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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 2023
Label revision date
May 19, 2023
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 2023
Label revision date
May 19, 2023
Manufacturer
Lifestar Pharma LLC
Registration number
ANDA216496
NDC root
70756-614
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 eye care. It is a topical medication that acts as an α-adrenergic agonist, meaning it stimulates specific receptors in the eye to produce effects. This solution is primarily indicated for dilating the pupil (mydriasis), which is important during eye examinations. When applied to the eye, phenylephrine works by contracting the dilator muscle of the pupil and constricting the small blood vessels in the conjunctiva, helping healthcare providers assess the health of your eyes more effectively.

Typically, the effects of phenylephrine can be seen within 20 to 90 minutes after application, and the dilation lasts for about 3 to 8 hours. This medication is specifically formulated for topical use in the eye and is not intended for injection.

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 eyeball). 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

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

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

Side Effects

You may experience some side effects while 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 heart rhythms (arrhythmia), and even serious conditions like subarachnoid hemorrhage.

If you are using the 10% strength of this medication, be aware that there is a risk of serious heart rhythm issues, some of which can be fatal. It's important to monitor blood pressure, especially in young children under 5 years old or those with existing heart conditions or hyperthyroidism. Overdosage may lead to a rapid increase in blood pressure, headaches, anxiety, nausea, vomiting, and heart rhythm problems. If you notice any concerning symptoms, please consult your healthcare provider.

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 reaching out for assistance if you notice any concerning symptoms.

Pregnancy Use

There have been no animal studies on the use of topical phenylephrine during pregnancy, so we don't know if it could harm a developing fetus or affect your ability to have children. If you are pregnant, phenylephrine hydrochloride should only be used if it is clearly necessary and recommended by your healthcare provider. Always discuss any medications with your doctor to ensure they are safe for 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

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 there are no significant differences in safety and effectiveness when using this medication compared to younger adults. This means that you can expect similar results and side effects, regardless of age.

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

Renal Impairment

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

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

Hepatic Impairment

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

Drug Interactions

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

Always discuss any medications you are taking with your healthcare provider. This includes prescription drugs, over-the-counter medications, and any anesthetics you may encounter during medical procedures. Your provider can help ensure that your treatment is safe and effective, minimizing the risk of harmful interactions.

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 prevent contamination, and protect it from light and excessive heat, as these factors can affect the solution's quality.

Once you open the bottle, you can continue to use the solution until the expiration date printed on the label. Always handle the bottle with clean hands and avoid touching the dropper tip to any surfaces to maintain sterility (the state of being free from bacteria or other living microorganisms). Following these guidelines will help ensure that the product remains safe and effective for your use.

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.

How should I use Phenylephrine Hydrochloride Ophthalmic Solution?

For patients 1 year of age and older, apply one drop of the 10% solution 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 this medication?

Yes, it is contraindicated in patients with hypertension, thyrotoxicosis, and in pediatric patients less than 1 year of age due to increased risk of systemic toxicity.

What are the possible ocular side effects?

Ocular adverse reactions may include eye pain, stinging on instillation, temporary blurred vision, and photophobia.

What cardiovascular effects can occur with this medication?

Cardiovascular adverse reactions may include increased blood pressure, syncope, myocardial infarction, tachycardia, and arrhythmia.

What should I do if I experience symptoms of overdose?

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

Can I use this medication if I am pregnant or breastfeeding?

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

What storage conditions are recommended for this medication?

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

What is the maximum time for mydriasis after using this solution?

Maximal mydriasis occurs within 20 to 90 minutes after application, with recovery taking 3 to 8 hours.

Is there a risk of rebound miosis?

Yes, rebound miosis has been reported one day after instillation.

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. 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. Each milliliter of the solution contains 100 mg of Phenylephrine Hydrochloride, corresponding to a concentration of 10%. Inactive ingredients include Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, 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. 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 drug.

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 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 optimize the therapeutic effect while minimizing potential side effects.

Contraindications

Use of this product is contraindicated in patients with hypertension or thyrotoxicosis due to the potential for exacerbating these conditions. Additionally, it is contraindicated in pediatric patients under 1 year of age due to 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 monitoring for this reaction and provide appropriate guidance to patients regarding its possible occurrence.

Side Effects

Patients may experience a range of adverse reactions associated with treatment. Ocular adverse reactions are common and include eye pain and stinging upon instillation, temporary blurred vision, and photophobia.

Cardiovascular adverse reactions can be 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 warrant caution, particularly in pediatric patients under 5 years of age and in those with pre-existing cardiovascular disease or hyperthyroidism. It is recommended to monitor blood pressure post-treatment in patients at high risk.

Rebound miosis has been reported one day after instillation, indicating a potential transient effect following treatment.

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

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 during the use of these anesthetics, 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 children, and healthcare professionals should evaluate the risks and benefits in this population.

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 should be administered to a pregnant woman only if clearly needed. Healthcare professionals are advised to weigh the potential benefits against any unknown risks when considering the use of this medication in pregnant patients.

Lactation

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

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable 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 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 critical 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 text.

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 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 20° to 25°C (68° to 77°F), in accordance with USP Controlled Room Temperature guidelines.

To ensure optimal preservation, the solution must be protected from light and excessive heat. Once opened, the product can be used 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 Lifestar Pharma LLC. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)

Data Generation & Sources

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

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

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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.