Phenylephrine 2.5% Ophth Soln 15ml
It makes the eye pupils larger.
Drug Class
Mydriatic; Ophthalmic Decongestant
Pharmacologic Class
Alpha-1 Adrenergic Agonist
Pregnancy Category
C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Phenylephrine eye drops are used to make your pupils (the black center of your eye) larger, which helps your eye doctor examine the back of your eye. It can also make the white part of your eye less red by shrinking tiny blood vessels.
How to Use This Medicine
To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. Use this medication only as directed and follow all instructions precisely. This medication is for ophthalmic use only, meaning it is intended for application in the eye.
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage method.
If you miss a dose, contact your doctor to receive guidance on the appropriate course of action.
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage method.
If you miss a dose, contact your doctor to receive guidance on the appropriate course of action.
Lifestyle & Tips
- Your vision may be blurry and you will be sensitive to light for several hours after using these drops. Avoid driving or operating machinery until your vision returns to normal.
- Wear sunglasses to protect your eyes from bright light after the drops are administered.
- Do not touch the dropper tip to your eye or any other surface to prevent contamination.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
1 drop of 2.5% solution in the affected eye(s) as directed. May repeat once after 10-60 minutes if needed for adequate mydriasis.
Condition-Specific Dosing:
mydriasis:
1 drop, may repeat once after 10-60 minutes if necessary.
vasoconstriction:
1 drop as needed, typically not more than every 3-4 hours.
Pediatric Dosing
Neonatal:
Not established. Use with extreme caution due to increased risk of systemic absorption and adverse effects (e.g., hypertension, bradycardia, cardiovascular collapse). 2.5% is generally preferred over 10% if necessary.
Infant:
Not established. Use with extreme caution due to increased risk of systemic absorption and adverse effects. 2.5% is generally preferred over 10% if necessary.
Child:
1 drop of 2.5% solution in the affected eye(s) as directed. May repeat once after 10-60 minutes if needed for adequate mydriasis. Use 2.5% concentration.
Adolescent:
1 drop of 2.5% solution in the affected eye(s) as directed. May repeat once after 10-60 minutes if needed for adequate mydriasis.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed for ophthalmic use due to minimal systemic absorption.
Moderate:
No specific adjustment needed for ophthalmic use due to minimal systemic absorption.
Severe:
No specific adjustment needed for ophthalmic use due to minimal systemic absorption.
Dialysis:
No specific adjustment needed for ophthalmic use due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No specific adjustment needed for ophthalmic use due to minimal systemic absorption.
Moderate:
No specific adjustment needed for ophthalmic use due to minimal systemic absorption.
Severe:
No specific adjustment needed for ophthalmic use due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Phenylephrine is a direct-acting sympathomimetic amine that acts primarily on alpha-1 adrenergic receptors. In the eye, it causes contraction of the pupillary dilator muscle, resulting in mydriasis (pupil dilation), and vasoconstriction of the conjunctival blood vessels, leading to blanching of the conjunctiva.
Pharmacokinetics
Absorption:
Bioavailability:
Not available (minimal systemic absorption from ophthalmic route)
Tmax:
Not available (systemic absorption is minimal)
FoodEffect:
Not applicable (ophthalmic)
Distribution:
Vd:
Not available (minimal systemic absorption)
ProteinBinding:
Not available (minimal systemic absorption)
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Not available (systemic half-life is short, but ophthalmic absorption is minimal)
Clearance:
Not available
ExcretionRoute:
Renal (as metabolites and unchanged drug if systemically absorbed)
Unchanged:
Not available
Pharmacodynamics
OnsetOfAction:
Mydriasis: 15-60 minutes
PeakEffect:
Mydriasis: 60-90 minutes
DurationOfAction:
Mydriasis: 3-7 hours (for 2.5% solution)
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Chest pain or pressure
Fast or abnormal heartbeat
Weakness on one side of the body
Trouble speaking or thinking
Changes in balance
Drooping on one side of the face
Blurred eyesight
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Stinging
Eye pain
Eye irritation
Blurred eyesight
Sensitivity to bright lights (wearing sunglasses may help)
This is not an exhaustive list of possible side effects. If you have questions or concerns, don't hesitate to reach out to your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Chest pain or pressure
Fast or abnormal heartbeat
Weakness on one side of the body
Trouble speaking or thinking
Changes in balance
Drooping on one side of the face
Blurred eyesight
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Stinging
Eye pain
Eye irritation
Blurred eyesight
Sensitivity to bright lights (wearing sunglasses may help)
This is not an exhaustive list of possible side effects. If you have questions or concerns, don't hesitate to reach out to your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe eye pain or discomfort
- Sudden vision changes or loss of vision
- Severe headache
- Palpitations or racing heart
- Chest pain
- Dizziness or fainting
- Unusual sweating
- Tremor or nervousness
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Heart disease
+ High blood pressure
+ Thyroid disease
If you have taken specific medications for depression or Parkinson's disease within the last 14 days, such as:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline
Note: Combining these medications with this drug may lead to severely high blood pressure.
This list is not exhaustive, and it is crucial to discuss all your medications and health conditions with your doctor. Please inform your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
Your complete medical history
To ensure your safety, always check with your doctor before:
Starting a new medication
Stopping a medication
* Changing the dosage of any medication
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Heart disease
+ High blood pressure
+ Thyroid disease
If you have taken specific medications for depression or Parkinson's disease within the last 14 days, such as:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline
Note: Combining these medications with this drug may lead to severely high blood pressure.
This list is not exhaustive, and it is crucial to discuss all your medications and health conditions with your doctor. Please inform your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
Your complete medical history
To ensure your safety, always check with your doctor before:
Starting a new medication
Stopping a medication
* Changing the dosage of any medication
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
While using this drug, avoid operating a vehicle or performing any tasks that require clear vision until your pupils return to normal, as this medication can cause pupil dilation.
If you have a known allergy to sulfites, consult your doctor before taking this medication, as some formulations may contain sulfites.
The 10% strength of this medication has been associated with severe cardiovascular adverse effects, including abnormal heart rhythms and myocardial infarction (heart attack), which have predominantly occurred in individuals with pre-existing heart disease. In some cases, these cardiac events have been fatal. If you have concerns or questions, discuss them with your doctor.
If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
While using this drug, avoid operating a vehicle or performing any tasks that require clear vision until your pupils return to normal, as this medication can cause pupil dilation.
If you have a known allergy to sulfites, consult your doctor before taking this medication, as some formulations may contain sulfites.
The 10% strength of this medication has been associated with severe cardiovascular adverse effects, including abnormal heart rhythms and myocardial infarction (heart attack), which have predominantly occurred in individuals with pre-existing heart disease. In some cases, these cardiac events have been fatal. If you have concerns or questions, discuss them with your doctor.
If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
Overdose Information
Overdose Symptoms:
- Significant increase in blood pressure (hypertension)
- Bradycardia (slow heart rate) or tachycardia (fast heart rate)
- Palpitations
- Headache
- Nervousness
- Tremor
- Sweating
- Nausea
- Vomiting
- Arrhythmias
- Subarachnoid hemorrhage (rare, severe)
What to Do:
If systemic overdose is suspected, seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive and symptomatic, potentially involving alpha-adrenergic blocking agents for severe hypertension.
Drug Interactions
Major Interactions
- Monoamine Oxidase Inhibitors (MAOIs)
- Tricyclic Antidepressants (TCAs)
- Systemic Beta-Blockers
- Inhalational Anesthetics (e.g., Halothane, Enflurane)
Moderate Interactions
- Atropine (ophthalmic)
- Cyclopentolate (ophthalmic)
- Antihypertensive agents (systemic)
Monitoring
Baseline Monitoring
Ocular examination (pupil size, intraocular pressure)
Rationale: To establish baseline and assess for contraindications (e.g., narrow-angle glaucoma).
Timing: Prior to administration.
Blood Pressure and Heart Rate
Rationale: To assess for baseline cardiovascular status, especially in patients at risk for systemic absorption or cardiovascular disease.
Timing: Prior to administration, particularly in infants, elderly, or those with pre-existing cardiovascular conditions.
Routine Monitoring
Pupil size and light reflex
Frequency: Periodically after administration until desired effect or return to baseline.
Target: Desired mydriasis (e.g., 6-8 mm)
Action Threshold: Inadequate mydriasis may warrant repeat dose (if indicated); excessive mydriasis or lack of light reflex may indicate over-response.
Intraocular Pressure (IOP)
Frequency: Post-procedure, if relevant to the ophthalmic exam.
Target: Normal range (e.g., 10-21 mmHg)
Action Threshold: Significant increase in IOP may indicate angle closure, requiring immediate intervention.
Systemic Vital Signs (Blood Pressure, Heart Rate)
Frequency: Monitor during and after administration, especially in high-risk patients (infants, elderly, cardiovascular disease).
Target: Within patient's normal range
Action Threshold: Significant increase in BP or HR, or development of arrhythmias, requires immediate medical attention.
Symptom Monitoring
- Palpitations
- Headache
- Tremor
- Sweating
- Nausea
- Vomiting
- Dizziness
- Blurred vision
- Eye pain
- Photophobia
- Eye irritation or redness
Special Patient Groups
Pregnancy
Pregnancy Category C. Use only if the potential benefit justifies the potential risk to the fetus. Systemic absorption is minimal, but caution is advised.
Trimester-Specific Risks:
First Trimester:
Risk not well-established; minimal systemic absorption expected.
Second Trimester:
Risk not well-established; minimal systemic absorption expected.
Third Trimester:
Risk not well-established; minimal systemic absorption expected.
Lactation
Use with caution. Minimal systemic absorption is expected, but phenylephrine can be excreted in breast milk. Monitor the infant for signs of irritability, poor feeding, or sleep disturbances.
Infant Risk:
Low to moderate risk. Potential for systemic effects in the infant if significant absorption occurs in the mother or if infant is sensitive.
Pediatric Use
Use with extreme caution, especially in low birth weight infants, neonates, and infants, due to increased risk of systemic absorption and severe adverse effects (e.g., hypertension, bradycardia, cardiovascular collapse). The 2.5% concentration is generally preferred over 10% in pediatric patients. Monitor vital signs closely.
Geriatric Use
Use with caution in elderly patients, particularly those with pre-existing cardiovascular disease (e.g., hypertension, coronary artery disease), hyperthyroidism, or diabetes, due to increased susceptibility to systemic adverse effects.
Clinical Information
Clinical Pearls
- Phenylephrine 2.5% is commonly used for diagnostic mydriasis and to relieve conjunctival congestion.
- Avoid use in patients with narrow-angle glaucoma or those with a narrow anterior chamber angle, as it can precipitate an acute angle-closure attack.
- Patients should be advised that their vision will be blurry and they will experience light sensitivity for several hours after administration; sunglasses are recommended.
- Systemic absorption, though usually minimal, can lead to significant cardiovascular effects, especially with higher concentrations (e.g., 10%), repeated doses, or in susceptible individuals (infants, elderly, those with cardiovascular disease).
- Transient stinging or burning upon instillation is common.
Alternative Therapies
- Tropicamide (for mydriasis and cycloplegia)
- Cyclopentolate (for mydriasis and cycloplegia)
- Atropine (for prolonged mydriasis and cycloplegia)
- Naphazoline (for ophthalmic decongestion, no mydriasis)
- Tetrahydrozoline (for ophthalmic decongestion, no mydriasis)
Cost & Coverage
Average Cost:
Varies, typically $15-$50 per 15ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (Generic)
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance.
To ensure your safety and the safety of others, never share your prescription medications with anyone, and do not take medications that have been prescribed to someone else.
All medications should be stored in a secure location, out of the reach of children and pets, to prevent accidental ingestion.
Proper disposal of unused or expired medications is crucial. Do not dispose of medications by flushing them down the toilet or pouring them down the drain unless you have been specifically instructed to do so by a healthcare professional or pharmacist. If you are unsure about the proper disposal method, consult with your pharmacist, who can provide guidance on the best approach. Additionally, you may want to inquire about potential drug take-back programs in your area, which can provide a safe and environmentally responsible way to dispose of unwanted medications.
It is possible that some medications may have an additional patient information leaflet. If you have questions or concerns about your medication, it is always best to consult with your pharmacist, who can provide you with more detailed information.
If you have any questions or concerns about your medication, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider, who can address your concerns and provide personalized guidance.
In the event of a suspected overdose, it is critical to seek immediate medical attention. Contact your local poison control center or visit the emergency room right away. When seeking help, be prepared to provide as much information as possible about the overdose, including the name of the medication, the amount taken, and the time it was taken, to ensure you receive the most effective treatment.
To ensure your safety and the safety of others, never share your prescription medications with anyone, and do not take medications that have been prescribed to someone else.
All medications should be stored in a secure location, out of the reach of children and pets, to prevent accidental ingestion.
Proper disposal of unused or expired medications is crucial. Do not dispose of medications by flushing them down the toilet or pouring them down the drain unless you have been specifically instructed to do so by a healthcare professional or pharmacist. If you are unsure about the proper disposal method, consult with your pharmacist, who can provide guidance on the best approach. Additionally, you may want to inquire about potential drug take-back programs in your area, which can provide a safe and environmentally responsible way to dispose of unwanted medications.
It is possible that some medications may have an additional patient information leaflet. If you have questions or concerns about your medication, it is always best to consult with your pharmacist, who can provide you with more detailed information.
If you have any questions or concerns about your medication, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider, who can address your concerns and provide personalized guidance.
In the event of a suspected overdose, it is critical to seek immediate medical attention. Contact your local poison control center or visit the emergency room right away. When seeking help, be prepared to provide as much information as possible about the overdose, including the name of the medication, the amount taken, and the time it was taken, to ensure you receive the most effective treatment.