PHENYLEPHRINE HYDROCHLORIDE solution

PHENYLEPHRINE HYDROCHLORIDE by

Drug Labeling and Warnings

PHENYLEPHRINE HYDROCHLORIDE by is a Prescription medication manufactured, distributed, or labeled by Leading Pharma, LLC, CAPLIN STERILES LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • 1 INDICATIONS AND USAGE

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

  • 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.

    2.2 Dosing in Pediatric Patients Less Than 1 Year of Age

    In pediatric patients less than 1 year of age, one drop of phenylephrine hydrochloride ophthalmic solution 2.5% should be instilled at 3 to 5 minute intervals up to a maximum of 3 drops per eye.

  • 3 DOSAGE FORMS AND STRENGTHS

    Phenylephrine hydrochloride ophthalmic solution, USP 2.5% is a clear, colorless to yellow solution, 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 to yellow solution, sterile topical ophthalmic solution containing phenylephrine hydrochloride 10%.: each mL contains 100 mg of phenylephrine hydrochloride.

  • 4 CONTRAINDICATIONS

    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 [SeeDosage 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.

    5.4. 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.

  • 6 ADVERSE REACTIONS

    The following serious adverse reactions are described below and elsewhere in the labeling:

    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 [SeeWarnings and Precautions (5.2 and 5.3)].

  • 7 DRUG INTERACTIONS

    7.1 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.

  • 8 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    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)].

    8.5 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.

  • 11 DESCRIPTION

    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

    chemicalstructure

    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 Dibasic, Sodium Phosphate Monobasic, 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 Dibasic, Sodium Phosphate Monobasic, 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.

    12.2 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.

    12.3 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.

  • 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

    Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% is supplied as a sterile, aqueous, topical ophthalmic solution in an opaque, white low density polyethylene (LDPE) bottle with a natural LDPE dropper tip and red cap in the following sizes:

    NDC: 69315-323-08                2 mL in 5 mL bottle

    NDC: 69315-323-15                15 mL in 15 mL bottle

    Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% is supplied as a sterile, aqueous, topical ophthalmic solution in an opaque, white low density polyethylene (LDPE) bottle with a natural LDPE dropper tip and red cap in the following sizes:

    NDC: 69315-324-05                5 mL in 10 mL bottle

    After opening, Phenylephrine Hydrochloride Ophthalmic Solution, USP can be used until the expiration date on the bottle.

    Storage: Store at 20° to 25°C (68° to 77°F).

    Keep container tightly closed.
    Protect from light and excessive heat.

    Do not use if solution is brown or contains precipitate.

  • 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:

    Caplin Steriles Limited,
    Gummidipoondi – 601 201,
    India.

    Distributed by:

    Leading Pharma, LLC
    Fairfield, NJ 07004,
    USA.

    Code:TN/Drugs/TN00003457

    Revised: 12/2023
    22200702

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 69315-323-08

    Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5%
    For eye use only
    2 mL
    Rx only

    containerlabel2p5p2mL

    cartonlabel2p5p2mL

    NDC 69315-323-15
    Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5%
    For eye use only
    15 mL
    Rx only

    containerlabel2p5p15mL

    cartonlabel2p5p15mL

    NDC 69315-324-05
    Phenylephrine Hydrochloride Ophthalmic Solution, USP 10%
    For eye use only
    5 mL
    Rx only

    containerlabel10p5mL

    cartonlabel10p5mL

  • INGREDIENTS AND APPEARANCE
    PHENYLEPHRINE HYDROCHLORIDE 
    phenylephrine hydrochloride solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 69315-323
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    WATER (UNII: 059QF0KO0R)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Product Characteristics
    Colorwhite (clear, colorless) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 69315-323-081 in 1 CARTON09/05/2024
    12 mL in 1 BOTTLE, DROPPER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    2NDC: 69315-323-151 in 1 CARTON09/05/2024
    215 mL in 1 BOTTLE, DROPPER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21518309/05/2024
    PHENYLEPHRINE HYDROCHLORIDE 
    phenylephrine hydrochloride solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 69315-324
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    WATER (UNII: 059QF0KO0R)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Product Characteristics
    Colorwhite (clear, colorless) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 69315-324-051 in 1 CARTON09/05/2024
    15 mL in 1 BOTTLE, DROPPER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21518309/05/2024
    Labeler - Leading Pharma, LLC (079575060)
    Establishment
    NameAddressID/FEIBusiness Operations
    CAPLIN STERILES LIMITED650744670manufacture(69315-323, 69315-324)
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