Proparacaine 0.5% Ophth Soln 15ml

Manufacturer BAUSCH HEALTH Active Ingredient Proparacaine(proe PAR a kane) Pronunciation proe PAR a kane
It is used to numb the eye.
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Drug Class
Ophthalmic Anesthetic
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Pharmacologic Class
Local Anesthetic (Ester-type)
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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?

Proparacaine is an eye drop that temporarily numbs the surface of your eye. It's used by eye doctors for procedures like eye exams, removing foreign objects, or measuring eye pressure, so you don't feel discomfort.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. It's essential to follow the instructions carefully. This medication is for eye use only.

Storing and Disposing of Your Medication

This medication will be administered in a hospital or doctor's office, so you will not need to store it at home.

Missing a Dose

Since this medication is given as needed in a healthcare setting, you will not need to worry about missing a dose. The healthcare provider will administer the medication according to your specific needs.
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Lifestyle & Tips

  • Do NOT rub or touch your eye while it is numb, as this can cause serious injury without you feeling it.
  • Do NOT use contact lenses until the numbness has completely worn off and your eye feels normal.
  • Avoid getting the solution on other parts of your body, especially mucous membranes.
  • This medication is for professional use only and should not be used for self-treatment of eye pain.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 1 to 2 drops in the eye(s) prior to procedure
Dose Range: 1 - 2 mg

Condition-Specific Dosing:

tonometry: 1 to 2 drops immediately before measurement
minorprocedures: 1 to 2 drops every 5 to 10 minutes for 5 to 7 doses
deepanesthesia: 1 drop every 5 to 10 minutes for 3 to 5 doses
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Pediatric Dosing

Neonatal: Not established (use with caution, consult ophthalmologist)
Infant: 1 to 2 drops in the eye(s) prior to procedure (use with caution, consult ophthalmologist)
Child: 1 to 2 drops in the eye(s) prior to procedure
Adolescent: 1 to 2 drops in the eye(s) prior to procedure
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (minimal systemic absorption)
Moderate: No adjustment needed (minimal systemic absorption)
Severe: No adjustment needed (minimal systemic absorption)
Dialysis: No specific considerations (minimal systemic absorption)

Hepatic Impairment:

Mild: No adjustment needed (minimal systemic absorption)
Moderate: No adjustment needed (minimal systemic absorption)
Severe: No adjustment needed (minimal systemic absorption)

Pharmacology

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Mechanism of Action

Proparacaine is a local anesthetic of the ester type. It stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby producing local anesthesia. It blocks nerve impulse conduction by decreasing the permeability of the neuronal membrane to sodium ions.
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Pharmacokinetics

Absorption:

Bioavailability: Not applicable (minimal systemic absorption from ophthalmic use)
Tmax: Not applicable (local effect, rapid onset)
FoodEffect: Not applicable

Distribution:

Vd: Not applicable (primarily local action)
ProteinBinding: Not applicable (primarily local action)
CnssPenetration: Limited (minimal systemic absorption)

Elimination:

HalfLife: Not well-defined for ophthalmic use (rapid local metabolism)
Clearance: Not well-defined for ophthalmic use
ExcretionRoute: Metabolites excreted renally
Unchanged: Not applicable (minimal systemic absorption)
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Pharmacodynamics

OnsetOfAction: 10-20 seconds
PeakEffect: 30-60 seconds
DurationOfAction: 10-20 minutes
Confidence: High

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor or seek medical attention immediately, as they may be signs of a severe and potentially life-threatening side effect:
- 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, or swelling of the mouth, face, lips, tongue, or throat
- Changes in eyesight, eye pain, or severe eye irritation

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. Contact your doctor if you experience any of the following side effects or if they persist or bother you:
- Burning or stinging
- Redness

Note: This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe or persistent eye pain after the numbing effect wears off
  • Significant vision changes or loss of vision
  • Increased redness, swelling, or discharge from the eye (signs of infection)
  • Allergic reactions such as rash, itching, severe dizziness, or trouble breathing (rare with topical use)
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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, any of its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions or exacerbate underlying health issues.

To ensure your safety, it is crucial to verify that this medication can be taken safely with all your other medications and health conditions. 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. When using this drug, exercise caution while driving or performing tasks that require clear vision to ensure your safety. To avoid any potential complications, refrain from touching or rubbing your eye while it is numb from the medication. This medication is intended for short-term use only, as prolonged use may lead to a serious eye condition that can result in vision loss. If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Local: Severe eye irritation, redness, swelling, corneal damage (with excessive or prolonged use).
  • Systemic (extremely rare with ophthalmic use): Central nervous system effects (e.g., nervousness, dizziness, blurred vision, tremors, convulsions, unconsciousness), cardiovascular effects (e.g., hypotension, bradycardia, cardiac arrest).

What to Do:

For local overdose, flush eye with water. For suspected systemic overdose (highly unlikely with ophthalmic use), seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). Management is supportive, focusing on maintaining airway, breathing, and circulation.

Drug Interactions

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Moderate Interactions

  • Sulfonamides (topical ophthalmic): May be inhibited by para-aminobenzoic acid (PABA), a metabolite of ester-type local anesthetics like proparacaine. Avoid concurrent use if possible.

Monitoring

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Baseline Monitoring

Ocular examination (cornea, conjunctiva)

Rationale: To assess baseline ocular health and identify any pre-existing conditions that may contraindicate use or affect outcome.

Timing: Prior to administration

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Routine Monitoring

Corneal integrity

Frequency: Post-procedure, especially with repeated use

Target: Intact, no epithelial defects

Action Threshold: Presence of corneal abrasions, erosions, or opacities warrants discontinuation and ophthalmologic evaluation.

Signs of local irritation/allergic reaction

Frequency: During and immediately after administration

Target: Absence of severe redness, swelling, itching, or pain

Action Threshold: Significant or worsening symptoms require discontinuation and appropriate management.

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Symptom Monitoring

  • Stinging or burning upon instillation (common, usually transient)
  • Redness or irritation of the eye
  • Blurred vision
  • Itching or swelling of the eyelids
  • Persistent pain or discomfort after the anesthetic effect should have worn off
  • Any signs of infection (e.g., discharge, increased pain, worsening redness)

Special Patient Groups

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Pregnancy

Proparacaine is classified as Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Systemic absorption from ophthalmic use is minimal.

Trimester-Specific Risks:

First Trimester: Limited human data; animal studies have not shown teratogenicity, but caution is advised.
Second Trimester: Limited human data; minimal systemic absorption suggests low risk.
Third Trimester: Limited human data; minimal systemic absorption suggests low risk.
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Lactation

Proparacaine is considered L3 (Moderately Safe) for lactation. Due to minimal systemic absorption, it is unlikely to be excreted in breast milk in clinically significant amounts. Caution is advised, but generally considered compatible with breastfeeding.

Infant Risk: Low risk of adverse effects to the breastfed infant due to minimal systemic absorption by the mother.
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Pediatric Use

Proparacaine ophthalmic solution has been used safely in pediatric patients for diagnostic and minor surgical procedures. Dosing is generally similar to adults, but caution should be exercised, especially in very young infants, due to potential for increased systemic absorption or sensitivity.

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Geriatric Use

No specific dosage adjustments are typically required for geriatric patients. The systemic absorption is minimal, so age-related changes in renal or hepatic function are unlikely to significantly impact drug clearance or safety. Use with caution in patients with pre-existing ocular conditions.

Clinical Information

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Clinical Pearls

  • Proparacaine is for diagnostic and short-term therapeutic procedures only; it is NOT for prolonged self-administration for pain relief due to the risk of severe corneal damage (e.g., corneal opacification, ulceration, perforation).
  • Patients should be warned not to rub or touch their eyes while numb to prevent inadvertent injury.
  • Advise patients to avoid wearing contact lenses until the anesthetic effect has completely worn off.
  • Store the solution in the refrigerator and protect from light to maintain potency.
  • Always check the expiration date; degraded solutions may be less effective or cause irritation.
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Alternative Therapies

  • Tetracaine ophthalmic solution (another ester-type local anesthetic)
  • Lidocaine ophthalmic solution (an amide-type local anesthetic, less common for topical ophthalmic use but available in some formulations)
  • Benoxinate ophthalmic solution (often combined with fluorescein for diagnostic purposes)
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Cost & Coverage

Average Cost: Relatively inexpensive per 15ml 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 for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed to 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: do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist or healthcare provider. 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 medical attention. Be prepared to provide information about the medication taken, the quantity, and the time of ingestion to ensure prompt and effective treatment.