Xopenex 1.25mg/3ml Neb 24x3ml
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 bronchodilator medication that helps relax the muscles in your airways, making it easier to breathe. It's used to treat or prevent breathing problems like wheezing, shortness of breath, and chest tightness in people with asthma or chronic obstructive pulmonary disease (COPD). It's 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 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
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 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
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 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
- Always use your nebulizer exactly as prescribed by your doctor and follow proper technique.
- Do not use more often than prescribed, even if you feel your breathing is worsening. Contact your doctor if your symptoms get worse or if you need to use your rescue inhaler more frequently.
- Avoid known triggers for your asthma or COPD (e.g., allergens, smoke, air pollution).
- Maintain good hydration.
- Do not stop other prescribed medications unless advised by your doctor.
- Regularly clean your nebulizer equipment as instructed.
Available Forms & Alternatives
Available Strengths:
Generic 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:
initial_dose:
For some patients, 0.31 mg three times a day may be sufficient.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (safety and efficacy not established in children under 6 years of age).
Child:
Children 6-11 years: 0.31 mg or 0.63 mg three times a day, every 6 to 8 hours, by nebulization. Children âĨ12 years: Same as adult dosing (0.63 mg or 1.25 mg three times a day).
Adolescent:
0.63 mg or 1.25 mg administered three times a day, every 6 to 8 hours, by nebulization.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
No specific adjustment recommended, but caution advised due to potential for increased systemic exposure.
Dialysis:
No specific adjustment recommended.
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
No specific adjustment recommended.
Pharmacology
Mechanism of Action
Levalbuterol is a selective beta2-adrenergic agonist. It stimulates beta2-adrenergic receptors in the lungs, leading to relaxation of bronchial smooth muscle and bronchodilation. It is the (R)-enantiomer of racemic albuterol, which is responsible for the bronchodilatory activity.
Pharmacokinetics
Absorption:
Bioavailability:
Not explicitly quantified for inhaled solution, but rapidly absorbed.
Tmax:
Approximately 0.2 hours (12 minutes) after nebulization.
FoodEffect:
Not applicable for inhaled solution.
Distribution:
Vd:
Not explicitly stated for levalbuterol, but generally distributes widely.
ProteinBinding:
Approximately 10% to 25%.
CnssPenetration:
Limited, but can cause CNS effects at high systemic concentrations.
Elimination:
HalfLife:
Approximately 3.3 to 4 hours.
Clearance:
Primarily renal clearance.
ExcretionRoute:
Primarily renal (urine).
Unchanged:
Approximately 69% of a dose is excreted in urine as unchanged drug within 72 hours.
Pharmacodynamics
OnsetOfAction:
Within 5-10 minutes.
PeakEffect:
Approximately 1.5 hours.
DurationOfAction:
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 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 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 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, 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 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 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 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
- Chest pain or discomfort
- Fast, pounding, or irregular heartbeat (palpitations)
- Severe headache
- Dizziness or lightheadedness
- Muscle cramps or unusual weakness
- Nervousness or tremor that is severe or bothersome
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 drug, any of its components, or other medications, foods, or substances. 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
It is crucial to verify that it is safe to take this medication with all of your existing 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 drug, any of its components, or other medications, foods, or substances. 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
It is crucial to verify that it is safe to take this medication with all of your existing medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is crucial that you inform all of 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. Overdosing on this drug can be fatal, so it is important 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 essential to closely monitor your blood sugar levels 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. Your doctor will discuss the potential benefits and risks of this medication to both you and your baby. For children under the age of 6, consult with your doctor, as the safety and effectiveness of this medication have not been established in this age group.
If you have diabetes (high blood sugar), it is essential to closely monitor your blood sugar levels 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. Your doctor will discuss the potential benefits and risks of this medication to both you and your baby. For children under the age of 6, consult with your doctor, as the safety and effectiveness of this medication have not been established in this age group.
Overdose Information
Overdose Symptoms:
- Tachycardia (fast heart rate)
- Palpitations
- Tremor
- Headache
- Nervousness
- 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.
Drug Interactions
Major Interactions
- Beta-blockers (non-selective, e.g., propranolol)
- Monoamine Oxidase Inhibitors (MAOIs)
- Tricyclic Antidepressants (TCAs)
Moderate Interactions
- Diuretics (potassium-depleting, e.g., loop or thiazide diuretics)
- Digoxin
- Other sympathomimetics
Monitoring
Baseline Monitoring
Baseline pulmonary function tests (e.g., FEV1, FVC)
Rationale: To assess severity of asthma/COPD and establish a baseline for evaluating treatment efficacy.
Timing: Prior to initiation of therapy.
Routine Monitoring
Symptom control (frequency of rescue inhaler use, nocturnal symptoms, activity limitation)
Frequency: Daily/weekly, as part of patient self-monitoring.
Target: Minimal to no symptoms, minimal rescue inhaler use (e.g., <2 days/week).
Action Threshold: Increased symptoms, increased need for rescue inhaler, decreased peak flow readings, or worsening of condition.
Serum potassium (if patient is at risk for hypokalemia or on potassium-depleting diuretics)
Frequency: Periodically, as clinically indicated.
Target: 3.5-5.0 mEq/L.
Action Threshold: <3.5 mEq/L.
Heart rate and blood pressure
Frequency: Periodically, as clinically indicated, especially in patients with cardiovascular disease.
Target: Within normal limits for the patient.
Action Threshold: Significant tachycardia, palpitations, or hypertension.
Symptom Monitoring
- Worsening shortness of breath
- Increased wheezing
- Chest tightness
- Increased need for rescue inhaler
- Palpitations
- Tremor
- Nervousness
- Dizziness
- Chest pain
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Beta-agonists may inhibit uterine contractions and delay labor. Monitor for potential fetal tachycardia or neonatal hypoglycemia.
Trimester-Specific Risks:
First Trimester:
Limited human data; animal studies have shown some developmental toxicity at high doses. Risk not well-established.
Second Trimester:
Limited human data; generally considered safer than first trimester, but still caution advised.
Third Trimester:
May inhibit uterine contractions and delay labor. Potential for fetal tachycardia and neonatal hypoglycemia. Use with caution near term.
Lactation
L3 - Moderately safe. Levalbuterol is excreted into breast milk. Use with caution. Monitor breastfed infant for potential adverse effects such as irritability, tremor, or changes in feeding patterns.
Infant Risk:
Low to moderate. Systemic absorption by the infant is likely to be low.
Pediatric Use
Approved for children 6 years and older. Dosing is weight-based or age-based for children 6-11 years, and adult dosing for children âĨ12 years. Safety and efficacy have not been established in children younger than 6 years of age.
Geriatric Use
No specific dose adjustment is generally needed. However, use with caution in elderly patients due to the increased likelihood of co-morbidities (e.g., cardiovascular disease) and concomitant drug therapy. Monitor for cardiovascular effects and hypokalemia.
Clinical Information
Clinical Pearls
- Levalbuterol is the R-enantiomer of albuterol, which is responsible for the bronchodilatory activity. It may be associated with fewer side effects (e.g., tremor, tachycardia) compared to racemic albuterol in some patients, though clinical significance is debated.
- Proper nebulizer technique is critical for effective drug delivery and patient response. Patients should be educated on how to use and clean their nebulizer.
- 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, if they need to use the rescue inhaler more frequently than usual, or if the usual dose does not provide relief.
- Paradoxical bronchospasm can occur with any inhaled bronchodilator, including levalbuterol. If this occurs, discontinue immediately and institute alternative therapy.
Alternative Therapies
- Short-acting beta-agonists (SABAs): Albuterol (e.g., ProAir, Ventolin, Proventil)
- Long-acting beta-agonists (LABAs): Salmeterol, formoterol, arformoterol, indacaterol, olodaterol (for maintenance therapy)
- Short-acting muscarinic antagonists (SAMAs): Ipratropium (e.g., Atrovent)
- Long-acting muscarinic antagonists (LAMAs): Tiotropium, aclidinium, glycopyrronium, umeclidinium (for maintenance therapy)
- Combination SABA/SAMA: Ipratropium/albuterol (e.g., Duoneb, Combivent Respimat)
- Inhaled corticosteroids (ICS): Budesonide, fluticasone, mometasone (for maintenance therapy in asthma)
- Combination LABA/ICS: Budesonide/formoterol, fluticasone/salmeterol, fluticasone/vilanterol (for maintenance therapy)
Cost & Coverage
Average Cost:
$100 - $300+ per 24 x 3ml vials (1.25mg/3ml)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (often preferred generic on many formularies).
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.