Levalbuterol 0.31mg/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
C
FDA Approved
Mar 1999
DEA Schedule
Not Controlled
Overview
What is this medicine?
Levalbuterol is a medicine that you breathe in using a nebulizer. It helps to open up the airways in your lungs, making it easier to breathe if you have conditions like asthma or COPD. It works by relaxing the muscles around your airways.
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.
Use only the type of nebulizer recommended by your doctor. If you're unsure, consult with your doctor.
Check the solution before use. Do not use it if it appears cloudy, is leaking, has particles, or has changed color.
Some products may need to be mixed with saline before use. Check with your doctor or pharmacist to determine if your product requires mixing.
Do not mix other medications in the nebulizer.
Avoid getting the solution in your eyes.
If you're using more than one inhaled medication, 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 foil pouches 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 and miss a dose, use it as soon as you remember.
If it's almost time for your next dose, skip the missed dose and continue with 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 medication directly into your lungs.
Use only the type of nebulizer recommended by your doctor. If you're unsure, consult with your doctor.
Check the solution before use. Do not use it if it appears cloudy, is leaking, has particles, or has changed color.
Some products may need to be mixed with saline before use. Check with your doctor or pharmacist to determine if your product requires mixing.
Do not mix other medications in the nebulizer.
Avoid getting the solution in your eyes.
If you're using more than one inhaled medication, 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 foil pouches 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 and miss a dose, use it as soon as you remember.
If it's almost time for your next dose, skip the missed dose and continue with 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 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. Follow the instructions provided with your device.
- Do not mix levalbuterol with other medications in the nebulizer unless specifically instructed 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 bronchodilators than inhaled steroids).
- Keep track of how often you use your levalbuterol. If you find yourself needing it more often than usual, or if your symptoms worsen, contact your doctor immediately as this may indicate worsening asthma/COPD control.
- Avoid known triggers for your breathing problems (e.g., allergens, smoke, cold air).
- Do not use levalbuterol as a substitute for inhaled corticosteroids or other long-term control medications if prescribed.
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. For 0.31mg/3ml, typically 0.31 mg three times a day.
Dose Range:
0.31 - 1.25 mg
Condition-Specific Dosing:
mild_to_moderate_bronchospasm:
0.63 mg three times a day
severe_bronchospasm:
1.25 mg three times a day
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For children 6-11 years: 0.31 mg or 0.63 mg administered three times a day, every 6 to 8 hours, by nebulization.
Adolescent:
For adolescents 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: Monitor for increased systemic effects due to potential accumulation.
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-receptors in the smooth muscle of the bronchi, leading to relaxation of the bronchial smooth muscle and subsequent bronchodilation. This action is mediated by adenyl cyclase, an enzyme that catalyzes the conversion of ATP to cyclic-3',5'-adenosine monophosphate (cAMP). Increased cAMP levels are associated with relaxation of bronchial smooth muscle and inhibition of mediator release from mast cells.
Pharmacokinetics
Absorption:
Bioavailability:
Not precisely quantified for inhaled route due to local action; systemic absorption occurs.
Tmax:
Approximately 0.5 to 1 hour after inhalation.
FoodEffect:
Not applicable for inhaled solution.
Distribution:
Vd:
Not well-defined for inhaled administration.
ProteinBinding:
Approximately 50% bound to plasma proteins.
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 3.3 to 4 hours (terminal half-life).
Clearance:
Not precisely quantified for inhaled route.
ExcretionRoute:
Primarily renal (urine).
Unchanged:
Approximately 80% of the systemically absorbed dose is excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Within 5-15 minutes.
PeakEffect:
Approximately 1 to 1.5 hours.
DurationOfAction:
Typically 5 to 8 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 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 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. 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 experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
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, 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 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 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. 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 experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
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, 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 discomfort.
- Very fast or irregular heartbeat (palpitations).
- Severe tremor or nervousness.
- Dizziness or lightheadedness.
- Signs of an allergic reaction (e.g., rash, hives, swelling of face/lips/tongue, severe dizziness, trouble 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 if it is safe for you to take this medication in conjunction 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 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 if it is safe for you to take this medication in conjunction 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. 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, so it is vital to consult with your doctor if you have any concerns. 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.
If you have diabetes (high blood sugar), it is crucial to monitor your blood sugar levels closely while taking this medication. Elderly patients (65 years or older) should exercise caution when using this drug, as they may be more susceptible to side effects.
Before taking this medication, inform your doctor if you are pregnant, planning to become pregnant, or are breastfeeding. This will allow you to discuss the potential benefits and risks of the medication to both you and your baby. 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 have diabetes (high blood sugar), it is crucial to monitor your blood sugar levels closely while taking this medication. Elderly patients (65 years or older) should exercise caution when using this drug, as they may be more susceptible to side effects.
Before taking this medication, inform your doctor if you are pregnant, planning to become pregnant, or are breastfeeding. This will allow you to discuss the potential benefits and risks of the medication to both you and your baby. 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
- Headache
- Nausea
- Vomiting
- Hypokalemia (low potassium levels)
- Hyperglycemia (high blood sugar)
- Metabolic acidosis
- Cardiac arrest (in severe cases)
What to Do:
Seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). Treatment is supportive and symptomatic. Consider judicious use of a cardioselective beta-receptor blocker in patients presenting with severe cardiac symptoms, but only with extreme caution as it could induce bronchospasm.
Drug Interactions
Major Interactions
- Beta-blockers (especially non-selective): May block the bronchodilatory effect of levalbuterol and produce severe bronchospasm in asthmatic patients. Avoid concomitant use.
- 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): May potentiate ECG changes and/or hypokalemia resulting from beta-agonists, especially at higher doses. Monitor potassium levels.
- Digoxin: Levalbuterol may decrease serum digoxin levels. Monitor digoxin levels.
- Other sympathomimetic agents: Concomitant use may potentiate adverse cardiovascular effects. Use with caution.
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 or on concomitant diuretics.
Timing: Prior to initiation of therapy, if indicated.
Routine Monitoring
Symptom Control (e.g., shortness of breath, wheezing)
Frequency: Daily, or as needed based on patient's condition.
Target: Improved breathing, reduced frequency of symptoms.
Action Threshold: Worsening symptoms, increased need for rescue medication, or lack of response to usual dose.
Frequency of Levalbuterol Use
Frequency: Daily, patient self-monitoring.
Target: Use as prescribed, not exceeding maximum daily dose.
Action Threshold: Increased frequency of use (e.g., more than 2 days a week for symptom control, or more than 2 times a month for nocturnal symptoms) may indicate worsening asthma control and require re-evaluation of therapy.
Heart Rate and Blood Pressure
Frequency: Periodically, or if patient reports palpitations/tremor.
Target: Within normal limits for the patient.
Action Threshold: Persistent tachycardia, palpitations, or significant hypertension.
Serum Potassium
Frequency: Periodically, if patient is at risk for hypokalemia (e.g., concomitant diuretic use).
Target: 3.5-5.0 mEq/L.
Action Threshold: Potassium < 3.5 mEq/L.
Symptom Monitoring
- Worsening shortness of breath
- Increased wheezing or coughing
- Chest tightness
- Increased need for rescue inhaler (more than usual)
- Palpitations or rapid heart rate
- Tremor or nervousness
- Dizziness or lightheadedness
Special Patient Groups
Pregnancy
Levalbuterol is Pregnancy Category C. There are no adequate and well-controlled studies 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:
Limited data, theoretical risk of teratogenicity, but generally considered low.
Second Trimester:
Generally considered safe if needed, monitor for maternal cardiovascular effects.
Third Trimester:
May inhibit labor due to uterine relaxation. Monitor for neonatal hypoglycemia and tachycardia if used close to delivery.
Lactation
It is not known whether levalbuterol is excreted in human milk. However, other beta-agonists are excreted in human milk. Caution should be exercised when levalbuterol is administered to a nursing mother. Generally considered compatible with breastfeeding, but monitor infant for adverse effects (e.g., irritability, tremor).
Infant Risk:
Low risk. Monitor for signs of irritability, tremor, or feeding difficulties in the infant.
Pediatric Use
Approved for children 6 years of age and older. Dosing is weight and age-dependent for younger children. Safety and efficacy in children younger than 6 years have not been established. Proper nebulizer technique is crucial for effective delivery in this population.
Geriatric Use
No specific dose adjustment is generally required. However, elderly patients may be more sensitive to the cardiovascular effects of sympathomimetic amines. Use with caution and monitor for adverse effects such as tachycardia, palpitations, and tremor.
Clinical Information
Clinical Pearls
- Levalbuterol is the R-isomer of racemic albuterol. It was developed with the theoretical advantage of fewer side effects (e.g., less tachycardia, tremor) due to the removal of the S-isomer, which is thought to contribute to some adverse effects. However, clinical studies have shown mixed results regarding significant clinical superiority over racemic albuterol in terms of side effect profiles at equipotent bronchodilator doses.
- Ensure patients understand proper nebulizer technique for optimal drug delivery and efficacy.
- Levalbuterol is a rescue medication for acute bronchospasm and should not be used as a substitute for long-term controller medications (e.g., inhaled corticosteroids).
- Patients should be advised 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 a deterioration of their underlying respiratory condition.
Alternative Therapies
- Albuterol (racemic albuterol) inhalation solution
- Other short-acting beta-agonists (SABAs) like terbutaline (though less common for inhalation)
- Long-acting beta-agonists (LABAs) such as formoterol or salmeterol (for maintenance, not rescue)
- Anticholinergics (e.g., ipratropium bromide) for COPD or as an add-on for asthma
- Inhaled corticosteroids (for long-term control of asthma/COPD inflammation)
Cost & Coverage
Average Cost:
Varies, typically $50-$200 per 25x3ml box
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic formulations)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your 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 for clarification. 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.