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Phenylephrine hydrochloride

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Active ingredient
Phenylephrine Hydrochloride 100 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 2024
Label revision date
September 3, 2024
FDA Insert
Prescribing information, PDF file
Active ingredient
Phenylephrine Hydrochloride 100 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 2024
Label revision date
September 3, 2024
Manufacturer
NorthStar RxLLC
Registration number
ANDA216496
NDC root
72603-530
FDA Insert
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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, sterile solution used in the eye to help dilate the pupil. It works as a topical α-adrenergic agonist, meaning it stimulates certain receptors in the eye to cause the muscles that control pupil size to contract. This results in the pupil becoming larger, which is useful for various eye examinations and procedures.

When applied to the eye, phenylephrine causes the dilator muscle of the pupil to contract and constricts the small blood vessels in the conjunctiva (the membrane covering the white part of the eye). The effects typically begin within 20 to 90 minutes and can last for several hours.

Uses

Phenylephrine Hydrochloride Ophthalmic Solution is used to help dilate your pupil. This can be important for various eye examinations or procedures where a larger pupil is needed for better visibility.

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

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 of the 10% strength solution into the conjunctival fornix (the space between your eyelid and your eye). You can do this every 3 to 5 minutes, but make sure not to exceed 3 drops in each eye. This stronger solution helps achieve a greater degree of mydriasis (dilation of the pupil).

For children under 1 year of age, the process is slightly different. You will need to use the 2.5% strength solution instead. Instill one drop into the conjunctival fornix at the same 3 to 5 minute intervals, again not exceeding 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 also occur, such as increased blood pressure, fainting (syncope), rapid heart rate (tachycardia), irregular heartbeats (arrhythmia), and in rare cases, serious conditions like heart attacks (myocardial infarction) or bleeding in the brain (subarachnoid hemorrhage).

If you are using the 10% strength of this medication, be aware that it may lead to serious heart rhythm issues, some of which can be fatal. It's important to monitor your blood pressure, especially if you have a history of heart problems. In young children under 5 years old, as well as those with certain health conditions, caution is advised due to the risk of significant blood pressure increases. If you accidentally take too much, you might experience a rapid rise in blood pressure, headaches, anxiety, nausea, vomiting, and potentially serious heart rhythm disturbances.

Warnings and Precautions

This medication is intended for use in the eyes only and should not 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). After treatment, you should check blood pressure in those at high risk. Additionally, be aware that you might 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, stop using the medication and contact your doctor immediately. If you experience any emergency symptoms, seek 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 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, so we don't have clear information about its safety during pregnancy. It's currently unknown whether phenylephrine can harm a developing fetus or affect your ability to have children in the future.

If you are pregnant or planning to become 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 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 baby. Always prioritize your infant's health and well-being when considering any medication while nursing.

Pediatric Use

If you are considering using phenylephrine hydrochloride ophthalmic solution 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 studies have shown no significant differences in safety and effectiveness between elderly patients and younger adults when using 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 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 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 each other, potentially affecting how well they work or increasing the risk of side effects. For example, 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 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), which is considered a controlled room temperature. Make sure the container is tightly closed to protect the solution from light and excessive heat.

Once you open the bottle, you can use the solution until the expiration date printed on it. However, if you notice that the solution has turned brown or contains any particles (precipitate), do not use it, as this indicates it may no longer be safe. 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 contains 100 mg of Phenylephrine Hydrochloride (10%) as the active ingredient.

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 solution?

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 ocular adverse reactions?

Common ocular adverse reactions include eye pain, stinging on instillation, temporary blurred vision, and photophobia.

What cardiovascular reactions can occur with Phenylephrine Hydrochloride?

Cardiovascular reactions may include increased blood pressure, syncope, tachycardia, and in severe cases, myocardial infarction.

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.

Can Phenylephrine Hydrochloride be used during pregnancy?

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

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 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 to yellow solution intended for topical ophthalmic use as an α-adrenergic agonist. The chemical name is (R)-3-hydroxy-α(methylamino)methylbenzenemethanol hydrochloride, with a molecular formula of C₉H₁₃NO₂·HCl and a molecular weight of 203.67 g/mol.

Each milliliter of the solution contains 100 mg of Phenylephrine Hydrochloride (10%) as the active ingredient. Inactive components include Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, and Water for Injection. Phosphoric 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 985 mOsm/kg and contains Benzalkonium Chloride as a preservative at a concentration of 0.1 mg (0.01%).

Uses and Indications

Phenylephrine Hydrochloride Ophthalmic Solution 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, it is recommended to apply one drop of Phenylephrine Hydrochloride Ophthalmic Solution (10% strength) to the conjunctival fornix at intervals of 3 to 5 minutes, with a maximum of 3 drops per eye. This concentration is indicated for achieving a greater degree of mydriasis.

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

Healthcare professionals should ensure proper administration techniques to maximize efficacy and minimize discomfort.

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 5 years of age, 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. It is recommended that blood pressure be monitored in patients with pre-existing cardiovascular disease.

Significant elevations in blood pressure have been noted, particularly in pediatric patients under 5 years of age, as well as in patients with cardiovascular disease or hyperthyroidism. For patients at high risk, it is advised to monitor blood pressure following treatment.

Rebound miosis has been reported to occur one day after instillation, indicating a potential delayed reaction.

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 and monitoring.

Drug Interactions

Atropine-like drugs may enhance the adrenergic pressor response when administered concurrently. Clinicians should monitor patients for increased blood pressure and adjust dosages of adrenergic agents as necessary to mitigate this effect.

Potent inhalation anesthetic agents have the potential to amplify cardiovascular depressant effects. It is advisable to closely monitor cardiovascular status in patients receiving these agents, and dosage adjustments may be required based on the patient's response to anesthesia.

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 due to the potential for adverse effects. Healthcare professionals should carefully evaluate the risks and benefits before prescribing this treatment to pediatric patients.

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 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 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 health of breastfed infants.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when prescribing to patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment.

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 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 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 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 from bright illumination during this time 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), in accordance with USP Controlled Room Temperature guidelines.

To ensure optimal quality, the solution must be protected from light and excessive heat. After opening, the solution can be used until the expiration date indicated on the bottle. It is important to note that the solution 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 NorthStar RxLLC. 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 (ANDA216496) 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.