Ipratropium Inhal Soln 60 X 2.5ml
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.
Drug Class
Bronchodilator
Pharmacologic Class
Anticholinergic, Muscarinic Antagonist
Pregnancy Category
Category B
FDA Approved
Aug 1986
DEA Schedule
Not Controlled
Overview
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 breathing problems like COPD (chronic bronchitis and emphysema). It works by relaxing the muscles around your airways.
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. It's essential to keep the medication out of your eyes. Continue using the medication as directed by your doctor or healthcare provider, even if you start feeling well.
If you're using multiple inhaled medications, consult your doctor to determine which one to use first. This medication is intended for inhalation only, using a special machine called a nebulizer, which delivers the liquid solution directly into your lungs.
Storing and Disposing of Your Medication
To maintain the medication's potency, 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're ready to use them. Always keep your medications in a safe 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's 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 the missed one.
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. It's essential to keep the medication out of your eyes. Continue using the medication as directed by your doctor or healthcare provider, even if you start feeling well.
If you're using multiple inhaled medications, consult your doctor to determine which one to use first. This medication is intended for inhalation only, using a special machine called a nebulizer, which delivers the liquid solution directly into your lungs.
Storing and Disposing of Your Medication
To maintain the medication's potency, 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're ready to use them. Always keep your medications in a safe 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's 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 the missed one.
Lifestyle & Tips
- Do not use this medicine for sudden breathing problems; it is for maintenance treatment.
- Use exactly as prescribed, usually 3-4 times a day, every 6-8 hours.
- Do not get the solution in your eyes, as it can cause eye problems like blurred vision or eye pain. If it gets in your eyes, rinse thoroughly with water and contact your doctor.
- If you use other inhaled medications, ask your doctor or pharmacist about the correct order and timing of use.
- Do not exceed the prescribed dose.
- Report any worsening of breathing problems or increased need for rescue inhalers to your doctor.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
0.5 mg (one 2.5 mL vial) administered by nebulization 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) administered by nebulization 3 to 4 times a day, every 6 to 8 hours.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established for routine use; off-label use for acute asthma exacerbations: 125-250 mcg (0.5-1 mL) every 20 minutes for 3 doses, then every 2-4 hours as needed.
Child:
Not established for routine use; off-label use for acute asthma exacerbations (5-12 years): 250-500 mcg (1-2 mL) every 20 minutes for 3 doses, then every 2-4 hours as needed.
Adolescent:
Not established for routine use; off-label use for acute asthma exacerbations (>12 years): 500 mcg (2 mL) every 20 minutes for 3 doses, then every 2-4 hours as needed.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No specific adjustment recommended due to minimal systemic absorption and renal excretion of unchanged drug.
Dialysis:
No specific adjustment recommended.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No specific adjustment recommended due to minimal systemic absorption and hepatic metabolism.
Pharmacology
Mechanism of Action
Ipratropium is an anticholinergic (parasympatholytic) agent which, by blocking muscarinic cholinergic receptors, inhibits vagally mediated reflexes by antagonizing the action of acetylcholine. This results in bronchodilation by preventing the increase in intracellular concentration of cyclic guanosine monophosphate (cGMP) that is caused by the interaction of acetylcholine with the muscarinic receptor on bronchial smooth muscle. It has no direct effect on the beta-adrenergic receptors.
Pharmacokinetics
Absorption:
Bioavailability:
<10% (systemic after inhalation)
Tmax:
1-2 hours (bronchodilation)
FoodEffect:
Not applicable (inhalation)
Distribution:
Vd:
Not available (minimal systemic absorption)
ProteinBinding:
<9% (in vitro)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 1.6 hours (terminal elimination half-life after IV administration)
Clearance:
Not available (systemic clearance is low)
ExcretionRoute:
Primarily via feces (unchanged drug and metabolites); small amount via urine.
Unchanged:
Approximately 25% (of systemically absorbed dose) excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Within 15 minutes
PeakEffect:
1-2 hours
DurationOfAction:
4-6 hours
Safety & Warnings
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 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
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 immediate medical help.
Other Possible Side Effects
Like all medications, this drug may cause side effects. While many people do not experience any side effects or only have mild ones, it is 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, 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.
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 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
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 immediate medical help.
Other Possible Side Effects
Like all medications, this drug may cause side effects. While many people do not experience any side effects or only have mild ones, it is 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, 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.
Seek Immediate Medical Attention If You Experience:
- Sudden worsening of breathing problems (paradoxical bronchospasm)
- Eye pain or discomfort
- Blurred vision or seeing halos around lights (signs of acute angle-closure glaucoma)
- Difficulty urinating or painful urination (signs of urinary retention)
- Allergic reactions (rash, hives, swelling of face/lips/tongue, difficulty breathing)
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.
Please note that this is not an exhaustive list of all potential interactions with this medication. To ensure your safety, it is crucial to discuss the following with your doctor and pharmacist:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
* Any existing health problems you have
Before starting, stopping, or changing the dosage of any medication, including this one, you must consult with your doctor to confirm that it is safe to do so in conjunction with your other medications and health conditions.
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.
Please note that this is not an exhaustive list of all potential interactions with this medication. To ensure your safety, it is crucial to discuss the following with your doctor and pharmacist:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
* Any existing health problems you have
Before starting, stopping, or changing the dosage of any medication, including this one, you must consult with your doctor to confirm that it is safe to do so in conjunction with your other medications and health conditions.
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.
In the event that this medication comes into contact with your eyes, flush them with water immediately. If eye exposure results in blurred vision, worsened glaucoma, or eye pain, seek medical attention right away.
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.
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.
In the event that this medication comes into contact with your eyes, flush them with water immediately. If eye exposure results in blurred vision, worsened glaucoma, or eye pain, seek medical attention right away.
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.
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 (1-800-222-1222). Treatment is generally supportive due to minimal systemic absorption.
Drug Interactions
Moderate Interactions
- Other anticholinergics (e.g., tiotropium, aclidinium, umeclidinium, atropine): May lead to additive anticholinergic effects, increasing risk of adverse events such as dry mouth, urinary retention, and blurred vision.
- Drugs with anticholinergic properties (e.g., tricyclic antidepressants, phenothiazines, antihistamines): May potentiate anticholinergic side effects.
Monitoring
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's symptom severity and frequency
Rationale: To establish baseline control of bronchospasm.
Timing: Prior to initiation of therapy.
Routine Monitoring
Symptom control (e.g., dyspnea, cough, wheezing)
Frequency: Regularly, at each follow-up visit.
Target: Improved or stable symptoms.
Action Threshold: Worsening symptoms or increased need for rescue medication may indicate inadequate control or disease progression, requiring re-evaluation of therapy.
Pulmonary Function Tests (e.g., FEV1)
Frequency: Periodically, as clinically indicated (e.g., every 6-12 months or with significant symptom changes).
Target: Maintenance or improvement in lung function.
Action Threshold: Significant decline in FEV1 may indicate disease progression or need for therapy adjustment.
Adverse effects (e.g., dry mouth, urinary retention, blurred vision, eye pain)
Frequency: Regularly, at each follow-up visit.
Target: Absence or mild, tolerable side effects.
Action Threshold: Development of severe or persistent anticholinergic side effects, especially acute angle-closure glaucoma symptoms (eye pain, blurred vision, halos), requires immediate medical attention.
Symptom Monitoring
- Worsening shortness of breath
- Increased wheezing
- Increased cough
- Chest tightness
- Difficulty urinating
- Eye pain or discomfort
- Blurred vision
- Seeing halos around lights
Special Patient Groups
Pregnancy
Ipratropium is 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. Use during pregnancy 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 inhibition of uterine contractions is theoretical but unlikely with inhaled doses.
Lactation
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. Use with caution.
Infant Risk:
Low risk. Monitor infant for anticholinergic effects (e.g., dry mouth, constipation, urinary retention), though unlikely.
Pediatric Use
Safety and efficacy for routine maintenance treatment of COPD in pediatric patients have not been established. Off-label use for acute asthma exacerbations is common, but dosing varies by age and weight. Close monitoring is required.
Geriatric Use
No specific dose adjustments are generally required. However, elderly patients may be more susceptible to anticholinergic side effects such as dry mouth, urinary retention, and acute angle-closure glaucoma. Use with caution and monitor for these effects.
Clinical Information
Clinical Pearls
- Ipratropium is a maintenance bronchodilator and should NOT be used for acute bronchospasm. Patients should have a short-acting beta-agonist (SABA) for rescue.
- Proper nebulizer technique is crucial for effective drug delivery. Patients should be instructed on how to use the nebulizer correctly.
- Advise patients to avoid getting the solution in their eyes, as it can precipitate or worsen acute angle-closure glaucoma, especially in patients with pre-existing narrow-angle glaucoma.
- Patients with prostatic hypertrophy or bladder-neck obstruction should be monitored for urinary retention.
- Combination therapy with a short-acting beta-agonist (e.g., albuterol/ipratropium) is often more effective for acute exacerbations than either agent alone.
Alternative Therapies
- Long-acting beta-agonists (LABAs) - e.g., salmeterol, formoterol, arformoterol, indacaterol, olodaterol.
- Long-acting muscarinic antagonists (LAMAs) - e.g., tiotropium, aclidinium, umeclidinium, glycopyrronium.
- Inhaled corticosteroids (ICS) - often used in combination with LABAs for COPD.
- Phosphodiesterase-4 (PDE4) inhibitors - e.g., roflumilast (for severe COPD with chronic bronchitis).
Cost & Coverage
Average Cost:
$30 - $100 per 60 x 2.5 mL vials (0.5 mg/2.5 mL)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.