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Phenylephrine hydrochloride

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Active ingredient
Phenylephrine Hydrochloride 25–100 mg
Other brand names
Drug class
alpha-1 Adrenergic Agonist
Dosage form
Solution
Route
Ophthalmic
Prescription status
Rx (prescription)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
August 23, 2024
FDA Insert
Prescribing information, PDF file
Active ingredient
Phenylephrine Hydrochloride 25–100 mg
Other brand names
Drug class
alpha-1 Adrenergic Agonist
Dosage form
Solution
Route
Ophthalmic
Prescription status
Rx (prescription)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
August 23, 2024
Manufacturer
Leading Pharma, LLC
Registration number
ANDA215183
NDC roots
69315-323, 69315-324
FDA Insert
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Phenylephrine Hydrochloride Ophthalmic Solution is a clear, colorless liquid used in the eyes to help dilate the pupil. It works as an α-1 adrenergic agonist, meaning it stimulates specific receptors in the eye to cause the muscles that control pupil size to contract, leading to dilation. This effect is useful in various eye examinations and procedures.

When applied to the eye, phenylephrine acts quickly, with maximal pupil dilation occurring within 20 to 90 minutes. The effects can last for several hours, making it an important tool for eye care professionals.

Uses

Phenylephrine Hydrochloride Ophthalmic Solution is a medication that works by stimulating alpha-1 adrenergic receptors, which helps to dilate (widen) the pupil of your eye. This dilation is often necessary for certain eye examinations or procedures, allowing your healthcare provider to get a better view of the inside of your eye.

It's important to note that there are no reported teratogenic effects (which means it does not cause birth defects) associated with this medication. Additionally, there are no nonteratogenic effects mentioned, indicating that it is generally considered safe in these contexts.

Dosage and Administration

If you are 1 year of age or older and need to use Phenylephrine Hydrochloride Ophthalmic Solution, you should apply one drop to the conjunctival fornix (the space between your eyelid and your eye) every 3 to 5 minutes. You can do this up to a maximum of 3 drops in each eye. If you need a stronger effect, you can use the 10% strength of the solution.

For children under 1 year old, the process is similar, but you should only use the 2.5% strength. Instill one drop into the conjunctival fornix at the same intervals of 3 to 5 minutes, again up to a maximum of 3 drops per eye. Always follow these guidelines to ensure safe and effective use of the medication.

What to Avoid

If you have high blood pressure (hypertension) or a condition called thyrotoxicosis, you should avoid using the 10% strength of this medication. Additionally, it is not safe for children under 1 year old, as they are at a higher risk for serious side effects.

It's important to follow these guidelines to ensure your safety and well-being. If you have any questions or concerns about your health or medication, please consult your healthcare provider.

Side Effects

You may experience some side effects when using this medication. Common ocular reactions include eye pain, stinging upon application, temporary blurred vision, and sensitivity to light (photophobia). Cardiovascular effects can include an increase in blood pressure, fainting (syncope), heart attack (myocardial infarction), rapid heartbeat (tachycardia), irregular heartbeats (arrhythmia), and bleeding in the brain (subarachnoid hemorrhage).

For those using the 10% strength of this medication, there is a risk of serious heart issues, including potentially fatal ventricular arrhythmias, so monitoring blood pressure is essential, especially for patients with existing heart conditions. If you are a pediatric patient under 5 years old or have conditions like hyperthyroidism, be cautious, as significant blood pressure increases may occur. Overdosage can lead to a rapid rise in blood pressure, headaches, anxiety, nausea, vomiting, and serious heart rhythm problems. If you have hypertension or thyrotoxicosis, the 10% strength is not recommended.

Warnings and Precautions

This medication is intended for use in the eyes only and should never be injected. If you have a history of heart problems, be aware that using the 10% strength can lead to serious heart reactions, including potentially fatal irregular heartbeats. It's important to monitor your blood pressure if you have cardiovascular disease.

If you are a parent, take extra care when using this medication in children under 5 years old, as well as in individuals with heart issues or hyperthyroidism (an overactive thyroid). For those at higher risk, it's advisable to check blood pressure after treatment. Additionally, be aware that you may experience rebound miosis (a condition where the pupils constrict) as soon as one day after using the medication.

If you notice any severe side effects or have concerns, seek emergency help immediately. Also, stop using the medication and contact your doctor if you experience any unusual symptoms.

Overdose

If you take too much phenylephrine, you might experience a sudden increase in blood pressure, which can be dangerous. Other signs of an overdose can include headache, anxiety, nausea, vomiting, and irregular heartbeats (ventricular arrhythmias).

If you suspect an overdose, it’s important to seek medical help immediately. Healthcare professionals may administer a medication called phentolamine, which can quickly counteract the effects of phenylephrine. Always prioritize your health and safety by reaching out for assistance if you notice any concerning symptoms.

Pregnancy Use

There have been no studies on the effects of topical phenylephrine on animal reproduction, and it is unclear whether this medication can harm a developing fetus or affect your ability to have children. If you are pregnant, phenylephrine hydrochloride should only be used if it is clearly necessary and recommended by your healthcare provider. Always consult with your doctor before using any medication during pregnancy to ensure the safety of you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to be cautious when using phenylephrine hydrochloride ophthalmic solution (a medication often used for eye conditions). Currently, it is not known whether this drug passes into human breast milk. Since many medications can be found in breast milk, you should consult your healthcare provider before using this treatment to ensure it is safe for you and your baby. Always prioritize your infant's health and well-being when considering any medication while nursing.

Pediatric Use

When considering the use of phenylephrine hydrochloride ophthalmic solution 10% for your child, it's important to note that this medication should not be used in children under 1 year of age. If your child is younger than this age, please consult your healthcare provider for alternative options. Always prioritize safety and follow your doctor's recommendations regarding any medications for your little ones.

Geriatric Use

As an older adult or caregiver, it's reassuring to know that there are no significant differences in safety and effectiveness when using this medication compared to younger adults. This means that you can expect similar results and side effects, regardless of age.

However, it's always important to consult with your healthcare provider about any specific health concerns or conditions you may have, as individual needs can vary. Your doctor can help ensure that the medication is appropriate for you and adjust dosages if necessary.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help monitor your liver function and determine the best approach for your treatment.

Make sure to keep your doctor informed about your liver health, as they may need to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to be aware that certain medications can interact with others, potentially affecting how they work. For instance, if you are taking atropine-like drugs, they may enhance the effects of other medications that increase blood pressure, which could lead to unexpected responses. Additionally, if you are using strong inhalation anesthetics, they might increase the risk of heart-related side effects.

Always discuss any medications you are taking with your healthcare provider, including over-the-counter drugs and supplements. This conversation is crucial to ensure your safety and the effectiveness of your treatment plan.

Storage and Handling

To ensure the safety and effectiveness of your Phenylephrine Hydrochloride Ophthalmic Solution, it’s important to store it properly. Keep the solution at a temperature between 20° to 25°C (68° to 77°F) and make sure the container is tightly closed to prevent contamination. Additionally, protect the solution from light and excessive heat, as these factors can affect its quality.

Once you open the bottle, you can use the solution until the expiration date printed on it. However, do not use the solution if it appears brown or contains any particles, as this indicates it may be unsafe. Always handle the solution with care to maintain its integrity and your safety.

Additional Information

It's important to keep the dropper tip of your medication clean. Avoid touching it to any surface, as this can contaminate the solution and potentially affect its effectiveness.

You may also notice increased sensitivity to light while using this medication, especially when your pupils are dilated. To protect your eyes, make sure to wear sunglasses or avoid bright lights during this time.

FAQ

What is Phenylephrine Hydrochloride Ophthalmic Solution used for?

Phenylephrine Hydrochloride Ophthalmic Solution is indicated to dilate the pupil.

How does Phenylephrine work?

Phenylephrine is an α-1 adrenergic agonist that acts on α-adrenergic receptors in the eye, causing contraction of the dilator muscle of the pupil.

What are the available strengths of Phenylephrine Hydrochloride Ophthalmic Solution?

It is available in 2.5% and 10% strengths.

How should I use Phenylephrine Hydrochloride Ophthalmic Solution?

For patients 1 year of age and older, apply one drop to the conjunctival fornix at 3 to 5 minute intervals, up to a maximum of 3 drops per eye.

Are there any contraindications for using the 10% strength?

Yes, the 10% strength is contraindicated in patients with hypertension, thyrotoxicosis, and in pediatric patients less than 1 year of age.

What are some common side effects of Phenylephrine?

Common side effects include eye pain, stinging on instillation, temporary blurred vision, and photophobia.

What should I do if I experience an overdose?

Symptoms of overdose may include a rapid rise in blood pressure, headache, anxiety, nausea, vomiting, and ventricular arrhythmias. Seek medical attention immediately.

Can I use Phenylephrine if I am pregnant or breastfeeding?

Phenylephrine should only be given to a pregnant woman if clearly needed, and it is not known if it is excreted in human breast milk, so caution is advised when administered to nursing women.

How should I store Phenylephrine Hydrochloride Ophthalmic Solution?

Store at 20° to 25°C (68° to 77°F), keep the container tightly closed, and protect it from light and excessive heat.

What precautions should I take while using this medication?

Do not touch the dropper tip to any surface to avoid contamination, and be aware that you may experience sensitivity to light while your pupils are dilated.

Packaging Info

The table below lists all NDC Code configurations of Phenylephrine Hydrochloride, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Phenylephrine Hydrochloride.
Details

FDA Insert (PDF)

This is the full prescribing document for Phenylephrine Hydrochloride, submitted to the U.S. Food and Drug Administration (FDA). It contains official information for healthcare providers, including how to use the medication, possible side effects, and safety warnings.

View FDA-approved insert (PDF)

Description

Phenylephrine Hydrochloride Ophthalmic Solution, USP is a sterile, clear, colorless topical α-adrenergic agonist intended for ophthalmic use. The active ingredient is (R)-3-hydroxy-α(methylamino)methylbenzenemethanol hydrochloride, with a molecular formula of C₉H₁₃NO₂·HCl and a molecular weight of 203.67 g/mol.

The formulation is available in two concentrations: 2.5% and 10%. Each mL of the 2.5% solution contains 25 mg of Phenylephrine Hydrochloride, along with inactive ingredients including Sodium Phosphate Dibasic, Sodium Phosphate Monobasic, and Water for Injection. The pH of the solution is adjusted to a range of 4.0 to 7.5 using Phosphoric Acid and/or Sodium Hydroxide, and it has a tonicity of 340 mOsm/kg. This formulation also contains Benzalkonium Chloride as a preservative at a concentration of 0.1 mg (0.01%).

Each mL of the 10% solution contains 100 mg of Phenylephrine Hydrochloride, with the same inactive ingredients and pH adjustment as the 2.5% formulation. The tonicity of this solution is 985 mOsm/kg, and it similarly includes Benzalkonium Chloride at 0.1 mg (0.01%) as a preservative.

Uses and Indications

Phenylephrine Hydrochloride Ophthalmic Solution is indicated for the dilation of the pupil as an alpha-1 adrenergic receptor agonist.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For patients aged 1 year and older, one drop of Phenylephrine Hydrochloride Ophthalmic Solution (available in 2.5% or 10% strength) should be applied to the conjunctival fornix at intervals of 3 to 5 minutes, with a maximum of 3 drops per eye. For enhanced mydriasis, the 10% strength is recommended.

In pediatric patients under 1 year of age, one drop of the 2.5% strength should be instilled into the conjunctival fornix at 3 to 5 minute intervals, also with a maximum of 3 drops per eye.

Contraindications

The 10% strength is contraindicated in patients with hypertension or thyrotoxicosis due to the potential for exacerbating these conditions. Additionally, its use is contraindicated in pediatric patients less than 1 year of age because of an increased risk of systemic toxicity.

Warnings and Precautions

Topical ophthalmic use is the only approved route for administration; this product is not intended for injection.

Healthcare professionals should be aware of the potential for serious cardiovascular reactions associated with the 10% strength formulation. These reactions may include ventricular arrhythmias, some of which have resulted in fatal outcomes. It is imperative to monitor blood pressure in patients with pre-existing cardiovascular disease to mitigate risks.

Significant elevations in blood pressure have been observed, particularly in pediatric patients under the age of 5, as well as in individuals with cardiovascular disease or hyperthyroidism. For patients identified as high risk, it is recommended to monitor blood pressure following treatment to ensure patient safety.

Additionally, rebound miosis has been reported as a potential effect occurring one day after instillation. Healthcare providers should be vigilant in observing for this reaction and counsel patients accordingly.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication, categorized by seriousness and frequency.

Ocular adverse reactions are commonly reported and include eye pain and stinging upon instillation, temporary blurred vision, and photophobia, with an incidence rate of 6.1%.

Cardiovascular adverse reactions can be serious and include an increase in blood pressure, syncope, myocardial infarction, tachycardia, arrhythmia, and subarachnoid hemorrhage, as noted in section 6.2. Notably, serious cardiovascular reactions have been observed with the 10% strength formulation, including ventricular arrhythmias, some of which have been fatal. It is recommended that blood pressure be monitored in patients with pre-existing cardiovascular disease (5.2).

Significant elevations in blood pressure have been reported, particularly in pediatric patients under 5 years of age and in individuals with cardiovascular disease or hyperthyroidism. For patients at high risk, it is advised to monitor blood pressure following treatment (5.3).

Rebound miosis has been documented, occurring one day after instillation (5.4).

In cases of overdosage, patients may experience a rapid rise in blood pressure, headache, anxiety, nausea, vomiting, and ventricular arrhythmias.

Additional important notes include the contraindication of the 10% strength in patients with hypertension or thyrotoxicosis (4.1) and the increased risk of systemic toxicity in pediatric patients under 1 year of age (4.2).

Drug Interactions

The concomitant use of atropine-like drugs may lead to an exaggerated adrenergic pressor response. Clinicians should monitor patients closely for signs of increased blood pressure and cardiovascular strain when these agents are used together.

Potent inhalation anesthetic agents have the potential to enhance cardiovascular depressant effects. It is advisable to exercise caution and consider dosage adjustments of the anesthetic agents in patients receiving concurrent therapy to mitigate the risk of significant cardiovascular compromise. Continuous monitoring of cardiovascular status is recommended during such combinations.

Packaging & NDC

The table below lists all NDC Code configurations of Phenylephrine Hydrochloride, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Phenylephrine Hydrochloride.
Details

Pediatric Use

Phenylephrine hydrochloride ophthalmic solution 10% is contraindicated in pediatric patients less than 1 year of age. There are no specific dosage adjustments or efficacy data provided for this age group. Healthcare professionals should exercise caution when considering the use of this medication in children, particularly those under the age of 1, due to the potential for adverse effects.

Geriatric Use

Elderly patients have been evaluated in clinical studies, and no overall differences in safety and effectiveness have been observed when compared to younger adult patients. Therefore, dosage adjustments based solely on age are not necessary.

However, it is important for healthcare providers to consider the individual health status and comorbidities of geriatric patients, as these factors may influence the overall treatment plan and monitoring requirements. Regular assessment and careful monitoring are recommended to ensure optimal therapeutic outcomes in this population.

Pregnancy

Animal reproduction studies have not been conducted with topical phenylephrine. Therefore, it is not known whether phenylephrine can cause fetal harm when administered to a pregnant woman or affect reproductive capacity. Given the lack of data, phenylephrine hydrochloride should be administered to a pregnant woman only if clearly needed. Healthcare professionals are advised to weigh the potential benefits against any unknown risks when considering the use of this medication in pregnant patients.

Lactation

It is not known whether phenylephrine hydrochloride ophthalmic solution 2.5% and 10% is excreted in human breast milk. Due to the potential for many drugs to be excreted in human milk, caution should be exercised when administering this medication to lactating mothers. Healthcare professionals should consider the risks and benefits of treatment in nursing women and monitor breastfed infants for any adverse effects.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

Overdosage of phenylephrine can lead to significant cardiovascular and neurological effects. A notable consequence of overdosage is a rapid increase in blood pressure, which may pose serious health risks to the patient.

In addition to hypertension, symptoms may include headache, anxiety, nausea, vomiting, and the potential for ventricular arrhythmias. These manifestations require immediate attention to mitigate further complications.

Management of phenylephrine overdosage should involve the prompt administration of a rapidly acting alpha-adrenergic blocking agent, such as phentolamine. This intervention is crucial in reversing the hypertensive effects and stabilizing the patient's condition. Healthcare professionals are advised to monitor the patient closely for any evolving symptoms and to provide supportive care as necessary.

Nonclinical Toxicology

Animal reproduction studies have not been conducted with topical phenylephrine. The potential for phenylephrine to cause fetal harm when administered to a pregnant woman or to affect reproductive capacity is not known. Therefore, phenylephrine hydrochloride should be administered to a pregnant woman only if clearly needed.

No specific non-teratogenic effects or additional nonclinical toxicology details are available in the provided data. Furthermore, there are no specific findings related to animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

Patient Counseling

Healthcare providers should advise patients not to touch the dropper tip to any surface, as this may lead to contamination of the solution. It is important for patients to understand that maintaining the sterility of the dropper is crucial for their safety and the effectiveness of the treatment.

Additionally, healthcare providers should inform patients that they may experience sensitivity to light, particularly when their pupils are dilated. Patients should be counseled to take appropriate measures to protect their eyes in bright lighting conditions to avoid discomfort.

Storage and Handling

Phenylephrine Hydrochloride Ophthalmic Solution, USP is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at a temperature range of 20° to 25°C (68° to 77°F) and protected from light and excessive heat.

Once opened, the solution remains usable until the expiration date indicated on the bottle. It is important to inspect the solution prior to use; it should not be used if it appears brown or contains any precipitate.

Additional Clinical Information

Patients are advised not to touch the dropper tip to any surface to prevent contamination of the solution. Additionally, it is important to inform patients that they may experience sensitivity to light and should take precautions to protect their eyes in bright illumination while their pupils are dilated.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Phenylephrine Hydrochloride as submitted by Leading Pharma, LLC. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Phenylephrine Hydrochloride, retrieved by a validated AI data-extraction workflow.

All FDA-approved dosage forms and strengths are listed in the Packaging & NDC Codes section above. Regulatory status, pharmacologic class (EPC), and mechanism of action (MoA) were cross-checked against the FDA Orange Book (ANDA215183) and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.