) (polyvinyl alcohol 1.4%)]


2.5% (OTC) [Ak-Dilate^{33} (sodium bisulfite )] [Dionephrine] [Minims Phenylephrine] [Mydfrin^{34}] [Spersaphrine^{37}]


10% (OTC) [Minims Phenylephrine^{38}]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight, light-resistant container of not more than 15-mL size. Protect from freezing.

Stability:
Prolonged exposure to air or strong light may cause oxidation and discoloration. ^{{17} {18}} Do not use if solution is brown or contains a precipitate. ^{{17} {18}}

Incompatibilities:
Phenylephrine is chemically incompatible with the local anesthetic butacaine.

Auxiliary labeling:
   • For the eye.
   • Keep container tightly closed.

Revised: 10/02/2000

References

1. Phenoptic 2.5% (Optopics—US). Personal communication, Optopics, 4/12/95.
   

2. Ak-Nefrine (Akorn). In: PDR Physicians" desk reference for ophthalmology. 23rd ed. 1995. Montvale, NJ: Medical Economics Data Production Company, 1995: 201.
   

3. I-Liqui-Tears and I-Phrine, International Pharmaceutical Products, product list l986.
   

4. Open.
   

5. Open.
   

6. Neo-Synephrine package insert (Winthrop—US), Rev 9/87, Rec 6/88.
   

7. Open.
   

8. Open.
   

9. Open.
   

10. Open.
    

11. Open.
    

12. Isopto Frin package insert (Alcon—US), Rev 10/83, Rec 4/88.
    

13. Ocu-Phrin 0.12% sterile eye drops (Ocumed). In: PDR Physicians" desk reference for ophthalmology. 23rd ed. 1995. Montvale, NJ: Medical Economics Data Production Company, 1995: 329.
    

14. Open.
    

15. Ocu-Phrin sterile ophthalmic solution (Ocumed). In: PDR Physicians" desk reference for ophthalmology. 23rd ed. 1995. Montvale, NJ: Medical Economics Data Production Company, 1995: 329.
    

16. Ak-Dilate (Akorn). In: PDR Physicians" desk reference for ophthalmology. 23rd ed. 1995. Montvale, NJ: Medical Economics Data Production Company, 1995: 201.
    

17. Mydfrin (Alcon). In: PDR Physicians" desk reference for ophthalmology. 23rd ed. 1995. Montvale, NJ: Medical Economics Data Production Company, 1995: 229.
    

18. Phenylephrine ophthalmic solution 10% (IOLAB). In: PDR Physicians" desk reference for ophthalmology. 23rd ed. 1995. Montvale, NJ: Medical Economics Data Production Company, 1995: 279.
    

19. Phenylephrine ophthalmic solution 2.5% (Bausch & Lomb). In: PDR Physicians" desk reference for ophthalmology. 23rd ed. 1995. Montvale, NJ: Medical Economics Data Production Company, 1995: 266.
    

20. Olin BR, editor. Drug facts and comparisons. St. Louis: Facts and Comparisons Inc. 1989: 447a.
    

21. Open.
    

22. Open.
    

23. Open.
    

24. Open.
    

25. Open.
    

26. Open.
    

27. Open.
    

28. Open.
    

29. Prefrin Liquifilm (Allergan). In: PDR Physicians" desk reference for ophthalmology. 19th ed. 1991. Montvale, NJ: Medical Economics Data, 1991: 251.
    

30. Relief Eye Drops for Red Eyes 0.12% (Allergan). In: PDR Physicians" desk reference for ophthalmology. 19th ed. 1991. Montvale, NJ: Medical Economics Data, 1991: 252.
    

31. Open.
    

32. Open.
    

33. Ak-Dilate 2.5% (Akorn). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 26th ed. Ottawa: Canadian Pharmaceutical Association, l991.
    

34. Mydrin 2.5% (Alcon). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 26th ed. Ottawa: Canadian Pharmaceutical Association, l991.
    

35. Open.
    

36. Prefrin Liquifilm 0.12% (Allergan). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 26th ed. Ottawa: Canadian Pharmaceutical Association, l991.
    

37. Spersaphrine 25 mg/mL (Dispersa). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 26th ed. Ottawa: Canadian Pharmaceutical Association, l991.
    

38. Minims Phenylephrine 10% (Smith & Nephew). CPS Compendium of pharmaceuticals and specialties 26th ed. Ottawa: Canadian Pharmaceutical Association, l991.
    

39. Open.
    

40. Open.
    

41. Product Information: Dionephrine, phenylephrine hydrochloride. Dioptic Laboratories, Markham/Ontario, Canada. In: Krogh CME (ed): Compendium of Pharmaceuticals and Specialties, 34th ed. Canadian Pharmaceutical Association, Ottawa, Ontario, Canada, 1999: p.530.
    

42. Product Information: Minims Phenylephrine, phenylephrine. Ophtapharma, Ophtapharma Canada, Inc., Montreal, Quebec, Canada. In: Krogh CME (ed): Compendium of Pharmaceuticals and Specialties, 34th ed. Canadian Pharmaceutical Association, Ottawa, Ontario, Canada, 1999: p.1057.
    

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