Levalbuterol Conc 1.25mg/0.5ml 30vl
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
Not available
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 in people with asthma or other lung conditions. It works quickly to relieve symptoms like wheezing, shortness of breath, and chest tightness.
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, or contains particles. Also, do not use the solution if it 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 any other medications in the nebulizer with this drug.
Avoid getting the solution in your eyes.
If you are 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.
Store unused containers in their foil pouches until you are 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 are 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 is close to the 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, or contains particles. Also, do not use the solution if it 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 any other medications in the nebulizer with this drug.
Avoid getting the solution in your eyes.
If you are 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.
Store unused containers in their foil pouches until you are 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 are 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 is close to the 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 your nebulizer correctly as instructed by your healthcare provider.
- Do not use more often than prescribed, as this can lead to serious side effects.
- Keep track of how often you use your rescue inhaler; if you need it more frequently, contact your doctor.
- Avoid known triggers for your asthma or lung condition (e.g., allergens, smoke, cold air).
- Do not stop using other prescribed asthma medications unless advised by your doctor.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
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 administered three times a day, every 6 to 8 hours, by nebulization. May increase to 1.25 mg if needed and tolerated.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (safety and efficacy not established in 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. May increase to 0.63 mg if needed and tolerated.
Adolescent:
12 years and older: Same as adult dosing (1.25 mg three times a day, every 6 to 8 hours, by nebulization).
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended.
Dialysis:
No specific dose adjustment recommended; however, use with caution and monitor for adverse effects due to potential for increased systemic exposure.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended.
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 and an increase in intracellular cyclic-3',5'-adenosine monophosphate (cAMP). The increase in cAMP levels leads to relaxation of bronchial smooth muscle, inhibition of mediator release from mast cells, and some inhibition of microvascular leakage, thereby causing bronchodilation.
Pharmacokinetics
Absorption:
Bioavailability:
Not precisely quantified for inhaled dose, but systemic absorption occurs.
Tmax:
Approximately 6 minutes (for inhalation solution).
FoodEffect:
Not applicable for inhaled administration.
Distribution:
Vd:
Not precisely quantified for inhaled dose.
ProteinBinding:
Approximately 40-50%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 3.3 to 4 hours (terminal half-life).
Clearance:
Not precisely quantified.
ExcretionRoute:
Primarily renal (urine), with a small amount excreted in feces.
Unchanged:
Approximately 69% of a single oral dose is excreted in urine 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 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. 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. 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 of breathing problems after using the medication (paradoxical bronchospasm).
- Chest pain or discomfort.
- Fast or irregular heartbeat (palpitations).
- Severe dizziness or lightheadedness.
- Tremor or nervousness that is severe or persistent.
- 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, any of 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 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 complete 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 confirm it is safe to do so.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of 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 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 complete 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 confirm it is safe to do so.
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. Overdosing on this drug can be fatal, 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. For individuals with diabetes (high blood sugar), it is necessary to monitor your blood sugar levels closely 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 the mother and the baby.
For children under 6 years of age, consult with your doctor before administering this medication, as its safety and efficacy 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 necessary to monitor your blood sugar levels closely 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 the mother and the baby.
For children under 6 years of age, consult with your doctor before administering this medication, as its safety and efficacy have not been established in this age group.
Overdose Information
Overdose Symptoms:
- Tachycardia (fast heart rate)
- Palpitations
- Tremor
- Nervousness
- Headache
- Nausea
- Dizziness
- Hypokalemia (low potassium)
- Hyperglycemia (high blood sugar)
- Metabolic acidosis
What to Do:
Seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). Treatment is supportive and symptomatic. A cardioselective beta-blocker may be considered, but only with extreme caution due to the risk of inducing bronchospasm.
Drug Interactions
Major Interactions
- Beta-blockers (especially non-selective): May block the bronchodilatory effect of levalbuterol and produce severe bronchospasm in asthmatic patients. Generally, beta-blockers and beta-agonists should not be co-administered.
Moderate Interactions
- Diuretics (loop or thiazide): May exacerbate ECG changes and/or hypokalemia associated with beta-agonists, especially at high doses.
- Monoamine Oxidase Inhibitors (MAOIs) and Tricyclic Antidepressants (TCAs): May potentiate the vascular effects of levalbuterol, increasing the risk of cardiovascular adverse effects. Use with extreme caution or consider alternative therapy.
- Other sympathomimetics: Concomitant use may potentiate cardiovascular adverse effects. Use with caution.
Monitoring
Baseline Monitoring
Pulmonary function tests (e.g., FEV1, peak flow)
Rationale: To establish baseline lung function and assess severity of asthma/COPD.
Timing: Prior to initiation of therapy.
Heart rate and blood pressure
Rationale: Levalbuterol can cause cardiovascular effects.
Timing: Prior to initiation of therapy.
Routine Monitoring
Asthma/COPD symptoms (e.g., shortness of breath, wheezing, cough)
Frequency: Daily, or as needed with each dose.
Target: Improved symptom control, reduced need for rescue inhaler.
Action Threshold: Worsening symptoms, increased frequency of use, or lack of response to usual dose indicates need for medical re-evaluation.
Heart rate and blood pressure
Frequency: Periodically, especially during initial therapy or dose adjustments.
Target: Within normal limits or patient's baseline.
Action Threshold: Significant tachycardia, palpitations, or hypertension.
Serum potassium (if clinically indicated)
Frequency: Periodically, especially in patients receiving high doses, concomitant diuretics, or with underlying cardiovascular disease.
Target: 3.5-5.0 mEq/L.
Action Threshold: Hypokalemia (<3.5 mEq/L).
Symptom Monitoring
- Worsening shortness of breath
- Increased wheezing
- Chest tightness
- Increased cough
- Decreased peak flow readings
- Increased need for rescue inhaler (more than usual or more than 2 days a week)
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies of levalbuterol in pregnant women. Beta-agonists can interfere with uterine contractility.
Trimester-Specific Risks:
First Trimester:
Limited data, theoretical risk of teratogenicity with high systemic exposure, but inhaled route minimizes this.
Second Trimester:
Generally considered safer than first trimester, but monitor for maternal cardiovascular effects.
Third Trimester:
May inhibit labor; monitor for neonatal hypoglycemia and tachycardia if used close to delivery.
Lactation
Caution should be exercised when levalbuterol is administered to a nursing woman. It is not known whether levalbuterol is excreted in human milk. However, other beta-agonists are excreted in human milk.
Infant Risk:
Low risk of adverse effects to the infant due to low systemic absorption and likely low excretion into breast milk. Monitor infant for irritability, poor feeding, or tachycardia.
Pediatric Use
Safety and efficacy have not been established in pediatric patients younger than 6 years of age. Dosing for children 6-11 years is lower than adults. Close monitoring for adverse effects is important.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Use with caution in elderly patients with cardiovascular disease or other comorbidities.
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 adverse effects. This may lead to fewer side effects (e.g., tachycardia, tremor) in some patients compared to racemic albuterol, though clinical significance is debated.
- Ensure patients are properly trained on nebulizer technique for optimal drug delivery.
- Advise patients that this is a 'rescue' medication for acute symptoms and should not replace maintenance therapy.
- Paradoxical bronchospasm can occur; if it happens, discontinue levalbuterol immediately and institute alternative therapy.
Alternative Therapies
- Albuterol (racemic albuterol) inhalation solution
- Other short-acting beta-agonists (SABAs) like pirbuterol (less common)
- Long-acting beta-agonists (LABAs) for maintenance therapy (e.g., salmeterol, formoterol) - not for acute relief
- Inhaled corticosteroids (ICS) for maintenance therapy
- Systemic corticosteroids for severe exacerbations
Cost & Coverage
Average Cost:
$50 - $150 per 30 vials (1.25mg/0.5ml)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (for generic), Tier 3 or higher (for brand)
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.