Olopatadine 0.2% Ophth Soln 2.5ml

Manufacturer AUROHEALTH Active Ingredient Olopatadine (Ophthalmic)(oh la PAT a deen) Pronunciation oh la PAT a deen
It is used to treat eye irritation due to allergies.
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Drug Class
Ophthalmic Antihistamine and Mast Cell Stabilizer
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Pharmacologic Class
H1-receptor antagonist; Mast cell stabilizer
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Pregnancy Category
Category C
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FDA Approved
May 2008
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Olopatadine 0.2% eye drops are used to relieve itchy, red, and watery eyes caused by allergies like pollen, dust, or pet dander. It works by blocking substances in your eyes that cause allergic reactions.
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How to Use This Medicine

Proper Use of This Medication

To use this eye medication correctly, follow your doctor's instructions and read all the information provided. For optimal results, use this medication as directed and follow these steps:

Use this medication only in the eye.
Wash your hands before and after use to maintain cleanliness.
Remove contact lenses before applying the medication. You can reinsert your lenses 10 minutes after application, unless your eyes are irritated or infected.
Avoid touching the container tip to your eye, lid, or surrounding skin, as this can introduce bacteria and potentially cause severe eye problems or vision loss.
Tilt your head back and gently drop the medication into your eye.
After application, keep your eyes closed and apply gentle pressure to the inner corner of your eye for 1 to 2 minutes. This helps the medication stay in your eye.
Replace the cap after use.

Important Safety Precautions

Do not use the medication if the solution has changed color, appears cloudy, or contains particles. Instead, obtain a new one.
If you are using multiple medications in the same eye, administer each medication at least 5 minutes apart.

Storage and Disposal

Store the medication at room temperature with the lid tightly closed.
Keep all medications in a safe and secure location, out of the reach of children and pets.
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. Consult your pharmacist for guidance on the best disposal method, and consider participating in local drug take-back programs.

Missed Dose Instructions

If you miss a dose, use it as soon as you remember.
If it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
* Do not use two doses at the same time or take extra doses.
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Lifestyle & Tips

  • Avoid touching the dropper tip to any surface (e.g., eye, fingers) to prevent contamination.
  • Remove contact lenses before applying the drops and wait at least 10 minutes before reinserting them.
  • Do not wear contact lenses if your eyes are red or irritated.
  • If using other eye drops, wait at least 5 minutes between applications.
  • Avoid known allergens (e.g., pollen, dust mites, pet dander) as much as possible.

Dosing & Administration

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Adult Dosing

Standard Dose: 1 drop in affected eye(s) once daily
Dose Range: 1 - 1 mg

Condition-Specific Dosing:

allergicConjunctivitis: 1 drop in affected eye(s) once daily
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (safety and efficacy not established in children under 2 years of age)
Child: 1 drop in affected eye(s) once daily (2 years of age and older)
Adolescent: 1 drop in affected eye(s) once daily
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Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed

Pharmacology

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Mechanism of Action

Olopatadine is a relatively selective H1-receptor antagonist and an inhibitor of histamine release from mast cells. It inhibits the in vivo and in vitro type 1 immediate hypersensitivity reaction, including inhibition of histamine-induced conjunctival hyperemia, itching, and tearing.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption after ophthalmic administration.
Tmax: Approximately 30-60 minutes (systemic, but negligible for ophthalmic use)
FoodEffect: Not applicable for ophthalmic administration.

Distribution:

Vd: Not available (minimal systemic distribution)
ProteinBinding: Approximately 55% (in vitro)
CnssPenetration: Limited (minimal systemic absorption)

Elimination:

HalfLife: Approximately 3 hours (systemic, but negligible for ophthalmic use)
Clearance: Not available (minimal systemic clearance)
ExcretionRoute: Primarily renal excretion (systemic)
Unchanged: Not available (minimal systemic exposure)
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Pharmacodynamics

OnsetOfAction: Within minutes (typically 30 minutes for symptom relief)
PeakEffect: Not precisely defined for ophthalmic use, but symptom relief is rapid.
DurationOfAction: Up to 24 hours (for 0.2% formulation)

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately
While rare, some people may experience severe and potentially life-threatening side effects when 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
Changes in eyesight, eye pain, or severe eye irritation
Eye redness

Other Possible Side Effects
Like all medications, this drug can cause side effects. Although 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 that bother you or do not go away, contact your doctor or seek medical help:

Headache
Blurred eyesight
Eye irritation
Dry eyes
Feeling that something is in the eye
Change in taste
Signs of a common cold
* Burning or stinging

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.
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Seek Immediate Medical Attention If You Experience:

  • Worsening eye irritation or redness
  • Eye pain
  • Changes in vision
  • Persistent or worsening symptoms after several days of use
  • Signs of an eye infection (e.g., pus, severe swelling)
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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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to avoid potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.

To ensure your safety, it is vital to verify that it is safe to take this medication with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
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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 when driving or performing tasks that require clear vision to ensure your safety.

This medication is not intended to treat irritation caused by contact lenses. If your eyes are red, avoid wearing contact lenses to prevent further irritation.

In the event of accidental ingestion, this medication can be harmful. If swallowed, immediately contact a doctor or a poison control center for assistance.

If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks of using this medication, both for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Unlikely with ophthalmic use due to minimal systemic absorption.
  • If accidentally ingested systemically, symptoms might include drowsiness, but this is highly improbable with eye drops.

What to Do:

If accidental ingestion occurs, drink fluids. For significant ingestion or unusual symptoms, call a poison control center (1-800-222-1222) or seek immediate medical attention.

Drug Interactions

Monitoring

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Baseline Monitoring

Ocular symptoms (itching, redness, tearing)

Rationale: To assess baseline severity of allergic conjunctivitis.

Timing: Prior to initiation of therapy

Visual acuity

Rationale: To establish baseline ocular health.

Timing: Prior to initiation of therapy

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Routine Monitoring

Improvement of ocular symptoms

Frequency: Daily, as needed

Target: Reduction or resolution of itching, redness, and tearing

Action Threshold: If symptoms worsen or do not improve after several days, re-evaluate diagnosis or treatment.

Signs of ocular irritation or adverse effects

Frequency: Daily, as needed

Target: Absence of new or worsening irritation, pain, or vision changes

Action Threshold: Discontinue use and consult healthcare provider if severe irritation, pain, or vision changes occur.

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Symptom Monitoring

  • Ocular itching
  • Ocular redness
  • Tearing
  • Foreign body sensation
  • Blurred vision
  • Eye pain
  • Swelling of eyelids

Special Patient Groups

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Pregnancy

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects at high systemic doses, but systemic exposure from ophthalmic use is minimal.

Trimester-Specific Risks:

First Trimester: Minimal risk due to negligible systemic absorption.
Second Trimester: Minimal risk due to negligible systemic absorption.
Third Trimester: Minimal risk due to negligible systemic absorption.
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Lactation

Caution should be exercised when olopatadine ophthalmic solution is administered to a nursing mother. It is unknown whether this drug is excreted in human milk, but systemic exposure is minimal.

Infant Risk: Low risk due to minimal systemic absorption in the mother, leading to very low potential for infant exposure.
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Pediatric Use

Safety and effectiveness have been established in pediatric patients 2 years of age and older. Not recommended for children under 2 years of age due to lack of data.

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Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients. No dosage adjustment is necessary.

Clinical Information

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Clinical Pearls

  • Olopatadine 0.2% is a once-daily formulation, offering convenience for patients.
  • It provides both antihistamine and mast cell stabilizing effects, addressing immediate and sustained allergic responses.
  • Patients should be instructed on proper eye drop instillation technique to maximize efficacy and minimize contamination.
  • Advise patients to remove contact lenses before instilling drops and wait 10 minutes before reinserting.
  • While generally well-tolerated, transient burning or stinging upon instillation can occur.
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Alternative Therapies

  • Cromolyn sodium ophthalmic solution (mast cell stabilizer)
  • Topical ophthalmic corticosteroids (for severe cases, short-term use)
  • Oral antihistamines (e.g., loratadine, cetirizine - less effective for direct eye symptoms)
  • Artificial tears (for symptomatic relief and allergen washout)
  • Cold compresses
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Cost & Coverage

Average Cost: Varies, typically $30-$100+ per 2.5ml bottle
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 for generic, Tier 2 or 3 for brand
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this 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. When seeking help, be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.