Olopatadine 0.6% Nasal Spr (240 Sp)

Manufacturer APOTEX Active Ingredient Olopatadine (Nasal)(oh la PAT a deen) Pronunciation oh la PAT a deen
It is used to ease allergy signs.
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Drug Class
Antihistamine, Mast Cell Stabilizer
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Pharmacologic Class
Selective H1-receptor antagonist, Mast cell stabilizer
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Pregnancy Category
Not available
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FDA Approved
Apr 2008
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Olopatadine nasal spray is a medicine used to treat symptoms of seasonal and perennial allergies in the nose, like sneezing, runny nose, and itchy nose. It works by blocking a natural substance called histamine that your body makes during an allergic reaction.
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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. It is essential to use this medication as directed.

This medication is for nasal use only. Do not take it by mouth, and avoid getting it in your eyes or mouth, as it may cause burning.
Before using the pump for the first time, prime it by spraying 5 times. If the pump has not been used for 7 days, prime it with 2 sprays.
To use the medication:
1. Blow your nose before use.
2. Close one nostril.
3. Tilt your head forward slightly.
4. Insert the nose spray tube into the other nostril.
5. While breathing in through your nose, press down once to release the spray.
6. Breathe out through your mouth, making sure to spray up the nose only. Avoid spraying onto the wall between the two nostrils.
After use, carefully follow the cleaning instructions and replace the cap.

Storage and Disposal

Store this medication at room temperature in a dry place, avoiding bathrooms.
Discard any unused portion after 240 sprays.
Keep all medications in a safe location, out of the reach of children and pets.

Missed Dose

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

  • Avoid known allergens (e.g., pollen, dust mites, pet dander) to reduce allergy symptoms.
  • Use the nasal spray regularly as prescribed, even if symptoms improve, for best results.
  • Prime the pump before first use or if not used for several days by spraying into the air until a fine mist appears.
  • Clear your nasal passages by gently blowing your nose before using the spray.
  • Tilt your head slightly forward and insert the nozzle into one nostril, pointing slightly away from the nasal septum (the wall between your nostrils).
  • Close the other nostril with your finger and press down firmly on the pump while sniffing gently.
  • Repeat for the other nostril if directed.
  • Avoid blowing your nose immediately after using the spray.

Dosing & Administration

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Adult Dosing

Standard Dose: 2 sprays per nostril twice daily
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: 2-5 years: 1 spray per nostril twice daily; 6-11 years: 2 sprays per nostril twice daily
Adolescent: 12 years and older: 2 sprays per nostril twice daily
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Dose Adjustments

Renal Impairment:

Mild: No adjustment recommended
Moderate: No adjustment recommended
Severe: No adjustment recommended
Dialysis: No specific recommendations due to low systemic absorption

Hepatic Impairment:

Mild: No adjustment recommended
Moderate: No adjustment recommended
Severe: No adjustment recommended

Pharmacology

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Mechanism of Action

Olopatadine is a selective histamine H1-receptor antagonist that also inhibits the release of histamine from mast cells. It exerts its effects by blocking histamine at H1-receptors, thereby reducing symptoms associated with allergic rhinitis such as sneezing, rhinorrhea, and nasal itching. Its mast cell stabilizing properties contribute to preventing the release of inflammatory mediators.
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Pharmacokinetics

Absorption:

Bioavailability: Not directly quantifiable for nasal route due to low systemic exposure; systemic exposure is minimal.
Tmax: Approximately 1 hour after nasal administration.
FoodEffect: Not applicable for nasal administration.

Distribution:

Vd: Not well-defined for nasal route due to low systemic levels; however, for oral, it's approximately 17.4 L/kg.
ProteinBinding: Approximately 55% bound to plasma proteins.
CnssPenetration: Limited (non-sedating antihistamine)

Elimination:

HalfLife: Approximately 8-12 hours (systemic elimination half-life).
Clearance: Approximately 13.7 L/hr (systemic clearance).
ExcretionRoute: Primarily renal (approximately 60-70% excreted unchanged in urine).
Unchanged: Approximately 60-70% (renal excretion)
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Pharmacodynamics

OnsetOfAction: Within 30 minutes
PeakEffect: Within a few hours
DurationOfAction: Up to 12 hours

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

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 immediately:

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
Nose sores
A whistling sound when you breathe

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 unusual symptoms that bother you or do not go away, contact your doctor:

Nose irritation
Bad taste in your mouth
Nosebleed
Headache
Throat pain

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:

  • Severe or persistent nosebleeds
  • Worsening nasal symptoms
  • Signs of an allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
  • Significant drowsiness or dizziness (rare with nasal spray)
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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 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 due to the allergy.

Additionally, this medication may interact with other medications or health conditions. To ensure safe use, provide your doctor and pharmacist with a comprehensive list of all your current medications, including:

Prescription medications
Over-the-counter (OTC) medications
Natural products
Vitamins

Also, inform them about any existing health problems. It is crucial to verify that it is safe to take this medication alongside 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. Before engaging in activities that require alertness, such as driving, wait until you understand how this drug affects you. If you have recently undergone nose surgery or experienced a nose injury, ulcers, or sores, consult with your doctor to discuss potential concerns. To minimize risks, avoid consuming alcohol, marijuana, or other forms of cannabis, as well as prescription or over-the-counter (OTC) medications that may cause drowsiness or impair your reactions. If you are pregnant, planning to become pregnant, or are breast-feeding, notify your doctor to carefully weigh the benefits and risks of this medication for both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Drowsiness
  • Somnolence
  • Tachycardia (rapid heart rate)

What to Do:

In case of suspected overdose, contact a poison control center immediately (e.g., 1-800-222-1222) or seek emergency medical attention. Treatment is generally supportive and symptomatic.

Drug Interactions

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Moderate Interactions

  • CNS depressants (e.g., alcohol, sedatives, hypnotics, anxiolytics): May potentiate CNS depression, although systemic absorption of olopatadine nasal spray is minimal and sedation is rare.

Monitoring

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Routine Monitoring

Symptom relief (nasal congestion, rhinorrhea, sneezing, itching)

Frequency: Daily, as needed

Target: Reduction or resolution of symptoms

Action Threshold: Lack of improvement or worsening symptoms after appropriate trial period

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Symptom Monitoring

  • Nasal congestion
  • Rhinorrhea (runny nose)
  • Sneezing
  • Nasal itching
  • Post-nasal drip
  • Nosebleeds (epistaxis)
  • Headache
  • Bitter taste

Special Patient Groups

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Pregnancy

Olopatadine nasal spray is generally considered to have low systemic absorption, which limits fetal exposure. While older classifications listed it as Category B, current guidelines emphasize a risk summary. Human data are limited, but animal studies have not shown evidence of teratogenicity. Use during pregnancy should be considered if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Low risk due to minimal systemic absorption; human data limited.
Second Trimester: Low risk due to minimal systemic absorption; human data limited.
Third Trimester: Low risk due to minimal systemic absorption; human data limited.
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Lactation

Olopatadine is excreted in the milk of lactating rats. It is unknown whether olopatadine is excreted in human milk. However, due to low systemic absorption from the nasal route, infant exposure is expected to be low. The benefits of breastfeeding should be weighed against the potential risk of infant exposure. Monitor the infant for drowsiness or unusual irritability.

Infant Risk: Low risk (L3 - Moderately safe, but data limited)
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Pediatric Use

Approved for use in children 2 years of age and older. Dosing varies by age group (1 spray per nostril twice daily for 2-5 years; 2 sprays per nostril twice daily for 6-11 years and 12 years and older). Safety and efficacy not established in children younger than 2 years.

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Geriatric Use

No specific dose adjustment is necessary in elderly patients. Systemic exposure is low, and the safety profile is similar to that in younger adults.

Clinical Information

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Clinical Pearls

  • Olopatadine nasal spray is effective for both seasonal and perennial allergic rhinitis.
  • It has a rapid onset of action, often providing relief within 30 minutes.
  • The most common side effect is a bitter taste, which can be minimized by proper administration technique (avoiding sniffing too hard).
  • Unlike some older oral antihistamines, olopatadine nasal spray is generally non-sedating due to its limited systemic absorption and low CNS penetration.
  • Ensure patients understand the correct priming and administration technique for optimal efficacy and to minimize side effects like bitter taste or epistaxis.
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Alternative Therapies

  • Other intranasal antihistamines (e.g., azelastine nasal spray)
  • Intranasal corticosteroids (e.g., fluticasone, mometasone)
  • Oral antihistamines (e.g., loratadine, fexofenadine, cetirizine)
  • Leukotriene receptor antagonists (e.g., montelukast)
  • Cromolyn sodium nasal spray (mast cell stabilizer)
  • Saline nasal rinses
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Cost & Coverage

Average Cost: Varies widely, typically $150-$300+ per 240 spray bottle
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (Brand), Tier 1 (Generic)
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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.