Ipratropi/alb 0.5/3mg Inh Solution
It is used to open the airways in lung diseases where spasm may cause breathing problems.
Drug Class
Bronchodilator Combination
Pharmacologic Class
Anticholinergic / Selective Beta2-Adrenergic Agonist
Pregnancy Category
Category C
FDA Approved
Jul 2001
DEA Schedule
Not Controlled
Overview
What is this medicine?
This medication is a combination of two medicines that help open up your airways to make breathing easier. Ipratropium helps relax the muscles around your airways, and albuterol helps widen them. It's used to treat lung conditions like COPD.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions and read all the information provided. This medication is for inhalation only, using a special machine called a nebulizer, which delivers the liquid solution directly into your lungs.
Important Usage Instructions
Do not use the solution if it appears cloudy, is leaking, or contains particles.
Do not use the solution if it has changed color.
Do not mix other medications in the nebulizer. If you are using multiple inhaled medications, consult your doctor about which one to use first.
Storing and Disposing of Your Medication
Store the medication at room temperature, avoiding freezing.
Protect the medication from light.
Keep unused containers in their original foil pouch until you are ready to use them.
* Store all medications in a safe location, out of the reach of children and pets.
Missing a Dose
If you take this medication on a regular schedule, use the missed dose as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses. If you use this medication as needed, do not use it more frequently than directed by your doctor.
To use this medication safely and effectively, follow your doctor's instructions and read all the information provided. This medication is for inhalation only, using a special machine called a nebulizer, which delivers the liquid solution directly into your lungs.
Important Usage Instructions
Do not use the solution if it appears cloudy, is leaking, or contains particles.
Do not use the solution if it has changed color.
Do not mix other medications in the nebulizer. If you are using multiple inhaled medications, consult your doctor about which one to use first.
Storing and Disposing of Your Medication
Store the medication at room temperature, avoiding freezing.
Protect the medication from light.
Keep unused containers in their original foil pouch until you are ready to use them.
* Store all medications in a safe location, out of the reach of children and pets.
Missing a Dose
If you take this medication on a regular schedule, use the missed dose as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses. If you use this medication as needed, do not use it more frequently than directed by your doctor.
Lifestyle & Tips
- Use this medication exactly as prescribed by your doctor. Do not use more often than directed.
- Learn the correct technique for using your nebulizer. Your doctor, nurse, or pharmacist can show you how.
- Do not get the solution in your eyes, as it can cause eye pain, blurred vision, or other eye problems, especially if you have glaucoma.
- Rinse your mouth after each use to help prevent dry mouth and reduce the risk of oral thrush (though less common with nebulized solutions than inhaled corticosteroids).
- Avoid smoking and exposure to respiratory irritants (e.g., dust, pollen, pet dander, air pollution) as these can worsen your lung condition.
- Stay hydrated to help thin mucus in your airways.
- Follow up with your doctor regularly to monitor your lung condition and medication effectiveness.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
One 3 mL vial (0.5 mg ipratropium and 3 mg albuterol sulfate, equivalent to 2.5 mg albuterol base) administered by nebulization 3 or 4 times a day, not to exceed 6 doses in 24 hours.
Dose Range:
3 - 6 mg
Condition-Specific Dosing:
COPD:
One 3 mL vial (0.5 mg ipratropium and 3 mg albuterol sulfate) administered by nebulization 3 or 4 times a day, not to exceed 6 doses in 24 hours.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For children 6-12 years: One 3 mL vial (0.5 mg ipratropium and 3 mg albuterol sulfate) administered by nebulization 3 or 4 times a day, not to exceed 6 doses in 24 hours. Safety and efficacy not established for children under 6 years of age.
Adolescent:
For adolescents >12 years: One 3 mL vial (0.5 mg ipratropium and 3 mg albuterol sulfate) administered by nebulization 3 or 4 times a day, not to exceed 6 doses in 24 hours.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, but use with caution.
Moderate:
No specific dose adjustment recommended, but use with caution.
Severe:
No specific dose adjustment recommended, but use with caution. Systemic exposure is minimal for ipratropium; albuterol is renally excreted, but inhaled dose is low.
Dialysis:
No specific recommendations; monitor for adverse effects.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended.
Pharmacology
Mechanism of Action
Ipratropium bromide is an anticholinergic (parasympatholytic) agent which, when inhaled, produces bronchodilation by inhibiting cholinergic bronchomotor tone. It blocks muscarinic cholinergic receptors (primarily M3) in the bronchial smooth muscle, preventing acetylcholine-induced bronchoconstriction. Albuterol sulfate is a short-acting selective beta2-adrenergic agonist. It stimulates beta2-adrenergic receptors in the bronchial smooth muscle, leading to activation of adenyl cyclase and an increase in intracellular cyclic-3',5'-adenosine monophosphate (cAMP). Increased cAMP levels cause relaxation of bronchial smooth muscle and inhibition of mediator release from mast cells.
Pharmacokinetics
Absorption:
Bioavailability:
Ipratropium: <10% (systemic); Albuterol: 10-20% (systemic from inhaled dose)
Tmax:
Ipratropium: Rapid (local effect); Albuterol: 0.5-2 hours (systemic)
FoodEffect:
Not applicable (inhaled medication)
Distribution:
Vd:
Ipratropium: Large (200-500 L); Albuterol: Large (150-200 L)
ProteinBinding:
Ipratropium: <9%; Albuterol: 10%
CnssPenetration:
Ipratropium: Limited; Albuterol: Limited
Elimination:
HalfLife:
Ipratropium: ~2 hours (terminal); Albuterol: ~3.8-5 hours
Clearance:
Not available
ExcretionRoute:
Ipratropium: Renal (primarily unchanged and metabolites), Fecal; Albuterol: Renal (primarily as metabolites, some unchanged)
Unchanged:
Ipratropium: ~25% (renal); Albuterol: ~60% (renal)
Pharmacodynamics
OnsetOfAction:
Within 15 minutes
PeakEffect:
1-2 hours
DurationOfAction:
4-5 hours
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
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 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 low potassium levels, including:
+ Muscle pain or weakness
+ Muscle cramps
+ An irregular heartbeat
Signs of high blood pressure, such as:
+ Severe headache or dizziness
+ Fainting or loss of consciousness
+ Changes in vision
Chest pain or pressure
Rapid or irregular heartbeat
Changes in vision, eye pain, or severe eye irritation
Seeing halos or bright colors around lights
Red eyes
Urination problems, such as:
+ Painful urination
+ Weak or dribbling urine stream
+ Frequent urination
This medication can also 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 contact your doctor if you're bothered by any of the following:
Feeling nervous or excitable
Headache
Shakiness
* Nose or throat irritation
This is not an exhaustive list of possible 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.
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 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 low potassium levels, including:
+ Muscle pain or weakness
+ Muscle cramps
+ An irregular heartbeat
Signs of high blood pressure, such as:
+ Severe headache or dizziness
+ Fainting or loss of consciousness
+ Changes in vision
Chest pain or pressure
Rapid or irregular heartbeat
Changes in vision, eye pain, or severe eye irritation
Seeing halos or bright colors around lights
Red eyes
Urination problems, such as:
+ Painful urination
+ Weak or dribbling urine stream
+ Frequent urination
This medication can also 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 contact your doctor if you're bothered by any of the following:
Feeling nervous or excitable
Headache
Shakiness
* Nose or throat irritation
This is not an exhaustive list of possible 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.
Seek Immediate Medical Attention If You Experience:
- Worsening shortness of breath or wheezing immediately after using the medication (paradoxical bronchospasm). Seek immediate medical attention.
- Chest pain, fast or irregular heartbeat, or palpitations.
- Severe dizziness or fainting.
- Eye pain, blurred vision, or seeing halos around lights (especially if you have glaucoma).
- Difficulty urinating (especially if you have prostate problems).
- Signs of an allergic reaction, such as rash, itching, swelling of the face/tongue/throat, severe dizziness, trouble 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, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you are taking other medications classified as anticholinergics, such as ipratropium or oxybutynin. If you are unsure whether a medication belongs to this category, consult your doctor.
Please note that this is not an exhaustive list of all potential interactions with this medication. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all medications you are currently taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss all your health problems with your doctor and pharmacist.
Verify that it is safe to take this medication in combination with your other medications and health conditions.
Never start, stop, or adjust the dosage of any medication without first consulting 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.
If you are taking other medications classified as anticholinergics, such as ipratropium or oxybutynin. If you are unsure whether a medication belongs to this category, consult your doctor.
Please note that this is not an exhaustive list of all potential interactions with this medication. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all medications you are currently taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss all your health problems with your doctor and pharmacist.
Verify that it is safe to take this medication in combination with your other medications and health conditions.
Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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 and clear vision, such as driving, wait until you understand how this drug affects you.
To ensure safe use, do not exceed the prescribed dose or frequency of this medication. Taking too much of this drug can be fatal. If you have concerns or questions, consult your doctor. Immediately notify your doctor if your usual dose is ineffective, your symptoms worsen, or you need to use this medication more frequently than prescribed.
If you have diabetes (high blood sugar), it is crucial to closely monitor your blood sugar levels while taking this medication. Avoid getting this drug in your eyes, as it can cause harm. If accidental exposure occurs, immediately rinse your eyes with water and seek medical attention if you experience blurred vision, worsened glaucoma, or eye pain.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
To ensure safe use, do not exceed the prescribed dose or frequency of this medication. Taking too much of this drug can be fatal. If you have concerns or questions, consult your doctor. Immediately notify your doctor if your usual dose is ineffective, your symptoms worsen, or you need to use this medication more frequently than prescribed.
If you have diabetes (high blood sugar), it is crucial to closely monitor your blood sugar levels while taking this medication. Avoid getting this drug in your eyes, as it can cause harm. If accidental exposure occurs, immediately rinse your eyes with water and seek medical attention if you experience blurred vision, worsened glaucoma, or eye pain.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Albuterol overdose: Tachycardia, palpitations, tremor, headache, nervousness, nausea, dizziness, hypokalemia, hyperglycemia, metabolic acidosis.
- Ipratropium overdose: Dry mouth, blurred vision, urinary retention, constipation, tachycardia (less common due to poor systemic absorption).
What to Do:
Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is supportive and symptomatic. Beta-blockers may be used cautiously for severe albuterol-induced cardiac effects.
Drug Interactions
Major Interactions
- Beta-adrenergic blocking agents (e.g., propranolol, carvedilol): May block the bronchodilatory effect of albuterol and produce severe bronchospasm in asthmatic patients. Should not be used concurrently.
- Monoamine Oxidase Inhibitors (MAOIs) and Tricyclic Antidepressants (TCAs): May potentiate the cardiovascular effects of albuterol. Use with extreme caution or avoid within 2 weeks of discontinuing MAOIs/TCAs.
Moderate Interactions
- Other anticholinergic agents (e.g., tiotropium, aclidinium): May lead to additive anticholinergic effects. Avoid co-administration.
- Diuretics (e.g., furosemide, hydrochlorothiazide): ECG changes and/or hypokalemia may result from beta-agonists, especially with concomitant use of non-potassium-sparing diuretics. Use with caution.
- Digoxin: Albuterol may decrease serum digoxin levels. Monitor digoxin levels.
Minor Interactions
- Xanthine derivatives (e.g., theophylline): May potentiate hypokalemia and cardiovascular effects.
Monitoring
Baseline Monitoring
Pulmonary Function Tests (e.g., FEV1)
Rationale: To establish baseline lung function and assess disease severity.
Timing: Prior to initiation of therapy.
Vital Signs (Heart Rate, Blood Pressure)
Rationale: To establish baseline cardiovascular status, especially due to potential beta-agonist effects.
Timing: Prior to initiation of therapy.
Ophthalmologic exam (for patients with narrow-angle glaucoma)
Rationale: Ipratropium can precipitate acute narrow-angle glaucoma.
Timing: Prior to initiation of therapy if risk factors present.
Urinary flow assessment (for patients with prostatic hyperplasia or bladder-neck obstruction)
Rationale: Ipratropium can worsen urinary retention.
Timing: Prior to initiation of therapy if risk factors present.
Routine Monitoring
Symptom control (e.g., dyspnea, cough, wheezing)
Frequency: Daily, or as needed
Target: Improved breathing, reduced frequency of rescue inhaler use
Action Threshold: Worsening symptoms, increased frequency of use, or lack of response to usual dose indicates need for medical re-evaluation.
Frequency of use
Frequency: Daily
Target: Within prescribed limits (e.g., not exceeding 6 doses/24 hours)
Action Threshold: Exceeding prescribed limits suggests inadequate control and requires medical re-evaluation.
Adverse effects (e.g., tremor, palpitations, dry mouth, blurred vision, urinary difficulty)
Frequency: Regularly, especially during dose titration or initiation
Target: Absence or minimal, tolerable side effects
Action Threshold: Persistent or severe adverse effects warrant dose adjustment or discontinuation.
Serum Potassium (if risk factors for hypokalemia)
Frequency: Periodically, as clinically indicated
Target: 3.5-5.0 mEq/L
Action Threshold: Hypokalemia (e.g., <3.5 mEq/L) may require supplementation or re-evaluation of therapy.
Symptom Monitoring
- Worsening shortness of breath or wheezing (paradoxical bronchospasm)
- Chest pain or discomfort
- Palpitations or rapid heart rate
- Tremor or nervousness
- Blurred vision or eye pain (especially with narrow-angle glaucoma history)
- Difficulty urinating (especially with prostatic hyperplasia history)
- Dry mouth or throat
- Headache
- Nausea or vomiting
Special Patient Groups
Pregnancy
Pregnancy Category C. Use only if the potential benefit justifies the potential risk to the fetus. Albuterol can inhibit uterine contractions and may delay labor. Ipratropium is poorly absorbed systemically, minimizing fetal exposure.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity with albuterol, though human data are generally reassuring. Ipratropium risk is low due to minimal systemic absorption.
Second Trimester:
Generally considered safer than first trimester for necessary medications. Monitor for maternal cardiovascular effects.
Third Trimester:
Albuterol may interfere with uterine contractility and should be used with caution during labor and delivery. Monitor for neonatal hypoglycemia and tachycardia if used close to delivery.
Lactation
Both ipratropium and albuterol are excreted in human milk. However, systemic absorption of ipratropium is low, and albuterol's oral bioavailability is also low, suggesting minimal infant exposure. Use with caution; weigh the benefits of breastfeeding against the potential risks to the infant.
Infant Risk:
L3 (Moderate risk). Potential for mild anticholinergic effects (e.g., dry mouth, constipation) or beta-agonist effects (e.g., irritability, tremor, tachycardia) in the infant, though unlikely with typical inhaled doses.
Pediatric Use
Safety and efficacy not established for children under 6 years of age. For children 6-12 years, the dose is the same as adults, but careful monitoring for adverse effects is crucial. Proper nebulizer technique is essential.
Geriatric Use
Use with caution in elderly patients due to increased susceptibility to adverse effects, particularly cardiovascular effects (tachycardia, arrhythmias) from albuterol and anticholinergic effects (urinary retention, glaucoma exacerbation) from ipratropium. Start with the lower end of the dosing range and monitor closely.
Clinical Information
Clinical Pearls
- This combination provides both rapid-onset bronchodilation (albuterol) and sustained bronchodilation (ipratropium), making it effective for acute exacerbations and maintenance therapy in COPD.
- It is crucial to emphasize proper nebulizer technique to ensure optimal drug delivery to the lungs and minimize systemic absorption and side effects.
- Patients should be advised to seek immediate medical attention if they experience paradoxical bronchospasm (worsening breathing immediately after use).
- Educate patients with a history of narrow-angle glaucoma or prostatic hyperplasia/bladder-neck obstruction about the specific risks (eye pain, blurred vision, urinary retention) and symptoms to watch for.
- This combination is not indicated for the primary treatment of asthma, although it may be used off-label for severe asthma exacerbations in some cases. Its primary indication is for COPD.
Alternative Therapies
- Short-acting Beta2-Agonists (SABAs) alone (e.g., albuterol)
- Short-acting Muscarinic Antagonists (SAMAs) alone (e.g., ipratropium)
- Long-acting Beta2-Agonists (LABAs) (e.g., salmeterol, formoterol)
- Long-acting Muscarinic Antagonists (LAMAs) (e.g., tiotropium, umeclidinium)
- Inhaled Corticosteroids (ICS) (e.g., fluticasone, budesonide)
- LABA/ICS combinations (e.g., fluticasone/salmeterol)
- LAMA/LABA combinations (e.g., umeclidinium/vilanterol)
- Oral corticosteroids (for exacerbations)
- Phosphodiesterase-4 (PDE4) inhibitors (e.g., roflumilast, for severe COPD)
Cost & Coverage
Average Cost:
$30 - $100 per 30 vials (3 mL each)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective 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's a good idea 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.