Levalbuterol HFA Inh (200pf) 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?
Levalbuterol HFA is an inhaler used to quickly open up the airways in your lungs when you have breathing problems like wheezing, shortness of breath, or chest tightness due to asthma or COPD. It's a 'rescue' inhaler, meaning you use it only when you need it, not every day for 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, shake the inhaler well before use. Before using the inhaler for the first time or if it has not been used for 3 days, prepare it by spraying 4 test sprays into the air. After using your dose, replace the cap. A spacer can be used with the inhaler to make it easier to use; follow the cleaning instructions carefully. Some inhalers have a dose counter to track the number of doses remaining. If your inhaler has a dose counter, discard it when the counter reaches "0". Avoid getting the medication in your eyes. If you are using multiple inhaled medications, consult your doctor about which one to use first.
Storage and Disposal
Store your medication at room temperature, away from freezing temperatures. Protect it from light and store it with the mouthpiece facing down. Keep it away from heat or open flames. Do not puncture or burn the inhaler, even if it appears empty.
Missed Dose
If you use this medication regularly, take a missed dose as soon as you remember. However, 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 once 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, shake the inhaler well before use. Before using the inhaler for the first time or if it has not been used for 3 days, prepare it by spraying 4 test sprays into the air. After using your dose, replace the cap. A spacer can be used with the inhaler to make it easier to use; follow the cleaning instructions carefully. Some inhalers have a dose counter to track the number of doses remaining. If your inhaler has a dose counter, discard it when the counter reaches "0". Avoid getting the medication in your eyes. If you are using multiple inhaled medications, consult your doctor about which one to use first.
Storage and Disposal
Store your medication at room temperature, away from freezing temperatures. Protect it from light and store it with the mouthpiece facing down. Keep it away from heat or open flames. Do not puncture or burn the inhaler, even if it appears empty.
Missed Dose
If you use this medication regularly, take a missed dose as soon as you remember. However, 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 once 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.
- Understand and avoid your asthma/COPD triggers (e.g., allergens, smoke, cold air).
- Follow your asthma action plan or COPD management plan.
- Do not use this inhaler more often than prescribed, as it can lead to serious side effects.
- Proper inhaler technique is crucial for effectiveness; ask your healthcare provider or pharmacist to demonstrate.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
2 inhalations (90 mcg) every 4-6 hours as needed
Dose Range:
45 - 90 mg
Condition-Specific Dosing:
acute_bronchospasm:
2 inhalations (90 mcg) repeated every 20 minutes for up to 1 hour if needed.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established for HFA inhaler (Nebulizer solution may be used for infants >6 years).
Child:
6-11 years: 1 inhalation (45 mcg) every 4-6 hours as needed. May increase to 2 inhalations (90 mcg) if needed.
Adolescent:
âĨ12 years: 2 inhalations (90 mcg) every 4-6 hours as needed.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment typically required.
Moderate:
No specific adjustment typically required.
Severe:
No specific adjustment typically required. Use with caution and monitor for increased systemic effects due to potential for decreased clearance.
Dialysis:
No specific adjustment typically required. Use with caution.
Hepatic Impairment:
Mild:
No specific adjustment typically required.
Moderate:
No specific adjustment typically required.
Severe:
No specific adjustment typically required. Use with caution and monitor for increased systemic effects.
Confidence:
Medium
Pharmacology
Mechanism of Action
Levalbuterol is a selective beta-2 adrenergic agonist. It acts on beta-2 adrenergic receptors in the smooth muscle of the airways, leading to activation of adenyl cyclase and an increase in intracellular cyclic-3',5'-adenosine monophosphate (cAMP). Increased cAMP levels cause relaxation of bronchial smooth muscle, resulting in bronchodilation. Levalbuterol is the (R)-enantiomer of albuterol, which is responsible for the bronchodilatory activity.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 10-20% (systemic bioavailability after inhalation)
Tmax:
Approximately 0.5-1 hour (plasma concentration)
FoodEffect:
Not applicable for inhaled administration.
Distribution:
Vd:
Approximately 160 L
ProteinBinding:
Approximately 10%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 3.3-4 hours (terminal half-life)
Clearance:
Not readily quantifiable due to extensive metabolism and renal excretion.
ExcretionRoute:
Renal (primarily as metabolites, some unchanged drug)
Unchanged:
Approximately 69% of a dose is excreted in urine as unchanged drug and metabolites within 72 hours.
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
While rare, some people may experience severe and potentially life-threatening side effects when 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 irregular 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, although many people may not experience any or may only have mild symptoms. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
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.
While rare, some people may experience severe and potentially life-threatening side effects when 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 irregular 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, although many people may not experience any or may only have mild symptoms. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
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 after using the inhaler (paradoxical bronchospasm).
- Chest pain or fast/irregular heartbeat.
- Severe headache or dizziness.
- Increased tremor or nervousness.
- If you need to use your rescue inhaler more often than usual, or if it's not working as well, seek medical attention immediately as this may indicate worsening asthma/COPD.
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 to determine if the medications are similar.
If you are taking inhaled epinephrine, as this may interact with the medication.
Additionally, to ensure your safety, 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 to determine if the medications are similar.
If you are taking inhaled epinephrine, as this may interact with the medication.
Additionally, to ensure your safety, 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. Adhere strictly to the prescribed dosage and frequency, as taking more of this drug or using it more often than directed can be fatal. If you have any concerns or questions, consult your doctor immediately.
If you find that your usual dose is not providing adequate relief, your symptoms are worsening, or you need to use this medication more frequently than normal, contact your doctor right away. Additionally, if you have diabetes (high blood sugar), it is crucial to monitor your blood sugar levels closely while taking this medication.
Older adults (65 years and older) should exercise caution when using this drug, as they may be more susceptible to side effects. If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks of this medication with your doctor to ensure the best decision for you and your 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 frequently than normal, contact your doctor right away. Additionally, if you have diabetes (high blood sugar), it is crucial to monitor your blood sugar levels closely while taking this medication.
Older adults (65 years and older) should exercise caution when using this drug, as they may be more susceptible to side effects. If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks of this medication with your doctor to ensure the best decision for you and your 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 (fast heart rate)
- Palpitations
- Tremor
- Nervousness
- Headache
- Dizziness
- Nausea
- Vomiting
- Hypokalemia (low potassium levels)
- Hyperglycemia (high blood sugar)
- Metabolic acidosis
What to Do:
Seek immediate medical attention or call Poison Control (1-800-222-1222). Treatment is supportive and symptomatic. Beta-blockers may be considered in severe cases, but use with extreme caution due to risk of bronchospasm.
Drug Interactions
Contraindicated Interactions
- Non-cardioselective beta-blockers (e.g., propranolol, carvedilol): May block the bronchodilatory effect of levalbuterol and produce severe bronchospasm in asthmatic patients.
Major Interactions
- Diuretics (loop or thiazide): May potentiate 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, leading to severe cardiovascular effects. Use with extreme caution or avoid within 14 days of discontinuing MAOIs/TCAs.
- Other sympathomimetic agents (e.g., other bronchodilators, decongestants): May potentiate adverse cardiovascular effects.
Moderate Interactions
- Digoxin: Beta-agonists may decrease serum digoxin levels.
- QTc-prolonging drugs: Theoretical risk of additive QTc prolongation, though less common with inhaled SABAs.
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, especially for new diagnosis or significant change in condition.
Vital Signs (Heart Rate, Blood Pressure)
Rationale: To establish baseline and monitor for cardiovascular effects.
Timing: Prior to initiation.
Routine Monitoring
Asthma/COPD Symptoms (e.g., wheezing, shortness of breath, cough)
Frequency: Daily (patient self-monitoring)
Target: Improved symptom control, decreased frequency of rescue inhaler use.
Action Threshold: Increased frequency of use (e.g., >2 days/week for asthma, or increasing use in COPD) or worsening symptoms indicates need for medical re-evaluation.
Frequency of Levalbuterol Use
Frequency: Daily (patient self-monitoring)
Target: As needed, not for daily maintenance.
Action Threshold: Regular daily use or increasing use suggests inadequate control and need for re-evaluation of maintenance therapy.
Adverse Effects (e.g., tremor, palpitations, nervousness)
Frequency: As reported by patient
Target: Absence or minimal, tolerable side effects.
Action Threshold: Persistent or bothersome side effects warrant dose adjustment or alternative therapy consideration.
Serum Potassium (if high doses or concomitant diuretics)
Frequency: Periodically, as clinically indicated
Target: 3.5-5.0 mEq/L
Action Threshold: Hypokalemia (<3.5 mEq/L) requires intervention.
Symptom Monitoring
- Worsening shortness of breath
- Increased wheezing
- Chest tightness
- Increased cough
- Paradoxical bronchospasm (worsening wheezing immediately after use)
- Palpitations
- Tremor
- Nervousness
- Headache
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown some adverse effects, but human data are limited. Uncontrolled asthma poses a greater risk to both mother and fetus than the potential risks of levalbuterol.
Trimester-Specific Risks:
First Trimester:
Limited data, theoretical risk of teratogenicity, but generally considered low for inhaled SABAs.
Second Trimester:
Generally considered safer than in the first trimester, but still use only if clearly needed.
Third Trimester:
May inhibit uterine contractions (due to beta-2 agonist activity), but this is generally not clinically significant at therapeutic doses. Monitor for maternal tachycardia or hyperglycemia.
Lactation
It is not known whether levalbuterol is excreted in human milk. However, other beta-agonists are excreted in human milk. Due to the low systemic absorption of inhaled levalbuterol, exposure to the infant is expected to be low. Use with caution, weighing benefits to mother against potential risks to infant.
Infant Risk:
Low risk. Monitor infant for irritability, poor feeding, or tachycardia, though unlikely with typical inhaled doses.
Pediatric Use
Approved for children 6 years of age and older. Dosing differs for children aged 6-11 years compared to adolescents and adults. Proper inhaler technique is critical and should be taught to both the child and caregiver.
Geriatric Use
No specific dose adjustment is required. However, elderly patients may be more susceptible to the cardiovascular adverse effects of beta-agonists (e.g., tremor, palpitations, increased heart rate). Use with caution and monitor for adverse effects.
Clinical Information
Clinical Pearls
- Levalbuterol is a 'rescue' inhaler for acute symptoms, not a maintenance medication. Patients requiring frequent use (e.g., more than twice a week for asthma) should be re-evaluated for their maintenance therapy.
- Ensure patients understand and demonstrate correct inhaler technique to maximize drug delivery to the lungs.
- Educate patients on the difference between their rescue inhaler and their daily controller medications (if applicable).
- Paradoxical bronchospasm is a rare but serious adverse effect; instruct patients to discontinue use and seek immediate medical attention if it occurs.
- Patients with cardiovascular conditions (e.g., ischemic heart disease, hypertension, arrhythmias) should use levalbuterol with caution due to potential for cardiovascular stimulation.
Alternative Therapies
- Albuterol (e.g., Ventolin HFA, ProAir HFA, Proventil HFA): Another short-acting beta-agonist (SABA).
- Other SABAs (e.g., pirbuterol - no longer widely available in US).
Cost & Coverage
Average Cost:
Varies widely, typically $50-$150 per 15gm inhaler (200 actuations)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (for generic), Tier 3 or Tier 4 (for brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. 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.