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Levalbuterol Tartrate Hfa Inhalation
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- Active ingredient
- Levalbuterol Tartrate 45 µg
- Other brand names
- Drug class
- beta2-Adrenergic Agonist
- Dosage form
- Aerosol, Metered
- Route
- Oral
- Prescription status
- Rx (prescription)
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2016
- Label revision date
- January 1, 2023
- FDA Insert
- Prescribing information, PDF file
- Active ingredient
- Levalbuterol Tartrate 45 µg
- Other brand names
- Drug class
- beta2-Adrenergic Agonist
- Dosage form
- Aerosol, Metered
- Route
- Oral
- Prescription status
- Rx (prescription)
- CSA schedule
- Not a scheduled drug
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2016
- Label revision date
- January 1, 2023
- Manufacturer
- Praxis, LLC
- Registration number
- NDA021730
- NDC root
- 59368-410
- FDA Insert
- Prescribing information, PDF file
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Drug Overview
Levalbuterol tartrate HFA inhalation aerosol is a medication primarily used to help relax the muscles in your airways, making it easier to breathe. It contains levalbuterol tartrate, which is a specific form of albuterol (a common asthma medication) that selectively targets beta2-adrenergic receptors in the lungs. When you use this inhaler, it activates these receptors, leading to increased levels of a substance called cyclic AMP in the cells. This process helps to relax the smooth muscles in your airways, providing relief from bronchoconstriction (tightening of the airways) and improving airflow.
This inhalation aerosol is delivered through a pressurized metered-dose inhaler, which allows you to receive a precise dose of the medication. It is designed to be effective for individuals experiencing breathing difficulties due to conditions like asthma or chronic obstructive pulmonary disease (COPD). By using levalbuterol, you can help protect against bronchoconstriction and improve your ability to breathe comfortably.
Uses
Levalbuterol tartrate HFA is a medication used to help treat or prevent bronchospasm, which is a tightening of the muscles around the airways, in people with reversible obstructive airway diseases like asthma. If you experience difficulty breathing or wheezing, this medication can provide relief.
Additionally, if you find that exercise triggers your breathing problems, levalbuterol can also help prevent bronchospasm caused by physical activity. This means you can engage in your favorite activities with less worry about your breathing.
Dosage and Administration
Before using your Levalbuterol tartrate HFA inhalation aerosol, make sure to shake the canister well. This medication comes in a pressurized aluminum canister that contains 200 metered actuations, which means you can take 200 inhalations. Each time you use it, you'll need to inhale the medication through the blue plastic actuator mouthpiece that comes with the canister.
Keep an eye on the dose indicator display window. When it shows zero, it means you have used all 200 actuations, and you should discard the canister. If the display shows a red zone, that indicates you have about 20 inhalations left, so it's time to get a refill. Remember, even if the canister feels like it still has some medication left after 200 actuations, the correct amount of medication cannot be guaranteed.
What to Avoid
You should avoid using Levalbuterol tartrate HFA inhalation aerosol if you are allergic to it, racemic albuterol, or any of its ingredients. It's important to follow your doctor's instructions carefully; do not use this inhaler more often than recommended or increase your dose without consulting your physician. Additionally, avoid using other inhaled or asthma medications unless directed by your doctor.
Be aware that abusing Levalbuterol tartrate HFA can lead to serious risks, including cardiac arrest and even death. To ensure your safety, do not spray the medication in your eyes, puncture or incinerate the canister, or store it near heat or open flames. Never freeze the inhaler or throw it into a fire. Always handle this medication responsibly to avoid potential harm.
Side Effects
You may experience some side effects when using Levalbuterol tartrate HFA inhalation aerosol. Common reactions include nervousness, headache, tremors, dry mouth, palpitations, nausea, dizziness, fatigue, and sleeplessness. In cases of overdose, more severe symptoms can occur, such as seizures, angina (chest pain), high or low blood pressure, rapid heart rate (up to 200 beats per minute), and even serious complications like cardiac arrest or death.
If you are a parent considering this treatment for a child under 4 years old, be aware that there is a higher chance of asthma-related side effects in this age group compared to older children. In clinical trials, 12% of young patients experienced these reactions, which is notably higher than the 4% seen in those receiving a placebo. Always consult your healthcare provider if you have concerns about side effects or the suitability of this medication for you or your child.
Warnings and Precautions
Using Levalbuterol tartrate HFA inhalation aerosol can sometimes lead to unexpected breathing problems, known as paradoxical bronchospasm. If you experience sudden shortness of breath after using this inhaler, stop using it immediately and contact your doctor. It's important to use this medication only as directed; using it too frequently can cause serious heart or lung issues, which could be life-threatening. Additionally, be aware of potential allergic reactions, such as swelling of the face, throat, or tongue, rash, hives, or difficulty breathing. If you notice any of these symptoms, stop using the inhaler and seek medical help right away.
If you find that your symptoms are not improving, are getting worse, or if you need to use the inhaler more often than usual, seek medical attention immediately. For those with kidney issues, monitoring renal function may be necessary, so discuss this with your healthcare provider. Always remember to reach out for emergency medical help if you experience any serious side effects or worsening lung symptoms.
Overdose
If you take too much Levalbuterol tartrate HFA inhalation aerosol, you may experience symptoms like rapid heart rate (tachycardia) of up to 200 beats per minute, seizures, high or low blood pressure (hypertension or hypotension), nervousness, headache, tremors, dry mouth, nausea, dizziness, fatigue, and trouble sleeping. In some cases, low potassium levels (hypokalemia) can also occur. Serious complications, such as cardiac arrest or even death, can happen with misuse of this medication.
If you suspect an overdose, stop using the inhaler immediately and seek medical help. Treatment typically involves stopping the medication and managing symptoms as they arise. In some cases, a specific type of medication called a cardioselective beta-receptor blocker may be used, but be aware that it can cause breathing issues (bronchospasm). There is not enough evidence to suggest that dialysis (a procedure to remove waste from the blood) is helpful in these situations, so it's crucial to get professional medical advice.
Pregnancy Use
There are currently no well-controlled studies on the use of Levalbuterol tartrate HFA inhalation aerosol in pregnant women, so caution is advised. While studies in pregnant rabbits showed no signs of birth defects at high doses, other forms of albuterol have been linked to serious birth defects in animal studies. The general risk of major birth defects and miscarriage in the U.S. is estimated to be between 2-4% and 15-20%, respectively.
If you have asthma that is not well controlled during pregnancy, you may face increased risks, such as preeclampsia and complications for your baby, including low birth weight. It's important to work closely with your healthcare provider to manage your condition effectively. Additionally, Levalbuterol tartrate is not approved for use in managing preterm labor, and its use during labor should only be considered if the benefits clearly outweigh the risks, as it may affect uterine contractions. Always consult your doctor before using any medication during pregnancy.
Lactation Use
If you are breastfeeding and considering the use of Levalbuterol tartrate HFA inhalation aerosol, it's important to know that there is currently no information available about whether this medication passes into breast milk or how it might affect your baby or your milk production.
While the benefits of breastfeeding are significant for both you and your child, you should weigh these advantages against your need for this medication and any potential risks it may pose to your baby. Always consult with your healthcare provider to make the best decision for your situation.
Pediatric Use
Levalbuterol tartrate HFA inhalation aerosol is approved for use in children aged 4 years and older, where its safety and effectiveness have been confirmed through clinical trials. However, it is not recommended for children under 4 years of age. In studies involving younger children, there was no significant benefit observed, and a higher number of asthma-related side effects were reported compared to those receiving a placebo (a treatment with no active medication).
If your child is 4 years or older and prescribed this medication, it is important to follow the dosing instructions carefully. Be aware that some children may experience asthma-related reactions while using this inhaler, and in rare cases, treatment may need to be stopped due to these side effects. Always consult your child's healthcare provider if you have concerns or notice any unusual symptoms.
Geriatric Use
When considering Levalbuterol tartrate HFA inhalation aerosol for older adults, it's important to note that clinical studies did not include enough participants aged 65 and older to fully understand how they might respond compared to younger individuals. However, based on other clinical experiences, no significant differences in responses have been reported between older and younger patients.
For older adults, healthcare providers typically recommend starting at the lower end of the dosing range. This cautious approach is due to the higher likelihood of decreased liver (hepatic), kidney (renal), or heart (cardiac) function, as well as the presence of other health conditions or medications. Always consult with your healthcare provider to ensure the safest and most effective treatment plan tailored to your needs.
Renal Impairment
If you have kidney issues, it's important to be aware of how your condition can affect the use of certain medications, such as Levalbuterol tartrate HFA inhalation aerosol. Studies have shown that in individuals with reduced kidney function (creatinine clearance of 7 to 53 mL/min), the clearance of racemic albuterol—a related medication—decreased by 67%. This means that the drug stays in your system longer, which could increase the risk of side effects.
Because of this, you should use caution when taking high doses of Levalbuterol if you have renal impairment. It's essential to discuss your kidney health with your healthcare provider, who may need to adjust your dosage or monitor you more closely while you are on this medication.
Hepatic Impairment
If you have liver problems, it's important to know that the effects of liver impairment on how your body processes Levalbuterol tartrate HFA inhalation aerosol have not been studied. This means that there is no specific information available about how your liver condition might affect the medication's effectiveness or safety.
Because of this uncertainty, it's crucial to discuss your liver health with your healthcare provider before using this medication. They can help determine the best approach for your treatment and monitor you for any potential issues. Always follow their guidance closely to ensure your safety and well-being.
Drug Interactions
It's important to talk to your healthcare provider about all the medications you are taking, as Levalbuterol tartrate HFA inhalation aerosol can interact with other drugs. This means that it may change how these other medicines work, and vice versa. Be sure to inform your doctor if you are using other inhaled medications, heart medications, diuretics (which help increase urination), antidepressants, or treatments for chronic obstructive pulmonary disease (COPD).
While using Levalbuterol tartrate HFA inhalation aerosol, follow your doctor's instructions carefully regarding any other inhaled drugs or asthma medications. This will help ensure that your treatment is safe and effective. Always keep an open line of communication with your healthcare provider about your medications and any concerns you may have.
Storage and Handling
To ensure the safety and effectiveness of your inhaler, store it in a cool, dry place at a temperature between 20° and 25°C (68° and 77°F). Avoid exposing it to freezing temperatures or direct sunlight, and always keep the inhaler with the actuator mouthpiece facing down. It's important not to puncture or incinerate the inhaler, as doing so can be dangerous. Additionally, keep it away from heat sources and open flames, as temperatures above 120°F can cause the canister to burst.
Make sure to keep the inhaler out of reach of children. When the dose indicator display window shows zero, it means that all 200 doses have been used, and you should safely dispose of the canister. Remember, never throw the container into a fire or incinerator to prevent any hazardous situations.
Additional Information
Levalbuterol tartrate HFA inhalation aerosol is intended for oral inhalation only and typically works for 4 to 6 hours. It's important to use this medication as directed and not more frequently than recommended. Before using the inhaler, make sure to prime it properly. Be aware that using this medication can sometimes lead to paradoxical bronchospasm, which is a sudden tightening of the muscles around the airways.
If you experience worsening symptoms or if the treatment seems less effective, seek medical attention right away. Common side effects may include palpitations (feeling your heart racing), chest pain, rapid heartbeat, tremors, and nervousness. If you are pregnant or nursing, consult your doctor before using this inhaler. Always read the FDA-approved patient labeling for detailed instructions and information. Additionally, be cautious, as abusing this medication can lead to serious health risks, including cardiac arrest and death.
FAQ
What is Levalbuterol tartrate HFA inhalation aerosol?
Levalbuterol tartrate HFA inhalation aerosol is a medication containing levalbuterol tartrate, a selective beta2-adrenergic receptor agonist, used to treat or prevent bronchospasm in patients with reversible obstructive airway disease.
How should I use Levalbuterol tartrate HFA inhalation aerosol?
Use Levalbuterol tartrate HFA inhalation aerosol exactly as your doctor instructs. Shake the inhaler well before each use and administer it via inhalation using the provided actuator mouthpiece.
What are the dosage instructions for Levalbuterol tartrate HFA?
After priming with 4 actuations, each actuation delivers 67.8 mcg of levalbuterol tartrate. Each canister provides 200 actuations, and you should discard it when the dose indicator shows zero.
What should I do if I experience paradoxical bronchospasm?
If you experience paradoxical bronchospasm, discontinue use of Levalbuterol tartrate HFA inhalation aerosol immediately and contact your doctor.
Are there any contraindications for using Levalbuterol tartrate HFA?
Do not use Levalbuterol tartrate HFA inhalation aerosol if you are allergic to levalbuterol, racemic albuterol, or any of its ingredients.
What are the common side effects of Levalbuterol tartrate HFA?
Common side effects include palpitations, chest pain, rapid heart rate, tremor, and nervousness. If you experience severe side effects, seek medical attention immediately.
Can I use Levalbuterol tartrate HFA during pregnancy?
There are no adequate studies of Levalbuterol tartrate HFA inhalation aerosol in pregnant women. Consult your doctor if you are pregnant or plan to become pregnant.
How should I store Levalbuterol tartrate HFA inhalation aerosol?
Store the inhaler between 20° and 25°C (68° and 77°F), protect it from freezing and direct sunlight, and do not puncture or incinerate the canister.
What should I do if my asthma symptoms worsen?
If your asthma symptoms worsen or if Levalbuterol tartrate HFA inhalation aerosol does not work as well, seek medical help immediately.
Is Levalbuterol tartrate HFA inhalation aerosol safe for children?
Levalbuterol tartrate HFA inhalation aerosol is not indicated for pediatric patients under 4 years of age due to an increased incidence of asthma-related adverse reactions.
Packaging Info
The table below lists all NDC Code configurations of Levalbuterol Tartrate Hfa Inhalation (levalbuterol tartrate), the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Aerosol, Metered | 45 µg | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
FDA Insert (PDF)
This is the full prescribing document for Levalbuterol Tartrate Hfa Inhalation, submitted to the U.S. Food and Drug Administration (FDA). It contains official information for healthcare providers, including how to use the medication, possible side effects, and safety warnings.
Description
Levalbuterol tartrate HFA inhalation aerosol contains levalbuterol tartrate, the (R)-enantiomer of albuterol, which acts as a relatively selective beta2-adrenergic receptor agonist. The chemical name for levalbuterol tartrate is (R)-α1-[1,1-dimethylethyl)aminomethyl]-4-hydroxy-1,3-benzenedimethanol L-tartrate (2:1 salt), with a molecular weight of 628.71 and an empirical formula of (C13H21NO3)2·C4H6O6. This compound appears as a white to light-yellow solid, is freely soluble in water, and is very slightly soluble in ethanol.
Levalbuterol tartrate is recognized as the generic name for (R)-albuterol tartrate in the United States. The inhalation aerosol is delivered via a pressurized metered-dose inhaler (MDI) equipped with a dose indicator, producing an aerosol intended for oral inhalation. The formulation includes a suspension of micronized levalbuterol tartrate, propellant HFA-134a (1,1,1,2-tetrafluoroethane), Dehydrated Alcohol USP, and Oleic Acid NF. After an initial priming of four actuations, each actuation of the inhaler dispenses 67.8 mcg of levalbuterol tartrate (equivalent to 51.6 mcg of levalbuterol free base) from the valve and 59 mcg of levalbuterol tartrate (equivalent to 45 mcg of levalbuterol free base) from the actuator mouthpiece. Each 15 g canister contains a total of 200 actuations.
Uses and Indications
Levalbuterol tartrate HFA is indicated for the treatment or prevention of bronchospasm in patients with reversible obstructive airway disease. Additionally, it is indicated for the prevention of exercise-induced bronchospasm.
There is no information provided regarding teratogenic effects associated with the use of levalbuterol tartrate HFA. Furthermore, the insert does not mention any nonteratogenic effects.
Dosage and Administration
Levalbuterol tartrate HFA inhalation aerosol is supplied in a pressurized aluminum canister containing 200 metered actuations. Prior to each use, the canister must be shaken well to ensure proper mixing of the medication. Administration is performed via inhalation using the blue plastic actuator mouthpiece provided with the canister.
Healthcare professionals should advise patients to monitor the dose indicator display window. The canister should be discarded when this window shows zero, indicating that all 200 actuations have been used. It is important to note that the correct amount of medication in each actuation cannot be guaranteed after 200 actuations, even if the canister appears to contain medication. When the dose indicator display window enters the red zone, approximately 20 inhalations remain, signaling that a refill is necessary.
Contraindications
Levalbuterol tartrate HFA inhalation aerosol is contraindicated in patients with a known allergy to levalbuterol, racemic albuterol, or any of the components of the formulation.
The product should not be used more frequently than recommended, nor should the dose or frequency be increased without prior consultation with a physician. Co-administration with other inhaled or asthma medications is not advised unless directed by a healthcare professional.
Additionally, the aerosol should not be sprayed in the eyes, punctured, or incinerated. It must be stored away from heat sources and open flames, and should not be frozen. Disposal of the inhaler in fire or incinerators is also contraindicated due to safety concerns.
Abuse of Levalbuterol tartrate HFA inhalation aerosol may lead to serious adverse events, including cardiac arrest and death.
Warnings and Precautions
Levalbuterol tartrate HFA inhalation aerosol is associated with several important warnings and precautions that healthcare professionals must communicate to patients to ensure safe use.
Warnings
Levalbuterol tartrate HFA inhalation aerosol has the potential to induce paradoxical bronchospasm. Patients should be instructed to discontinue use immediately if they experience this adverse effect. Additionally, sudden shortness of breath may occur immediately following administration of the aerosol.
Overuse of Levalbuterol tartrate HFA inhalation aerosol can lead to severe cardiovascular or pulmonary complications, which may be fatal. Healthcare providers should be vigilant in monitoring patients for signs of overuse.
Serious allergic reactions, including symptoms such as facial, throat, or tongue swelling, rash, hives, or respiratory difficulties, may occur. Patients should be advised to stop using the inhaler and seek medical attention promptly if any of these symptoms arise.
General Precautions
Patients must be cautioned against using Levalbuterol tartrate HFA inhalation aerosol more frequently than prescribed. If patients notice a decrease in the effectiveness of the treatment, experience worsening symptoms, or find themselves needing to use the inhaler more often than usual, they should seek immediate medical attention.
Particular caution is warranted when administering high doses of Levalbuterol tartrate HFA inhalation aerosol to individuals with renal impairment. Monitoring renal function in these patients may be beneficial to prevent potential complications.
Laboratory Tests
It is advisable to monitor renal function in patients with known renal impairment to ensure safe use of Levalbuterol tartrate HFA inhalation aerosol.
Emergency Medical Help Instructions
Patients should be instructed to seek emergency medical assistance if they find that Levalbuterol tartrate HFA inhalation aerosol is not providing adequate relief for their asthma symptoms, if their symptoms worsen, or if they need to use the inhaler more frequently than usual.
Stop Taking and Call Your Doctor Instructions
Patients must be advised to contact their healthcare provider or visit the nearest emergency room immediately if they experience any serious side effects or if their lung symptoms worsen.
Side Effects
Patients receiving Levalbuterol tartrate HFA inhalation aerosol may experience a range of adverse reactions, which can be categorized by seriousness and frequency.
In cases of overdosage, symptoms indicative of excessive beta-adrenergic receptor stimulation may occur. These include seizures, angina, hypertension or hypotension, tachycardia with rates reaching up to 200 beats per minute, and arrhythmias. Additional symptoms may encompass nervousness, headache, tremor, dry mouth, palpitations, nausea, dizziness, fatigue, malaise, and sleeplessness. Hypokalemia is also a potential consequence of overdosage. Severe outcomes, such as cardiac arrest and even death, have been associated with the abuse of Levalbuterol tartrate HFA inhalation aerosol.
In pediatric patients, particularly those under the age of 4 years, there is an increased incidence of asthma-related adverse reactions when treated with Levalbuterol tartrate HFA inhalation aerosol compared to placebo. In a clinical trial, 12% of subjects receiving Levalbuterol reported asthma-related adverse reactions, in contrast to 4% in the placebo group. Notably, one subject in the Levalbuterol group discontinued treatment due to asthma, while no subjects in the placebo group did so.
Other adverse reactions observed in the clinical trial population of patients aged 4 years and older were consistent with those reported in the pediatric cohort. This highlights the importance of monitoring for adverse reactions across different age groups when administering Levalbuterol tartrate HFA inhalation aerosol.
Drug Interactions
Levalbuterol tartrate HFA inhalation aerosol may influence the pharmacological effects of other medications, and conversely, other medications may alter the efficacy of Levalbuterol tartrate HFA inhalation aerosol.
Patients are advised to inform their healthcare provider if they are concurrently using any of the following classes of medications:
Inhaled Medicines and Asthma Medications: Co-administration of other inhaled drugs or asthma treatments should be conducted strictly under the guidance of a physician to avoid potential interactions that may affect therapeutic outcomes.
Cardiovascular Medications: The use of heart medications alongside Levalbuterol tartrate HFA inhalation aerosol may necessitate careful monitoring due to possible interactions that could impact cardiac function.
Diuretics: Medications that promote increased urination (diuretics) may interact with Levalbuterol tartrate HFA inhalation aerosol, warranting attention to fluid and electrolyte balance during concurrent use.
Antidepressants: The interaction between Levalbuterol tartrate HFA inhalation aerosol and antidepressants should be evaluated, as it may influence the management of both respiratory and psychiatric conditions.
Chronic Obstructive Pulmonary Disease (COPD) Treatments: Patients receiving treatment for COPD should consult their healthcare provider regarding the use of Levalbuterol tartrate HFA inhalation aerosol to ensure safe and effective management of their respiratory condition.
It is essential for patients to adhere to their physician's instructions regarding the use of Levalbuterol tartrate HFA inhalation aerosol in conjunction with other medications to mitigate the risk of adverse interactions.
Packaging & NDC
The table below lists all NDC Code configurations of Levalbuterol Tartrate Hfa Inhalation (levalbuterol tartrate), the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Aerosol, Metered | 45 µg | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
Pediatric Use
The safety and efficacy of Levalbuterol tartrate HFA inhalation aerosol have been established in pediatric patients aged 4 years and older through an adequate and well-controlled clinical trial. In this population, the medication demonstrated favorable outcomes.
For pediatric patients less than 4 years of age, Levalbuterol tartrate HFA inhalation aerosol is not indicated. A clinical trial involving 196 pediatric patients with asthma or reactive airway disease, including 68 patients aged birth to <2 years and 128 patients aged 2 to <4 years, showed no statistically significant difference in the primary efficacy endpoint between treatment groups. Furthermore, there was an increased incidence of asthma-related adverse reactions in patients under 4 years treated with Levalbuterol tartrate HFA compared to placebo. Specifically, 12% of patients receiving Levalbuterol tartrate HFA (45-90 mcg) reported asthma-related adverse reactions, compared to 10% for Levalbuterol inhalation solution (0.31 mg) and 4% for placebo. Notably, one subject in the Levalbuterol tartrate HFA group discontinued treatment due to asthma, while no subjects in the placebo group did.
Dosing for the clinical trial included Levalbuterol tartrate HFA inhalation aerosol at 45 mcg (N=23), 90 mcg (N=42), Levalbuterol inhalation solution at 0.31 mg (N=63), and placebo (N=68), administered three times daily. The increased number of treatment-emergent asthma-related adverse reactions in the Levalbuterol tartrate HFA group raises safety concerns for its use in younger pediatric patients.
Geriatric Use
Clinical studies of Levalbuterol tartrate HFA inhalation aerosol did not include a sufficient number of subjects aged 65 and older to determine whether these elderly patients respond differently from younger subjects. However, other reported clinical experience has not identified significant differences in responses between geriatric patients and their younger counterparts.
In general, dose selection for elderly patients should be approached with caution. It is advisable to start at the low end of the dosing range, taking into account the increased likelihood of decreased hepatic, renal, or cardiac function, as well as the presence of concomitant diseases or other drug therapies. Careful monitoring of these patients is recommended to ensure safety and efficacy.
Pregnancy
There are no adequate and well-controlled studies of Levalbuterol tartrate HFA inhalation aerosol in pregnant women. Clinical considerations regarding the use of Levalbuterol tartrate HFA inhalation aerosol in pregnant women should be taken into account. Following oral administration of levalbuterol HCl to pregnant rabbits, no evidence of teratogenicity was observed at doses up to 25 mg/kg/day, which is approximately 750 times the maximum recommended human daily inhalation dose (MRHDID) of levalbuterol tartrate for adults on a mg/m² basis. However, racemic albuterol sulfate has demonstrated teratogenic effects in mice and rabbits at doses slightly higher than the human therapeutic range.
The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Women with poorly or moderately controlled asthma may experience an increased risk of preeclampsia, as well as prematurity, low birth weight, and small for gestational age neonates. Therefore, pregnant women should be closely monitored, and medication should be adjusted as necessary to maintain optimal control.
Due to the potential for beta-adrenergic agonists to interfere with uterine contractility, the use of Levalbuterol tartrate HFA inhalation aerosol for the treatment of bronchospasm during labor should be restricted to those patients in whom the benefits clearly outweigh the risks. Levalbuterol tartrate HFA inhalation aerosol has not been approved for the management of preterm labor, and the benefit:risk ratio when levalbuterol tartrate is administered for tocolysis has not been established. Serious adverse reactions, including maternal pulmonary edema, have been reported during or following treatment of premature labor with beta2-agonists, including racemic albuterol.
In developmental studies, oral administration of levalbuterol HCl to pregnant New Zealand White rabbits during the period of organogenesis found no evidence of teratogenicity at doses up to 25 mg/kg/day. In a rat developmental study, a racemic albuterol sulfate (comprising approximately 50% levalbuterol)/HFA-134a formulation administered by inhalation did not produce any teratogenic effects at exposures approximately 160 times the MRHDID. However, other developmental studies with racemic albuterol sulfate resulted in teratogenic effects in mice and rabbits at doses slightly higher than the human therapeutic range. Specifically, in a rabbit development study, orally administered albuterol sulfate induced cranioschisis in 37% of fetuses at approximately 1500 times the MRHDID, while a mouse developmental study showed cleft palate formation in 4.5% to 9.3% of fetuses at exposures approximately 2 to 20 times the MRHDID. Similar effects were not observed at approximately 0.2 times the MRHDID of levalbuterol tartrate for adults.
Lactation
There are no available data on the presence of levalbuterol in human milk, the effects on the breastfed child, or the effects on milk production.
The developmental and health benefits of breastfeeding should be considered alongside the lactating mother's clinical need for levalbuterol tartrate HFA inhalation aerosol. Additionally, potential adverse effects on the breastfed infant from levalbuterol tartrate HFA inhalation aerosol or from the underlying maternal condition should be evaluated.
Renal Impairment
In patients with renal impairment, the pharmacokinetics of racemic albuterol may be significantly affected. A study evaluating five subjects with creatinine clearance ranging from 7 to 53 mL/min demonstrated that while renal disease did not alter the half-life of racemic albuterol, there was a notable 67% decline in its clearance.
Given this substantial reduction in clearance, caution is advised when administering high doses of Levalbuterol tartrate HFA inhalation aerosol to patients with reduced kidney function. Monitoring and potential dose adjustments may be necessary to ensure safety and efficacy in this population.
Hepatic Impairment
The effect of hepatic impairment on the pharmacokinetics of Levalbuterol tartrate HFA inhalation aerosol has not been evaluated. Therefore, no specific dosage adjustments or monitoring requirements can be recommended for patients with compromised liver function. Caution should be exercised when prescribing this medication to patients with hepatic impairment, as the lack of data necessitates careful consideration of potential risks and benefits. Regular monitoring of liver function may be warranted in these patients to ensure safety and efficacy.
Overdosage
In cases of overdosage with Levalbuterol tartrate HFA inhalation aerosol, the expected symptoms primarily result from excessive stimulation of beta-adrenergic receptors. Healthcare professionals should be vigilant for the occurrence or exacerbation of symptoms typically associated with adverse reactions. These may include seizures, angina, hypertension or hypotension, tachycardia (with rates potentially reaching up to 200 beats per minute), arrhythmias, nervousness, headache, tremor, dry mouth, palpitations, nausea, dizziness, fatigue, malaise, and sleeplessness. Additionally, hypokalemia may also be observed.
Given the sympathomimetic nature of Levalbuterol, it is critical to note that severe outcomes, including cardiac arrest and death, may occur, particularly in instances of abuse.
Management of overdosage involves the immediate discontinuation of Levalbuterol tartrate HFA inhalation aerosol. Appropriate symptomatic therapy should be initiated to address the specific symptoms presented. In certain cases, the judicious use of a cardioselective beta-receptor blocker may be considered; however, caution is advised as such medications can induce bronchospasm.
Currently, there is insufficient evidence to support the efficacy of dialysis in the management of overdosage with Levalbuterol tartrate HFA inhalation aerosol. Therefore, healthcare professionals should focus on symptomatic treatment and monitoring of the patient’s condition.
Nonclinical Toxicology
Although there have been no carcinogenesis studies specifically conducted with levalbuterol tartrate, the carcinogenic potential of racemic albuterol sulfate has been evaluated. In a 2-year study involving Sprague-Dawley rats, dietary administration of racemic albuterol sulfate resulted in a significant dose-related increase in the incidence of benign leiomyomas of the mesovarium at doses of 2 mg/kg/day and greater, which is approximately 30 times the maximum recommended human daily inhalation dose (MRHDID) of levalbuterol tartrate for adults and approximately 15 times for children on a mg/m² basis. Conversely, in an 18-month study in CD-1 mice and a 22-month study in golden hamsters, dietary administration of racemic albuterol sulfate did not demonstrate any evidence of tumorigenicity. The doses administered in the CD-1 mice study reached up to 500 mg/kg/day (approximately 3800 times the MRHDID for adults and approximately 1800 times for children on a mg/m² basis), while the doses in the golden hamster study were up to 50 mg/kg/day (approximately 500 times the MRHDID for adults and approximately 240 times for children on a mg/m² basis).
Levalbuterol HCl has been shown to be non-mutagenic in the Ames test and the CHO/HPRT Mammalian Forward Gene Mutation Assay. Additionally, it was not found to be clastogenic in the in vivo micronucleus test conducted in mouse bone marrow. Racemic albuterol sulfate also did not exhibit clastogenic effects in an in vitro chromosomal aberration assay using CHO cell cultures. No fertility studies have been performed with levalbuterol tartrate; however, reproduction studies in rats using racemic albuterol sulfate indicated no evidence of impaired fertility at oral doses up to 50 mg/kg/day, which is approximately 750 times the MRHDID of levalbuterol tartrate for adults on a mg/m² basis.
In terms of animal pharmacology and toxicology, the propellant HFA-134a has been found to be rapidly absorbed and eliminated in both animals and humans, with an elimination half-life ranging from 3 to 27 minutes in animals and 5 to 7 minutes in humans. The time to maximum plasma concentration (tmax) and mean residence time are both extremely short, resulting in a transient presence of HFA-134a in the bloodstream without evidence of accumulation. Based on animal studies, HFA-134a exhibited no detectable toxicological activity at exposure levels less than 380 times the maximum human exposure, as determined by comparisons of area under the curve (AUC) values. Toxicological effects observed at very high doses included ataxia, tremors, dyspnea, and salivation, which are similar to effects produced by structurally-related chlorofluorocarbons (CFCs) previously used in metered-dose inhalers.
Postmarketing Experience
Postmarketing experience has identified several common adverse effects associated with the use of inhaled beta-agonists. Reports received voluntarily or through surveillance programs indicate that patients may experience palpitations, chest pain, rapid heart rate, tremor, and nervousness. These events have been documented in the context of routine clinical use and are consistent with the pharmacological profile of inhaled beta-agonists.
Patient Counseling
Patients should be advised to read the FDA-approved patient labeling, which includes important information regarding the use of Levalbuterol tartrate HFA inhalation aerosol. It is essential to inform patients that the action of this medication typically lasts for 4 to 6 hours. They should be cautioned against using the inhalation aerosol more frequently than recommended and instructed not to increase the dose or frequency of doses without consulting their physician.
Healthcare providers should emphasize the importance of seeking medical attention immediately if patients find that the treatment becomes less effective for symptomatic relief, if their symptoms worsen, or if they need to use the product more frequently than usual.
Patients must be instructed on the proper priming of the inhaler. They should shake the inhaler well before use and prime it by releasing 4 test sprays into the air, away from the face, before using it for the first time or if it has not been used for more than 3 days. Additionally, to ensure proper dosing and prevent blockage of the actuator orifice, patients should be advised to wash the actuator in warm water and air-dry it thoroughly at least once a week. Detailed cleaning instructions are available in the FDA-approved patient labeling.
Storage conditions should also be communicated to patients; they should store the canister between 20° and 25°C (68° and 77°F) and protect it from freezing temperatures and direct sunlight.
Patients should be made aware that Levalbuterol tartrate HFA inhalation aerosol can produce paradoxical bronchospasm, and they should discontinue use immediately if this occurs. While using this inhalation aerosol, patients should only take other inhaled drugs and asthma medications as directed by their physician.
Finally, healthcare providers should inform patients of common adverse effects associated with inhaled beta-agonists, which may include palpitations, chest pain, rapid heart rate, tremor, and nervousness.
Storage and Handling
The product is supplied in a canister format, with specific handling and storage requirements to ensure safety and efficacy. It should be stored at a temperature range of 20° to 25°C (68° to 77°F), in accordance with USP controlled room temperature guidelines. It is essential to protect the product from freezing temperatures and direct sunlight.
For optimal performance, the inhaler must be stored with the actuator mouthpiece facing down. Care should be taken to avoid puncturing or incinerating the canister, and it should not be stored near heat sources or open flames. Exposure to temperatures exceeding 120°F may result in bursting of the canister.
The container must never be thrown into fire or incinerated. Additionally, it is crucial to keep the product out of reach of children. The canister should be discarded once the dose indicator display window shows zero, which indicates that all 200 actuations have been used.
Additional Clinical Information
Levalbuterol tartrate HFA inhalation aerosol is indicated for oral inhalation use only, with an expected duration of action lasting 4 to 6 hours. Clinicians should advise patients not to exceed the recommended frequency of use. It is essential for patients to read the FDA-approved patient labeling, which includes instructions for use and the importance of priming the inhaler prior to administration.
Patients should be informed about the potential for paradoxical bronchospasm and advised to seek medical attention if their treatment becomes less effective or if symptoms worsen. Common adverse effects include palpitations, chest pain, rapid heart rate, tremor, and nervousness. Pregnant or nursing patients are encouraged to consult their physicians regarding the use of this medication. Additionally, it is important to note that the abuse of Levalbuterol tartrate HFA inhalation aerosol may be associated with serious cardiovascular events, including cardiac arrest and death.
FDA Insert (PDF)
This document is the official FDA-approved prescribing information for Levalbuterol Tartrate Hfa Inhalation as submitted by Praxis, LLC. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.