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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/ Drops
Route
Ophthalmic
Prescription status
Rx (prescription)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
January 23, 2025
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/ 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 2025
Label revision date
January 23, 2025
Manufacturer
Caplin Steriles Limited
Registration number
ANDA215183
NDC roots
65145-148, 65145-149, 65145-150
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 medication used in eye care. It is a topical α-adrenergic agonist, which means it works by stimulating specific receptors in the eye. This medication is primarily indicated for dilating the pupil (a process known as mydriasis), which is often necessary for eye examinations or certain surgical procedures.

When applied to the eye, phenylephrine acts directly on the α-adrenergic receptors, causing the muscles that control pupil size to contract and leading to pupil dilation. The effects typically begin within 20 to 90 minutes and can last for several hours.

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) or nonteratogenic effects associated with this medication. This makes it a safe option for use in appropriate situations.

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 want 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 3 to 5 minute intervals, also 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

You should avoid using the 10% strength of this medication if you have hypertension (high blood pressure) or thyrotoxicosis (an overactive thyroid). Additionally, it is not safe for children under 1 year of age due to a higher risk of serious side effects. Always consult with your healthcare provider if you have any concerns or questions about your health and medication use.

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, there is a risk of serious heart rhythm issues, some of which can be fatal. If you are a child under 5 years old or have a history of heart problems or hyperthyroidism, it's important to monitor your blood pressure closely after treatment. Additionally, if you take too much of the medication, you might experience a rapid rise in blood pressure, headache, anxiety, nausea, vomiting, and serious heart rhythm disturbances.

Warnings and Precautions

This medication is intended for topical (applied to the surface) 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.

You should also be cautious if you are a parent of a child under 5 years old, or if you have conditions like cardiovascular disease or hyperthyroidism, as this medication can significantly raise blood pressure. If you are at high risk, make sure to have your blood pressure checked after treatment. Additionally, some people may experience rebound miosis (a condition where the pupils constrict) the day after using the medication, so keep an eye out for any unusual changes in your vision.

If you experience any severe side effects or have concerns, seek emergency help immediately. If you notice any troubling symptoms, stop using the medication 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

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 conceive. 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. This precaution helps ensure their safety and well-being. Always consult with your child's healthcare provider for guidance on appropriate treatments and dosages based on 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 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.

It's always best to discuss your individual situation with your healthcare provider, who can offer personalized advice and ensure that any medications you take are safe and effective for you.

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 determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want 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 each other, potentially affecting how well they work or increasing the risk of side effects. For instance, if you are taking atropine-like drugs, they may enhance the effects of other medications that raise blood pressure, which could lead to unexpected reactions. 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, including over-the-counter drugs and supplements, with your healthcare provider. 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 in a cool, dry place at a temperature between 20° to 25°C (68° to 77°F). Make sure the container is tightly closed to protect it from light and excessive heat.

Once you open the bottle, you can use the solution until the expiration date printed on the label. However, do not use it if the solution appears brown or has any particles floating in it, as this could indicate that it is no longer safe to use. Always handle the solution with care to maintain its quality and your safety.

Additional Information

No further information is available.

FAQ

What is Phenylephrine Hydrochloride Ophthalmic Solution used for?

Phenylephrine Hydrochloride Ophthalmic Solution 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 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 of this medication?

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 Hydrochloride Ophthalmic Solution?

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

What serious cardiovascular reactions can occur with the 10% strength?

Serious cardiovascular reactions may include ventricular arrhythmias, some of which have been fatal.

What should I do if I experience symptoms of overdosage?

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

Is Phenylephrine Hydrochloride safe to use during pregnancy?

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

Can Phenylephrine Hydrochloride be used while breastfeeding?

It is not known whether this drug is excreted in human breast milk, so caution should be exercised when administered to a nursing woman.

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.

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: a 2.5% solution and a 10% solution. 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% solution. The tonicity of the 10% solution is 985 mOsm/kg, and it also 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 medication.

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 those requiring a greater degree of 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, it 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. These reactions are generally mild and transient.

Cardiovascular adverse reactions can be more serious and include an increase in blood pressure, syncope, myocardial infarction, tachycardia, arrhythmia, and subarachnoid hemorrhage. Notably, serious cardiovascular reactions have been observed with the 10% strength formulation, including ventricular arrhythmias, some of which have been fatal. Significant elevations in blood pressure have been documented, particularly in pediatric patients under 5 years of age and in individuals with pre-existing cardiovascular disease or hyperthyroidism. In patients identified as high risk, it is recommended to monitor blood pressure following treatment.

Rebound miosis has been reported as an adverse reaction occurring one day after instillation, indicating a potential need for monitoring in patients.

In cases of overdosage, patients may experience a rapid rise in blood pressure, accompanied by headache, anxiety, nausea, vomiting, and ventricular arrhythmias. These symptoms necessitate immediate medical attention to mitigate potential complications.

Drug Interactions

The concomitant use of atropine-like drugs may lead to an exaggerated adrenergic pressor response. Clinicians should exercise caution when administering these agents together, as the enhanced response could result in significant cardiovascular effects.

Additionally, the use of potent inhalation anesthetic agents in conjunction with this medication may potentiate cardiovascular depressant effects. It is advisable to monitor cardiovascular status closely in patients receiving both the medication and inhalation 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 10% is contraindicated in pediatric patients less than 1 year of age. Caution should be exercised when considering the use of this medication in infants and young children, as safety and efficacy have not been established in this age group.

Geriatric Use

Elderly patients, defined as those aged 65 years and older, have not demonstrated any overall differences in safety and effectiveness compared to younger adult patients. Therefore, no specific dosage adjustments are necessary for this population.

However, healthcare providers should remain vigilant in monitoring geriatric patients for any potential age-related changes that may affect drug metabolism and response. It is essential to consider individual patient factors, including comorbidities and concurrent medications, when prescribing to elderly patients to ensure optimal therapeutic outcomes.

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 should 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 benefits of treatment against any potential risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in terms of dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be prudent in these patients to ensure safety and efficacy.

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 the risks associated with elevated blood pressure and other adverse effects.

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 and 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 have been provided. Furthermore, there are no specific findings related to animal pharmacology and toxicology available in the current data.

Postmarketing Experience

No postmarketing experience details were identified for SPL code 90375-7.

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 integrity 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 illumination to prevent discomfort and potential harm.

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

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 Caplin Steriles Limited. 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.