Ipratropium 0.03% Nas Sp 30ml (345)

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
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Pharmacologic Class
Antimuscarinic agent
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Pregnancy Category
Category B
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FDA Approved
Sep 1987
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Ipratropium nasal spray is a medicine that helps reduce a runny nose (rhinorrhea) caused by allergies or other conditions. It works by blocking certain natural chemicals in your nose that cause mucus production.
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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 medication for the first time or if you haven't used it in more than 7 days, prime the pump by spraying 7 times. If you haven't used it in more than 24 hours, prime the pump by spraying 2 times.

Step-by-Step Instructions for Use

1. Blow your nose before using the medication.
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, making sure to spray the medication up your nose and not onto the septum (the wall between your nostrils).
7. After spraying, tilt your head back for a few seconds.

Important Reminders

Do not change the size of the nasal spray opening, as this may affect the dose.
Use the medication only as directed by your doctor.

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.

What to Do If You Miss a 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 return to your regular schedule.
Do not take two doses at the same time or take extra doses.
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Lifestyle & Tips

  • Avoid getting the spray in your eyes, as it can cause temporary blurred vision or eye irritation. If it gets in your eyes, rinse thoroughly with water.
  • Prime the pump before first use or if it hasn't been used for more than 24 hours by spraying into the air until a fine mist appears.
  • Clear your nasal passages before using the spray.
  • Tilt your head slightly forward and insert the nozzle into one nostril, pointing slightly towards the back of your nose, away from the septum. Close the other nostril and spray while sniffing gently.

Dosing & Administration

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Adult Dosing

Standard Dose: 2 sprays (42 mcg) per nostril 3 to 4 times daily

Condition-Specific Dosing:

perennial rhinitis: 2 sprays (42 mcg) per nostril 2 to 3 times daily
seasonal allergic rhinitis: 2 sprays (42 mcg) per nostril 4 times daily
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: 6-11 years: 2 sprays (42 mcg) per nostril 3 times daily for perennial rhinitis; 2 sprays (42 mcg) per nostril 4 times daily for seasonal allergic rhinitis.
Adolescent: 12 years and older: Same as adult dosing.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: No specific recommendations; systemic absorption is minimal.

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Ipratropium is a quaternary ammonium anticholinergic (antimuscarinic) agent that inhibits cholinergic receptors in the nasal mucosa. It blocks the action of acetylcholine at muscarinic receptors, thereby reducing glandular secretions (e.g., rhinorrhea) without affecting the central nervous system due to its poor penetration of the blood-brain barrier.
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Pharmacokinetics

Absorption:

Bioavailability: <20% (systemic after nasal administration)
Tmax: Not applicable (local action); systemic absorption is minimal and variable.
FoodEffect: Not applicable (nasal administration)

Distribution:

Vd: Not available (minimal systemic distribution)
ProteinBinding: Not available (minimal systemic distribution)
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 1.6 hours (systemic, after IV administration; not clinically relevant for nasal)
Clearance: Not available (minimal systemic absorption)
ExcretionRoute: Renal and fecal (for systemically absorbed portion)
Unchanged: Not available
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Pharmacodynamics

OnsetOfAction: Within 15 minutes
PeakEffect: 1-2 hours
DurationOfAction: 4-8 hours

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Help Immediately

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 right away:

Signs of an allergic reaction, including:
+ 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. 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 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:

  • Sudden eye pain or discomfort
  • Blurred vision or halos around lights (especially if you have glaucoma)
  • Difficulty urinating
  • Severe or persistent nosebleeds
  • Worsening of nasal symptoms
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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) medications, 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. Do not initiate, discontinue, or modify 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 your doctor to discuss potential concerns.

In the event that you accidentally get this medication in your eyes, immediately rinse them with water. If eye exposure results in blurred vision, worsened glaucoma, or eye pain, promptly contact your doctor.

If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Dry mouth
  • Blurred vision
  • Tachycardia (fast heart rate)
  • Urinary retention
  • Constipation

What to Do:

Due to minimal systemic absorption, overdose from nasal administration is unlikely to cause severe systemic anticholinergic effects. Treatment is generally supportive. Call 1-800-222-1222 (Poison Control Center) for advice.

Drug Interactions

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Moderate Interactions

  • Other anticholinergic medications (e.g., tricyclic antidepressants, phenothiazines, disopyramide, quinidine, antihistamines with anticholinergic effects): May potentiate anticholinergic side effects (e.g., dry mouth, urinary retention, blurred vision).

Monitoring

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Baseline Monitoring

Nasal symptoms (rhinorrhea)

Rationale: To assess baseline severity and guide treatment.

Timing: Prior to initiation of therapy

History of narrow-angle glaucoma or prostatic hypertrophy

Rationale: To identify contraindications or precautions due to anticholinergic effects.

Timing: Prior to initiation of therapy

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Routine Monitoring

Effectiveness in reducing rhinorrhea

Frequency: Regularly during treatment

Target: Reduction in symptom severity

Action Threshold: If symptoms persist or worsen, re-evaluate diagnosis and treatment.

Adverse effects (e.g., nasal dryness, epistaxis, headache, pharyngitis, urinary retention, blurred vision)

Frequency: Regularly during treatment

Target: Absence or mild, tolerable side effects

Action Threshold: If severe or persistent side effects occur, consider dose reduction or discontinuation.

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Symptom Monitoring

  • Nasal dryness
  • Epistaxis (nosebleeds)
  • Headache
  • Pharyngitis
  • Nasal irritation
  • Blurred vision (if spray contacts eyes)
  • Urinary retention (rare, due to systemic absorption)

Special Patient Groups

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Pregnancy

Ipratropium nasal spray is generally considered safe for use during pregnancy (Category B). Studies in animals have not shown harm to the fetus, and systemic absorption in humans is minimal.

Trimester-Specific Risks:

First Trimester: Low risk, minimal systemic absorption.
Second Trimester: Low risk, minimal systemic absorption.
Third Trimester: Low risk, minimal systemic absorption.
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Lactation

Ipratropium is minimally absorbed systemically and is unlikely to be excreted in breast milk in clinically significant amounts. It is considered compatible with breastfeeding (L3 - Moderately Safe).

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

Approved for use in children 6 years and older for perennial rhinitis and seasonal allergic rhinitis. Dosing is age-dependent. Safety and efficacy not established in children younger than 6 years.

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Geriatric Use

No specific dose adjustments are required for elderly patients. However, elderly patients may be more susceptible to anticholinergic side effects (e.g., urinary retention, glaucoma exacerbation), especially if they have pre-existing conditions. Use with caution.

Clinical Information

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Clinical Pearls

  • Ipratropium nasal spray is effective for rhinorrhea (runny nose) but does not significantly relieve nasal congestion, sneezing, or itching.
  • It is particularly useful for non-allergic rhinorrhea (vasomotor rhinitis) and for rhinorrhea associated with the common cold.
  • Patients should be instructed on proper nasal spray technique to maximize efficacy and minimize side effects.
  • Advise patients to avoid spraying into the eyes, as this can cause temporary blurred vision, pupil dilation, or precipitation/exacerbation of narrow-angle glaucoma.
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Alternative Therapies

  • Intranasal corticosteroids (e.g., fluticasone, mometasone) for allergic rhinitis (more comprehensive symptom relief including congestion, sneezing, itching).
  • Oral antihistamines (e.g., loratadine, fexofenadine, cetirizine) for allergic rhinitis.
  • Oral decongestants (e.g., pseudoephedrine, phenylephrine) for nasal congestion.
  • Saline nasal sprays for symptomatic relief and nasal hygiene.
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Cost & Coverage

Average Cost: $50 - $150 per 30ml bottle
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic), Tier 3 (brand)
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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 this 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 emergency medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.