Phenylephrine 2.5% Ophth Soln 2ml

Manufacturer LIFESTAR PHARMA Active Ingredient Phenylephrine Eye Drops 2. 5%(fen il EF rin) Pronunciation fen il EF rin
It makes the eye pupils larger.
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Drug Class
Mydriatic; Vasoconstrictor
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Pharmacologic Class
Alpha-1 adrenergic agonist
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Pregnancy Category
Category C
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Phenylephrine eye drops are used to make your pupil (the black center of your eye) larger. This helps your eye doctor examine the back of your eye. It works by temporarily tightening tiny muscles in your eye.
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How to Use This Medicine

To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. It is essential to adhere to the prescribed dosage and administration guidelines. This medication is for ophthalmic use only.

For proper storage and disposal, consult with your doctor, nurse, or pharmacist to determine the best approach for storing this medication at home.

If you miss a dose, contact your doctor promptly to receive guidance on the appropriate course of action.
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Lifestyle & Tips

  • Do not drive or operate machinery after using these drops, as your vision will be blurry and you will be sensitive to light. Wear sunglasses to protect your eyes from bright light.
  • Avoid touching the dropper tip to your eye or any other surface to prevent contamination.
  • Remove contact lenses before instilling drops and wait at least 15 minutes before reinserting them.

Dosing & Administration

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Adult Dosing

Standard Dose: 1 drop of 2.5% solution instilled into the conjunctival sac, may repeat in 10-60 minutes if needed for adequate dilation. For funduscopy, 1 drop is usually sufficient.
Dose Range: 1 - 2 mg

Condition-Specific Dosing:

mydriasis: 1 drop of 2.5% solution, repeat in 10-60 minutes if necessary. For funduscopy, 1 drop is usually sufficient.
vasoconstriction: 1 drop of 2.5% solution as needed.
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Pediatric Dosing

Neonatal: Not established (use 0.5% or 1% solution with extreme caution due to risk of systemic absorption and adverse effects, especially in premature infants). 2.5% is generally not recommended for neonates.
Infant: Not established (use 0.5% or 1% solution with extreme caution due to risk of systemic absorption and adverse effects). 2.5% is generally not recommended for infants.
Child: 1 drop of 2.5% solution instilled into the conjunctival sac, may repeat in 10-60 minutes if needed. Use with caution, especially in low-weight children, due to risk of systemic absorption.
Adolescent: 1 drop of 2.5% solution instilled into the conjunctival sac, may repeat in 10-60 minutes if needed.
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Dose Adjustments

Renal Impairment:

Mild: Not typically required for ophthalmic use due to minimal systemic absorption.
Moderate: Not typically required for ophthalmic use due to minimal systemic absorption.
Severe: Not typically required for ophthalmic use due to minimal systemic absorption.
Dialysis: Not typically required for ophthalmic use due to minimal systemic absorption.

Hepatic Impairment:

Mild: Not typically required for ophthalmic use due to minimal systemic absorption.
Moderate: Not typically required for ophthalmic use due to minimal systemic absorption.
Severe: Not typically required for ophthalmic use due to minimal systemic absorption.

Pharmacology

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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 pupillary dilation (mydriasis), and vasoconstriction of conjunctival blood vessels.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption from ophthalmic administration; however, significant systemic absorption can occur, especially with higher concentrations (e.g., 10%) or compromised ocular surface.
Tmax: Not well-characterized for ophthalmic use; mydriasis typically occurs within 10-60 minutes.
FoodEffect: Not applicable for ophthalmic use.

Distribution:

Vd: Not well-characterized for ophthalmic use.
ProteinBinding: Not well-characterized for ophthalmic use.
CnssPenetration: Limited (if systemic absorption occurs, can cross blood-brain barrier to some extent).

Elimination:

HalfLife: Not well-characterized for ophthalmic use; systemic half-life is short (approx. 2-3 hours).
Clearance: Not well-characterized for ophthalmic use.
ExcretionRoute: Renal (if absorbed systemically).
Unchanged: Not well-characterized for ophthalmic use.
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Pharmacodynamics

OnsetOfAction: Mydriasis: 10-60 minutes
PeakEffect: Mydriasis: 15-60 minutes
DurationOfAction: Mydriasis: 3-7 hours (may vary based on concentration and individual response)
Confidence: Medium

Safety & Warnings

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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 or seek immediate 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 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)

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe eye pain
  • Sudden vision changes
  • Severe headache
  • Chest pain
  • Fast or irregular heartbeat
  • Dizziness or fainting
  • Unusual sweating
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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 can lead to severely high blood pressure.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your existing health conditions and other medications. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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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, be cautious when performing tasks that require clear vision, such as driving, as your pupils may be dilated.

If you have a sulfite allergy, consult your doctor before taking this medication, as some formulations may contain sulfites.

The 10% strength of this medication has been associated with severe cardiac adverse effects, including abnormal heart rhythms and heart attacks, which have predominantly occurred in individuals with pre-existing heart disease. In some cases, these cardiac events were 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.
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Overdose Information

Overdose Symptoms:

  • Severe headache
  • Palpitations
  • Rapid or irregular heartbeat
  • High blood pressure
  • Nausea
  • Vomiting
  • Tremor
  • Anxiety
  • Shortness of breath

What to Do:

If you suspect an overdose or experience severe symptoms, seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222 in the US).

Drug Interactions

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Major Interactions

  • Monoamine Oxidase Inhibitors (MAOIs): Concurrent use or use within 21 days of MAOIs can lead to hypertensive crisis due to enhanced adrenergic effects.
  • Tricyclic Antidepressants (TCAs): May potentiate the pressor effect of phenylephrine.
  • Beta-blockers (systemic): May increase the risk of systemic hypertension and bradycardia.
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Moderate Interactions

  • Atropine and other anticholinergics: May potentiate the mydriatic effect.
  • Halogenated anesthetics (e.g., halothane): May sensitize the myocardium to the effects of sympathomimetics, increasing risk of arrhythmias.
  • Cardiac glycosides (e.g., digoxin): May increase risk of arrhythmias.

Monitoring

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Baseline Monitoring

Intraocular Pressure (IOP)

Rationale: To identify patients at risk for acute angle-closure glaucoma, as phenylephrine can precipitate an attack in susceptible individuals.

Timing: Prior to administration, especially in patients with narrow angles or a history of glaucoma.

Blood Pressure and Heart Rate

Rationale: To assess baseline cardiovascular status, especially in patients with cardiovascular disease, hypertension, or hyperthyroidism, due to potential for systemic absorption and adverse effects.

Timing: Prior to administration, particularly with higher concentrations or in susceptible patients.

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Routine Monitoring

Pupillary Response (degree of mydriasis)

Frequency: As needed to assess efficacy.

Target: Desired level of dilation for examination/procedure.

Action Threshold: If inadequate dilation, consider re-dosing or alternative agent; if excessive, monitor for discomfort.

Intraocular Pressure (IOP)

Frequency: Post-dilation, especially in patients at risk for angle-closure.

Target: Normal range (e.g., 10-21 mmHg)

Action Threshold: Significant increase in IOP requires immediate intervention.

Systemic Vital Signs (Blood Pressure, Heart Rate)

Frequency: Monitor periodically, especially in susceptible patients (e.g., infants, elderly, cardiovascular disease).

Target: Within patient's normal range.

Action Threshold: Significant changes (e.g., marked hypertension, tachycardia, bradycardia) require immediate medical attention.

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Symptom Monitoring

  • Eye pain or discomfort
  • Blurred vision (expected, but monitor for severe or persistent changes)
  • Headache
  • Palpitations
  • Tremor
  • Dizziness
  • Nausea
  • Sweating
  • Pallor

Special Patient Groups

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Pregnancy

Use with caution during pregnancy. Animal studies have shown adverse effects, but human data are limited. Systemic absorption is minimal with ophthalmic use, but potential for systemic effects exists, especially with higher concentrations or repeated dosing. Weigh potential benefits against risks.

Trimester-Specific Risks:

First Trimester: Limited data; theoretical risk of vasoconstrictive effects on uterine blood flow, but unlikely with minimal ophthalmic absorption.
Second Trimester: Limited data.
Third Trimester: Limited data; theoretical risk of vasoconstrictive effects.
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Lactation

Use with caution during breastfeeding. It is unknown if phenylephrine is excreted in human milk. Due to minimal systemic absorption from ophthalmic use, infant exposure is likely low. Monitor infant for irritability, feeding changes, or cardiovascular effects. Consider using the lowest effective concentration and limiting exposure.

Infant Risk: L3 (Moderate risk - no human data, but systemic absorption is minimal, so infant exposure is likely low. Monitor for adverse effects.)
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Pediatric Use

Use 2.5% solution with caution in children, especially infants and low-weight children, due to increased risk of systemic absorption and adverse cardiovascular effects (e.g., hypertension, bradycardia, arrhythmias). 0.5% or 1% solutions are generally preferred for infants and young children. Avoid use in premature infants. Monitor vital signs closely.

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Geriatric Use

Use with caution in elderly patients, particularly those with pre-existing cardiovascular disease (e.g., hypertension, coronary artery disease, arrhythmias) or hyperthyroidism, due to increased susceptibility to systemic adverse effects. Also, increased risk of precipitating acute angle-closure glaucoma in elderly patients with narrow anterior chamber angles.

Clinical Information

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Clinical Pearls

  • Always check the concentration of phenylephrine before administration, as 10% solution carries a significantly higher risk of systemic adverse effects.
  • Warn patients about blurred vision and light sensitivity after dilation and advise them to wear sunglasses and avoid driving.
  • Apply gentle pressure to the lacrimal sac (inner corner of the eye) for 1-2 minutes after instillation to minimize systemic absorption.
  • Contraindicated in patients with narrow angles or angle-closure glaucoma unless iridectomy has been performed.
  • Use with extreme caution in patients with severe hypertension, cardiac disease, hyperthyroidism, or cerebral arteriosclerosis.
  • The 2.5% solution is generally safer than the 10% solution for routine mydriasis, especially in pediatric and elderly populations.
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Alternative Therapies

  • Tropicamide (another mydriatic, often preferred for rapid onset and shorter duration)
  • Cyclopentolate (mydriatic and cycloplegic, longer duration than tropicamide)
  • Atropine (strong mydriatic and cycloplegic, very long duration, typically for therapeutic use)
  • Homatropine (mydriatic and cycloplegic, intermediate duration)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 2ml bottle
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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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 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 correct 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 of ingestion.