Phenylephrine Ophthalmic Solution

Pronunciation

Generic Name: phenylephrine hydrochloride
Dosage Form: ophthalmic solution

Indications and Usage for Phenylephrine Ophthalmic Solution

Phenylephrine Hydrochloride Ophthalmic Solution, 2.5% and 10% is indicated to dilate the pupil.

Phenylephrine Ophthalmic Solution Dosage and Administration

General Dosing Recommendations

In patients 1 year of age or greater, apply one drop of either Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% or 10% every 3 to 5 minutes to the conjunctival fornix as required up to a maximum of 3 drops. If necessary, this dose may be repeated.

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In order to obtain a greater degree of mydriasis, Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% may be needed.

Pediatric Patients Less Than 1 Year of Age

In pediatric patients less than 1 year of age, one drop of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% should be instilled at 3 to 5 minute intervals up to a maximum of 3 drops per eye.

Dosage Forms and Strengths

Phenylephrine Hydrochloride Ophthalmic Solution, 2.5% is a clear, colorless, sterile topical ophthalmic solution containing phenylephrine hydrochloride 2.5%.

Phenylephrine Hydrochloride Ophthalmic Solution, 10% is a clear, colorless, sterile topical ophthalmic solution containing phenylephrine hydrochloride 10%.

Contraindications

Cardiac and Endocrine Disease

Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% is contraindicated in patients with hypertension or thyrotoxicosis. Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% should be used in these patients.

Pediatric Patients Less Than 1 Year of Age

Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% is contraindicated in pediatric patients less than 1 year of age due to the increased risk of systemic toxicity. Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% should be used in these patients [See Dosage and Administration section].

Warnings and Precautions

Topical Ophthalmic Use Only

Phenylephrine Hydrochloride Ophthalmic Solution, 2.5% and 10% is not indicated for injection.

Cardiovascular Reactions

There have been reports of serious cardiovascular reactions, including ventricular arrhythmias and myocardial infarctions, in patients using phenylephrine 10%. These episodes, some fatal, have usually occurred in patients with pre-existing cardiovascular diseases. Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% should be used in these patients.

Elevation in Blood Pressure

A significant elevation in blood pressure is not common but has been reported following conjunctival instillation of recommended doses of phenylephrine 10%. The risk is less with phenylephrine 2.5%. Caution should be exercised with the use of phenylephrine 10% in pediatric patients less than 5 years of age and patients with hyperthyroidism, or cardiovascular disease. The post-treatment blood pressure of patients with cardiac and endocrine diseases and any patients who develop symptoms should be carefully monitored.

Rebound Miosis

Rebound miosis has been reported one day after receiving phenylephrine hydrochloride ophthalmic solution, and re instillation of the drug produced a lesser mydriatic effect.

Adverse Reactions

The following serious adverse reactions are described below and elsewhere in the labeling: • Cardiac Disease [See Warnings and Precautions (5.2)] • Elevation in Blood Pressure [See Warnings and Precautions (5.3)] The following adverse reactions have been identified following use of phenylephrine hydrochloride ophthalmic solution. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Ocular Adverse Reactions

Eye pain and stinging on instillation, temporary blurred vision and photophobia, and conjunctival sensitization may occur.

Systemic Adverse Reactions

A marked increase in blood pressure has been reported particularly, but not limited to low weight premature neonates, infants and hypertensive patients.

Cardiovascular reactions which have occurred primarily in hypertensive patients following topical ocular use of phenylephrine hydrochloride ophthalmic solution 10% solution include marked increase in blood pressure, syncope, myocardial infarction, tachycardia, arrhythmia and subarachnoid hemorrhage. [See Warnings and Precautions (5.2 and 5.3)]

Drug Interactions

Agents That May Exaggerate Pressor Responses

Concomitant use of phenylephrine and atropine may enhance the pressor effects and induce tachycardia in some patients. Phenylephrine may potentiate the cardiovascular depressant effects of some inhalation anesthetic agents.

USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category C: Animal reproduction studies have not been conducted with topical phenylephrine. It is also not known whether phenylephrine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Phenylephrine hydrochloride should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in breast milk. Because many drugs are excreted in human milk, caution should be exercised when Phenylephrine Hydrochloride Ophthalmic Solution, 2.5% and 10% is administered to a nursing woman.

Pediatric Use

Phenylephrine Hydrochloride Ophthalmic Solution, 10% is contraindicated in pediatric patients less than 1 year of ageinfants. Phenylephrine Hydrochloride Ophthalmic Solution, 2.5% should be used in these patients [See 4.2 Contraindications].

Geriatric Use

No overall differences in safety and effectiveness have been observed between elderly and younger adult patients.

10. OVERDOSAGE

Overdosage of phenylephrine may cause a rapid rise in blood pressure. It may also cause headache, anxiety, nausea, and vomiting, and ventricular arrhythmias. Prompt injection of a rapidly acting alpha-adrenergic blocking agent such as phentolamine has been recommended.

Phenylephrine Ophthalmic Solution Description

Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10% is a sterile, clear, colorless, topical mydriatic agent for ophthalmic use. The chemical name is (R)-3-hydroxy-α-[(methylamino)methyl]benzenemethanol hydrochloride. Phenylephrine hydrochloride is represented by the following structural formula:

Phenylephrine hydrochloride has a molecular weight of 203.67 and an empirical formula of C9H13NO2-HCl.

Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, 2.5% contains: ACTIVE: phenylephrine hydrochloride 25 mg (2.5%); INACTIVES: sodium phosphate monobasic, sodium phosphate dibasic; boric acid, water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH (6.0-6.4). The solution has a tonicity of 500 mOsm/kg. PRESERVATIVE: benzalkonium chloride 0.01%.

Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, 10% contains: ACTIVE: phenylephrine hydrochloride 100 mg (10.0%); INACTIVES: sodium phosphate monobasic, sodium phosphate dibasic; water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH (6.3-6.7). The solution has a tonicity of 1000 mOsm/kg. PRESERVATIVE: benzalkonium chloride 0.01%.

Phenylephrine Ophthalmic Solution - Clinical Pharmacology

Mechanism of Action

Phenylephrine is an alpha-1 adrenergic receptor agonist used for dilation of the pupil due to its vasoconstrictor and mydriatic action. Phenylephrine possesses predominantly α-adrenergic effects. In the eye, phenylephrine acts locally as a potent vasoconstrictor and mydriatic, by constricting ophthalmic blood vessels and the radial muscle of the iris.

. Pharmacodynamics

Maximal mydriasis occurs in 20 to 90 minutes with recovery after 3 to 8 hours.

Systemic absorption of sufficient quantities of phenylephrine may lead to systemic α-adrenergic effects, such as rise in blood pressure which may be accompanied by a reflex atropine-sensitive bradycardia.

Pharmacokinetics

The systemic exposure following topical administration of phenylephrine hydrochloride ophthalmic solution has not been studied. A higher systemic absorption is expected for the 10% solution than the 2.5% solution and when the corneal barrier function is compromised.

Clinical Studies

Pupillary dilation following topical administration of phenylephrine hydrochloride ophthalmic solution has been demonstrated in controlled clinical studies in adults and pediatric patients with different levels of iris pigmentation. Pupil movement is generally seen within 15 minutes, maximal mydriasis between 20 to 90 minutes and recovery after 3 to 8 hours. Darker irides tend to dilate slower than lighter irides

How Supplied/Storage and Handling

Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% is supplied as a sterile, aqueous, topical ophthalmic solution  with a fill volume of 15 mL in a 15 mL opaque, white low density polyethylene (LDPE) bottle with a linear low density polyethylene (LLDPE) dropper tip and red cap. (NDC 42702-102-15)

Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% is supplied as a sterile, aqueous, topical ophthalmic solution  with a fill volume of 5 mL in a 10 mL opaque, white LDPE bottle with a LLDPE dropper tip and red cap. (NDC 42702-103-05)

Storage:

Store in a refrigerator at 2° to 8°C (36°-46°F).

Patient Counseling Information

Advise patients not to touch the dropper tip to any surface as this may contaminate the solution.

Inform patients they may experience sensitivity to light and should protect their eyes in bright illumination while their pupils are dilated.

Principal Display Panel - Phenylephrine Hydrochloride Ophthalmic Solution - 2.5% 15 mL Bottle Label

Principal Display Panel - Phenylephrine Hydrochloride Ophthalmic Solution - 2.5% 15 mL Bottle Carton

Principal Display Panel - Phenylephrine Hydrochloride Ophthalmic Solution - 10% 5 mL Bottle Label

Principal Display Panel - Phenylephrine Hydrochloride Ophthalmic Solution - 10% 5 mL Bottle Carton

PHENYLEPHRINE HYDROCHLORIDE 
phenylephrine hydrochloride solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42702-102
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
phenylephrine hydrochloride (phenylephrine) phenylephrine hydrochloride 2.5 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
hydrochloric acid  
sodium hydroxide  
boric acid  
sodium phosphate, monobasic  
sodium phosphate, dibasic  
water  
Packaging
# Item Code Package Description
1 NDC:42702-102-15 1 BOTTLE, DROPPER in 1 CARTON
1 15 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA203510 04/15/2013
PHENYLEPHRINE HYDROCHLORIDE 
phenylephrine hydrochloride solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42702-103
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
phenylephrine hydrochloride (phenylephrine) phenylephrine hydrochloride 100 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
hydrochloric acid  
sodium hydroxide  
boric acid  
sodium phosphate, monobasic  
sodium phosphate, dibasic  
water  
Packaging
# Item Code Package Description
1 NDC:42702-103-05 1 BOTTLE, DROPPER in 1 CARTON
1 5 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA203510 04/15/2013
Labeler - Paragon BioTeck, Inc. (078279037)
Registrant - Paragon BioTeck, Inc. (078279037)
Revised: 03/2013
 
Paragon BioTeck, Inc.

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