Ipratropi/alb 0.5/3mg Inh Sl 30x3ml
It is used to open the airways in lung diseases where spasm may cause breathing problems.
Drug Class
Bronchodilator Combination
Pharmacologic Class
Anticholinergic / Selective Beta-2 Adrenergic Agonist
Pregnancy Category
Category C
FDA Approved
Aug 1999
DEA Schedule
Not Controlled
Overview
What is this medicine?
This medication is a combination of two bronchodilators (medicines that open up your airways) used to help you breathe easier if you have chronic obstructive pulmonary disease (COPD). It works by relaxing the muscles around your airways and reducing mucus production, making it easier for air to flow in and out of your lungs.
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.
Before using the medication, check the solution for any signs of damage or contamination. Do not use the solution if it appears cloudy, is leaking, or contains particles. Additionally, do not use the solution if it has changed color.
When using the nebulizer, do not mix this medication with any other drugs. If you are taking multiple inhaled medications, consult your doctor about which medication to use first.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication, store it at room temperature, away from light and freezing temperatures. Keep unused containers in their original foil pouches until you are ready to use them. It is essential to keep all medications in a secure 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 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.
If you use this medication as needed, do not take it more frequently than directed by your doctor. Always follow your doctor's instructions for using this medication.
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.
Before using the medication, check the solution for any signs of damage or contamination. Do not use the solution if it appears cloudy, is leaking, or contains particles. Additionally, do not use the solution if it has changed color.
When using the nebulizer, do not mix this medication with any other drugs. If you are taking multiple inhaled medications, consult your doctor about which medication to use first.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication, store it at room temperature, away from light and freezing temperatures. Keep unused containers in their original foil pouches until you are ready to use them. It is essential to keep all medications in a secure 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 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.
If you use this medication as needed, do not take it more frequently than directed by your doctor. Always follow your doctor's instructions for using this medication.
Lifestyle & Tips
- Use exactly as prescribed; do not use more often than directed.
- Understand how to use your nebulizer correctly for effective delivery of the medication.
- Do not mix with other medications in the nebulizer unless directed by your doctor.
- Rinse your mouth with water 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 getting the solution in your eyes, as it can cause blurred vision, eye pain, or worsening of narrow-angle glaucoma.
- If you smoke, quitting smoking is the most important step to manage COPD.
- Maintain good hydration to help thin mucus.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
One 3 mL vial (0.5 mg ipratropium and 3 mg albuterol) administered 3 to 4 times a day via nebulizer.
Dose Range:
3 - 4 mg
Condition-Specific Dosing:
Maximum Dose:
Not to exceed 6 doses in 24 hours.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Safety and efficacy not established for patients under 12 years of age).
Adolescent:
For patients 12 years of age and older: One 3 mL vial (0.5 mg ipratropium and 3 mg albuterol) administered 3 to 4 times a day via nebulizer, not to exceed 6 doses in 24 hours.
Dose Adjustments
Renal Impairment:
Mild:
Use with caution; dose adjustment may be considered based on clinical response.
Moderate:
Use with caution; dose adjustment may be considered based on clinical response.
Severe:
Use with caution; dose adjustment may be considered based on clinical response due to potential for increased systemic exposure to albuterol.
Dialysis:
Albuterol is dialyzable; ipratropium is minimally dialyzable. Use with caution, monitor for adverse effects.
Hepatic Impairment:
Mild:
Use with caution; no specific dose adjustment guidelines available.
Moderate:
Use with caution; no specific dose adjustment guidelines available.
Severe:
Use with caution; no specific dose adjustment guidelines available.
Pharmacology
Mechanism of Action
Ipratropium bromide is an anticholinergic (antimuscarinic) bronchodilator that blocks muscarinic cholinergic receptors in the airways, leading to a reduction in vagally mediated bronchoconstriction. Albuterol sulfate is a short-acting selective beta2-adrenergic agonist that stimulates beta2-receptors in bronchial smooth muscle, leading to relaxation of the smooth muscle and bronchodilation. The combination provides additive bronchodilation through different mechanisms.
Pharmacokinetics
Absorption:
Bioavailability:
Ipratropium: Low systemic bioavailability (approx. 7% of nebulized dose). Albuterol: Approximately 20% of nebulized dose reaches the lungs, with systemic absorption occurring from both the lungs and GI tract.
Tmax:
Ipratropium: Systemic levels are very low, Tmax not clinically relevant for bronchodilation. Albuterol: Approximately 0.5-2 hours (for systemic effects).
FoodEffect:
Not applicable for inhalation solution.
Distribution:
Vd:
Ipratropium: Not well characterized due to low systemic absorption. Albuterol: Approximately 300 L.
ProteinBinding:
Ipratropium: Less than 9%. Albuterol: 10% to 20%.
CnssPenetration:
Limited for both.
Elimination:
HalfLife:
Ipratropium: Approximately 1.6 hours (systemic). Albuterol: Approximately 3.8-5 hours (systemic).
Clearance:
Not readily quantifiable for inhaled ipratropium due to low systemic absorption. Albuterol: Approximately 270 mL/min/1.73m².
ExcretionRoute:
Ipratropium: Primarily via feces (unabsorbed drug) and urine (systemically absorbed). Albuterol: Primarily via urine (80-100% within 24 hours, 60% as metabolite).
Unchanged:
Ipratropium: Approximately 25% of systemically absorbed dose excreted unchanged in urine. Albuterol: Approximately 60% excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
15-30 minutes
PeakEffect:
1-2 hours
DurationOfAction:
4-6 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: 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, or swelling of the mouth, face, lips, tongue, or throat
Signs of low potassium levels: muscle pain or weakness, muscle cramps, or an irregular heartbeat
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision
Chest pain or pressure, rapid heartbeat, or abnormal heartbeat
Changes in vision, eye pain, or severe eye irritation
Seeing halos or bright colors around lights
Red eyes
Urination problems: difficulty passing urine, pain while urinating, weak urine stream, or frequent urination
Respiratory Emergency
This medication can cause severe breathing problems, which can 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. Contact your doctor or seek medical help if you experience:
Feeling nervous and excitable
Headache
Shakiness
Nose or throat irritation
Reporting Side Effects
These are not all the possible side effects of this medication. 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.
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: 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, or swelling of the mouth, face, lips, tongue, or throat
Signs of low potassium levels: muscle pain or weakness, muscle cramps, or an irregular heartbeat
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision
Chest pain or pressure, rapid heartbeat, or abnormal heartbeat
Changes in vision, eye pain, or severe eye irritation
Seeing halos or bright colors around lights
Red eyes
Urination problems: difficulty passing urine, pain while urinating, weak urine stream, or frequent urination
Respiratory Emergency
This medication can cause severe breathing problems, which can 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. Contact your doctor or seek medical help if you experience:
Feeling nervous and excitable
Headache
Shakiness
Nose or throat irritation
Reporting Side Effects
These are not all the possible side effects of this medication. 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.
Seek Immediate Medical Attention If You Experience:
- Worsening shortness of breath or wheezing after using the medication
- Chest pain or discomfort
- Fast or irregular heartbeat (palpitations)
- Severe headache
- Dizziness or lightheadedness
- Blurred vision, eye pain, or red eyes (especially if you have glaucoma)
- Difficulty urinating (especially in men with prostate problems)
- Muscle cramps or weakness (signs of low potassium)
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 allergic reaction you experienced, including any symptoms that occurred.
If you are taking other medications classified as anticholinergics, such as ipratropium or oxybutynin. If you are unsure whether any of your medications belong to this category, consult your doctor 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:
Inform your doctor and pharmacist about all the medications you are currently taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss any health problems you have, as they may affect the safety of taking this medication.
* Never start, stop, or change the dosage of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this medication.
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 allergic reaction you experienced, including any symptoms that occurred.
If you are taking other medications classified as anticholinergics, such as ipratropium or oxybutynin. If you are unsure whether any of your medications belong to this category, consult your doctor 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:
Inform your doctor and pharmacist about all the medications you are currently taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss any health problems you have, as they may affect the safety of taking this medication.
* Never start, stop, or change the dosage of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this medication.
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.
Adhering to the prescribed dosage is crucial. Do not exceed the recommended dose or frequency, as overdoses have been fatal. If you have concerns, consult your doctor.
Immediately notify your doctor if your usual dose becomes ineffective, your symptoms worsen, or you need to use this medication more frequently than prescribed.
If you have diabetes (high blood sugar), closely monitor your blood sugar levels while taking this medication.
Avoid getting this medication in your eyes. If accidental exposure occurs, immediately rinse your eyes with water. If you experience blurred vision, worsened glaucoma, or eye pain after getting the medication in your eyes, seek medical attention right away.
If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks of this medication with your doctor to make an informed decision regarding your health and the health of your baby.
Before engaging in activities that require alertness or clear vision, such as driving, wait until you understand how this medication affects you.
Adhering to the prescribed dosage is crucial. Do not exceed the recommended dose or frequency, as overdoses have been fatal. If you have concerns, consult your doctor.
Immediately notify your doctor if your usual dose becomes ineffective, your symptoms worsen, or you need to use this medication more frequently than prescribed.
If you have diabetes (high blood sugar), closely monitor your blood sugar levels while taking this medication.
Avoid getting this medication in your eyes. If accidental exposure occurs, immediately rinse your eyes with water. If you experience blurred vision, worsened glaucoma, or eye pain after getting the medication in your eyes, seek medical attention right away.
If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks of this medication with your doctor to make an informed decision regarding your health and the health of your baby.
Overdose Information
Overdose Symptoms:
- Exaggeration of albuterol's effects: tachycardia, palpitations, tremor, nervousness, headache, dizziness, nausea, muscle cramps, hypokalemia, hyperglycemia, metabolic acidosis.
- Exaggeration of ipratropium's anticholinergic effects: dry mouth, blurred vision, urinary retention, constipation, increased heart rate.
What to Do:
Seek immediate medical attention or call 911. For suspected overdose, contact 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, but only under strict medical supervision due to risk of bronchospasm.
Drug Interactions
Major Interactions
- Beta-adrenergic blocking agents (e.g., propranolol, carvedilol): May block the bronchodilatory effect of albuterol and produce severe bronchospasm in patients with COPD. Generally, patients with COPD should not be treated with beta-blockers.
- Other anticholinergic agents (e.g., tiotropium, umeclidinium): Concomitant administration may lead to an additive anticholinergic effect and increased risk of adverse events. Avoid co-administration.
- Other sympathomimetic agents (e.g., epinephrine, pseudoephedrine): May potentiate the cardiovascular effects of albuterol.
Moderate Interactions
- Monoamine Oxidase Inhibitors (MAOIs) and Tricyclic Antidepressants (TCAs): May potentiate the cardiovascular effects of albuterol. Use with extreme caution, or consider alternative therapy.
- Diuretics (e.g., furosemide, hydrochlorothiazide): The ECG changes and/or hypokalemia that may result from the administration of non-potassium-sparing diuretics can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Monitor potassium levels.
- Digoxin: Beta-agonists may decrease serum digoxin levels. Monitor digoxin levels.
Confidence Interactions
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, as albuterol can cause tachycardia and blood pressure changes.
Timing: Prior to initiation of therapy.
Routine Monitoring
Symptom Control (e.g., dyspnea, wheezing, cough)
Frequency: Regularly, at each clinical visit.
Target: Improved or stable symptoms, reduced need for rescue medication.
Action Threshold: Worsening symptoms, increased frequency of use, or lack of response may indicate disease progression or need for therapy adjustment.
Frequency of Use
Frequency: Regularly, at each clinical visit.
Target: Within prescribed limits (e.g., not exceeding 6 doses in 24 hours).
Action Threshold: Increased frequency of use suggests worsening asthma/COPD control and requires re-evaluation.
Serum Potassium (if risk factors for hypokalemia)
Frequency: Periodically, especially with high doses or concomitant diuretics.
Target: 3.5-5.0 mEq/L
Action Threshold: Hypokalemia (<3.5 mEq/L) may require potassium supplementation or dose adjustment.
Intraocular Pressure (for patients with narrow-angle glaucoma)
Frequency: Periodically, as clinically indicated.
Target: Normal range for the individual.
Action Threshold: Significant increase in IOP requires immediate medical attention.
Symptom Monitoring
- Worsening shortness of breath
- Increased wheezing or coughing
- Chest tightness
- Increased need for rescue inhaler
- Palpitations or rapid heart rate
- Tremor
- Blurred vision or eye pain (especially in patients with narrow-angle glaucoma)
- Urinary retention (especially in patients with prostatic hypertrophy or bladder-neck obstruction)
Special Patient Groups
Pregnancy
Category C. There are no adequate and well-controlled studies of ipratropium/albuterol in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though human data are limited. Use only if clearly needed.
Second Trimester:
Potential for adverse effects on fetal development. Use only if clearly needed.
Third Trimester:
Albuterol may inhibit uterine contractions and increase the risk of hemorrhage. Ipratropium may have anticholinergic effects on the fetus. Use with caution, especially near term.
Lactation
L3 (Moderately safe). It is not known whether ipratropium or albuterol are excreted in human milk. Caution should be exercised when ipratropium/albuterol is administered to a nursing mother.
Infant Risk:
Potential for anticholinergic effects (e.g., dry mouth, constipation) or beta-agonist effects (e.g., irritability, tremor) in the infant. Monitor the infant for adverse effects.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients under 12 years of age for the inhalation solution. For adolescents 12 years and older, dosing is the same as adults. Use in younger children is off-label and requires careful consideration of risks vs. benefits.
Geriatric Use
Use with caution. Elderly patients may be more susceptible to the cardiovascular effects of albuterol (e.g., tachycardia, arrhythmias) and the anticholinergic effects of ipratropium (e.g., urinary retention, blurred vision, glaucoma exacerbation). Monitor closely for adverse effects.
Clinical Information
Clinical Pearls
- This medication is for the maintenance treatment of bronchospasm associated with COPD in patients requiring more than one bronchodilator. It is not indicated for the initial treatment of acute episodes of bronchospasm where additional doses of a short-acting bronchodilator are required.
- Patients should be instructed on the proper use of the nebulizer and the importance of not exceeding the prescribed dose.
- Advise patients to seek immediate medical attention if their breathing problems worsen or if the medication becomes less effective.
- Patients with narrow-angle glaucoma or prostatic hypertrophy/bladder-neck obstruction should use this medication with caution and be monitored for exacerbation of these conditions.
- The combination provides synergistic bronchodilation, often more effective than either agent alone for moderate to severe COPD.
Alternative Therapies
- Short-acting beta-agonists (SABAs) alone (e.g., albuterol, levalbuterol) for rescue relief.
- Short-acting muscarinic antagonists (SAMAs) alone (e.g., ipratropium) for bronchodilation.
- Long-acting beta-agonists (LABAs) (e.g., salmeterol, formoterol, indacaterol, olodaterol) for maintenance.
- Long-acting muscarinic antagonists (LAMAs) (e.g., tiotropium, aclidinium, glycopyrrolate, umeclidinium) for maintenance.
- Inhaled corticosteroids (ICS) (e.g., fluticasone, budesonide) for patients with frequent exacerbations or asthma-COPD overlap syndrome.
- Oral corticosteroids (for acute exacerbations).
- Phosphodiesterase-4 (PDE4) inhibitors (e.g., roflumilast) for severe COPD with chronic bronchitis and history of exacerbations.
Cost & Coverage
Average Cost:
$30 - $100 per 30 x 3mL vials
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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.