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Phenylephrine hydrochloride

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Active ingredient
Phenylephrine Hydrochloride 25 mg/1 mL
Other brand names
Drug class
alpha-1 Adrenergic Agonist
Dosage form
Solution/ Drops
Route
Ophthalmic
Prescription status
Rx (prescription)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2023
Label revision date
March 31, 2023
FDA Insert
Prescribing information, PDF file
Active ingredient
Phenylephrine Hydrochloride 25 mg/1 mL
Other brand names
Drug class
alpha-1 Adrenergic Agonist
Dosage form
Solution/ Drops
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 2023
Label revision date
March 31, 2023
Manufacturer
Bausch & Lomb Americas Inc.
Registration number
NDA203510
NDC roots
82260-102, 82260-103
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 eye care to dilate the pupil. It contains phenylephrine, which is an alpha-1 adrenergic receptor agonist. This means it works by constricting blood vessels in the eye and relaxing the muscles of the iris, leading to pupil dilation. This effect is useful during eye examinations or certain surgical procedures.

Available in two concentrations, 2.5% and 10%, phenylephrine is applied topically to the eye. The dilation effect typically occurs within 20 to 90 minutes and can last for several hours. This medication is designed to help healthcare providers assess your eye health more effectively.

Uses

Phenylephrine Hydrochloride Ophthalmic Solution, available in concentrations of 2.5% and 10%, is primarily used to dilate the pupil. This can be important for various eye examinations and procedures, allowing your eye care professional to get a better view of the inside of your eye.

It's worth noting that there are no reported teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects associated with this medication. This makes it a safe option for its intended use in pupil dilation.

Dosage and Administration

If you are using Phenylephrine Hydrochloride Ophthalmic Solution, it’s important to know how to apply it correctly. For anyone aged 1 year and older, you should apply one drop of the solution, either at a concentration of 2.5% or 10%, into your eye. You can repeat this every 3 to 5 minutes, but make sure not to exceed a total of 3 drops in one eye.

For children under 1 year of age, the process is similar, but you should only use the 2.5% concentration. Again, instill one drop at 3 to 5 minute intervals, ensuring that you do not go beyond 3 drops in one eye. Always follow these guidelines to ensure safe and effective use of the medication.

What to Avoid

You should avoid using Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% if you have high blood pressure (hypertension) or a condition called thyrotoxicosis, which is an overproduction of thyroid hormones. Additionally, this medication is not safe for children under 1 year old due to a higher risk of serious side effects.

If you have hypertension or thyrotoxicosis, or if you are treating a child younger than 1 year, do not use Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5%. It's important to follow these guidelines to ensure your safety and well-being.

Side Effects

You may experience some side effects when using Phenylephrine Hydrochloride Ophthalmic Solution, including eye pain, stinging upon application, temporary blurred vision, and sensitivity to light (photophobia). It's important to be aware of potential cardiovascular reactions, which can be serious and even fatal. These may include increased blood pressure, fainting (syncope), heart attack (myocardial infarction), rapid heartbeat (tachycardia), irregular heartbeats (arrhythmia), and bleeding in the brain (subarachnoid hemorrhage).

If you have a history of cardiovascular issues, it's crucial to monitor your blood pressure while using this medication. Significant increases in blood pressure have been noted, especially in children under 5 and those with pre-existing high blood pressure. Additionally, if you use too much of this medication, you might experience a rapid rise in blood pressure along with symptoms like headache, anxiety, nausea, vomiting, and irregular heartbeats.

Warnings and Precautions

Phenylephrine Hydrochloride Ophthalmic Solution is intended for use in the eyes only and should never be injected. If you have a history of heart problems, it's important to monitor your blood pressure while using this medication, as serious cardiovascular reactions, including some that can be fatal, have been reported.

You should be particularly cautious if you are a parent of a child under 5 years old or if you have high blood pressure, as significant increases in blood pressure have been noted in these groups. Additionally, be aware that rebound miosis (a condition where the pupil constricts again after it has been dilated) can occur one day after using the solution.

If you experience any severe side effects or unusual symptoms, seek emergency help immediately. If you notice any concerning changes or have questions about your use of this medication, stop using it and contact your doctor right away.

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 contacting a medical provider if you notice any concerning symptoms.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be cautious with medications. Currently, there have been no animal studies on the effects of topical phenylephrine, which means we don't know if it could harm a developing fetus or affect your ability to have children. Because of this uncertainty, phenylephrine hydrochloride ophthalmic solution (available in 2.5% and 10% concentrations) should only be used during pregnancy if it is clearly necessary and prescribed by your healthcare provider. Always discuss any medications with your doctor to ensure the safety of you and your baby.

Lactation Use

It is currently unclear whether Phenylephrine Hydrochloride Ophthalmic Solution (a medication used in the eyes) passes into human breast milk. Since many medications can be found in breast milk, it's important to be cautious if you are a nursing mother considering this treatment. Always consult with your healthcare provider to discuss any potential risks and to ensure the safety of both you and your baby while breastfeeding.

Pediatric Use

If you are considering using Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% for your child, it's important to know that this medication should not be used in children under 1 year of age. This means that if your child is younger than this age, you should avoid using this eye solution. Always consult with your child's healthcare provider for guidance on safe and appropriate treatments for their specific age and health needs.

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. Staying informed and discussing your treatment options can help ensure the best care for you or your loved one.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no detailed guidelines available for how the medication may affect you or how your liver health might influence the treatment.

Given this lack of information, it's crucial to discuss your liver condition with your healthcare provider before starting any new medication. They can help determine the best approach for your treatment and ensure your safety. Always keep them informed about your liver health to receive the most appropriate care.

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, some medications may increase your body's response to these drugs, which can lead to heightened effects. Additionally, if you are undergoing surgery and receiving potent inhalation anesthetics, some medications might enhance their effects on your heart and blood pressure.

To ensure your safety and the effectiveness of your treatment, always discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. They can help you understand any potential interactions and adjust your treatment plan as needed.

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 in a cool place, ideally between 2°C to 25°C (36°F to 77°F), and make sure the container is tightly closed when not in use.

Before using the solution, check its appearance. Do not use it if the solution is brown or has any particles floating in it, as this could indicate contamination. Once you open the bottle, you can use the solution until the expiration date printed on the label. Always handle the product with care to maintain its quality and safety.

Additional Information

No further information is available.

FAQ

What is Phenylephrine Hydrochloride Ophthalmic Solution used for?

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

What are the active ingredients in Phenylephrine Hydrochloride Ophthalmic Solution?

Each mL of the 2.5% solution contains 25 mg of phenylephrine hydrochloride, while the 10% solution contains 100 mg.

How should I use Phenylephrine Hydrochloride Ophthalmic Solution?

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

Are there any contraindications for using Phenylephrine Hydrochloride Ophthalmic Solution?

Yes, the 10% solution 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 Hydrochloride Ophthalmic Solution?

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

What should I be cautious about when using this medication?

Monitor blood pressure, especially in patients with cardiovascular disease, as significant elevations in blood pressure have been reported.

Can Phenylephrine Hydrochloride Ophthalmic Solution be used during pregnancy?

It should only be given to a pregnant woman if clearly needed, as it is not known whether it can cause fetal harm.

Is it safe to use Phenylephrine Hydrochloride Ophthalmic Solution while breastfeeding?

Caution should be exercised when administering this solution to a nursing woman, as it is not known if it is excreted in human breast milk.

How should I store Phenylephrine Hydrochloride Ophthalmic Solution?

Store at 2°C to 25°C (36°F to 77°F) and keep the container tightly closed. Do not use if the solution is brown or contains a precipitate.

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 2.5% and 10% is a sterile, clear, colorless topical mydriatic agent intended for ophthalmic use. The chemical name of the active ingredient is (R)-3-hydroxy-α-(methylamino)methylbenzenemethanol hydrochloride. The structural formula of phenylephrine hydrochloride is provided, with a molecular weight of 203.67 and an empirical formula of C9H13NO2-HCl.

Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, 2.5% contains 25 mg of phenylephrine hydrochloride (2.5%) as the active ingredient, along with inactive components including sodium phosphate monobasic, sodium phosphate dibasic, boric acid, and water for injection. Hydrochloric acid and/or sodium hydroxide may be utilized to adjust the pH within the range of 4.0 to 7.5. The solution exhibits a tonicity of 500 mOsm/kg and contains 0.01% benzalkonium chloride as a preservative.

Each mL of Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% contains 100 mg of phenylephrine hydrochloride (10%) as the active ingredient, with inactive ingredients comprising sodium phosphate monobasic, sodium phosphate dibasic, and water for injection. Similar to the 2.5% formulation, hydrochloric acid and/or sodium hydroxide may be added to adjust the pH (4.0-7.5). This solution has a tonicity of 1000 mOsm/kg and also includes 0.01% benzalkonium chloride as a preservative.

Uses and Indications

Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10% is indicated for the dilation of the pupil.

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

Dosage and Administration

For patients aged 1 year and older, one drop of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% or 10% should be applied at intervals of 3 to 5 minutes, with a maximum of 3 drops per eye.

In pediatric patients under 1 year of age, one drop of Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% is to be instilled at the same intervals of 3 to 5 minutes, also with a maximum of 3 drops per eye.

Care should be taken to ensure proper administration technique to avoid contamination of the dropper tip and to ensure accurate dosing.

Contraindications

Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% is contraindicated in patients with hypertension or thyrotoxicosis due to the potential for exacerbating these conditions. Additionally, its use is contraindicated in pediatric patients under 1 year of age because of the increased risk of systemic toxicity.

Warnings and Precautions

Phenylephrine Hydrochloride Ophthalmic Solution, USP is strictly indicated for topical ophthalmic use and is not intended for injection.

Healthcare professionals should be aware of the potential for serious cardiovascular reactions associated with the use of Phenylephrine Hydrochloride Ophthalmic Solution, USP, particularly with the 10% solution. These reactions can be severe and, in some cases, fatal. It is imperative to monitor blood pressure in patients with a history of cardiovascular disease to mitigate risks.

Significant elevations in blood pressure have been documented following administration of this solution. Therefore, caution is advised when prescribing to pediatric patients under 5 years of age, as well as to individuals with pre-existing elevated blood pressure.

Additionally, rebound miosis has been observed in some patients one day after instillation of the solution. This phenomenon should be taken into consideration when evaluating the treatment plan and monitoring patient outcomes.

Side Effects

Patients may experience a range of ocular adverse reactions, including eye pain and stinging upon instillation, temporary blurred vision, and photophobia.

Cardiovascular adverse reactions have been reported, with some being serious in nature. These include increases in blood pressure, syncope, myocardial infarction, tachycardia, arrhythmia, and subarachnoid hemorrhage. Notably, there have been reports of serious cardiovascular reactions, some of which have been fatal, associated with the use of Phenylephrine Hydrochloride Ophthalmic Solution, USP 10% solution. Therefore, it is essential to monitor blood pressure in patients with pre-existing cardiovascular disease. Significant elevations in blood pressure have also been documented, warranting caution in pediatric patients under 5 years of age and in those with elevated blood pressure.

Additional adverse reactions include rebound miosis, which has been reported one day after instillation. Overdosage of phenylephrine may lead to a rapid rise in blood pressure and can also result in headache, anxiety, nausea, vomiting, and ventricular arrhythmias.

Drug Interactions

The use of this medication in conjunction with 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 co-administered.

Additionally, this medication may enhance the cardiovascular depressant effects of potent inhalation anesthetic agents. It is advisable to exercise caution and consider dosage adjustments or increased monitoring of cardiovascular status during procedures involving such anesthetics to mitigate potential risks.

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, USP 10% is contraindicated in pediatric patients less than 1 year of age. There are no specific dosage recommendations or study outcomes provided for this age group. Caution should be exercised when considering the use of this medication in children, particularly those under the specified age limit.

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, healthcare providers should remain vigilant when prescribing to geriatric patients, as individual responses may vary. It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, given the possibility of altered pharmacokinetics and pharmacodynamics 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 Ophthalmic Solution, USP 2.5% and 10% should be administered to pregnant patients only if clearly needed. Healthcare professionals should weigh the potential benefits against any unknown risks when considering the use of this medication in pregnant women.

Lactation

It is not known whether Phenylephrine Hydrochloride Ophthalmic Solution, USP 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, particularly in relation to the possible effects on breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 outlined 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 Ophthalmic Solution, USP 2.5% and 10% should be administered to a pregnant woman only if clearly needed.

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

Postmarketing Experience

No specific postmarketing experience details have been reported. As such, there are no additional adverse events or rare case reports to summarize at this time.

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 protect their eyes in bright lighting conditions to avoid discomfort. This precaution is essential for ensuring a comfortable experience while using the medication.

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 2°C to 25°C (36°F to 77°F).

Healthcare professionals are advised to inspect the solution prior to use; it should not be used if it appears brown or contains any precipitate. Once opened, the solution can be utilized until the expiration date indicated on the bottle.

Additional Clinical Information

No further data are available.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Phenylephrine Hydrochloride as submitted by Bausch & Lomb Americas Inc.. 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 (NDA203510) 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.