Duoneb Inhalation Solution 3ml
It is used to open the airways in lung diseases where spasm may cause breathing problems.
Drug Class
Bronchodilator Combination
Pharmacologic Class
Anticholinergic / Beta2-Adrenergic Agonist
Pregnancy Category
Category C
FDA Approved
Aug 2001
DEA Schedule
Not Controlled
Overview
What is this medicine?
Duoneb is a medicine that combines two different types of bronchodilators to help open up your airways and make breathing easier. It's used for people with chronic obstructive pulmonary disease (COPD). One part (ipratropium) helps relax the muscles around your airways, and the other part (albuterol) quickly opens them up. It's given as a mist through a nebulizer.
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 this medication with other drugs 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, away from freezing temperatures.
Protect the medication from light.
Keep unused containers in their original foil pouch until you are ready to use them.
* Keep all 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 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 normal dosing 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 this medication with other drugs 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, away from freezing temperatures.
Protect the medication from light.
Keep unused containers in their original foil pouch until you are ready to use them.
* Keep all 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 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 normal dosing 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
- Do not use this medication for sudden, severe breathing problems (acute bronchospasm) unless directed by your doctor, as it is primarily for maintenance treatment.
- Follow your doctor's instructions for how often to use it and do not exceed the prescribed dose.
- 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 forms).
- Avoid getting the mist in your eyes, as it can cause blurred vision, eye pain, or worsen glaucoma.
- If you have heart problems, high blood pressure, diabetes, or an overactive thyroid, inform your doctor before starting this medication.
- Report any worsening of breathing, increased need for rescue inhaler, or new symptoms immediately to your doctor.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
One 3 mL vial (0.5 mg ipratropium and 2.5 mg albuterol) administered by nebulization 3 to 4 times a day, not to exceed 4 doses in 24 hours.
Dose Range:
3 - 4 mg
Condition-Specific Dosing:
COPD:
One 3 mL vial (0.5 mg ipratropium and 2.5 mg albuterol) administered by nebulization 3 to 4 times a day, not to exceed 4 doses in 24 hours.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Safety and efficacy not established in patients under 6 years of age)
Adolescent:
One 3 mL vial (0.5 mg ipratropium and 2.5 mg albuterol) administered by nebulization 3 to 4 times a day, not to exceed 4 doses in 24 hours (for patients 12 years and older).
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, use with caution.
Moderate:
No specific dose adjustment recommended, use with caution.
Severe:
No specific dose adjustment recommended, use with caution. Monitor for increased systemic effects.
Dialysis:
Considerations: Albuterol is dialyzable, ipratropium is minimally absorbed systemically. No specific dose adjustment guidance, monitor patient response.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended, use with caution.
Moderate:
No specific dose adjustment recommended, use with caution.
Severe:
No specific dose adjustment recommended, use with caution. Monitor for increased systemic effects.
Pharmacology
Mechanism of Action
Ipratropium bromide is an anticholinergic (parasympatholytic) agent which, by blocking muscarinic receptors, causes bronchodilation by reducing vagally mediated bronchoconstriction. Albuterol sulfate is a short-acting beta2-adrenergic agonist that stimulates beta2-receptors in the lungs, leading to relaxation of bronchial smooth muscle and bronchodilation.
Pharmacokinetics
Absorption:
Bioavailability:
Ipratropium: Low systemic bioavailability (<10% after inhalation). Albuterol: Approximately 20% of an inhaled dose reaches the lungs, with systemic absorption from the lungs and GI tract.
Tmax:
Ipratropium: Not well characterized due to low systemic absorption. Albuterol: Approximately 0.5 hours (plasma peak after inhalation).
FoodEffect:
Not applicable for inhalation solution.
Distribution:
Vd:
Ipratropium: Not well characterized due to low systemic absorption. Albuterol: 3.1 L/kg.
ProteinBinding:
Ipratropium: <9% plasma protein binding. Albuterol: 10% plasma protein binding.
CnssPenetration:
Ipratropium: Limited. Albuterol: Limited.
Elimination:
HalfLife:
Ipratropium: Approximately 1.6 hours (terminal half-life after inhalation). Albuterol: Approximately 3.8 hours (terminal half-life after inhalation).
Clearance:
Not available for combination, varies by component.
ExcretionRoute:
Ipratropium: Primarily renal excretion of unchanged drug and metabolites. Albuterol: Primarily renal excretion of unchanged drug (80%) and metabolites.
Unchanged:
Ipratropium: Approximately 25% of an inhaled dose is excreted unchanged in urine. Albuterol: Approximately 80% of an IV dose is excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Approximately 15 minutes
PeakEffect:
Approximately 1 to 2 hours
DurationOfAction:
Approximately 4 to 5 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 low potassium levels, including:
+ Muscle pain or weakness
+ Muscle cramps
+ An abnormal heartbeat
Signs of high blood pressure, such as:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Chest pain or pressure
Fast or abnormal heartbeat
Changes in eyesight, eye pain, or severe eye irritation
Seeing halos or bright colors around lights
Red eyes
Urination problems, such as:
+ Trouble passing urine
+ Pain when passing urine
+ Weak stream or dripping
+ Frequent urination
Severe breathing problems, which can be life-threatening, may occur shortly after taking a dose. If you experience trouble breathing, worsening breathing, wheezing, or coughing, 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 notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Feeling nervous and excitable
Headache
Shakiness
Nose or throat irritation
This is not an exhaustive list of possible side effects. If you have questions or concerns, 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, 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 low potassium levels, including:
+ Muscle pain or weakness
+ Muscle cramps
+ An abnormal heartbeat
Signs of high blood pressure, such as:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Chest pain or pressure
Fast or abnormal heartbeat
Changes in eyesight, eye pain, or severe eye irritation
Seeing halos or bright colors around lights
Red eyes
Urination problems, such as:
+ Trouble passing urine
+ Pain when passing urine
+ Weak stream or dripping
+ Frequent urination
Severe breathing problems, which can be life-threatening, may occur shortly after taking a dose. If you experience trouble breathing, worsening breathing, wheezing, or coughing, 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 notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Feeling nervous and excitable
Headache
Shakiness
Nose or throat irritation
This is not an exhaustive list of possible side effects. If you have questions or concerns, 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)
- Chest pain or fast/irregular heartbeat (palpitations)
- Severe headache or dizziness
- Blurred vision, eye pain, or redness (especially if you have glaucoma)
- Difficulty urinating
- Muscle cramps or weakness (signs of low potassium)
- 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, 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 the 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 the 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 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.
If you find that your usual dose is ineffective, your symptoms worsen, or you need to use this medication more frequently than prescribed, contact your doctor immediately.
For individuals with diabetes (high blood sugar), it is necessary to 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.
If you find that your usual dose is ineffective, your symptoms worsen, or you need to use this medication more frequently than prescribed, contact your doctor immediately.
For individuals with diabetes (high blood sugar), it is necessary to 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:
- Exaggerated beta-adrenergic effects (e.g., tachycardia, palpitations, tremor, nervousness, headache, nausea, dizziness, hypokalemia, hyperglycemia)
- Exaggerated anticholinergic effects (e.g., dry mouth, blurred vision, urinary retention, constipation, increased heart rate)
What to Do:
Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is supportive and symptomatic. Consider cardiovascular monitoring and potassium levels.
Drug Interactions
Major Interactions
- Other anticholinergics (e.g., tiotropium, aclidinium, umeclidinium): Increased risk of anticholinergic adverse effects.
- Beta-blockers (non-selective): May antagonize the bronchodilatory effect of albuterol and cause severe bronchospasm.
- Monoamine Oxidase Inhibitors (MAOIs) and Tricyclic Antidepressants (TCAs): May potentiate the cardiovascular effects of albuterol (e.g., increased heart rate, blood pressure).
- Diuretics (non-potassium sparing, e.g., thiazides, loop diuretics): May worsen ECG changes and/or hypokalemia induced by beta-agonists.
Moderate Interactions
- Sympathomimetics (e.g., pseudoephedrine, phenylephrine): Additive cardiovascular effects.
- Digoxin: Albuterol may decrease serum digoxin levels.
- Other short-acting beta-agonists: Increased risk of adverse cardiovascular effects.
Monitoring
Baseline Monitoring
Pulmonary Function Tests (FEV1)
Rationale: To establish baseline lung function and assess disease severity.
Timing: Prior to initiation of therapy.
Cardiovascular assessment (HR, BP, ECG if indicated)
Rationale: Albuterol can cause cardiovascular effects; assess baseline status, especially in patients with pre-existing cardiac conditions.
Timing: Prior to initiation of therapy.
Intraocular pressure (IOP)
Rationale: Ipratropium can precipitate or worsen narrow-angle glaucoma. Assess baseline in patients at risk.
Timing: Prior to initiation of therapy in at-risk patients.
Routine Monitoring
Pulmonary Function Tests (FEV1)
Frequency: Periodically (e.g., every 3-12 months or as clinically indicated)
Target: Improvement from baseline, individualized goals.
Action Threshold: Lack of improvement or worsening of lung function may indicate inadequate control or disease progression.
Heart Rate and Blood Pressure
Frequency: Periodically, or as clinically indicated, especially during dose titration or in patients with cardiovascular comorbidities.
Target: Within normal limits or patient's baseline.
Action Threshold: Significant tachycardia, palpitations, or hypertension may require dose adjustment or discontinuation.
Serum Potassium
Frequency: Periodically, especially in patients receiving concomitant diuretics or corticosteroids, or with severe exacerbations.
Target: 3.5-5.0 mEq/L
Action Threshold: Hypokalemia (<3.5 mEq/L) may require supplementation or dose adjustment.
Symptoms of COPD/Asthma control
Frequency: Regularly (e.g., daily symptom diary)
Target: Reduced frequency and severity of symptoms (e.g., dyspnea, cough, wheezing).
Action Threshold: Increased use of rescue inhaler, worsening symptoms, or nocturnal awakenings indicate inadequate control.
Symptom Monitoring
- Worsening shortness of breath
- Increased wheezing or coughing
- Chest tightness
- Increased need for rescue inhaler
- Palpitations or rapid heart rate
- Tremor or nervousness
- Dry mouth
- Blurred vision or eye pain (especially in patients with glaucoma)
- Difficulty urinating (especially in men with prostatic hyperplasia)
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Both ipratropium and albuterol have been shown to be teratogenic in animal studies at high doses. Albuterol can inhibit uterine contractions.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though human data are limited and generally reassuring for inhaled forms.
Second Trimester:
Generally considered safer than first trimester, but still use with caution.
Third Trimester:
Albuterol may interfere with uterine contractility and labor. Use with caution near term.
Lactation
Both ipratropium and albuterol are excreted in human milk. Caution should be exercised when Duoneb is administered to a nursing mother. The decision to discontinue nursing or to discontinue the drug should take into account the importance of the drug to the mother.
Infant Risk:
Low risk for ipratropium due to poor systemic absorption. Moderate risk for albuterol; potential for infant exposure and adverse effects (e.g., irritability, tremor, tachycardia) though systemic levels in infant are likely low with inhaled maternal use.
Pediatric Use
Safety and efficacy have not been established in pediatric patients under 6 years of age. Use in children 6-11 years old is off-label and should be done with caution and careful monitoring. For patients 12 years and older, adult dosing applies.
Geriatric Use
Use with caution in elderly patients, as they may be more susceptible to the cardiovascular effects of albuterol (e.g., tachycardia, arrhythmias) and the anticholinergic effects of ipratropium (e.g., urinary retention, glaucoma exacerbation). Monitor for these adverse effects.
Clinical Information
Clinical Pearls
- Duoneb is a maintenance bronchodilator for COPD and 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 avoiding contact of the solution with the eyes to prevent ocular adverse events.
- Paradoxical bronchospasm can occur with any inhaled bronchodilator; if it occurs, discontinue Duoneb immediately and institute alternative therapy.
- Monitor for signs of hypokalemia, especially in patients with severe COPD, during acute exacerbations, or with concomitant use of diuretics or corticosteroids.
- Advise patients to seek immediate medical attention if their breathing problems worsen or if they need to use their rescue inhaler more often than usual.
Alternative Therapies
- Short-acting beta-agonists (SABAs) monotherapy (e.g., albuterol, levalbuterol)
- Short-acting muscarinic antagonists (SAMAs) monotherapy (e.g., ipratropium)
- Long-acting beta-agonists (LABAs) monotherapy (e.g., salmeterol, formoterol)
- Long-acting muscarinic antagonists (LAMAs) monotherapy (e.g., tiotropium, aclidinium, umeclidinium)
- Inhaled corticosteroids (ICS) (often in combination with LABA for asthma or severe COPD)
- Oral corticosteroids (for exacerbations)
- Phosphodiesterase-4 (PDE4) inhibitors (e.g., roflumilast for severe COPD)
Cost & Coverage
Average Cost:
Varies widely, typically $50-$200 per 30 vials
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic), Tier 3 (for brand)
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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.