Loading...
Loading...
Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brand Name
Xopenex Hfa
Generic Name
Levalbuterol Tartrate
Active Ingredient
LevalbuterolCategory
beta2-Adrenergic Agonist [EPC]
Salt Form
Hydrochloride
Variants
1
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 45 ug/1 | AEROSOL, METERED | ORAL | 27437-056 |
Detailed information about Xopenex Hfa
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Xopenex Hfa, you must consult a qualified healthcare professional.
Levalbuterol is a short-acting beta2-adrenergic agonist (SABA) used to treat and prevent bronchospasm in patients with reversible obstructive airway disease. As the (R)-enantiomer of albuterol, it provides targeted bronchodilation.
For adults and adolescents aged 12 years and older, the standard dosing for levalbuterol depends heavily on the delivery method and the severity of the respiratory distress.
Levalbuterol is approved for use in children, but the dosage and delivery method are age-dependent.
Levalbuterol is primarily excreted by the kidneys. While specific dosage adjustment tables are not provided by the manufacturer, caution should be exercised when administering high doses to patients with significantly impaired renal function. Monitoring for systemic toxicity (such as increased heart rate) is recommended in these individuals.
Since levalbuterol is not significantly metabolized by the liver's cytochrome P450 system, hepatic impairment does not typically require a dose adjustment. However, as with any medication, the patient's overall clinical status should be considered.
Clinical studies of levalbuterol did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently than younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Proper administration is the most important factor in ensuring the medication reaches the lungs where it is needed.
If you miss a dose of levalbuterol, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and return to your regular schedule. Do not double the dose to catch up. Since levalbuterol is often used 'as needed' for symptoms, a missed dose may not be an issue unless you are on a fixed schedule for maintenance.
An overdose of levalbuterol can be serious due to its effects on the heart and electrolyte balance. Symptoms of overdose include:
In the event of a suspected overdose, contact your local poison control center or seek emergency medical attention immediately. Treatment usually involves supportive care and monitoring of cardiac function and serum potassium levels.
> Important: Follow your healthcare provider's dosing instructions. Do not adjust your dose without medical guidance. Excessive use of SABA inhalers can be a sign that your asthma is not well-controlled and may require a change in your 'controller' medication (like inhaled steroids).
Common side effects of levalbuterol are typically related to its 'sympathomimetic' nature—meaning it stimulates the nervous system similarly to adrenaline. These effects are often dose-dependent and may diminish as your body adjusts to the medication.
> Warning: Stop taking Levalbuterol and call your doctor immediately if you experience any of these serious symptoms.
Levalbuterol is intended for acute relief and is not typically associated with permanent long-term side effects when used correctly. However, chronic over-reliance on levalbuterol (using it daily or several times a day for long periods) can lead to:
No FDA black box warnings for Levalbuterol. Unlike Long-Acting Beta-Agonists (LABAs) which once carried black box warnings regarding asthma-related death when used without inhaled corticosteroids, short-acting agonists like levalbuterol do not carry this specific warning. However, the lack of a black box warning does not mean the drug is without risk; the risk of paradoxical bronchospasm is a major safety concern listed in the 'Warnings and Precautions' section of the FDA label.
Report any unusual symptoms to your healthcare provider. Keeping a 'symptom diary' can help your doctor determine if your side effects are dose-related or if a different medication is required.
Levalbuterol is a powerful bronchodilator that must be used with caution. The most critical safety point is that levalbuterol should not be used as the only treatment for patients with persistent asthma. If you find yourself needing to use your levalbuterol inhaler more than two days a week (excluding use before exercise), your asthma may not be well-controlled, and you must consult your healthcare provider about adding a 'controller' medication, such as an inhaled corticosteroid. Over-reliance on 'reliever' medications like levalbuterol is associated with an increased risk of severe asthma attacks and death.
No FDA black box warnings for Levalbuterol.
Patients using levalbuterol for chronic management should undergo regular monitoring to ensure the drug remains safe and effective:
Levalbuterol generally does not interfere with the ability to drive or operate machinery. However, because some individuals experience dizziness, tremors, or nervousness, you should observe how the medication affects you before engaging in activities that require focus and coordination.
There is no direct chemical interaction between alcohol and levalbuterol. However, alcohol can sometimes trigger asthma symptoms in certain individuals (especially those sensitive to sulfites in wine). Furthermore, excessive alcohol consumption can impair your ability to recognize worsening asthma symptoms or use your inhaler correctly in an emergency.
Levalbuterol does not typically require a 'tapering' period because it is a short-acting medication used for symptom relief. However, you should never stop taking your other asthma medications (like steroid inhalers) just because you feel better after using levalbuterol. Stopping controller medications can lead to a severe rebound in inflammation and airway constriction.
> Important: Discuss all your medical conditions with your healthcare provider before starting Levalbuterol. Ensure your provider knows if you have a history of heart disease, high blood pressure, or thyroid problems.
While few drugs are strictly 'contraindicated' with levalbuterol, certain combinations are avoided due to the high risk of severe adverse events:
Levalbuterol may interfere with the results of certain laboratory tests:
For each major interaction, the mechanism usually involves either 'pharmacodynamic antagonism' (drugs working against each other) or 'pharmacodynamic synergism' (drugs adding together to cause too much of an effect).
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking. This includes over-the-counter cold medicines, which often contain stimulants that can interact with levalbuterol.
There are very few absolute contraindications for levalbuterol because it is often a life-saving medication during acute respiratory distress. However, it must NEVER be used in the following case:
Relative contraindications are conditions where the drug should only be used if the benefit clearly outweighs the risk, and only under close medical supervision:
As mentioned, there is a 100% cross-sensitivity between levalbuterol and racemic albuterol. If you are allergic to ProAir, Ventolin, or AccuNeb (brands of albuterol), you will also be allergic to Xopenex (levalbuterol). There is also a potential for cross-sensitivity with other beta-agonists like salmeterol or formoterol, though this is less common. Patients with a history of 'paradoxical bronchospasm' with any inhaled beta-agonist should be monitored with extreme caution when starting levalbuterol.
> Important: Your healthcare provider will evaluate your complete medical history before prescribing Levalbuterol. Always disclose any previous 'bad reactions' to inhalers, even if they seemed minor at the time.
Levalbuterol was previously classified as FDA Pregnancy Category C. This means that animal reproduction studies have shown an adverse effect on the fetus, but there are no adequate and well-controlled studies in humans.
It is not known whether levalbuterol is excreted in human milk. Because of the potential for tumorigenicity shown for albuterol in animal studies and the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Most clinical experts suggest that the amount of drug reaching the infant via breast milk after maternal inhalation is likely to be clinically insignificant, but caution is still advised.
Elderly patients (65 years and older) are more likely to have underlying cardiac conditions or be taking medications like diuretics or beta-blockers that interact with levalbuterol.
Levalbuterol is primarily eliminated by the kidneys. In patients with a GFR (Glomerular Filtration Rate) of less than 30 mL/min, the clearance of the drug may be reduced. While specific dose-adjustment guidelines are not established, these patients should be monitored for signs of systemic beta-agonist toxicity, such as persistent tremors or palpitations. It is not significantly removed by hemodialysis.
The liver does not play a major role in the primary clearance of levalbuterol. Therefore, no specific dose adjustments are typically required for patients with mild to moderate hepatic impairment (Child-Pugh Class A or B). In severe hepatic impairment, the general clinical status of the patient should guide therapy.
> Important: Special populations require individualized medical assessment. Always inform your specialist if you are pregnant or planning to become pregnant while using respiratory medications.
Levalbuterol is the (R)-enantiomer of the racemic bronchodilator albuterol. It is a highly selective beta2-adrenergic receptor agonist. Its primary action is to stimulate adenyl cyclase, the enzyme which catalyzes the formation of cyclic-3',5'-adenosine monophosphate (cAMP) from adenosine triphosphate (ATP). The increased cAMP levels are associated with the relaxation of bronchial smooth muscle and the inhibition of the release of mediators of immediate hypersensitivity from cells, especially mast cells.
By increasing cAMP, levalbuterol also activates protein kinase A, which inhibits the phosphorylation of myosin and lowers intracellular calcium. This is a critical molecular pathway because calcium is the primary 'trigger' for muscle contraction. By 'mopping up' or sequestering this calcium, levalbuterol ensures the airways remain open even in the presence of inflammatory triggers.
| Parameter | Value |
|---|---|
| Bioavailability | ~10-20% (Pulmonary); ~80% (Systemic/Swallowed) |
| Protein Binding | 7% to 10% |
| Half-life | 3.3 to 4.8 hours |
| Tmax (Peak Time) | 0.2 to 1.5 hours |
| Metabolism | Primarily via Sulfotransferase (SULT1A3) in GI/Liver |
| Excretion | Renal 80-100% (as parent drug and sulfate metabolite) |
Levalbuterol is classified as a Short-Acting Beta2-Adrenergic Agonist (SABA). It belongs to the broader class of sympathomimetic amines. Related medications include racemic albuterol (Ventolin, ProAir), pirbuterol (Maxair), and terbutaline. It is distinct from Long-Acting Beta-Agonists (LABAs) like salmeterol, which have a much longer duration of action and are not used for acute relief.
Common questions about Xopenex Hfa
Levalbuterol is primarily used for the treatment and prevention of bronchospasm in individuals with reversible obstructive airway diseases, such as asthma or chronic obstructive pulmonary disease (COPD). It works by relaxing the smooth muscles in the lungs, which helps to open the airways and make breathing easier during an acute attack or before exposure to a known trigger. Healthcare providers often prescribe it to patients who experience unwanted side effects, like a racing heart or tremors, from standard albuterol inhalers. It is available as both a nebulizer solution and a metered-dose inhaler for quick-relief therapy. While it provides rapid symptom relief, it does not treat the underlying inflammation associated with asthma.
The most frequently reported side effects of levalbuterol include nervousness, tremors (shaking, especially in the hands), headache, dizziness, and a rapid or pounding heartbeat (tachycardia). These symptoms occur because the medication can stimulate the nervous system and affect receptors in the heart and muscles, even though it is designed to target the lungs. Some patients also report a sore throat, dry mouth, or a minor cough immediately after using the inhaler. Most of these side effects are mild and temporary, often resolving within an hour of treatment. However, if these symptoms become severe or persistent, you should contact your healthcare provider to discuss a possible dose adjustment.
There is no known direct chemical interaction between alcohol and levalbuterol that would make the combination toxic. However, many healthcare providers advise caution because alcohol can sometimes act as a trigger for asthma symptoms, particularly in patients sensitive to the sulfites found in many wines and beers. Additionally, alcohol can cause dehydration and may increase your heart rate, which could compound the cardiovascular side effects of levalbuterol. Being under the influence of alcohol may also impair your ability to recognize a worsening asthma attack or use your inhalation device correctly. It is always best to discuss your alcohol consumption habits with your doctor to ensure your asthma management plan is safe.
Levalbuterol should only be used during pregnancy if the potential benefit to the mother justifies the potential risk to the fetus. It was historically classified as Category C, meaning animal studies showed some risks, but human data is limited. However, medical experts emphasize that maintaining good asthma control is vital during pregnancy, as uncontrolled asthma can lead to serious complications like low birth weight or preeclampsia. Most guidelines suggest that short-acting beta-agonists like levalbuterol are acceptable for use when needed for acute symptoms. You should work closely with your obstetrician and pulmonologist to manage your respiratory health while pregnant. Always inform your doctor if you become pregnant while using this medication.
Levalbuterol is a fast-acting 'rescue' or 'reliever' medication, with an onset of action typically occurring within 5 to 15 minutes after inhalation. This rapid response makes it an essential tool for managing sudden bouts of wheezing or shortness of breath. The peak effect, or the time when you will feel the maximum improvement in your breathing, usually occurs between 60 and 90 minutes after the dose. The bronchodilating effects generally last for about 3 to 6 hours, though this can vary depending on the individual and the severity of their airway obstruction. If you do not feel relief within 15 minutes of using the medication, you should follow your asthma action plan or seek emergency medical help.
Yes, you can stop taking levalbuterol suddenly because it is a short-acting medication used primarily for symptom relief rather than as a long-term 'controller.' It does not cause a physical withdrawal syndrome like some other classes of drugs. However, you should only stop using it if your symptoms have resolved or if your doctor has instructed you to switch to a different medication. It is crucial to distinguish between levalbuterol and 'maintenance' medications like inhaled steroids; you should never stop taking your maintenance inhalers without consulting your doctor, as this can lead to a severe increase in airway inflammation. If you find you no longer need levalbuterol, it usually means your asthma is well-controlled.
If you are using levalbuterol on a fixed schedule and you miss a dose, you should take it as soon as you remember. If it is almost time for your next scheduled dose, skip the missed one and continue with your regular timing. You should never take two doses at once to make up for a missed one, as this increases the risk of side effects like a racing heart and tremors. Because levalbuterol is frequently used on an 'as-needed' basis for symptoms, missing a dose may not be a problem if you are not currently experiencing breathing difficulties. Always keep your inhaler with you so that you can treat sudden symptoms regardless of your schedule.
No, levalbuterol is not associated with weight gain. Unlike oral corticosteroids (such as prednisone), which are known to cause weight gain and fluid retention when used long-term, short-acting beta-agonists like levalbuterol do not affect metabolism or appetite in a way that leads to increased body weight. If you are experiencing unexplained weight gain while managing asthma, it is more likely related to other medications you may be taking or a decrease in physical activity due to respiratory symptoms. If weight gain is a concern, discuss your full medication list with your healthcare provider to identify the potential cause. Levalbuterol is generally considered weight-neutral.
Levalbuterol can interact with several other types of medications, so it is important to provide your doctor with a complete list of what you are taking. Significant interactions can occur with beta-blockers (often used for heart conditions), which can block the effects of levalbuterol and cause the airways to tighten. Diuretics (water pills) can increase the risk of low potassium levels when combined with levalbuterol. Additionally, certain antidepressants, like MAOIs or TCAs, can increase the cardiovascular risks associated with this drug. Most patients can safely take levalbuterol alongside inhaled corticosteroids or other long-term asthma controllers, but always verify new combinations with a pharmacist or physician.
Yes, levalbuterol is available in generic form for both the inhalation solution (used with a nebulizer) and the metered-dose inhaler (HFA). The generic versions are required by the FDA to have the same active ingredient, strength, and effectiveness as the brand-name version, Xopenex. Choosing the generic version can often significantly reduce the cost of the medication for patients. Availability may vary by pharmacy, so it is helpful to check with your insurance provider or pharmacist to see which version is covered under your plan. Regardless of whether you use the brand or generic, the instructions for use and safety precautions remain exactly the same.
Other drugs with the same active ingredient (Levalbuterol)