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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 2013
Label revision date
June 29, 2023
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 2013
Label revision date
June 29, 2023
Manufacturer
Paragon BioTeck, Inc.
Registration number
NDA203510
NDC roots
42702-102, 42702-103
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, leading to the dilation of the pupil, a process known as mydriasis. This medication is typically used during eye examinations or surgical procedures to allow better visibility of the interior of the eye.

Available in two concentrations, 2.5% and 10%, phenylephrine is applied topically to the eye. The effects of pupil dilation usually peak within 20 to 90 minutes and can last for several hours. By helping to widen the pupil, phenylephrine plays a crucial role in facilitating various ophthalmic assessments and treatments.

Uses

Phenylephrine Hydrochloride Ophthalmic Solution, available in concentrations of 2.5% and 10%, is used to dilate the pupil. This can be helpful during eye examinations or certain medical procedures where a wider view of the eye is necessary.

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 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 in your eye every 3 to 5 minutes, but do not exceed more than 3 drops in total for each eye.

For children under 1 year old, the process is similar, but you will use the 2.5% solution specifically. In this case, you should also instill one drop at 3 to 5 minute intervals, with a maximum of 3 drops per eye. Always ensure you 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 hypertension (high blood pressure) or thyrotoxicosis (an overactive thyroid). Additionally, this solution 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 that this medication can also lead to serious cardiovascular issues, such as increased blood pressure, fainting (syncope), heart attack (myocardial infarction), rapid heart rate (tachycardia), irregular heartbeats (arrhythmia), and even bleeding in the brain (subarachnoid hemorrhage).

If you have a history of cardiovascular disease, it's crucial to monitor your blood pressure while using this medication, as significant increases have been reported. Caution is advised for children under 5 years old and individuals with high blood pressure. Overdosage can lead to a rapid rise in blood pressure and symptoms like headache, anxiety, nausea, vomiting, and irregular heartbeats. Additionally, rebound miosis (constriction of the pupil) may occur one day after use.

Warnings and Precautions

This medication is intended for use in your 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 solution, as serious cardiovascular reactions, some of which can be fatal, have been reported. You should also be cautious if you are a child under 5 years old or if you have high blood pressure, as significant increases in blood pressure have been noted.

After using this eye solution, you may experience rebound miosis (a temporary constriction of the pupils) the day after application. If you notice any unusual symptoms or if your blood pressure rises significantly, stop using the medication and contact your doctor immediately. If you experience severe reactions, seek emergency help 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 fast-acting medication called phentolamine to help manage the situation. Always prioritize your safety and don’t hesitate to reach out for assistance 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

If you are breastfeeding or planning to breastfeed, it's important to be cautious when using Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10%. Currently, it is not known whether this medication passes into human breast milk. Since many medications can be found in breast milk, you should consult your healthcare provider before using this drug to ensure it is safe for you and your nursing infant. Always prioritize open communication with your doctor about any medications you are considering 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 old. 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 between elderly patients and younger adults when it comes to this medication. This means that you can expect similar outcomes 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 monitor any potential side effects.

Renal Impairment

If you have kidney issues, 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 for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney problems).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can provide guidance based on your individual situation.

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 liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

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 ability to depress heart function.

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 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 continue to use it until the expiration date printed on the label. Always handle the solution 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 or thyrotoxicosis, and in pediatric patients less than 1 year of age.

What are some common ocular side effects of Phenylephrine Hydrochloride?

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

What cardiovascular effects can occur with Phenylephrine Hydrochloride?

Potential cardiovascular effects include increased blood pressure, syncope, tachycardia, and arrhythmia.

What should I do if I experience serious side effects?

If you experience serious side effects such as significant elevations in blood pressure or cardiovascular reactions, seek medical attention immediately.

Can Phenylephrine Hydrochloride be used during pregnancy?

Phenylephrine Hydrochloride Ophthalmic Solution should be given to a pregnant woman only if clearly needed, as its effects on fetal harm are not known.

Is it safe to use Phenylephrine Hydrochloride 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 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, 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. Inactive components include 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. The inactive ingredients are 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 to 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 drug.

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.

It is essential to ensure proper administration technique to avoid contamination of the dropper tip and to achieve optimal therapeutic effect.

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 associated with this age group.

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 considered when evaluating the treatment plan and monitoring patient outcomes.

Side Effects

Patients may experience a range of adverse reactions associated with the use of Phenylephrine Hydrochloride Ophthalmic Solution, USP 10%. These reactions can be categorized based on their seriousness and frequency.

Serious adverse reactions include significant cardiovascular events such as myocardial infarction, syncope, tachycardia, arrhythmia, and subarachnoid hemorrhage. Reports indicate that some of these cardiovascular reactions may be fatal. Therefore, it is crucial to monitor blood pressure in patients with pre-existing cardiovascular disease. Notably, significant elevations in blood pressure have been documented, particularly in pediatric patients under 5 years of age and in individuals with pre-existing hypertension.

Common ocular adverse reactions reported by patients include eye pain and stinging upon instillation, temporary blurred vision, and photophobia. Additionally, rebound miosis has been noted to occur one day after instillation.

Overdosage of phenylephrine may lead to a rapid increase in blood pressure and can also result in headache, anxiety, nausea, vomiting, and ventricular arrhythmias. Given these potential adverse reactions, careful consideration and monitoring are advised when administering this medication.

Drug Interactions

The concomitant use of certain medications may lead to significant drug interactions that warrant careful consideration.

Interactions with Atropine-like Drugs The use of this medication may exaggerate the adrenergic pressor response in patients who are concurrently taking atropine-like drugs. Clinicians should monitor patients closely for increased blood pressure and other adrenergic effects, and consider dosage adjustments as necessary.

Interactions with Inhalation Anesthetics This medication may potentiate the cardiovascular depressant effects of potent inhalation anesthetic agents. It is advisable to monitor cardiovascular status during procedures involving these anesthetics, and to adjust dosages accordingly to mitigate potential adverse effects.

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 established safety or efficacy profiles for this medication in infants and children within this age group. Caution should be exercised when considering the use of this product in pediatric populations, particularly in those under the specified age limit.

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, it is essential for healthcare providers to remain vigilant when prescribing to geriatric patients, considering the potential for altered pharmacokinetics and increased sensitivity to medications in this age group. Regular monitoring and assessment of therapeutic outcomes are recommended to ensure optimal safety and efficacy in elderly patients.

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, weighing the potential benefits against any unknown risks to fetal outcomes.

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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular monitoring of renal function may be warranted to ensure patient safety and therapeutic 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 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 considered as part of standard clinical practice.

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 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 findings related to animal pharmacology and toxicology available in the current data.

Postmarketing Experience

No specific postmarketing experience details are available in the extracted data. As such, there are no additional adverse events or rare case reports to summarize.

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 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 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 Paragon BioTeck, 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

Last AI update:

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.