Phenylephrine 2.5% Ophth Soln 10ml
It makes the eye pupils larger.
Drug Class
Mydriatic, Ophthalmic Decongestant
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 (the black part in the center of your eye) larger. This is often done for eye exams or before eye surgery. It works by making the muscles that control your pupil contract, opening it wider. It can also make the whites of your eyes appear less red by constricting 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 (photophobia) for several hours after using these drops. Avoid driving or operating machinery until your vision returns to normal.
- Wear sunglasses when outdoors to protect your eyes from bright light.
- Do not touch the dropper tip to your eye or any other surface to prevent contamination.
- Wait at least 5 minutes before using any other eye drops.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
1 drop of 2.5% solution instilled into the conjunctival sac, may be repeated once after 10-60 minutes if needed for adequate dilation.
Dose Range:
1 - 2 mg
Condition-Specific Dosing:
mydriasis:
1 drop of 2.5% solution, repeat once if necessary after 10-60 minutes.
vasoconstriction:
1 drop of 2.5% solution as needed, not for prolonged use.
Pediatric Dosing
Neonatal:
Not established for routine use; use with extreme caution due to risk of systemic absorption and adverse effects. 0.5% or 1% solutions are preferred if necessary.
Infant:
1 drop of 2.5% solution, single application. Use with extreme caution due to risk of systemic absorption and adverse effects. 0.5% or 1% solutions are preferred if necessary.
Child:
1 drop of 2.5% solution, single application. Use with caution due to risk of systemic absorption and adverse effects. 0.5% or 1% solutions are preferred if necessary.
Adolescent:
1 drop of 2.5% solution, may be repeated once after 10-60 minutes if needed for adequate dilation.
Dose Adjustments
Renal Impairment:
Mild:
Not typically adjusted for ophthalmic use due to minimal systemic absorption.
Moderate:
Not typically adjusted for ophthalmic use due to minimal systemic absorption.
Severe:
Not typically adjusted for ophthalmic use due to minimal systemic absorption. Monitor for systemic effects if renal function is severely compromised and systemic absorption occurs.
Dialysis:
Not typically adjusted for ophthalmic use. Monitor for systemic effects if systemic absorption occurs.
Hepatic Impairment:
Mild:
Not typically adjusted for ophthalmic use due to minimal systemic absorption.
Moderate:
Not typically adjusted for ophthalmic use due to minimal systemic absorption.
Severe:
Not typically adjusted for ophthalmic use due to minimal systemic absorption. Monitor for systemic effects if hepatic function is severely compromised and systemic absorption occurs.
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 pupillary dilator muscle, resulting in mydriasis (pupil dilation), and vasoconstriction of conjunctival arterioles, leading to blanching of the conjunctiva.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption from ophthalmic administration, but can occur, especially with higher concentrations (e.g., 10%), repeated doses, or compromised ocular surface. Systemic effects are more pronounced with higher concentrations.
Tmax:
Not precisely quantified for ophthalmic systemic absorption, but local effects (mydriasis) onset within 15-60 minutes.
FoodEffect:
Not applicable for ophthalmic administration.
Distribution:
Vd:
Not precisely quantified for ophthalmic administration; primarily localized to ocular tissues.
ProteinBinding:
Not extensively protein bound.
CnssPenetration:
Limited, but systemic absorption can lead to CNS effects (e.g., headache, tremor).
Elimination:
HalfLife:
Approximately 2-3 hours (systemic, if absorbed).
Clearance:
Rapid systemic clearance if absorbed.
ExcretionRoute:
Renal excretion of metabolites and unchanged drug.
Unchanged:
Small percentage excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Mydriasis: 15-60 minutes
PeakEffect:
Mydriasis: 60-90 minutes
DurationOfAction:
Mydriasis: 3-7 hours (can vary based on concentration and individual response)
Confidence:
Medium
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention 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 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:
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, contact 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, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention 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 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:
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, contact 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 sudden vision changes (could indicate angle-closure glaucoma)
- Severe headache
- Pounding heart, fast or irregular heartbeat, chest pain
- Dizziness or fainting
- Excessive sweating
- Nausea or vomiting
- Unusual weakness or tiredness
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 can 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 provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products
Vitamins
* Any health problems you have
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to ensure your safety. It is vital to verify that it is safe to take this medication with all your other medications and health conditions.
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 can 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 provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products
Vitamins
* Any health problems you have
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to ensure your safety. It is vital to verify that it is safe to take this medication with all your other medications and health conditions.
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 activities 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 attacks, which have predominantly occurred in individuals with pre-existing heart disease. In some cases, these 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, inform 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 activities 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 attacks, which have predominantly occurred in individuals with pre-existing heart disease. In some cases, these 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, inform 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 (hypertensive crisis)
- Tachycardia or bradycardia
- Palpitations
- Headache
- Tremor
- Nervousness
- Pallor
- Sweating
- Cardiac arrhythmias
What to Do:
Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 21 days of MAOI discontinuation due to risk of hypertensive crisis)
- Tricyclic Antidepressants (TCAs) (potentiate pressor effects)
Major Interactions
- Beta-adrenergic blockers (systemic absorption of phenylephrine can cause hypertension, which may be exacerbated by beta-blockers)
- Atropine (additive mydriatic effect, increased risk of systemic absorption of phenylephrine)
- Other sympathomimetics (additive pressor effects)
- Halogenated anesthetics (e.g., halothane, enflurane, isoflurane) (increased risk of ventricular arrhythmias)
Moderate Interactions
- Antihypertensive agents (phenylephrine may reduce their effect)
- Cardiac glycosides (increased risk of arrhythmias)
- Thyroid hormones (increased risk of cardiovascular effects)
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Ocular history (e.g., narrow angles, glaucoma)
Rationale: To assess risk of angle-closure glaucoma or other ocular complications.
Timing: Prior to administration
Systemic medical history (e.g., hypertension, cardiovascular disease, hyperthyroidism, diabetes)
Rationale: To assess risk of systemic adverse effects from absorption.
Timing: Prior to administration
Blood pressure and heart rate (especially in pediatric, elderly, or patients with cardiovascular risk factors)
Rationale: To establish baseline and monitor for systemic adrenergic effects.
Timing: Prior to administration
Routine Monitoring
Pupillary response (degree of dilation)
Frequency: After administration, as needed for procedure
Target: Adequate mydriasis for examination/procedure
Action Threshold: Insufficient dilation may warrant repeat dose (if indicated) or alternative agent; excessive dilation may indicate systemic absorption.
Intraocular pressure (IOP)
Frequency: Post-dilation, especially in patients at risk for angle-closure glaucoma
Target: Within normal limits or patient's baseline
Action Threshold: Significant increase in IOP may indicate angle-closure and requires immediate intervention.
Vital signs (blood pressure, heart rate)
Frequency: Periodically, especially in pediatric, elderly, or patients with cardiovascular risk factors, or if systemic symptoms occur.
Target: Within patient's normal range
Action Threshold: Significant increase in BP or HR may indicate systemic absorption and require medical attention.
Symptom Monitoring
- Blurred vision
- Photophobia (light sensitivity)
- Eye irritation, stinging, burning
- Headache
- Palpitations, tachycardia, irregular heartbeat
- Tremor, nervousness
- Pallor
- Sweating
- Dizziness
- Nausea, vomiting
- Sudden eye pain or vision changes (signs of angle-closure glaucoma)
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Systemic absorption is minimal but possible, and phenylephrine is a vasoconstrictor.
Trimester-Specific Risks:
First Trimester:
Limited data. Potential for vasoconstriction affecting placental blood flow.
Second Trimester:
Limited data. Potential for vasoconstriction affecting placental blood flow.
Third Trimester:
Limited data. Potential for vasoconstriction affecting placental blood flow. Avoid close to term due to potential for uterine contractions.
Lactation
L3 (Moderately Safe). Minimal systemic absorption is expected, but caution is advised. Monitor the infant for signs of systemic adrenergic effects (e.g., irritability, changes in feeding/sleep patterns).
Infant Risk:
Low risk of adverse effects due to minimal systemic absorption, but theoretical risk of irritability or cardiovascular effects if significant absorption occurs.
Pediatric Use
Use 2.5% solution with caution, especially in infants and young children, due to increased risk of systemic absorption and adverse effects (e.g., hypertension, bradycardia, cardiovascular collapse). 0.5% or 1% solutions are generally preferred for pediatric mydriasis. Avoid 10% solution in children. Monitor vital signs closely.
Geriatric Use
Use with caution in elderly patients, especially those with pre-existing cardiovascular disease (e.g., hypertension, coronary artery disease), hyperthyroidism, or diabetes, due to increased susceptibility to systemic adrenergic effects. Monitor vital signs closely.
Clinical Information
Clinical Pearls
- Phenylephrine 2.5% is generally preferred over 10% for routine mydriasis, especially in pediatric and elderly patients, to minimize the risk of systemic adverse effects.
- Always check for a history of narrow angles or angle-closure glaucoma before administering, as phenylephrine can precipitate an acute angle-closure attack.
- Patients should be advised about photophobia and blurred vision post-dilation and instructed to wear sunglasses and avoid driving.
- Systemic absorption, though usually minimal, can lead to significant cardiovascular effects (e.g., hypertension, tachycardia, arrhythmias), particularly with higher concentrations, repeated doses, or in susceptible individuals.
- The mydriatic effect of phenylephrine can be reversed with topical alpha-adrenergic blocking agents like dapiprazole, though this is not commonly done for routine mydriasis.
Alternative Therapies
- Tropicamide (another mydriatic, often preferred for faster onset and shorter duration, with less systemic risk)
- Cyclopentolate (cycloplegic and mydriatic, used for refraction)
- Atropine (potent cycloplegic and mydriatic, long duration, higher systemic risk)
- Paremyd (hydroxyamphetamine/tropicamide combination)
Cost & Coverage
Average Cost:
$10 - $50 per 10ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (Generic)
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or pour them down the drain. If you are unsure about the proper disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken to ensure prompt and effective treatment.