Levalbuterol 0.63mg/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 beta-2 adrenergic agonist
Pregnancy Category
Category C
FDA Approved
Mar 1999
DEA Schedule
Not Controlled
Overview
What is this medicine?
Levalbuterol is a medicine used to help you breathe easier if you have asthma or certain other lung conditions. It works by relaxing the muscles in your airways, which opens them up and makes it easier to get air in and out of your lungs. It is given using a nebulizer, which turns the liquid medicine into a fine mist that you breathe in.
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 cloudiness, leakage, or particles. Do not use the solution if it has changed color. Some products may need to be mixed with saline before use, so check with your doctor or pharmacist to determine if this applies to your medication.
Important Safety Precautions
Do not mix other medications in the nebulizer.
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 solution. 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 use 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. 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 cloudiness, leakage, or particles. Do not use the solution if it has changed color. Some products may need to be mixed with saline before use, so check with your doctor or pharmacist to determine if this applies to your medication.
Important Safety Precautions
Do not mix other medications in the nebulizer.
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 solution. 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 use two doses at the same time or take extra doses. If you use this medication as needed, do not use it more frequently than directed by your doctor.
Lifestyle & Tips
- Use exactly as prescribed; do not use more often or in larger amounts than directed.
- Understand how to properly use your nebulizer and clean it regularly.
- Do not stop using other prescribed asthma medications unless directed by your doctor.
- Avoid known asthma triggers (e.g., allergens, smoke, cold air).
- Keep a rescue inhaler (if prescribed) readily available for sudden breathing problems.
- Seek immediate medical attention if your breathing problems worsen or if you need to use this medicine more often than usual.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
0.63 mg or 1.25 mg administered three times a day, every 6 to 8 hours, by nebulization.
Dose Range:
0.63 - 1.25 mg
Condition-Specific Dosing:
mildToModerateAsthma:
0.63 mg three times a day
severeAsthmaOrInsufficientResponse:
1.25 mg three times a day
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For children 6-11 years: 0.31 mg administered three times a day, every 6 to 8 hours, by nebulization. May increase to 0.63 mg three times a day if initial dose is insufficient and well-tolerated.
Adolescent:
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, but use with caution.
Moderate:
No specific dose adjustment recommended, but use with caution.
Severe:
No specific dose adjustment recommended, but use with caution due to potential for increased systemic exposure and adverse effects.
Dialysis:
Consideration for reduced frequency or dose may be warranted, but no specific guidelines available. Monitor for adverse effects.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended, but use with caution.
Moderate:
No specific dose adjustment recommended, but use with caution.
Severe:
No specific dose adjustment recommended, but use with caution due to potential for increased systemic exposure and adverse effects.
Pharmacology
Mechanism of Action
Levalbuterol is a selective beta-2 adrenergic agonist. It acts by stimulating beta-2 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 muscle relaxation.
Pharmacokinetics
Absorption:
Bioavailability:
Not precisely quantified due to local action; systemic absorption occurs after inhalation.
Tmax:
Approximately 6 minutes (for bronchodilation effect), plasma Tmax is about 0.2 hours.
FoodEffect:
Not applicable for inhaled solution.
Distribution:
Vd:
Not well-defined for inhaled administration; distributes widely.
ProteinBinding:
Approximately 10%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 3.3 to 4 hours (terminal half-life)
Clearance:
Not precisely quantified for inhaled administration.
ExcretionRoute:
Renal excretion (primarily as sulfate conjugate and unchanged drug).
Unchanged:
Approximately 69% of a single oral dose is excreted in urine as unchanged drug.
Pharmacodynamics
OnsetOfAction:
Within 5-15 minutes
PeakEffect:
Approximately 1.5 hours
DurationOfAction:
Typically 5-8 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 mild symptoms. 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 mild symptoms. 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 or discomfort
- Fast or irregular heartbeat (palpitations)
- Severe headache
- Dizziness or lightheadedness
- 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 symptoms you experienced.
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 treatment, 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 existing health problems
This information will help your doctor determine whether 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, such as foods or drugs. Be sure to describe the symptoms you experienced.
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 treatment, 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 existing health problems
This information will help your doctor determine whether 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 crucial that you 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 essential; do not take more of this medication or use it more frequently than directed by your healthcare provider. Overdose of this drug has been associated with fatal outcomes. If you have 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 diabetes (high blood sugar), it is important 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 the age of 6, consult with your doctor, as the safety and efficacy of this drug 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 important 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 the age of 6, consult with your doctor, as the safety and efficacy of this drug have not been established in this age group.
Overdose Information
Overdose Symptoms:
- Tachycardia (rapid heart rate)
- Palpitations
- Tremor
- Nervousness
- Headache
- Nausea
- Dizziness
- Hypokalemia (low potassium levels)
- Hyperglycemia (high blood sugar)
- Metabolic acidosis
What to Do:
If you suspect an overdose, seek immediate medical attention or call Poison Control at 1-800-222-1222. Treatment is generally supportive and symptomatic, including monitoring of vital signs, ECG, and serum potassium levels.
Drug Interactions
Contraindicated Interactions
- Non-selective beta-blockers (e.g., propranolol, carvedilol): May block the bronchodilatory effect of levalbuterol and produce severe bronchospasm in asthmatic patients.
Major Interactions
- Monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants (TCAs): May potentiate the vascular effects of levalbuterol, increasing the risk of cardiovascular adverse events (e.g., hypertension, tachycardia). Use with extreme caution or avoid within 14 days of discontinuing MAOIs/TCAs.
- Other sympathomimetic agents: Concomitant use may potentiate adverse cardiovascular effects. Avoid concurrent use of other short-acting sympathomimetic bronchodilators.
Moderate Interactions
- Diuretics (e.g., loop or thiazide diuretics): May exacerbate ECG changes and/or hypokalemia associated with beta-agonists, especially at higher doses. Monitor potassium levels.
- Digoxin: Beta-agonists may decrease serum digoxin levels. Monitor digoxin levels.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Pulmonary function (FEV1)
Rationale: To establish baseline lung function and assess severity of asthma/COPD.
Timing: Prior to initiation of therapy.
Heart rate and rhythm
Rationale: To assess for baseline cardiovascular status, as beta-agonists can cause tachycardia and arrhythmias.
Timing: Prior to initiation of therapy.
Blood pressure
Rationale: To assess for baseline cardiovascular status, as beta-agonists can cause changes in blood pressure.
Timing: Prior to initiation of therapy.
Routine Monitoring
Pulmonary function (FEV1)
Frequency: Periodically, or as clinically indicated, especially if symptoms worsen.
Target: Improvement from baseline, or maintenance of optimal lung function.
Action Threshold: Worsening FEV1 despite regular use may indicate inadequate control or need for alternative therapy.
Heart rate and rhythm
Frequency: Periodically, or if patient reports palpitations/tachycardia.
Target: Within normal limits for the patient.
Action Threshold: Persistent tachycardia, arrhythmias, or chest pain warrant medical evaluation.
Serum potassium
Frequency: If patient has risk factors for hypokalemia (e.g., concomitant diuretic use, severe asthma exacerbation).
Target: 3.5-5.0 mEq/L
Action Threshold: Potassium <3.5 mEq/L may require supplementation or dose adjustment.
Frequency of rescue inhaler use
Frequency: At each clinical visit.
Target: Decreased or stable use, indicating good asthma control.
Action Threshold: Increased frequency of use (e.g., >2 days/week, or more than 2 times/week for children 6-11) indicates worsening asthma control and need for re-evaluation of therapy.
Symptom Monitoring
- Worsening shortness of breath
- Increased wheezing
- Chest tightness
- Paradoxical bronchospasm (immediate worsening of breathing after dose)
- Palpitations
- Tremor
- Nervousness
- Chest pain
Special Patient Groups
Pregnancy
Levalbuterol is classified as Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenic effects not definitively established in humans; animal studies show some evidence of developmental toxicity at high doses.
Second Trimester:
Risk of uterine relaxation and potential for premature labor inhibition at high systemic doses.
Third Trimester:
Risk of uterine relaxation and potential for premature labor inhibition. May cause transient hyperglycemia, tachycardia, or hypokalemia in the mother, which could potentially affect the fetus.
Lactation
It is not known whether levalbuterol is excreted in human milk. Caution should be exercised when levalbuterol 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:
Risk is generally considered low for inhaled beta-agonists due to low systemic absorption, but potential for infant exposure and adverse effects (e.g., irritability, tremor) cannot be ruled out. Monitor infant for adverse effects.
Pediatric Use
Approved for children 6 years of age and older. Dosing for children 6-11 years is lower than for adults. Safety and efficacy in children younger than 6 years have not been established.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, elderly patients may be more sensitive to the cardiovascular effects of sympathomimetic amines. Use with caution and monitor for adverse effects.
Clinical Information
Clinical Pearls
- Levalbuterol is the R-isomer of racemic albuterol, which is thought to be responsible for the bronchodilatory activity and potentially fewer side effects (e.g., tremor, tachycardia) compared to racemic albuterol in some patients.
- It is a rescue medication for acute bronchospasm and should not be used as a substitute for long-term asthma control medications (e.g., inhaled corticosteroids).
- Patients should be instructed on the proper use and cleaning of their nebulizer equipment.
- Paradoxical bronchospasm can occur with any inhaled bronchodilator; if it occurs, discontinue levalbuterol immediately and institute alternative therapy.
- Patients should be advised to seek medical attention if their usual dose of levalbuterol becomes less effective, if they need to use it more frequently, or if their symptoms worsen, as this may indicate deteriorating asthma control.
Alternative Therapies
- Albuterol (racemic albuterol) inhalation solution
- Formoterol (long-acting beta-agonist, LABA)
- Salmeterol (LABA)
- Ipratropium (anticholinergic bronchodilator)
- Combination products (e.g., albuterol/ipratropium)
Cost & Coverage
Average Cost:
Varies widely, typically $100-$300+ per 25 x 3ml vials
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic), Tier 3 or higher (for brand) depending on insurance plan formulary.
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 this 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 overdose, including the medication taken, the amount, and the time it occurred.