Label: PHENYLEPHRINE HYDROCHLORIDE solution/ drops
Contains inactivated NDC Code(s)
NDC Code(s): 50090-4514-0
- Packager: A-S Medication Solutions
- This is a repackaged label.
- Source NDC Code(s): 17478-201
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated April 15, 2021
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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP safely and effectively. See full prescribing information for PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP.
PHENYLEPHRINE HYDROCHLORIDE ophthalmic solution, USP 2.5% and 10%.
Initial U.S. Approval: 1939
INDICATIONS AND USAGE
Phenylephrine Hydrochloride Ophthalmic Solution is an alpha-1 adrenergic receptor agonist indicated to dilate the pupil (1)
DOSAGE AND ADMINISTRATION
For patients 1 year of age and older: (2.1)
- Apply one drop of Phenylephrine Hydrochloride Ophthalmic Solution (2.5% or 10% strength) to conjunctival fornix at 3 to 5 minute intervals up to a maximum of 3 drops per eye.
- To obtain a greater degree of mydriasis, use 10% strength
For pediatric patients less than 1 year of age: (2.2)
- Instill one drop of 2.5% strength to conjunctival fornix at 3 to 5 minute intervals up to a maximum of 3 drops per eye
DOSAGE FORMS AND STRENGTHS
Ophthalmic solution (sterile): (3)
- 25 mg of phenylephrine hydrochloride in one mL of solution (2.5%)
- 100 mg of phenylephrine hydrochloride in one mL of solution (10%)
WARNINGS AND PRECAUTIONS
- Not for injection: Topical ophthalmic use only (5.1)
- Serious cardiovascular reactions with 10% strength: Reactions have included ventricular arrhythmias and some have been fatal. Monitor blood pressure in patients with cardiovascular disease (5.2).
- Significant elevations in blood pressure: Caution in pediatric patients less than 5 years of age, and in patients with cardiovascular disease or hyperthyroidism. In patients at high risk, monitor blood pressure post treatment (5.3).
- Rebound miosis: Reported one day after instillation (5.4)
- Ocular adverse reactions include eye pain and stinging on instillation, temporary blurred vision, and photophobia (6.1)
- Cardiovascular adverse reactions include increase in blood pressure, syncope, myocardial infarction, tachycardia, arrhythmia and subarachnoid hemorrhage (6.2)
To report SUSPECTED ADVERSE REACTIONS, contact Akorn, Inc. at 1-800-932-5676 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
See 17 for PATIENT COUNSELING INFORMATION.
Table of Contents
FULL PRESCRIBING INFORMATION: CONTENTS*
- Sections or subsections omitted from the full prescribing information are not listed.
- 1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 General Dosing Recommendations
In patients 1 year of age or greater, apply one drop of either phenylephrine hydrochloride ophthalmic solution 2.5% or 10% every 3 to 5 minutes to the conjunctival fornix as required up to a maximum of 3 drops per eye per day.
In order to obtain a greater degree of mydriasis, phenylephrine hydrochloride ophthalmic solution 10% may be needed.
3 DOSAGE FORMS AND STRENGTHS
Phenylephrine hydrochloride ophthalmic solution, USP 2.5% is a clear, colorless, sterile topical ophthalmic solution containing phenylephrine hydrochloride 2.5%: each mL contains 25 mg of phenylephrine hydrochloride.
Phenylephrine hydrochloride ophthalmic solution, USP 10% is a clear, colorless, sterile topical ophthalmic solution containing phenylephrine hydrochloride 10%.: each mL contains 100 mg of phenylephrine hydrochloride.
4.1 Cardiac and Endocrine Disease
Phenylephrine hydrochloride ophthalmic solution 10% is contraindicated in patients with hypertension or thyrotoxicosis. Phenylephrine hydrochloride ophthalmic solution 2.5% should be used in these patients.
4.2 Pediatric Patients Less Than 1 Year of Age
Phenylephrine hydrochloride ophthalmic solution 10% is contraindicated in pediatric patients less than 1 year of age due to the increased risk of systemic toxicity. Phenylephrine hydrochloride ophthalmic solution 2.5% should be used in these patients [See Dosage and Administration (2.2)].
5 WARNINGS AND PRECAUTIONS
5.1 Topical Ophthalmic Use Only
Phenylephrine hydrochloride ophthalmic solution 2.5% and 10% is not indicated for injection.
5.2 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.
5.3 Elevation of 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.
6 ADVERSE REACTIONS
The following serious adverse reactions are described below and elsewhere in the labeling:
- Cardiovascular Effects [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.
6.1 Ocular Adverse Reactions
Eye pain and stinging on instillation, temporary blurred vision and photophobia, and conjunctival sensitization may occur.
6.2 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 effects which have been seen primarily in hypertensive patients following topical ocular use of phenylephrine hydrochloride ophthalmic solution 10% include marked increase in blood pressure, syncope, myocardial infarction, tachycardia, arrhythmia and subarachnoid hemorrhage [See Warnings and Precautions (5.2 and 5.3)].
- 7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
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.
8.3 Nursing Mothers
It is not known whether this drug is excreted in human 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.
8.4 Pediatric Use
Phenylephrine hydrochloride ophthalmic solution 10% is contraindicated in pediatric patients less than 1 year of age [See Contraindications (4.2)].
- 10 OVERDOSAGE
Phenylephrine Hydrochloride Ophthalmic Solution, USP is a sterile, clear, colorless, topical α-adrenergic agonist for ophthalmic use. The active ingredient is represented by the chemical structure
Chemical Name: (R)-3-hydroxy-α[(methylamino)methyl]benzenemethanol hydrochloride.
Molecular Formula: C9H13NO2.HCl
Molecular Weight: 203.67 g/mol
Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% contains: ACTIVE: Phenylephrine Hydrochloride 25 mg (2.5%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 340 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%).
Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% contains: ACTIVE: Phenylephrine Hydrochloride 100 mg (10%); INACTIVES: Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Water for Injection. Phosphoric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 to 7.5). The solution has a tonicity of 985 mOsm/kg; PRESERVATIVE: Benzalkonium Chloride 0.1 mg (0.01%).
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Phenylephrine hydrochloride is an α-1 adrenergic agonist drug that is used in ophthalmology mainly for its mydriatic effect. After topical application to the conjunctiva, phenylephrine acts directly on α-adrenergic receptors in the eye, producing contraction of the dilator muscle of the pupil and constriction of the arterioles in the conjunctiva.
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.
14 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.
- 16 HOW SUPPLIED/STORAGE AND HANDLING
17. PATIENT COUNSELING INFORMATION
Advise patients not to touch the dropper tip to any surface as this may contaminate the solution. Inform patients that they may experience sensitivity to light and should protect their eyes in bright illumination while their pupils are dilated.
Manufactured by: Akorn, Inc.
Lake Forest, IL 60045
EL00N Rev. 02/19
- STORAGE AND HANDLING
- Phenylephrine Hydrochloride
INGREDIENTS AND APPEARANCE
phenylephrine hydrochloride solution/ drops
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-4514(NDC:17478-201) Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 25 mg in 1 mL Inactive Ingredients Ingredient Name Strength Sodium Phosphate, Dibasic, Anhydrous (UNII: 22ADO53M6F) Sodium Phosphate, Monobasic, Anhydrous (UNII: KH7I04HPUU) Sodium Hydroxide (UNII: 55X04QC32I) Phosphoric Acid (UNII: E4GA8884NN) Water (UNII: 059QF0KO0R) Benzalkonium Chloride (UNII: F5UM2KM3W7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50090-4514-0 1 in 1 CARTON 09/10/2019 1 2 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA207926 01/15/2015 Labeler - A-S Medication Solutions (830016429) Establishment Name Address ID/FEI Business Operations A-S Medication Solutions 830016429 RELABEL(50090-4514)