Ipratropium 0.06% Nasal Spray 15ml

Manufacturer APOTEX Active Ingredient Ipratropium (Nasal)(i pra TROE pee um) Pronunciation i pra TROE pee um
It is used to ease allergy signs.
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Drug Class
Anticholinergic, Nasal
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Pharmacologic Class
Antimuscarinic agent
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Pregnancy Category
Category B
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FDA Approved
Mar 1995
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Ipratropium nasal spray is a medication used to help stop a runny nose caused by allergies (perennial rhinitis) or the common cold. It works by drying up the excess mucus in your nose.
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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 or if it has not been used for more than 7 days, prime it by spraying 7 times. If the pump has not been used for more than 24 hours, prime it by spraying 2 times.
To use the nasal spray:
1. Blow your nose gently 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 the pump once to release the spray.
6. Breathe out through your mouth.
7. Spray the medication up your nose, avoiding the septum (the wall between the two nostrils).
8. After spraying, tilt your head back for a few seconds.
Do not alter the size of the nasal spray opening, as this may affect the dose.

Storage and Disposal

Store the medication at room temperature with the lid tightly closed.
Do not freeze the medication.
Keep all medications in a safe place, out of the reach of children and pets.

Missed Dose

If you miss a dose, take 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 dosing schedule.
Do not take two doses at the same time or take extra doses.
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Lifestyle & Tips

  • Shake the bottle gently before each use.
  • Prime the pump before first use or if not used for a long time by spraying into the air until a fine mist appears.
  • Clear your nasal passages by blowing your nose before use.
  • Tilt your head slightly forward and insert the tip of the nozzle into one nostril, pointing slightly away from the septum (the wall between your nostrils).
  • Close the other nostril with your finger.
  • Press the pump firmly and quickly while sniffing gently.
  • Repeat for the other nostril.
  • Avoid spraying into your eyes. If contact occurs, rinse eyes thoroughly with water.
  • Do not share your nasal spray with others.

Dosing & Administration

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Adult Dosing

Standard Dose: For rhinorrhea associated with perennial rhinitis: 2 sprays (84 mcg) per nostril 2 or 3 times daily. For rhinorrhea associated with the common cold: 2 sprays (84 mcg) per nostril 3 or 4 times daily.
Dose Range: 168 - 336 mg

Condition-Specific Dosing:

perennial_rhinitis: 2 sprays (84 mcg) per nostril 2 or 3 times daily
common_cold: 2 sprays (84 mcg) per nostril 3 or 4 times daily
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: For rhinorrhea associated with the common cold (ages 5 years and older): 2 sprays (84 mcg) per nostril 3 or 4 times daily. For rhinorrhea associated with perennial rhinitis (ages 6 years and older): 2 sprays (84 mcg) per nostril 2 or 3 times daily.
Adolescent: For rhinorrhea associated with the common cold: 2 sprays (84 mcg) per nostril 3 or 4 times daily. For rhinorrhea associated with perennial rhinitis: 2 sprays (84 mcg) per nostril 2 or 3 times daily.
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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

Ipratropium is an anticholinergic (parasympatholytic) agent which, when applied locally to the nasal mucosa, inhibits serous and seromucous gland secretions. It antagonizes the action of acetylcholine by blocking muscarinic cholinergic receptors, thereby reducing glandular secretions in the nasal mucosa.
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Pharmacokinetics

Absorption:

Bioavailability: <20% (systemic absorption from nasal administration)
Tmax: 1-2 hours (for systemic absorption)
FoodEffect: Not applicable for nasal spray.

Distribution:

Vd: Not readily quantifiable due to low systemic absorption.
ProteinBinding: Not extensively protein bound (systemically absorbed portion).
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 1.6 hours (for systemically absorbed drug)
Clearance: Not readily quantifiable due to low systemic absorption.
ExcretionRoute: Primarily via feces (unabsorbed drug) and urine (systemically absorbed drug).
Unchanged: Minimal (systemically absorbed drug)
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Pharmacodynamics

OnsetOfAction: Within 15-30 minutes
PeakEffect: 1-2 hours
DurationOfAction: 4-6 hours

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
Nosebleed
Changes in eyesight, eye pain, or severe eye irritation
Seeing halos or bright colors around lights

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 persist, contact your doctor for advice:

Nose or throat irritation
Dry nose
Headache
Signs of a common cold

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
  • Eye pain or discomfort
  • Blurred vision or halos around lights (especially if you have glaucoma)
  • Worsening of your runny nose or other symptoms
  • Signs of an allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
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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 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.

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. 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 or clear vision, such as driving, wait until you understand how this drug affects you.

If you have recently undergone nose surgery, experienced a nose injury, or have nose ulcers or sores, consult with your doctor before using this medication.

In the event that you accidentally get this drug in your eyes, immediately rinse them with water. If you experience blurred vision, worsening of glaucoma, or eye pain after getting the drug in your eyes, seek medical attention right away by calling your doctor.

If you are pregnant, planning to become pregnant, or are breastfeeding, discuss the potential benefits and risks of this medication with your doctor to make an informed decision about its use.
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Overdose Information

Overdose Symptoms:

  • Due to minimal systemic absorption, overdose symptoms are rare but could include:
  • Dry mouth
  • Blurred vision
  • Tachycardia (fast heart rate)
  • Urinary retention

What to Do:

If overdose is suspected, contact a poison control center immediately (e.g., 1-800-222-1222 in the US) or seek emergency medical attention. Treatment is generally supportive.

Drug Interactions

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Moderate Interactions

  • Other anticholinergic medications (e.g., atropine, scopolamine, tricyclic antidepressants, some antihistamines)

Monitoring

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Baseline Monitoring

Assessment of rhinorrhea severity

Rationale: To establish baseline symptom burden and guide treatment.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Symptom improvement (reduction in rhinorrhea)

Frequency: Daily/As needed

Target: Patient-reported improvement

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

Nasal irritation/dryness

Frequency: Daily/As needed

Target: Minimal to no irritation

Action Threshold: Persistent or severe irritation may require dose adjustment or discontinuation.

Epistaxis (nosebleeds)

Frequency: As needed

Target: Absence of nosebleeds

Action Threshold: Frequent or severe nosebleeds warrant medical attention.

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Symptom Monitoring

  • Reduction in runny nose (rhinorrhea)
  • Nasal dryness or irritation
  • Epistaxis (nosebleeds)
  • Dry mouth
  • Blurred vision (if accidentally sprayed in eyes)
  • Eye pain (if accidentally sprayed in eyes)

Special Patient Groups

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Pregnancy

Ipratropium nasal spray is classified as Pregnancy Category B. Studies in animals have not shown harm to the fetus, and there are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if clearly needed.

Trimester-Specific Risks:

First Trimester: Generally considered low risk, but use only if clearly indicated.
Second Trimester: Generally considered low risk, but use only if clearly indicated.
Third Trimester: Generally considered low risk, but use only if clearly indicated.
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Lactation

Ipratropium is minimally absorbed systemically, and it is unlikely that clinically significant amounts would be excreted in breast milk. It is considered L3 (likely compatible). Use with caution.

Infant Risk: Low risk of adverse effects to the breastfed infant due to low systemic absorption and excretion into milk.
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Pediatric Use

Approved for use in children aged 5 years and older for the common cold, and 6 years and older for perennial rhinitis. Dosing is specific to age groups and indication. Safety and efficacy in children younger than these ages have not been established.

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Geriatric Use

No specific dose adjustments are generally required for elderly patients. However, use with caution in elderly patients with prostatic hypertrophy or narrow-angle glaucoma, as systemic anticholinergic effects, though rare with nasal spray, could theoretically exacerbate these conditions.

Clinical Information

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Clinical Pearls

  • Ipratropium nasal spray is effective for rhinorrhea (runny nose) but does not relieve nasal congestion.
  • Patients should be instructed on proper nasal spray technique to ensure optimal delivery and minimize side effects.
  • Emphasize avoiding contact with eyes, as this can cause temporary blurred vision, eye pain, or precipitation/exacerbation of narrow-angle glaucoma.
  • Nasal dryness and epistaxis (nosebleeds) are common local side effects.
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Alternative Therapies

  • Intranasal corticosteroids (e.g., fluticasone, mometasone) for allergic rhinitis
  • Oral antihistamines (e.g., loratadine, cetirizine) for allergic rhinitis
  • Antihistamine nasal sprays (e.g., azelastine, olopatadine) for allergic rhinitis
  • Saline nasal sprays/washes for symptomatic relief and nasal hygiene
  • Oral decongestants (e.g., pseudoephedrine, phenylephrine) for nasal congestion (not rhinorrhea)
  • Cromolyn sodium nasal spray for allergic rhinitis
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Cost & Coverage

Average Cost: Varies, typically $30-$100 per 15ml bottle
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (preferred generic)
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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's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't 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 medication taken, the amount, and the time it occurred.