Levalbuterol 1.25mg/3ml Neb 25x3ml
It is used to open the airways in lung diseases where spasm may cause breathing problems.
Drug Class
Bronchodilator
Pharmacologic Class
Selective beta2-adrenergic agonist
Pregnancy Category
Category C
FDA Approved
Mar 1999
DEA Schedule
Not Controlled
Overview
What is this medicine?
Levalbuterol is a medicine that helps open up the airways in your lungs, making it easier to breathe. It's used to treat or prevent breathing problems like wheezing and shortness of breath in people with asthma or COPD. It works quickly to relieve symptoms.
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 medication 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
Store the medication 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 regularly and miss a dose, use it as soon as you remember. However, if it's 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 take 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 medication 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
Store the medication 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 regularly and miss a dose, use it as soon as you remember. However, if it's 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 take it more frequently than directed by your doctor.
Lifestyle & Tips
- Use exactly as prescribed by your doctor. Do not use more often or in larger amounts than recommended.
- Understand how to properly use your nebulizer machine and the levalbuterol solution. Your doctor or pharmacist can demonstrate.
- Keep track of how often you use your rescue inhaler. If you find yourself needing it more often, or if your symptoms worsen, contact your doctor immediately.
- Avoid known triggers for your asthma or COPD (e.g., smoke, allergens, pollutants).
- Carry your rescue medication with you at all times.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
1.25 mg (one 3 mL vial) administered three times a day, every 6 to 8 hours, by nebulization.
Dose Range:
0.63 - 1.25 mg
Condition-Specific Dosing:
mild_moderate_bronchospasm:
0.63 mg three times a day, every 6 to 8 hours.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
6-11 years: 0.31 mg or 0.63 mg administered three times a day, every 6 to 8 hours, by nebulization. The 0.63 mg dose should be used for patients not responding adequately to the 0.31 mg dose.
Adolescent:
12 years and older: Same as adult dosing (0.63 mg or 1.25 mg three times a day).
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.
Dialysis:
Considerations: Levalbuterol is primarily eliminated renally. Monitor for increased systemic effects.
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.
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 relaxation of bronchial smooth muscle and bronchodilation. This action is mediated by activation of adenyl cyclase, which catalyzes the conversion of ATP to cyclic-3',5'-adenosine monophosphate (cAMP). Increased cAMP levels lead to activation of protein kinase A, which inhibits phosphorylation of myosin and lowers intracellular ionic calcium concentrations, resulting in relaxation.
Pharmacokinetics
Absorption:
Bioavailability:
Not fully quantified due to local action in the lungs; systemic absorption occurs.
Tmax:
Approximately 6 minutes (for nebulization solution).
FoodEffect:
Not applicable for inhalation solution.
Distribution:
Vd:
Not well-defined for inhalation; widely distributed.
ProteinBinding:
Approximately 10% to 25% (in vitro).
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 3.3 to 4 hours (systemic).
Clearance:
Not precisely quantified for inhalation.
ExcretionRoute:
Primarily renal (urine).
Unchanged:
Approximately 80% of the systemically absorbed dose is excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Within 5-10 minutes.
PeakEffect:
Approximately 1.5 hours.
DurationOfAction:
Typically 5-6 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, 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 or 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. 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 minor side effects. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical attention:
Feeling nervous and excitable
Dizziness or headache
Runny nose
Shakiness
Throat irritation
Vomiting
This is not a comprehensive list of all 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, 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 high or low blood pressure, including:
+ Severe headache or 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. 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 minor side effects. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical attention:
Feeling nervous and excitable
Dizziness or headache
Runny nose
Shakiness
Throat irritation
Vomiting
This is not a comprehensive list of all 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, rapid or irregular heartbeat (palpitations).
- Severe headache or dizziness.
- Increased tremor or nervousness.
- Signs of an allergic reaction (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 allergic reaction you experienced, including any symptoms that occurred.
If you are currently using a similar medication. If you are unsure, consult your doctor or pharmacist for clarification.
If you are taking inhaled epinephrine, as this may interact with the medication.
Additionally, to ensure safe use, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
Your medical history, including any health problems you have
This information will help your doctor determine if it is safe for you 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 to ensure your safety.
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 currently using a similar medication. If you are unsure, consult your doctor or pharmacist for clarification.
If you are taking inhaled epinephrine, as this may interact with the medication.
Additionally, to ensure safe use, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
Your medical history, including any health problems you have
This information will help your doctor determine if it is safe for you 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 to ensure your safety.
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. Overdose of this drug has been associated with fatal outcomes. If you have concerns or questions, consult 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 diabetes (high blood sugar), 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 make an informed decision. For children under 6 years of age, consult with your doctor, as the safety and efficacy of this medication have not been established in this age group.
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 diabetes (high blood sugar), 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 make an informed decision. For children under 6 years of age, consult with your doctor, as the safety and efficacy of this medication have not been established in this age group.
Overdose Information
Overdose Symptoms:
- Tachycardia (rapid heart rate)
- Palpitations
- Tremor
- Nervousness
- Headache
- Dizziness
- Nausea
- Vomiting
- Hypokalemia (low potassium levels)
- Hyperglycemia (high blood sugar)
What to Do:
Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is supportive and symptomatic. Consider monitoring serum potassium levels and ECG.
Drug Interactions
Major Interactions
- Beta-blockers (e.g., propranolol, carvedilol): May block the bronchodilatory effect of levalbuterol and produce severe bronchospasm, especially in patients with asthma. Generally, beta-blockers and levalbuterol should not be used concomitantly.
- Monoamine Oxidase Inhibitors (MAOIs) and Tricyclic Antidepressants (TCAs): May potentiate the cardiovascular effects of levalbuterol. Administer with extreme caution to patients being treated with MAOIs or TCAs, or within 2 weeks of discontinuation of such agents.
Moderate Interactions
- Diuretics (e.g., loop or thiazide diuretics): ECG changes and/or hypokalemia may result from the administration of non-potassium-sparing diuretics. These changes can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Clinical significance is unknown.
- Digoxin: Beta-agonists may decrease serum digoxin levels. Monitor digoxin levels.
- Other sympathomimetic agents: Concomitant administration may potentiate adverse cardiovascular effects. Use with extreme caution.
Confidence Interactions
Monitoring
Baseline Monitoring
Pulmonary Function Tests (e.g., FEV1)
Rationale: To assess baseline lung function and severity of airway obstruction.
Timing: Prior to initiation of therapy.
Heart Rate and Blood Pressure
Rationale: To establish baseline cardiovascular status, as beta-agonists can cause cardiovascular effects.
Timing: Prior to initiation of therapy.
Serum Potassium
Rationale: To establish baseline, especially in patients at risk for hypokalemia (e.g., on diuretics).
Timing: Prior to initiation of therapy, if indicated.
Routine Monitoring
Asthma/COPD Symptoms (e.g., shortness of breath, wheezing, cough)
Frequency: Daily, patient self-monitoring.
Target: Improvement or stability of symptoms.
Action Threshold: Worsening symptoms, increased frequency of rescue inhaler use, or lack of response to usual dose indicates need for medical re-evaluation.
Heart Rate and Blood Pressure
Frequency: Periodically, or if symptoms of cardiovascular effects occur.
Target: Within patient's normal range.
Action Threshold: Significant tachycardia, palpitations, or hypertension.
Serum Potassium
Frequency: Periodically, if patient is at risk for hypokalemia (e.g., on diuretics).
Target: 3.5-5.0 mEq/L.
Action Threshold: Hypokalemia (<3.5 mEq/L).
Proper Nebulizer Technique
Frequency: Periodically, or as needed.
Target: Correct and consistent technique.
Action Threshold: Incorrect technique or poor symptom control despite regular use.
Symptom Monitoring
- Worsening shortness of breath
- Increased wheezing or coughing
- Increased need for rescue inhaler (more than usual or more than 2 days a week)
- Chest pain or discomfort
- Palpitations or rapid heart rate
- Tremor or nervousness
- Dizziness or lightheadedness
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 interfere with uterine contractility.
Trimester-Specific Risks:
First Trimester:
Potential for fetal harm not definitively established; use only if clearly needed.
Second Trimester:
Potential for fetal harm not definitively established; use only if clearly needed.
Third Trimester:
May inhibit labor due to uterine relaxation effects. Monitor for neonatal hypoglycemia and tachycardia if used close to delivery.
Lactation
L3 (Moderately Safe). It is not known whether levalbuterol is excreted in human milk. However, due to the low systemic absorption and short half-life, significant infant exposure is unlikely. Use with caution.
Infant Risk:
Low risk of adverse effects to the infant, but monitor for irritability, poor feeding, or changes in heart rate.
Pediatric Use
Approved for children 6 years of age and older. Safety and efficacy in children younger than 6 years have not been established for the nebulizer solution. Dosing for children 6-11 years is lower than for adults.
Geriatric Use
No specific dose adjustment is generally required. However, elderly patients may be more susceptible to the cardiovascular effects of beta-agonists. Use with caution and monitor for adverse effects such as tachycardia, palpitations, and tremor.
Clinical Information
Clinical Pearls
- Levalbuterol is the R-isomer of albuterol, which is thought to be responsible for the bronchodilatory activity, while the S-isomer may contribute to some adverse effects. This theoretically leads to a similar bronchodilatory effect with potentially fewer side effects (e.g., tremor, tachycardia) compared to racemic albuterol, though clinical significance is debated.
- Levalbuterol is a rescue medication, not a maintenance therapy. It should not be used for long-term control of asthma or COPD.
- Patients should be instructed on the correct use of the nebulizer and the importance of daily cleaning to ensure proper drug delivery.
- Increased use of levalbuterol (or any SABA) indicates worsening asthma control and warrants immediate medical re-evaluation.
- Paradoxical bronchospasm, though rare, can occur with any inhaled bronchodilator. If it occurs, discontinue levalbuterol immediately and institute alternative therapy.
Alternative Therapies
- Albuterol (racemic albuterol) inhalation solution or metered-dose inhaler (MDI)
- Other short-acting beta2-agonists (SABAs) if available in other regions
- Long-acting beta2-agonists (LABAs) for maintenance therapy (e.g., formoterol, salmeterol)
- Inhaled corticosteroids (ICS) for maintenance therapy (e.g., fluticasone, budesonide)
- Combination ICS/LABA inhalers for maintenance therapy (e.g., fluticasone/salmeterol, budesonide/formoterol)
- Anticholinergics (e.g., ipratropium) or LAMA/LABA combinations for COPD.
Cost & Coverage
Average Cost:
$50 - $200 per 25 x 3mL vials (1.25mg/3mL)
Generic Available:
Yes
Insurance Coverage:
Often Tier 2 or Tier 3, may require prior authorization depending on insurance plan.
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.