Xopenex HFA Oral Inh (200 Pfs) 15gm
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 2005
DEA Schedule
Not Controlled
Overview
What is this medicine?
Xopenex HFA is a 'rescue' inhaler that helps open up your airways quickly when you have trouble breathing due to asthma or COPD. It works by relaxing the muscles around your airways, making it easier to breathe. It's used for quick relief of symptoms, not for daily prevention.
How to Use This Medicine
Proper Use of Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. For inhalation into the lungs, make sure to:
Shake the inhaler well before each use.
Prepare the inhaler before first use or if it has not been used for 3 days by spraying 4 test sprays into the air.
Replace the cap after each use.
Consider using a spacer with the inhaler for easier use, and follow the cleaning instructions carefully.
If your inhaler has a dose counter, discard the inhaler when the counter reaches "0".
Important Safety Precautions
Avoid getting the medication in your eyes.
If you are using multiple inhaled medications, ask your doctor which one to use first.
Storage and Disposal
Store the medication at room temperature, away from light and heat sources.
Keep the mouthpiece down and protect the inhaler from open flames.
Do not puncture or burn the inhaler, even if it seems empty.
Do not freeze the medication.
Missed Dose Instructions
If you use this medication regularly, take a missed dose as soon as you remember.
If it is 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 use extra doses.
* If you use this medication as needed, do not use it more frequently than directed by your doctor.
To use this medication correctly, follow your doctor's instructions and read all the information provided. For inhalation into the lungs, make sure to:
Shake the inhaler well before each use.
Prepare the inhaler before first use or if it has not been used for 3 days by spraying 4 test sprays into the air.
Replace the cap after each use.
Consider using a spacer with the inhaler for easier use, and follow the cleaning instructions carefully.
If your inhaler has a dose counter, discard the inhaler when the counter reaches "0".
Important Safety Precautions
Avoid getting the medication in your eyes.
If you are using multiple inhaled medications, ask your doctor which one to use first.
Storage and Disposal
Store the medication at room temperature, away from light and heat sources.
Keep the mouthpiece down and protect the inhaler from open flames.
Do not puncture or burn the inhaler, even if it seems empty.
Do not freeze the medication.
Missed Dose Instructions
If you use this medication regularly, take a missed dose as soon as you remember.
If it is 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 use extra doses.
* If you use this medication as needed, do not use it more frequently than directed by your doctor.
Lifestyle & Tips
- Always carry your rescue inhaler with you.
- Use proper inhaler technique as demonstrated by your healthcare provider.
- Do not use more often than prescribed. If you need to use it more frequently, contact your doctor as this may indicate worsening asthma/COPD.
- Avoid your known asthma/COPD triggers (e.g., smoke, allergens, cold air).
- Rinse your mouth with water after each use to prevent dry mouth and throat irritation, although this is less critical than with inhaled corticosteroids.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
2 inhalations (90 mcg levalbuterol base) every 4-6 hours as needed
Dose Range:
45 - 90 mg
Condition-Specific Dosing:
mildSymptoms:
1 inhalation (45 mcg levalbuterol base) every 4-6 hours as needed
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
4 years and older: 2 inhalations (90 mcg levalbuterol base) every 4-6 hours as needed
Adolescent:
2 inhalations (90 mcg levalbuterol base) every 4-6 hours as needed
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:
Consider monitoring for adverse effects due to potential accumulation
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 beta2-adrenergic agonist. It stimulates beta2-adrenergic receptors in the lungs, leading to relaxation of bronchial smooth muscle and bronchodilation. This action is mediated by cyclic AMP, which causes relaxation of bronchial smooth muscle and inhibition of mediator release from mast cells.
Pharmacokinetics
Absorption:
Bioavailability:
Low systemic bioavailability due to first-pass metabolism and pulmonary deposition (approximately 10-20% of inhaled dose reaches systemic circulation)
Tmax:
0.5-1 hour (plasma)
FoodEffect:
Not applicable for inhaled administration
Distribution:
Vd:
Not well-defined for inhaled administration
ProteinBinding:
Approximately 25%
CnssPenetration:
Limited
Elimination:
HalfLife:
3.3-4 hours
Clearance:
Not precisely quantified for inhaled dose
ExcretionRoute:
Primarily renal (80% within 24 hours, mainly as inactive sulfate conjugate)
Unchanged:
Approximately 10% (renal)
Pharmacodynamics
OnsetOfAction:
10-17 minutes
PeakEffect:
1-1.5 hours
DurationOfAction:
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 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
+ Dizziness
+ Passing out
+ Changes in eyesight
Signs of low potassium levels, such as:
+ Muscle pain or weakness
+ Muscle cramps
+ 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 after the first use of a new canister or vial of this medication, or right after a dose. 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. Many people may not experience any side effects or only have minor ones. If you notice any of the following side effects, or if they bother you or 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, 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 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
+ Dizziness
+ Passing out
+ Changes in eyesight
Signs of low potassium levels, such as:
+ Muscle pain or weakness
+ Muscle cramps
+ 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 after the first use of a new canister or vial of this medication, or right after a dose. 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. Many people may not experience any side effects or only have minor ones. If you notice any of the following side effects, or if they bother you or 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 inhaler
- Chest pain or rapid/pounding heartbeat (palpitations)
- Severe headache
- Dizziness or lightheadedness
- Muscle cramps or weakness (signs of low potassium)
- Nervousness or tremor that is 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 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.
To ensure your safety, it is crucial to 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 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.
To ensure your safety, it is crucial to 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 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, as taking more of this medication or using it more frequently than directed can be fatal. If you have any concerns or questions, consult 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, it is vital to closely monitor your blood sugar levels while taking this medication.
If you are 65 years 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 mother and baby.
For children under 4 years of age, consult with your doctor before administering this medication, as its safety and effectiveness 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, it is vital to closely monitor your blood sugar levels while taking this medication.
If you are 65 years 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 mother and baby.
For children under 4 years of age, consult with your doctor before administering this medication, as its safety and effectiveness 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
- Chest pain
What to Do:
Seek immediate medical attention or call 911. For advice, call a poison control center at 1-800-222-1222. Treatment is generally supportive and symptomatic. Beta-blockers may be considered in severe cases, but with extreme caution due to risk of bronchospasm.
Drug Interactions
Major Interactions
- Beta-blockers (non-selective, e.g., propranolol): May block the bronchodilatory effect of levalbuterol and produce severe bronchospasm in asthmatic patients. Use is generally contraindicated.
- Monoamine Oxidase Inhibitors (MAOIs) and Tricyclic Antidepressants (TCAs): May potentiate the cardiovascular effects of levalbuterol. Use with extreme caution or avoid within 14 days of discontinuing MAOIs/TCAs.
Moderate Interactions
- Diuretics (e.g., loop or thiazide diuretics): May potentiate ECG changes and/or hypokalemia associated with beta-agonists, especially at higher doses.
- Digoxin: Levalbuterol may decrease serum digoxin levels. Monitor digoxin levels.
- Other sympathomimetic agents: Additive cardiovascular effects; use with caution.
Confidence Interactions
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 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.
Serum Potassium
Rationale: To establish baseline, especially if patient has pre-existing hypokalemia or is on concomitant diuretics.
Timing: Prior to initiation of therapy if indicated.
Routine Monitoring
Frequency of Inhaler Use
Frequency: Daily
Target: As needed, but not exceeding recommended maximum (e.g., 12 inhalations/day)
Action Threshold: Increased frequency of use (e.g., >2 days/week for symptom control, or >2 times/week for nocturnal symptoms) indicates worsening asthma control and need for re-evaluation of maintenance therapy.
Symptom Control (e.g., shortness of breath, wheezing, cough)
Frequency: Daily
Target: Minimal to no symptoms
Action Threshold: Worsening or persistent symptoms despite regular use.
Peak Expiratory Flow (PEF) Readings (if patient uses a peak flow meter)
Frequency: Daily
Target: Patient's personal best or green zone
Action Threshold: Decreased PEF readings (e.g., yellow or red zone) indicating worsening airway obstruction.
Cardiovascular Status (e.g., heart rate, blood pressure, palpitations)
Frequency: Periodically, or if symptoms occur
Target: Within normal limits for the patient
Action Threshold: Significant tachycardia, palpitations, or hypertension.
Serum Potassium
Frequency: Periodically, if patient is at risk for hypokalemia (e.g., high doses, concomitant diuretics)
Target: 3.5-5.0 mEq/L
Action Threshold: Hypokalemia (<3.5 mEq/L).
Symptom Monitoring
- Worsening shortness of breath
- Increased wheezing or coughing
- Chest tightness
- Increased need for rescue inhaler
- Palpitations or rapid heart beat
- Tremor
- Nervousness
- Dizziness
- Chest pain
Special Patient Groups
Pregnancy
Levalbuterol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown some adverse effects at high doses. Monitor for maternal tachycardia and hyperglycemia.
Trimester-Specific Risks:
First Trimester:
Limited human data; animal studies suggest potential for developmental toxicity at high doses.
Second Trimester:
No specific increased risks identified beyond general beta-agonist effects.
Third Trimester:
May inhibit uterine contractions and increase risk of maternal tachycardia and hyperglycemia. Monitor neonate for hypoglycemia and hypokalemia.
Lactation
It is unknown whether levalbuterol is excreted in human milk. Use with caution in nursing mothers. Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for levalbuterol and any potential adverse effects on the breastfed infant.
Infant Risk:
Risk is generally considered low due to low systemic absorption and short half-life, but monitor infant for irritability, poor feeding, or changes in heart rate.
Pediatric Use
Approved for children 4 years of age and older. Safety and efficacy in children younger than 4 years have not been established for the HFA inhaler. Proper inhaler technique is crucial and should be taught to both child and caregiver.
Geriatric Use
No specific dose adjustment is required. However, elderly patients may be more susceptible to the cardiovascular effects of beta-agonists (e.g., tachycardia, palpitations, hypertension). Monitor closely for adverse effects.
Clinical Information
Clinical Pearls
- Xopenex HFA is a rescue inhaler for acute symptoms, not a maintenance medication. Over-reliance or increased use indicates worsening disease control and necessitates re-evaluation of the patient's treatment plan.
- Proper inhaler technique is paramount for effective drug delivery. Patients should be regularly instructed and re-evaluated on their technique.
- Patients should be advised to seek immediate medical attention if their symptoms worsen or if they experience severe side effects after using the inhaler.
- Unlike some other beta-agonists, levalbuterol is the R-isomer of albuterol, which is thought to be responsible for the bronchodilatory activity and potentially fewer side effects compared to racemic albuterol, though clinical significance is debated.
- The canister should be primed before first use and if not used for a certain period (e.g., 3 days or more), as per package insert instructions.
Alternative Therapies
- Albuterol (e.g., Ventolin HFA, ProAir HFA, Proventil HFA) - another short-acting beta-agonist (SABA)
- Long-acting beta-agonists (LABAs) - for maintenance therapy (e.g., salmeterol, formoterol)
- Inhaled Corticosteroids (ICS) - for maintenance therapy (e.g., fluticasone, budesonide)
- Combination ICS/LABA inhalers - for maintenance therapy (e.g., Advair, Symbicort)
- Leukotriene receptor antagonists (e.g., montelukast)
- Systemic corticosteroids (for acute exacerbations)
Cost & Coverage
Average Cost:
Varies widely, typically $100-$300+ per 15gm inhaler (200 puffs)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (generic may be Tier 1)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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.