Olopatadine 0.1% Opth Soln 5ml

Manufacturer SOMERSET THERAPEUTICS 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
Dec 1996
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Olopatadine ophthalmic solution is an eye drop used to relieve itchy eyes caused by allergies. It works by blocking substances in your body that cause allergic reactions and by stabilizing cells that release these substances, helping to reduce symptoms like itching and redness.
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How to Use This Medicine

Proper Use of This Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. For optimal results, use this medication only in the eye.

Preparation and Administration

1. Wash your hands before and after using this medication.
2. Remove contact lenses before administration. You can reinsert them 10 minutes after using the medication, unless your eyes are irritated or infected.
3. Avoid touching the container tip to your eye, lid, or surrounding skin, as this can introduce bacteria and lead to severe eye problems or vision loss.
4. Tilt your head back and gently drop the medication into your eye.
5. After administration, keep your eyes closed and apply gentle pressure to the inner corner of your eye for 1 to 2 minutes to help the medication stay in your eye.
6. Replace the cap tightly after use.

Important Safety Precautions

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

Storage and Disposal

Store this medication at room temperature with the lid tightly closed. Keep all medications in a safe place, 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. However, 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 (eye, fingers, etc.) to prevent contamination.
  • Remove contact lenses before administering the drops and wait at least 10 minutes after instillation before reinserting contact lenses.
  • If using other ophthalmic medications, administer them at least 5 to 10 minutes apart.
  • Avoid known allergens (e.g., pollen, pet dander) if possible to reduce allergic symptoms.

Dosing & Administration

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Adult Dosing

Standard Dose: 1 drop in the affected eye(s) twice daily, approximately 6 to 8 hours apart.

Condition-Specific Dosing:

allergicConjunctivitis: 1 drop in the affected eye(s) twice 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: 2 years and older: 1 drop in the affected eye(s) twice daily, approximately 6 to 8 hours apart.
Adolescent: Same as adult
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed due to minimal systemic absorption.
Moderate: No adjustment needed due to minimal systemic absorption.
Severe: No adjustment needed due to minimal systemic absorption.
Dialysis: No specific considerations due to minimal systemic absorption.

Hepatic Impairment:

Mild: No adjustment needed due to minimal systemic absorption.
Moderate: No adjustment needed due to minimal systemic absorption.
Severe: No adjustment needed due to minimal systemic absorption.

Pharmacology

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Mechanism of Action

Olopatadine is a selective H1-receptor antagonist and mast cell stabilizer. It exerts its effects by inhibiting the release of histamine from mast cells and by blocking histamine's effects on conjunctival H1 receptors. It also inhibits the release of other pro-inflammatory mediators from mast cells.
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Pharmacokinetics

Absorption:

Bioavailability: Not applicable (minimal systemic absorption)
Tmax: Not clinically relevant (systemic concentrations typically below quantification limit)
FoodEffect: Not applicable (ophthalmic administration)

Distribution:

Vd: Not clinically relevant (minimal systemic absorption)
ProteinBinding: Approximately 55% (systemic, if absorbed)
CnssPenetration: Limited (minimal systemic absorption)

Elimination:

HalfLife: Not clinically relevant (systemic half-life approximately 3 hours if absorbed, but systemic levels are negligible)
Clearance: Not clinically relevant (minimal systemic absorption)
ExcretionRoute: Primarily renal if systemically absorbed, but systemic levels are negligible.
Unchanged: Not clinically relevant (minimal systemic absorption)
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Pharmacodynamics

OnsetOfAction: Within minutes (e.g., 30 minutes for symptom relief)
PeakEffect: Not precisely defined for ophthalmic use, rapid relief of symptoms.
DurationOfAction: Up to 8 hours (supports twice-daily dosing)
Confidence: Medium

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

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 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
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:

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, 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:

  • Worsening eye redness or irritation
  • Eye pain
  • Changes in vision
  • Signs of eye infection (e.g., pus, severe swelling)
  • Persistent or worsening allergic symptoms despite 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, 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 identify 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 crucial 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, including this one.
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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. 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 that this drug is ingested, it can be harmful, so it is crucial to contact a doctor or a poison control center immediately. 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:

  • Unlikely with ophthalmic administration due to minimal systemic absorption.
  • If accidentally ingested orally in large quantities, systemic antihistamine effects such as drowsiness, lethargy, or dizziness could theoretically occur.

What to Do:

In case of accidental ingestion, contact a poison control center immediately (e.g., call 1-800-222-1222 in the US) or seek emergency medical attention. Treatment is generally supportive.

Drug Interactions

Monitoring

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Baseline Monitoring

Ocular examination

Rationale: To assess baseline ocular health and severity of allergic conjunctivitis.

Timing: Prior to initiation of therapy.

Symptom assessment (itching, redness)

Rationale: To establish baseline symptom severity for evaluating treatment efficacy.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Symptom resolution (ocular itching, redness)

Frequency: As needed, during follow-up visits.

Target: Reduction or absence of symptoms.

Action Threshold: Lack of improvement or worsening symptoms may require re-evaluation or alternative therapy.

Adverse ocular effects (e.g., irritation, blurred vision)

Frequency: As needed, during follow-up visits.

Target: Absence of significant adverse effects.

Action Threshold: Persistent or severe adverse effects may require discontinuation.

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Symptom Monitoring

  • Ocular itching
  • Ocular redness
  • Foreign body sensation
  • Ocular discharge
  • Blurred vision
  • Ocular irritation

Special Patient Groups

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Pregnancy

Category C. Animal studies have shown adverse effects on the fetus, but there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Potential risk based on animal data; human data lacking.
Second Trimester: Potential risk based on animal data; human data lacking.
Third Trimester: Potential risk based on animal data; human data lacking.
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Lactation

L3 (Moderately Safe). Minimal systemic absorption is expected after ophthalmic administration, making significant excretion into breast milk unlikely. However, caution should be exercised when administered to a nursing mother.

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

Safety and effectiveness have been established in pediatric patients 2 years of age and older. Not established for use in children younger than 2 years of age.

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Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients. No specific dose adjustment is required.

Clinical Information

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Clinical Pearls

  • Olopatadine ophthalmic solution is effective for the relief of ocular itching associated with allergic conjunctivitis.
  • It has a dual mechanism of action, acting as both an antihistamine and a mast cell stabilizer, providing rapid onset of action and sustained relief.
  • Patients should be instructed on proper instillation technique to avoid contamination of the dropper tip.
  • Advise patients to remove contact lenses before instillation and wait at least 10 minutes before reinserting them.
  • Due to minimal systemic absorption, systemic side effects and drug interactions are rare with ophthalmic use.
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Alternative Therapies

  • Other ophthalmic antihistamines (e.g., azelastine, ketotifen, emedastine)
  • Other ophthalmic mast cell stabilizers (e.g., cromolyn sodium, lodoxamide)
  • Ophthalmic NSAIDs (e.g., ketorolac) for ocular itching/inflammation
  • Ophthalmic corticosteroids (for severe, refractory cases, under specialist supervision)
  • Artificial tears (for symptomatic relief and to wash out allergens)
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Cost & Coverage

Average Cost: Varies widely (e.g., $20 - $100+) per 5ml bottle
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 for generic formulations; higher tiers for brand names.
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General Drug Facts

If your symptoms or health issues persist or worsen, it's 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 be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.