Xopenex 0.31mg/3ml Neb 24x3ml Green
It is used to open the airways in lung diseases where spasm may cause breathing problems.
Drug Class
Bronchodilator
Pharmacologic Class
Selective Beta-2 Adrenergic Agonist
Pregnancy Category
Category C
FDA Approved
Oct 1999
DEA Schedule
Not Controlled
Overview
What is this medicine?
Levalbuterol is a medicine that helps open up your airways when you have asthma or COPD. It's a 'rescue' medicine, meaning it works quickly to relieve symptoms like wheezing, shortness of breath, and chest tightness. You breathe it in using 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. Be sure to use the type of nebulizer recommended by your doctor. If you're unsure, consult with your doctor.
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.
Some products may require mixing with saline before use. Check with your doctor or pharmacist to determine if your product needs to be mixed. Never mix other medications in the nebulizer, and avoid getting the solution in your eyes.
If you're using multiple inhaled medications, ask your doctor which one to use first.
Storing and Disposing of Your Medication
To maintain the medication's effectiveness, store it at room temperature, away from heat and light. Do not freeze the medication. Keep unused containers in their original foil pouch until you're ready to use them. After opening the foil pouch, make sure you understand how long the product remains effective and how to store it properly. If you're unsure, consult with your doctor or pharmacist.
Missing a Dose
If you take this medication on a regular schedule, use a missed dose as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your normal schedule. Do not take two doses at the same time or use extra doses.
In some cases, this medication is used as needed. Be sure to follow your doctor's instructions and do not use the medication more frequently than recommended.
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. Be sure to use the type of nebulizer recommended by your doctor. If you're unsure, consult with your doctor.
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.
Some products may require mixing with saline before use. Check with your doctor or pharmacist to determine if your product needs to be mixed. Never mix other medications in the nebulizer, and avoid getting the solution in your eyes.
If you're using multiple inhaled medications, ask your doctor which one to use first.
Storing and Disposing of Your Medication
To maintain the medication's effectiveness, store it at room temperature, away from heat and light. Do not freeze the medication. Keep unused containers in their original foil pouch until you're ready to use them. After opening the foil pouch, make sure you understand how long the product remains effective and how to store it properly. If you're unsure, consult with your doctor or pharmacist.
Missing a Dose
If you take this medication on a regular schedule, use a missed dose as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your normal schedule. Do not take two doses at the same time or use extra doses.
In some cases, this medication is used as needed. Be sure to follow your doctor's instructions and do not use the medication more frequently than recommended.
Lifestyle & Tips
- Always carry your rescue inhaler with you.
- Use exactly as prescribed; do not use more often or in larger doses than recommended.
- Understand your asthma action plan and when to use your rescue inhaler versus your controller medications.
- Avoid known triggers for your asthma or COPD (e.g., smoke, allergens, cold air).
- Maintain good hydration.
- Practice proper nebulizer technique as instructed by your healthcare provider.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
0.31 mg administered three times a day, every 6 to 8 hours, by nebulization.
Dose Range:
0.31 - 1.25 mg
Condition-Specific Dosing:
severe_asthma:
May consider 0.63 mg or 1.25 mg three times a day, based on clinical response and tolerability.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (safety and efficacy not established for patients under 6 years of age)
Child:
6-11 years: 0.31 mg administered three times a day, every 6 to 8 hours, by nebulization.
Adolescent:
12 years and older: Same as adult dosing (0.31 mg, 0.63 mg, or 1.25 mg three times a day).
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended; use with caution due to potential for increased systemic exposure, though minimal for inhaled route.
Dialysis:
No specific recommendations; use with caution.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended; use with caution due to potential for altered metabolism, though minimal for inhaled route.
Pharmacology
Mechanism of Action
Levalbuterol is a selective beta2-adrenergic agonist. It acts by stimulating beta2-adrenergic receptors in the smooth muscle of the bronchi, leading to activation of adenyl cyclase, which increases intracellular cyclic-3',5'-adenosine monophosphate (cAMP). Increased cAMP levels result in relaxation of bronchial smooth muscle, bronchodilation, and inhibition of mediator release from mast cells.
Pharmacokinetics
Absorption:
Bioavailability:
Low systemic bioavailability after inhalation (approximately 16% of the nebulized dose reaches the lungs).
Tmax:
Approximately 0.5 to 1 hour (for systemic plasma concentrations).
FoodEffect:
Not applicable for inhaled solution.
Distribution:
Vd:
Not well characterized for inhaled administration.
ProteinBinding:
Approximately 10% (low).
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 3.3 to 4 hours (systemic plasma half-life).
Clearance:
Not well characterized for inhaled administration.
ExcretionRoute:
Renal (primarily as sulfate conjugate).
Unchanged:
Approximately 80-100% of the dose is excreted in urine, mostly as the sulfate conjugate, with a small percentage as unchanged drug.
Pharmacodynamics
OnsetOfAction:
Within 10-17 minutes.
PeakEffect:
Approximately 1.5 hours.
DurationOfAction:
Approximately 5-6 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 high or low blood pressure, including:
+ Severe headache
+ Dizziness
+ Passing out
+ Changes in eyesight
Signs of low potassium levels, such as:
+ Muscle pain or weakness
+ Muscle cramps
+ An abnormal heartbeat
Chest pain or pressure
Fast or abnormal heartbeat
Severe breathing problems, which can be life-threatening, especially when using an inhaler or liquid for breathing in. This may occur right after a dose or when using a new canister or vial of this medication for the first time. If you experience trouble breathing, worsening breathing, wheezing, or coughing, seek medical help immediately.
Other Possible Side Effects
Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:
Feeling nervous and excitable
Dizziness or headache
Runny nose
Shakiness
Throat irritation
Vomiting
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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 high or low blood pressure, including:
+ Severe headache
+ Dizziness
+ Passing out
+ Changes in eyesight
Signs of low potassium levels, such as:
+ Muscle pain or weakness
+ Muscle cramps
+ An abnormal heartbeat
Chest pain or pressure
Fast or abnormal heartbeat
Severe breathing problems, which can be life-threatening, especially when using an inhaler or liquid for breathing in. This may occur right after a dose or when using a new canister or vial of this medication for the first time. If you experience trouble breathing, worsening breathing, wheezing, or coughing, seek medical help immediately.
Other Possible Side Effects
Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:
Feeling nervous and excitable
Dizziness or headache
Runny nose
Shakiness
Throat irritation
Vomiting
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Worsening shortness of breath or wheezing after using the medication (paradoxical bronchospasm).
- Chest pain, fast or irregular heartbeat (palpitations).
- Severe headache or dizziness.
- Increased nervousness or tremor.
- If your symptoms do not improve or worsen after using the medication, or if you need to use it more often than usual, seek medical attention immediately.
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. Be sure to describe the allergic reaction and its symptoms.
If you are currently taking a similar medication. If you are unsure, consult your doctor or pharmacist for clarification.
If you are using inhaled epinephrine, as this may interact with the medication.
Additionally, to ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
Your medical history, including any health problems
This information will help your doctor determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose 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. Be sure to describe the allergic reaction and its symptoms.
If you are currently taking a similar medication. If you are unsure, consult your doctor or pharmacist for clarification.
If you are using inhaled epinephrine, as this may interact with the medication.
Additionally, to ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
Your medical history, including any health problems
This information will help your doctor determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose 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. To avoid any potential issues, make sure you do not run out of this drug. Adhering to your prescribed dosage is crucial; do not take more of this medication or use it more frequently than directed by your healthcare provider. Taking too much of this drug can be fatal. If you have any concerns or questions, consult with your doctor.
If you find that your usual dose is not providing adequate relief, your symptoms are worsening, or you need to use this medication more often than prescribed, contact your doctor immediately. For individuals with high blood sugar (diabetes), it is vital to closely monitor your blood sugar levels while taking this medication.
If you are 65 years of age or older, exercise caution when using this drug, as you may be more susceptible to side effects. Pregnant women, those planning to become pregnant, or breastfeeding mothers should discuss the potential benefits and risks of this medication with their doctor to ensure the best outcome for both mother and baby.
For children under 6 years of age, consult with your doctor before administering this medication, as its safety and effectiveness in this age group have not been established.
If you find that your usual dose is not providing adequate relief, your symptoms are worsening, or you need to use this medication more often than prescribed, contact your doctor immediately. For individuals with high blood sugar (diabetes), it is vital to closely monitor your blood sugar levels while taking this medication.
If you are 65 years of age or older, exercise caution when using this drug, as you may be more susceptible to side effects. Pregnant women, those planning to become pregnant, or breastfeeding mothers should discuss the potential benefits and risks of this medication with their doctor to ensure the best outcome for both mother and baby.
For children under 6 years of age, consult with your doctor before administering this medication, as its safety and effectiveness in this age group have not been established.
Overdose Information
Overdose Symptoms:
- Tachycardia (fast heart rate)
- Palpitations
- Tremor
- Headache
- Nervousness
- Dizziness
- Nausea
- Vomiting
- Hypokalemia (low potassium levels)
- Hyperglycemia (high blood sugar)
- Metabolic acidosis
What to Do:
Seek immediate medical attention or call Poison Control at 1-800-222-1222. Treatment is generally supportive and symptomatic. Beta-blockers may be considered in severe cases of cardiovascular effects, but use with extreme caution due to potential for inducing bronchospasm.
Drug Interactions
Contraindicated Interactions
- Non-selective beta-blockers (e.g., propranolol, carvedilol) due to pharmacodynamic antagonism and potential for severe bronchospasm.
Major Interactions
- Monoamine Oxidase Inhibitors (MAOIs) and Tricyclic Antidepressants (TCAs): May potentiate the vascular effects of levalbuterol, increasing risk of cardiovascular adverse events. Use with extreme caution or avoid within 14 days of discontinuing MAOIs/TCAs.
- Other sympathomimetic agents (e.g., epinephrine, pseudoephedrine): Additive cardiovascular effects; use with caution.
Moderate Interactions
- Diuretics (e.g., loop or thiazide diuretics): May potentiate ECG changes and/or hypokalemia associated with beta-agonists, especially at higher doses.
- Digoxin: Beta-agonists may decrease serum digoxin levels; monitor digoxin levels.
Monitoring
Baseline Monitoring
Pulmonary function tests (e.g., FEV1)
Rationale: To assess baseline lung function and severity of asthma/COPD.
Timing: Prior to initiation of therapy and periodically.
Vital signs (heart rate, blood pressure)
Rationale: To establish baseline and monitor for cardiovascular effects.
Timing: Prior to initiation.
Routine Monitoring
Symptom control (e.g., frequency of rescue inhaler use, nocturnal symptoms)
Frequency: Daily by patient, reviewed at each clinical visit.
Target: Minimal symptoms, infrequent rescue use.
Action Threshold: Increased frequency of use, worsening symptoms, or need for more than 2 days/week of rescue use (excluding exercise-induced bronchospasm) indicates inadequate control and need for reassessment.
Peak expiratory flow (PEF)
Frequency: Daily (if patient uses a peak flow meter).
Target: Patient's personal best or >80% of predicted.
Action Threshold: Significant drop from personal best or predicted values.
Heart rate and rhythm
Frequency: Periodically, or if patient reports palpitations/tremor.
Target: Normal sinus rhythm, heart rate within patient's baseline.
Action Threshold: Persistent tachycardia, arrhythmias.
Serum potassium (if risk factors for hypokalemia)
Frequency: Periodically, especially with concomitant diuretics or high doses.
Target: 3.5-5.0 mEq/L.
Action Threshold: <3.5 mEq/L.
Symptom Monitoring
- Worsening shortness of breath or wheezing
- Increased need for rescue inhaler
- Chest pain or discomfort
- Palpitations or rapid heart rate
- Tremor or nervousness
- Paradoxical bronchospasm (immediate worsening of breathing after inhalation)
Special Patient Groups
Pregnancy
Category C. There are no adequate and well-controlled studies of levalbuterol in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Beta-agonists may inhibit uterine contractions and increase the risk of hemorrhage.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity not established; use only if clearly needed.
Second Trimester:
Monitor for maternal cardiovascular effects; potential for inhibition of labor.
Third Trimester:
Potential for inhibition of labor and transient maternal/fetal hyperglycemia or hypokalemia. Use with caution near term.
Lactation
L3 (Moderately Safe). It is not known whether levalbuterol is excreted in human milk. However, other beta-agonists are excreted into human milk. Caution should be exercised when levalbuterol is administered to a nursing woman. The amount transferred to milk is likely low, and adverse effects in the infant are not expected.
Infant Risk:
Low risk of adverse effects to the breastfed infant. Monitor infant for signs of agitation, tremor, or feeding difficulties.
Pediatric Use
Safety and efficacy have not been established for patients under 6 years of age. For patients 6 years and older, dosing is established. Children may be more susceptible to systemic adverse effects.
Geriatric Use
No specific dose adjustment is required. However, elderly patients may be more sensitive to the effects of sympathomimetic amines, particularly cardiovascular effects (e.g., tachycardia, arrhythmias, blood pressure changes). Monitor closely for adverse reactions.
Clinical Information
Clinical Pearls
- Levalbuterol is the R-isomer of albuterol, which is responsible for the bronchodilatory activity, potentially leading to fewer side effects (e.g., tachycardia, tremor) compared to racemic albuterol in some patients, though clinical significance is debated.
- It is a rescue medication and should not be used as a substitute for long-term controller medications.
- Patients should be instructed on proper nebulizer technique to ensure optimal drug delivery.
- Advise patients to seek immediate medical attention if their symptoms worsen or if they need to use the medication more frequently than prescribed, as this may indicate worsening asthma control.
- Paradoxical bronchospasm can occur; if it happens, discontinue the drug immediately and use an alternative bronchodilator.
Alternative Therapies
- Albuterol (racemic albuterol) inhalation solution
- Other short-acting beta-agonists (SABAs) in metered-dose inhaler (MDI) or dry powder inhaler (DPI) formulations (e.g., albuterol MDI)
- Long-acting beta-agonists (LABAs) for maintenance therapy (e.g., salmeterol, formoterol) - not for rescue.
Cost & Coverage
Average Cost:
$50 - $150 per box of 24 x 3ml vials (0.31mg/3ml)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic levalbuterol)
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.