Ipratropium Inhal Soln 30 X 2.5ml

Manufacturer RITEDOSE 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
Aug 1986
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Ipratropium is a medicine that helps open up the airways in your lungs, making it easier to breathe. It's used for long-term treatment of lung conditions like COPD (chronic bronchitis and emphysema). It works by relaxing the muscles around your airways.
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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 the medication as directed by your doctor or healthcare provider, even if you start to feel better.

If you are using multiple inhaled medications, ask your doctor which one to use first. This medication is 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 foil pouches until you are ready to use them. Always keep your 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. However, if it is close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
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Lifestyle & Tips

  • Do not use this medication for sudden breathing problems (it is not a rescue inhaler).
  • Use regularly as prescribed, even if you feel better.
  • Avoid getting the solution in your eyes, as it can cause blurred vision or eye pain, especially if you have glaucoma.
  • Rinse your mouth after use to help prevent dry mouth and improve taste.
  • Maintain good hydration to help with dry mouth.
  • Avoid smoking and exposure to irritants that can worsen lung conditions.

Dosing & Administration

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Adult Dosing

Standard Dose: 0.5 mg (1 unit dose vial) administered 3 to 4 times a day by nebulization
Dose Range: 0.5 - 0.5 mg

Condition-Specific Dosing:

COPD: 0.5 mg (1 unit dose vial) administered 3 to 4 times a day by nebulization. Doses may be increased up to 2.5 mg (5 unit dose vials) 3 to 4 times a day in severe cases, but efficacy beyond 0.5 mg has not been established in controlled trials.
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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 acute asthma exacerbations (off-label): 0.25-0.5 mg every 20 minutes for 3 doses, then every 2-4 hours as needed.
Adolescent: For acute asthma exacerbations (off-label): 0.5 mg every 20 minutes for 3 doses, then every 2-4 hours as needed.
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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 adjustment needed

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Ipratropium bromide is an anticholinergic (parasympatholytic) agent which, by blocking the muscarinic cholinergic receptors in the bronchial smooth muscle, inhibits vagally mediated reflexes, thereby producing bronchodilation. It prevents the increase in intracellular concentration of cyclic guanosine monophosphate (cGMP) that results from the interaction of acetylcholine with the muscarinic receptor on bronchial smooth muscle. The bronchodilation following inhalation is primarily local and site-specific.
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Pharmacokinetics

Absorption:

Bioavailability: <10% (systemic bioavailability after inhalation)
Tmax: 1-2 hours (for bronchodilation)
FoodEffect: Not applicable (inhalation solution)

Distribution:

Vd: Not readily determined due to low systemic absorption
ProteinBinding: Not extensively bound to plasma proteins (<9%)
CnssPenetration: Limited (does not readily cross the blood-brain barrier)

Elimination:

HalfLife: Approximately 1.6 hours (terminal elimination half-life after intravenous administration; not relevant for inhaled drug)
Clearance: Not well characterized for inhaled route due to minimal systemic absorption
ExcretionRoute: Primarily renal (unchanged drug and metabolites) after systemic absorption; majority of inhaled dose is swallowed and excreted in feces.
Unchanged: Approximately 25% of systemically absorbed dose excreted unchanged in urine.
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Pharmacodynamics

OnsetOfAction: Within 15 minutes
PeakEffect: 1-2 hours
DurationOfAction: 4-5 hours
Confidence: Medium

Safety & Warnings

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Side Effects

Urgent 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 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 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

Reporting Side Effects

This list is not exhaustive, and you may experience other 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:

  • Sudden worsening of breathing or wheezing after using the medication (paradoxical bronchospasm)
  • Eye pain or discomfort, blurred vision, or seeing halos around lights (signs of acute angle-closure glaucoma)
  • Difficulty urinating
  • 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 to determine if the medications are similar.

This list is not exhaustive, and it is crucial to discuss all your medications and health conditions with your doctor. Provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your health problems, including any medical conditions or concerns

Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to ensure your safety. It is vital to verify that it is safe to take this medication with all your other medications and health conditions.
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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 results in 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
  • Tachycardia (fast heart rate)
  • Urinary retention
  • Constipation

What to Do:

Seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). Treatment is generally supportive and symptomatic.

Drug Interactions

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Moderate Interactions

  • Other anticholinergic medications (e.g., tiotropium, aclidinium, umeclidinium, atropine, scopolamine, tricyclic antidepressants, phenothiazines, quinidine, disopyramide) - potential for additive anticholinergic effects (e.g., dry mouth, urinary retention, blurred vision, increased intraocular pressure).

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 history for 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

Symptom control (e.g., dyspnea, cough, wheezing)

Frequency: Regularly, at each visit

Target: Improved or stable symptoms

Action Threshold: Worsening symptoms or increased rescue inhaler use may indicate need for re-evaluation of therapy.

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

Frequency: Regularly, at each visit

Target: Absence or mild, tolerable effects

Action Threshold: Significant or bothersome adverse effects may require dose adjustment or discontinuation.

Inhaler technique

Frequency: Periodically, especially if symptoms are not well controlled

Target: Correct technique demonstrated

Action Threshold: Incorrect technique may lead to suboptimal drug delivery and poor symptom control.

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Symptom Monitoring

  • Worsening shortness of breath
  • Increased wheezing
  • Chest tightness
  • Increased cough
  • Difficulty urinating
  • Blurred vision or eye pain (especially in patients with narrow-angle glaucoma)
  • Dry mouth

Special Patient Groups

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Pregnancy

Ipratropium is considered Category B. Animal studies have not shown harm, but human studies are limited. Use only if clearly needed.

Trimester-Specific Risks:

First Trimester: Low risk, but use only if clearly indicated.
Second Trimester: Low risk, but use only if clearly indicated.
Third Trimester: Low risk, but use only if clearly indicated. Potential for anticholinergic effects on the fetus at term is theoretical but unlikely given minimal systemic absorption.
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Lactation

It is not known whether ipratropium is excreted in human milk. However, because only a small amount is systemically absorbed, it is considered unlikely to cause adverse effects in a breastfed infant. Use with caution.

Infant Risk: Low risk
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Pediatric Use

Safety and effectiveness in pediatric patients (under 12 years of age) for COPD have not been established. Used off-label for acute asthma exacerbations in children.

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Geriatric Use

No specific dose adjustments are generally required. Elderly patients may be more susceptible to anticholinergic side effects such as dry mouth, urinary retention, and acute angle-closure glaucoma, especially if pre-existing conditions are present.

Clinical Information

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Clinical Pearls

  • Ipratropium is a maintenance bronchodilator, not a rescue inhaler for acute bronchospasm.
  • Advise patients to avoid spraying the solution into their eyes, especially those with narrow-angle glaucoma.
  • Can be combined with albuterol (e.g., DuoNeb) for enhanced bronchodilation in acute exacerbations.
  • Patients should be instructed on proper nebulizer technique for optimal drug delivery.
  • Dry mouth is a common side effect; advise patients to rinse their mouth after use and maintain good oral hygiene.
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Alternative Therapies

  • Long-acting beta-agonists (LABAs) e.g., salmeterol, formoterol, indacaterol, olodaterol
  • Long-acting muscarinic antagonists (LAMAs) e.g., tiotropium, aclidinium, umeclidinium, glycopyrrolate
  • Inhaled corticosteroids (ICS) for patients with frequent exacerbations or asthma-COPD overlap
  • Theophylline
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Cost & Coverage

Average Cost: $30 - $60 per 30 x 2.5ml unit dose vials
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 evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, do not 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 details about the medication taken, the amount, and the time it occurred, as this information is crucial for proper treatment.