Ipratropium 0.02% Inhalation Soln

Manufacturer RISING PHARMACEUTICALS Active Ingredient Ipratropium Inhalation Solution(i pra TROE pee um) Pronunciation i pra TROE pee um
It is used to open the airways in lung diseases where spasm may cause breathing problems. Do not use this drug to treat intense flare-ups of shortness of breath. Use a rescue inhaler. If you have questions, talk with the doctor.
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Drug Class
Bronchodilator
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Pharmacologic Class
Anticholinergic; Muscarinic Antagonist
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Pregnancy Category
Category B
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FDA Approved
Sep 1986
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Ipratropium is a medicine that you breathe in through a nebulizer to help open up your airways and make breathing easier. It works by relaxing the muscles around your airways, which can become tight in conditions like COPD. It's used regularly to prevent breathing problems, not for sudden attacks.
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How to Use This Medicine

Taking Your Medication Correctly

To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. Be sure to keep the medication out of your eyes. Continue using this medication as directed by your doctor or healthcare provider, even if you start to feel better.

If you are using multiple inhaled medications, consult your doctor to determine which medication to use first. This medication is intended for inhalation only, using a special machine called a nebulizer, which delivers the medication directly into your lungs as a liquid solution.

Storing and Disposing of Your Medication

To maintain the quality and safety of your medication, store it at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep unused containers in their original foil pouch until you are ready to use them. Always keep your medications in a safe and secure location, 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. 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 take two doses at the same time or take extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Do not use this medication for sudden breathing problems; use a fast-acting rescue inhaler if prescribed.
  • Follow your doctor's instructions carefully on how to use the nebulizer and how often to take the medication.
  • Rinse your mouth with water after each use to help prevent dry mouth and reduce the risk of oral thrush (though less common with ipratropium than steroids).
  • Avoid getting the solution in your eyes, as it can cause temporary blurred vision or worsen glaucoma. If it gets in your eyes, rinse thoroughly with water.
  • Report any worsening breathing, eye pain, blurred vision, or difficulty urinating to your doctor immediately.
  • Do not exceed the prescribed dose.

Dosing & Administration

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Adult Dosing

Standard Dose: 0.5 mg (one 2.5 mL vial of 0.02% solution) administered by nebulizer 3 to 4 times a day, every 6 to 8 hours.
Dose Range: 0.5 - 0.5 mg

Condition-Specific Dosing:

COPD: 0.5 mg (one 2.5 mL vial of 0.02% solution) administered by nebulizer 3 to 4 times a day, every 6 to 8 hours. Maximum 2.5 mg in 24 hours (5 vials).
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for routine use in children under 12 years for COPD. For asthma (off-label): 0.25-0.5 mg every 6-8 hours.
Adolescent: 12 years and older: Same as adult dosing for COPD (0.5 mg 3-4 times a day).
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed (minimal systemic absorption)
Dialysis: No specific considerations due to minimal systemic absorption and renal excretion.

Hepatic Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed (minimal hepatic metabolism of absorbed drug)
Confidence: Medium

Pharmacology

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Mechanism of Action

Ipratropium is a quaternary ammonium anticholinergic (parasympatholytic) bronchodilator. It blocks muscarinic cholinergic receptors in the bronchial smooth muscle, preventing the action of acetylcholine. This leads to a reduction in vagally mediated bronchoconstriction and mucus secretion, resulting in bronchodilation.
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Pharmacokinetics

Absorption:

Bioavailability: 10-30% (systemic absorption from inhaled dose is minimal, <20% of dose reaches systemic circulation)
Tmax: 1-2 hours (for bronchodilator effect)
FoodEffect: Not applicable (inhaled medication)

Distribution:

Vd: Not readily determined due to minimal systemic absorption; primarily acts locally in the lungs.
ProteinBinding: Not available (minimal systemic absorption)
CnssPenetration: Limited (quaternary ammonium compound, does not readily cross blood-brain barrier)

Elimination:

HalfLife: Approximately 1.6 hours (for systemically absorbed portion)
Clearance: Not readily determined due to minimal systemic absorption.
ExcretionRoute: Primarily renal excretion of systemically absorbed drug and metabolites; majority of inhaled dose is excreted in feces (unabsorbed).
Unchanged: Approximately 25% of systemically absorbed dose is excreted unchanged in urine.
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Pharmacodynamics

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

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice 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
Signs of bronchitis, including:
+ Fever
+ Chills
+ Sore throat
+ Yellow or green mucus
+ Coughing
+ Wheezing
Signs of a urinary tract infection (UTI), such as:
+ Blood in the urine
+ Burning or pain when passing urine
+ Frequent or urgent need to pass urine
+ Fever
+ Lower stomach pain
+ Pelvic pain
Changes in eyesight, eye pain, or severe eye irritation
Seeing halos or bright colors around lights
Red eyes
Trouble passing urine, pain when passing urine, weak urine stream, or frequent urination
Severe dizziness or fainting
Fast or abnormal heartbeat
Mouth irritation or mouth sores

Respiratory Emergency

This medication can cause severe breathing problems, which may be life-threatening. If you experience trouble breathing, worsening breathing, wheezing, or coughing after taking this medication, use a rescue inhaler and seek medical help immediately.

Other Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

Back pain
Headache
Dry mouth
Upset stomach
Flu-like symptoms
Nose or throat irritation
* Nose stuffiness

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact 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 shortness of breath or wheezing immediately after using the medication (paradoxical bronchospasm)
  • Eye pain or discomfort
  • Blurred vision or seeing halos around lights (signs of acute narrow-angle glaucoma)
  • Difficulty urinating or painful urination (signs of urinary retention)
  • Rash or hives
  • Swelling of the face, lips, or tongue (allergic reaction)
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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 allergic reaction you experienced, including any symptoms that occurred.
If you are currently taking another medication similar to this one. If you are unsure, consult your doctor or pharmacist for clarification.

To ensure your safety, it is crucial to disclose all of your medications, including:

Prescription and over-the-counter (OTC) drugs
Natural products
* Vitamins

Additionally, inform your doctor about any existing health problems. This information will help your doctor determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions.

Remember, do not start, stop, or change the dosage of any medication without first consulting your doctor. This precaution is vital to prevent potential interactions and ensure your well-being.
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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 medication affects you.

If you experience worsening breathing problems, a decrease in the effectiveness of your rescue inhaler, or an increased need to use your rescue inhaler, contact your doctor immediately.

If the medication accidentally gets into your eyes, flush them with water right away. If eye exposure leads to blurred vision, worsened glaucoma, or eye pain, seek medical attention promptly.

If you are pregnant, planning to become pregnant, or 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:

  • Dry mouth
  • Blurred vision
  • Increased heart rate (tachycardia)
  • Urinary retention
  • Constipation
  • Dizziness

What to Do:

Due to minimal systemic absorption, acute overdose by inhalation is unlikely to produce severe systemic anticholinergic effects. Treatment is generally supportive. Call 1-800-222-1222 (Poison Control) or seek immediate medical attention if overdose is suspected.

Drug Interactions

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Moderate Interactions

  • Other anticholinergics (e.g., tiotropium, aclidinium, umeclidinium, atropine, tricyclic antidepressants, antihistamines, phenothiazines): May potentiate anticholinergic effects (e.g., dry mouth, urinary retention, blurred vision).

Monitoring

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Baseline Monitoring

Pulmonary function tests (e.g., FEV1)

Rationale: To assess baseline lung function and severity of COPD.

Timing: Prior to initiation of therapy.

Patient symptoms (e.g., dyspnea, cough, wheezing)

Rationale: To establish baseline symptom burden.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Pulmonary function tests (e.g., FEV1)

Frequency: Periodically, as clinically indicated (e.g., every 6-12 months or with significant symptom changes).

Target: Improvement from baseline or maintenance of stable lung function.

Action Threshold: Significant decline in FEV1 or lack of improvement may indicate need for therapy adjustment or re-evaluation.

Patient symptoms (e.g., dyspnea, cough, wheezing)

Frequency: At each clinical visit.

Target: Reduction in symptom frequency and severity.

Action Threshold: Worsening symptoms, increased rescue inhaler use, or acute exacerbations require immediate evaluation.

Adverse effects (e.g., dry mouth, urinary retention, blurred vision, paradoxical bronchospasm)

Frequency: At each clinical visit and as reported by patient.

Target: Absence or minimal severity of side effects.

Action Threshold: Development of significant anticholinergic side effects, especially urinary retention or acute narrow-angle glaucoma symptoms, requires discontinuation or dose adjustment.

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Symptom Monitoring

  • Worsening shortness of breath
  • Increased wheezing
  • Increased cough
  • Increased sputum production
  • Chest tightness
  • Difficulty urinating
  • Eye pain or discomfort
  • Blurred vision
  • Dry mouth

Special Patient Groups

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Pregnancy

Category B. Animal studies have not shown harm to the fetus. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed and the potential benefit outweighs the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Low risk based on animal data; human data limited.
Second Trimester: Low risk based on animal data; human data limited.
Third Trimester: Low risk based on animal data; human data limited. Potential for inhibition of uterine contractions is theoretical but unlikely with inhaled doses.
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Lactation

L3 (Moderately safe). It is not known whether ipratropium is excreted in human milk. However, because only a small amount of the drug is systemically absorbed, it is unlikely to be present in breast milk in clinically significant amounts. Caution should be exercised when administered to a nursing mother.

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

Safety and effectiveness in pediatric patients under 12 years of age with COPD have not been established. For asthma (off-label use), dosing is typically adjusted by weight or age. Close monitoring for anticholinergic side effects is important.

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Geriatric Use

No specific dose adjustments are generally required for elderly patients. However, elderly patients may be more susceptible to anticholinergic side effects such as urinary retention (especially in men with prostatic hypertrophy) and acute narrow-angle glaucoma. Monitor closely for these effects.

Clinical Information

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Clinical Pearls

  • Ipratropium is a maintenance bronchodilator for COPD; it is NOT a rescue inhaler for acute bronchospasm.
  • Patients should be instructed on proper nebulizer technique to ensure effective drug delivery.
  • Advise patients to avoid getting the mist in their eyes, especially those with a history of narrow-angle glaucoma, as it can precipitate an acute attack.
  • Monitor for signs of urinary retention, particularly in elderly men with prostatic hyperplasia.
  • Can be combined with a short-acting beta-agonist (e.g., albuterol) for enhanced bronchodilation (e.g., Combivent Respimat, Duoneb solution).
  • Paradoxical bronchospasm, though rare, can occur; if it does, discontinue immediately and use an alternative bronchodilator.
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Alternative Therapies

  • Long-acting beta-agonists (LABAs) for COPD (e.g., salmeterol, formoterol, indacaterol, olodaterol)
  • Long-acting muscarinic antagonists (LAMAs) for COPD (e.g., tiotropium, aclidinium, umeclidinium, glycopyrronium)
  • Inhaled corticosteroids (ICS) for COPD (often in combination with LABA/LAMA)
  • Oral corticosteroids (for exacerbations)
  • Phosphodiesterase-4 (PDE4) inhibitors (e.g., roflumilast) for severe COPD
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Cost & Coverage

Average Cost: Varies widely, typically $30-$100 per 30 vials (2.5 mL each)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (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 substance taken, the amount, and the time it occurred.