Phenylephrine 10% Ophth Soln 5ml
It makes the eye pupils larger.
Drug Class
Mydriatic; Vasoconstrictor
Pharmacologic Class
Alpha-1 Adrenergic Agonist
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Phenylephrine eye drops are used to make your pupils bigger (dilate them) for eye exams or before eye surgery. It works by making the muscles in your eye that control pupil size contract. It can also make the blood vessels in your eye smaller, which can reduce redness.
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 closely. 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 what steps to take next.
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 what steps to take next.
Lifestyle & Tips
- Avoid driving or operating machinery until your vision returns to normal (pupil dilation can cause blurred vision and light sensitivity).
- Wear sunglasses to protect your eyes from bright light after dilation.
- Do not touch the dropper tip to your eye or any other surface to prevent contamination.
- Wash hands before and after use.
- Remove contact lenses before instilling drops and wait at least 15 minutes before reinserting.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
1 drop of 10% solution instilled into the conjunctival sac, may repeat in 10-60 minutes if needed for maximal dilation. Not to exceed 3 drops in 24 hours.
Dose Range:
1 - 3 mg
Condition-Specific Dosing:
diagnostic_mydriasis:
1 drop of 10% solution, repeat in 10-60 minutes if necessary. Max 3 drops in 24 hours.
pre_surgical_mydriasis:
1 drop of 10% solution 30-60 minutes prior to surgery.
Pediatric Dosing
Neonatal:
Not established; 10% solution generally contraindicated due to risk of systemic toxicity. 2.5% solution may be used with extreme caution and reduced frequency if absolutely necessary.
Infant:
Not established; 10% solution generally contraindicated due to risk of systemic toxicity. 2.5% solution may be used with extreme caution and reduced frequency if absolutely necessary.
Child:
Not established; 10% solution generally contraindicated due to risk of systemic toxicity. 2.5% solution may be used with extreme caution and reduced frequency if absolutely necessary.
Adolescent:
Similar to adult dosing, but caution advised due to potential for systemic effects. 2.5% solution often preferred.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended for ophthalmic use.
Moderate:
No specific adjustment recommended for ophthalmic use.
Severe:
No specific adjustment recommended for ophthalmic use.
Dialysis:
No specific adjustment recommended for ophthalmic use.
Hepatic Impairment:
Mild:
No specific adjustment recommended for ophthalmic use.
Moderate:
No specific adjustment recommended for ophthalneric use.
Severe:
No specific adjustment recommended for ophthalmic use.
Pharmacology
Mechanism of Action
Phenylephrine is a direct-acting sympathomimetic amine that acts predominantly on alpha-1 adrenergic receptors. In the eye, it causes contraction of the radial muscle of the iris, leading to mydriasis (pupil dilation), and vasoconstriction of conjunctival blood vessels. It has little or no effect on the ciliary muscle, thus not causing cycloplegia.
Pharmacokinetics
Absorption:
Bioavailability:
Not available (systemic absorption occurs after ophthalmic administration)
Tmax:
Peak mydriasis typically occurs within 15-60 minutes.
FoodEffect:
Not applicable for ophthalmic administration.
Distribution:
Vd:
Not available
ProteinBinding:
Not available
CnssPenetration:
Limited (systemic absorption can lead to CNS effects like headache, tremor, anxiety).
Elimination:
HalfLife:
Not precisely established for ophthalmic use, but systemic half-life is short (approx. 2-3 hours).
Clearance:
Not available
ExcretionRoute:
Renal (as metabolites and unchanged drug)
Unchanged:
Small percentage
Pharmacodynamics
OnsetOfAction:
10-15 minutes (mydriasis)
PeakEffect:
15-60 minutes (mydriasis)
DurationOfAction:
3-6 hours (mydriasis), up to 7 hours for some effects.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
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 or seek medical help right away:
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 heartbeat 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 symptoms that bother you or do not go away, contact your doctor or seek medical help:
Stinging
Eye pain
Eye irritation
Blurred eyesight
Sensitivity to bright lights (wearing sunglasses may help)
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor for medical advice. 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 or seek medical help right away:
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 heartbeat 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 symptoms that bother you or do not go away, contact your doctor or seek medical help:
Stinging
Eye pain
Eye irritation
Blurred eyesight
Sensitivity to bright lights (wearing sunglasses may help)
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor for medical advice. 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 headache
- Chest pain or palpitations
- Dizziness or fainting
- Unusual sweating
- Tremor or nervousness
- Blurred vision that doesn't resolve
- Eye pain or redness that worsens
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.
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 can lead to severely high blood pressure.
If the patient is a child under 1 year of age. This medication is not suitable for children younger than 1 year old.
To ensure safe treatment, it is crucial to disclose all of the following to your doctor and pharmacist:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your complete medical history, including any health problems
Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug, consult with your doctor to confirm that it is safe to do so. This medication may interact with other drugs or health conditions, so it is essential to verify that it is safe for you to take this medication with your existing treatments and health status.
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.
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 can lead to severely high blood pressure.
If the patient is a child under 1 year of age. This medication is not suitable for children younger than 1 year old.
To ensure safe treatment, it is crucial to disclose all of the following to your doctor and pharmacist:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your complete medical history, including any health problems
Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug, consult with your doctor to confirm that it is safe to do so. This medication may interact with other drugs or health conditions, so it is essential to verify that it is safe for you to take this medication with your existing treatments and health status.
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 size, as your eyesight may be affected.
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 heart attack, which have predominantly occurred in individuals with pre-existing heart disease. In some cases, these events have been fatal. If you have concerns, discuss them with your doctor.
This medication should be used with caution in children under 5 years of age, as they may be at a higher risk of developing hypertension.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor, as it is crucial to weigh the benefits and risks of this medication to both you and your baby.
While using this drug, avoid operating a vehicle or performing any tasks that require clear vision until your pupils return to normal size, as your eyesight may be affected.
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 heart attack, which have predominantly occurred in individuals with pre-existing heart disease. In some cases, these events have been fatal. If you have concerns, discuss them with your doctor.
This medication should be used with caution in children under 5 years of age, as they may be at a higher risk of developing hypertension.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor, as it is crucial to weigh the benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Significant increase in blood pressure (hypertensive crisis)
- Tachycardia (fast heart rate)
- Bradycardia (slow heart rate, reflex)
- Palpitations
- Headache
- Tremor
- Anxiety
- Nausea
- Vomiting
- Ventricular arrhythmias
- Subarachnoid hemorrhage (rare, severe)
What to Do:
Immediately seek emergency medical attention. Call 911 or your local poison control center (1-800-222-1222). Treatment is supportive and symptomatic, potentially involving alpha-adrenergic blocking agents (e.g., phentolamine) for severe hypertension.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - risk of hypertensive crisis.
- Tricyclic Antidepressants (TCAs) - potentiates pressor effects.
- Beta-adrenergic blockers (systemic) - risk of acute hypertension and bradycardia.
- Atropine (ophthalmic) - potentiates mydriatic effect and systemic absorption.
Major Interactions
- Antihypertensive agents (e.g., guanethidine, reserpine, methyldopa) - may reduce antihypertensive effect or cause severe hypertension.
- Cardiac glycosides (e.g., digoxin) - increased risk of arrhythmias.
- Inhalation anesthetics (e.g., halothane) - increased risk of arrhythmias.
Moderate Interactions
- Other sympathomimetics (systemic or ophthalmic) - additive pressor effects.
- Anticholinergic agents (systemic) - may enhance systemic effects.
Monitoring
Baseline Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Rationale: To establish baseline and identify patients at risk for systemic adverse effects (hypertension, tachycardia, bradycardia).
Timing: Prior to administration, especially in patients with cardiovascular disease, hypertension, or in pediatric/geriatric populations.
Intraocular Pressure (IOP)
Rationale: To rule out narrow-angle glaucoma or identify patients at risk for acute angle closure.
Timing: Prior to administration.
Routine Monitoring
Pupil Dilation
Frequency: Within 15-60 minutes post-instillation
Target: Desired mydriasis
Action Threshold: If inadequate dilation, consider re-dosing (within limits) or alternative.
Blood Pressure (BP) and Heart Rate (HR)
Frequency: Periodically for several hours post-instillation, especially in at-risk patients (infants, elderly, cardiovascular disease).
Target: Within patient's normal range
Action Threshold: Significant increase in BP (>20-30 mmHg systolic) or HR (>20-30 bpm) warrants intervention or monitoring.
Ocular discomfort/pain
Frequency: As reported by patient
Target: Minimal to none
Action Threshold: Persistent or severe pain may indicate angle closure or other adverse reaction.
Symptom Monitoring
- Headache
- Palpitations
- Tremor
- Dizziness
- Nausea
- Sweating
- Pallor
- Increased blood pressure
- Increased heart rate
- Bradycardia (reflex)
- Chest pain
- Blurred vision
- Photophobia
Special Patient Groups
Pregnancy
Use with caution during pregnancy only if the potential benefit justifies the potential risk to the fetus. Systemic absorption can occur.
Trimester-Specific Risks:
First Trimester:
Limited data, theoretical risk of vasoconstriction affecting placental blood flow.
Second Trimester:
Limited data.
Third Trimester:
Limited data, theoretical risk of vasoconstriction affecting placental blood flow.
Lactation
Use with caution. It is not known if phenylephrine is excreted in human milk. Systemic absorption could lead to excretion into breast milk. Monitor infant for irritability, changes in feeding, or sleep patterns.
Infant Risk:
L3 - Moderate risk. Consider using the lowest effective concentration (2.5%) and applying nasolacrimal occlusion to minimize systemic absorption. Observe infant for signs of systemic effects.
Pediatric Use
The 10% solution is generally contraindicated in infants and low-weight children due to a high risk of systemic toxicity (e.g., severe hypertension, cardiovascular events, death). The 2.5% solution is preferred and should be used with extreme caution, especially in premature infants and those with cardiac or respiratory conditions. Nasolacrimal occlusion should be used to minimize systemic absorption.
Geriatric Use
Use with caution in elderly patients, especially those with cardiovascular disease (hypertension, coronary artery disease, arrhythmias), diabetes, or hyperthyroidism, due to increased risk of systemic adverse effects. Lower concentrations (2.5%) may be preferred.
Clinical Information
Clinical Pearls
- Phenylephrine 10% has a higher risk of systemic adverse effects compared to 2.5%, especially in infants, elderly, and patients with cardiovascular disease. Always consider using the lowest effective concentration.
- Always check blood pressure and heart rate before administering, especially in at-risk patients.
- Apply gentle pressure to the nasolacrimal duct (inner corner of the eye) for 1-2 minutes after instillation to minimize systemic absorption.
- Warn patients about photophobia and blurred vision after dilation and advise them to wear sunglasses.
- Avoid use in patients with narrow-angle glaucoma or those predisposed to angle closure.
- Carefully review patient's medication list for potential drug interactions, especially MAOIs, TCAs, and systemic beta-blockers.
Alternative Therapies
- Tropicamide (for mydriasis and cycloplegia)
- Cyclopentolate (for mydriasis and cycloplegia)
- Atropine (for prolonged mydriasis and cycloplegia)
- Homatropine (for mydriasis and cycloplegia)
Cost & Coverage
Average Cost:
$20 - $50 per 5ml 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 guidance. To ensure safe use, never share your medication with others or take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion.
Proper disposal of unused or expired medications is crucial. Do not dispose of them by flushing down the toilet or pouring down the drain unless specifically instructed to do so. If you are unsure about the correct disposal method, consult your pharmacist for advice. Many communities have drug take-back programs, which your pharmacist can help you locate.
Some medications may come with an additional patient information leaflet. Check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the name of the medication, the amount taken, and the time it occurred, to ensure prompt and effective treatment.
Proper disposal of unused or expired medications is crucial. Do not dispose of them by flushing down the toilet or pouring down the drain unless specifically instructed to do so. If you are unsure about the correct disposal method, consult your pharmacist for advice. Many communities have drug take-back programs, which your pharmacist can help you locate.
Some medications may come with an additional patient information leaflet. Check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the name of the medication, the amount taken, and the time it occurred, to ensure prompt and effective treatment.