PHENYLEPHRINE HYDROCHLORIDE solution/ drops

Phenylephrine Hydrochloride by

Drug Labeling and Warnings

Phenylephrine Hydrochloride by is a Prescription medication manufactured, distributed, or labeled by Paragon BioTeck, Inc., Jubilant HollisterStier General Partnership. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • 1 INDICATIONS AND USAGE

    Phenylephrine Hydrochloride Ophthalmic Solution, 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, 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.

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

    2.2 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.

  • 3 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%.

  • 4 CONTRAINDICATIONS

    4.1 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.

    4.2 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] .

  • 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 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.

    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: 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.

    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 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)]

  • 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

    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.

    8.3 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.

    8.4 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] .

    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 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 structural formula

    Phenylephrine hydrochloride has a molecular weight of 203.67 and an empirical formula of C 9H 13NO 2-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%.

  • 12 CLINICAL PHARMACOLOGY

    12.1 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.

    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  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).

  • 17 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

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

    Phenylephrine Hydrochloride Ophthalmic Solution - 2.5% 15 mL Bottle Label

  • PRINCIPAL DISPLAY PANEL

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

    Phenylephrine Hydrochloride Ophthalmic Solution - 2.5% 15 mL Bottle Carton

  • PRINCIPAL DISPLAY PANEL

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

    Phenylephrine Hydrochloride Ophthalmic Solution - 10% 5 mL Bottle Label

  • PRINCIPAL DISPLAY PANEL

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

    Phenylephrine Hydrochloride Ophthalmic Solution - 10% 5 mL Bottle Carton

  • INGREDIENTS AND APPEARANCE
    PHENYLEPHRINE HYDROCHLORIDE 
    phenylephrine hydrochloride solution/ drops
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 42702-102
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    BORIC ACID (UNII: R57ZHV85D4)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 42702-102-151 in 1 CARTON04/15/2013
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC: 42702-102-101 in 1 CARTON04/15/2020
    210 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20351004/15/2013
    PHENYLEPHRINE HYDROCHLORIDE 
    phenylephrine hydrochloride solution/ drops
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 42702-103
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    BORIC ACID (UNII: R57ZHV85D4)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 42702-103-051 in 1 CARTON04/15/2013
    15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20351004/15/2013
    Labeler - Paragon BioTeck, Inc. (078279037)
    Registrant - Paragon BioTeck, Inc. (078279037)
    Establishment
    NameAddressID/FEIBusiness Operations
    Paragon BioTeck, Inc.078279037manufacture(42702-102, 42702-103)
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