Xopenex 0.63mg/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
Mar 2000
DEA Schedule
Not Controlled
Overview
What is this medicine?
Xopenex 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 asthma or other breathing problems. It works quickly to relieve symptoms like wheezing and shortness of breath.
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. Unused containers should be kept in their original foil pouch until use. After opening the 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 use this medication regularly, take the missed dose 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 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. 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. Unused containers should be kept in their original foil pouch until use. After opening the 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 use this medication regularly, take the missed dose 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 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 medication vials.
- Keep track of how often you use your rescue inhaler. If you need to use it more frequently, contact your doctor as this may indicate worsening asthma control.
- Avoid known triggers for your asthma or COPD (e.g., smoke, allergens, cold air).
- Do not use Xopenex for long-term control of your breathing problems; it is a 'rescue' medication for quick relief.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
0.63 mg administered 3 times a day, every 6 to 8 hours, by nebulization. Some patients may benefit from a 1.25 mg dose.
Dose Range:
0.63 - 1.25 mg
Condition-Specific Dosing:
acute_bronchospasm:
0.63 mg or 1.25 mg 3 times a day, every 6 to 8 hours.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For children 6-11 years: 0.31 mg administered 3 times a day, every 6 to 8 hours, by nebulization. May increase to 0.63 mg 3 times a day if needed.
Adolescent:
For adolescents 12 years and older: Same as adult dosing (0.63 mg or 1.25 mg 3 times a day).
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended, use with caution.
Moderate:
No specific adjustment recommended, use with caution.
Severe:
No specific adjustment recommended, use with caution.
Dialysis:
Considerations: Levalbuterol is primarily eliminated renally. Monitor for increased systemic effects.
Hepatic Impairment:
Mild:
No specific adjustment recommended, use with caution.
Moderate:
No specific adjustment recommended, use with caution.
Severe:
No specific adjustment recommended, use with caution.
Pharmacology
Mechanism of Action
Levalbuterol is a selective beta-2 adrenergic agonist. It stimulates beta-2 adrenergic receptors in the smooth muscle of the bronchi, leading to activation of adenyl cyclase, which increases intracellular cyclic-3',5'-adenosine monophosphate (cAMP). Increased cAMP levels cause relaxation of bronchial smooth muscle, inhibition of mediator release from mast cells, and some inhibition of edema.
Pharmacokinetics
Absorption:
Bioavailability:
Not precisely quantified (local action), but rapid systemic absorption occurs.
Tmax:
0.5 to 1 hour (for bronchodilation effect, plasma Tmax is around 0.2 hours)
FoodEffect:
Not applicable for inhaled solution.
Distribution:
Vd:
Not well-defined for inhaled drug, but distributes widely.
ProteinBinding:
Approximately 25%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 3.3 to 4 hours (terminal half-life)
Clearance:
Not precisely quantified for inhaled route.
ExcretionRoute:
Primarily renal (approximately 80% as metabolites, 20% as unchanged drug).
Unchanged:
Approximately 20%
Pharmacodynamics
OnsetOfAction:
Within 10-17 minutes
PeakEffect:
Approximately 1.5 hours
DurationOfAction:
5 to 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 or irregular heartbeat (palpitations)
- Severe tremor or nervousness
- Dizziness or lightheadedness
- Signs of an allergic reaction (rash, hives, swelling of face/lips/tongue, difficulty breathing/swallowing)
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 taking a similar medication. If you are unsure, consult your doctor or pharmacist for clarification.
If you are using inhaled epinephrine.
To ensure your safety, it is crucial to disclose all of your medications, including:
Prescription and over-the-counter (OTC) drugs
Natural products
Vitamins
Additionally, inform your doctor about any existing health problems. This information will help your doctor determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions.
Remember, do not start, stop, or change 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 taking a similar medication. If you are unsure, consult your doctor or pharmacist for clarification.
If you are using inhaled epinephrine.
To ensure your safety, it is crucial to disclose all of your medications, including:
Prescription and over-the-counter (OTC) drugs
Natural products
Vitamins
Additionally, inform your doctor about any existing health problems. This information will help your doctor determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions.
Remember, do not start, stop, or change 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 need to 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 efficacy 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 need to 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 efficacy of this medication have not been established in this age group.
Overdose Information
Overdose Symptoms:
- Exaggeration of common side effects: tachycardia (rapid heart rate), palpitations, tremor, nervousness, headache, dizziness, nausea, muscle cramps.
- More severe symptoms: hypokalemia (low potassium), hyperglycemia (high blood sugar), metabolic acidosis, cardiac arrest.
What to Do:
Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is supportive and symptomatic. Consider a cardioselective beta-blocker if severe cardiac symptoms are present, but use with extreme caution in patients with a history of bronchospasm.
Drug Interactions
Major Interactions
- Beta-blockers (non-selective): May block the bronchodilator effect of levalbuterol and produce severe bronchospasm in asthmatic patients.
- Monoamine Oxidase Inhibitors (MAOIs) and Tricyclic Antidepressants (TCAs): May potentiate the cardiovascular effects of levalbuterol.
Moderate Interactions
- Diuretics (e.g., loop or thiazide diuretics): May exacerbate ECG changes and/or hypokalemia associated with beta-agonists.
- Digoxin: Beta-agonists may decrease serum digoxin levels.
- Other sympathomimetic agents: Additive cardiovascular effects.
Confidence Interactions
Monitoring
Baseline Monitoring
Pulmonary Function Tests (e.g., FEV1)
Rationale: To assess baseline airway obstruction and response to therapy.
Timing: Prior to initiation of therapy and periodically as clinically indicated.
Heart Rate and Blood Pressure
Rationale: To establish baseline cardiovascular status, as beta-agonists can cause cardiovascular effects.
Timing: Prior to initiation of therapy.
Routine Monitoring
Pulmonary Function (e.g., peak flow, FEV1)
Frequency: As clinically indicated, especially during exacerbations or changes in symptoms.
Target: Improvement in baseline values.
Action Threshold: Lack of improvement or worsening indicates need for re-evaluation of therapy.
Heart Rate and Blood Pressure
Frequency: Periodically, especially in patients with pre-existing cardiovascular conditions.
Target: Within patient's normal range.
Action Threshold: Significant tachycardia, palpitations, or hypertension warrant re-evaluation.
Serum Potassium
Frequency: Consider in patients receiving concomitant diuretics or high doses of levalbuterol.
Target: 3.5-5.0 mEq/L
Action Threshold: Hypokalemia (e.g., <3.5 mEq/L) may require potassium supplementation or dose adjustment.
Symptom Monitoring
- Worsening shortness of breath
- Increased wheezing
- Chest tightness
- Increased cough
- Need for more frequent use of rescue inhaler
- Palpitations
- Tremor
- Nervousness
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.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though human data are limited.
Second Trimester:
Potential for adverse effects on fetal heart rate and uterine contractions.
Third Trimester:
May inhibit labor due to beta-2 agonist effects on uterine smooth muscle. Transient hyperglycemia and hypokalemia in the mother and/or fetus are possible.
Lactation
It is not known whether levalbuterol is excreted in human milk. Caution should be exercised when levalbuterol is administered to a nursing mother.
Infant Risk:
Risk is generally considered low for inhaled beta-agonists due to low systemic absorption, but potential for infant exposure and effects (e.g., irritability, tremor) cannot be ruled out. Monitor breastfed infant for adverse effects.
Pediatric Use
Approved for children 6 years of age and older. Safety and effectiveness in children younger than 6 years have not been established. Dosing is weight-based for younger children (6-11 years).
Geriatric Use
No specific dose adjustment is required based on age. However, elderly patients may be more sensitive to the cardiovascular effects of sympathomimetic amines. Monitor for adverse effects such as tremor, nervousness, and cardiovascular changes.
Clinical Information
Clinical Pearls
- Levalbuterol is the R-isomer of albuterol, which is thought to be the pharmacologically active component, potentially leading to fewer side effects (e.g., tremor, tachycardia) compared to racemic albuterol, though clinical significance is debated.
- It is a rescue bronchodilator and should not be used as a substitute for long-term asthma control medications (e.g., inhaled corticosteroids).
- Proper nebulizer technique is crucial for effective drug delivery. Patients should be instructed on how to use, clean, and maintain their nebulizer.
- Patients should be advised to seek medical attention if their symptoms worsen or if they need to use the medication more frequently than prescribed, as this may indicate inadequate asthma control.
Alternative Therapies
- Albuterol (racemic albuterol) inhalation solution or HFA inhaler
- Metaproterenol (another SABA, less commonly used)
- Ipratropium bromide (anticholinergic bronchodilator, often used in combination with SABAs for severe exacerbations)
- Long-acting beta-agonists (LABAs) such as salmeterol or formoterol (for maintenance therapy, not acute relief)
- Inhaled corticosteroids (ICS) for long-term asthma control
Cost & Coverage
Average Cost:
Variable, typically $100-$300 per 24 x 3ml vials (0.63mg/3ml)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (preferred or non-preferred brand/generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective 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. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.