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Levalbuterol Tartrate

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Last Updated: 24 October 2020

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General | Latest Info

Xopenex HFA Inhalation Aerosol is a bronchodilator used to treat reversible obstructive airway conditions such as Asthma, bronchitis, and emphysema. Common Side Effects of Xopenex HFA include: headache, nausea, vomiting, nervousness, anxiety, dizziness, shaking, trouble sleeping, dry mouth and throat, cough, sore throat, runny or stuffy nose, muscle pain, or diarrhea. Tell your doctor if you have serious side effects of Xopenex HFA, including fast or pounding heartbeat. For treatment of acute episodes of bronchospasm or prevention of asthmatic symptoms, usual dosage of Xopenex HFA Inhalation Aerosol for adults and children 4 years of age and older is 2 inhalations repeated every 4 to 6 hours. Xopenex HFA may interact with beta-blockers, tricyclic antidepressants, monoamine oxidase inhibitors, diuretics, digoxin, other inhaled bronchodilators, caffeine, diet pills, or decongestants. Tell your doctor about all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant while USING Xopenex HFA; it is unknown if it will harm the unborn baby. It is unknown if Xopenex HFA passes into breast milk or if it could harm nursing baby. Breastfeeding While USING Xopenex HFA is not recommend. Our Xopenex HFA Inhalation Aerosol Side Effects Drug Center provides a comprehensive view of available Drug INFORMATION on potential side effects when taking this medication. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about Side Effects. You may report Side Effects to FDA at 1-800-FDA-1088. Get Emergency medical help If you have signs of allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Wheezing, choking, or other breathing problems after USING this Medicine; pounding heartbeats or fluttering in your chest; worsening Asthma symptoms; or low potassium-leg cramps, constipation, irregular heartbeats, fluttering in your chest, extreme thirst, increased urination, numbness or tingling, muscle weakness or limp feeling. Dizziness, nervousness, tremors; runny nose, sore throat; chest pain or tightness, irregular heartbeats; pain; or vomiting. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about Side Effects. You may report Side Effects to FDA at 1-800-FDA-1088. Read the entire detailed PATIENT monograph for Xopenex HFA

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Uses

Levalbuterol is used to prevent and treat wheezing and shortness of breath caused by breathing problems. It is a quick-relief drug. Levalbuterol belongs to class of drugs know as bronchodilators. It works by relaxing muscles around airways so that they open up and you can breathe more easily. Controlling symptoms of breathing problems can decrease time lost from work or school. This drug is not approved for use in children younger than 4 years due to increased risk of side effects. Ask your doctor or pharmacist for details.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Side Effects

Use of Levalbuterol tartrate HFA inhalation aerosol may be associated with the following: paradoxical bronchospasm Cardiovascular effects Immediate hypersensitivity reactions Hypokalemia because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of drug cannot be directly compared with rates in clinical trials of another drug and may not reflect rates observe in practice. Adult s and Adolescents 12 Years of Age and Older adverse reaction information concerning Levalbuterol tartrate HFA inhalation aerosol in adults and Adolescents is derived from two 8-week, multicenter, randomize, double-blind, active-and placebo-control trials in 748 adult and adolescent patients with asthma that compared Levalbuterol tartrate HFA inhalation aerosol, market albuterol HFA inhaler, and HFA-134a placebo inhaler. Table 1 lists the incidence of all adverse reactions from these trials that occurred at a rate of 2% or greater in the group treated with Levalbuterol tartrate HFA inhalation aerosol and more frequently than in HFA-134a placebo inhaler group. Adverse reactions reported by less than 2% and at least 2 or more of adolescent and adult patients receiving Levalbuterol tartrate HFA inhalation aerosol and by greater proportion than receiving HFA-134a placebo inhaler include cyst, flu syndrome, viral infection, constipation, gastroenteritis, myalgia, hypertension, epistaxis, lung disorder, acne, herpes simplex, conjunctivitis, ear pain, dysmenorrhea, hematuria, and vaginal moniliasis. There were no significant laboratory abnormalities observed in these studies. Adverse reaction information concerning Levalbuterol tartrate HFA inhalation aerosol in children is derived from a 4-week, randomize, double-blind trial of Levalbuterol tartrate HFA inhalation aerosol, market albuterol HFA inhaler, and HFA-134a placebo inhaler in 150 children aged 4 to 11 years with asthma. Table 2 lists adverse reactions reported for Levalbuterol tartrate HFA inhalation aerosol in children at a rate of 2% or greater and more frequently than for placebo. Incidence of systemic beta-adrenergic adverse reactions was low and comparable across all treatment groups, including placebo. In addition to adverse reactions reported in clinical trials, following adverse reactions have been observed in post-approval use of Levalbuterol inhalation solution. Because these reactions are reported voluntarily from population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events have been chosen for inclusion due to their seriousness, their frequency of reporting, or their likely beta-mediate mechanism: angioedema, anaphylaxis, arrhythmias, asthma, chest pain, cough increase, dysphonia, dyspnea, gastrooesophageal reflux disease, metabolic acidosis, nausea, nervousness, rash, tachycardia, tremor, urticaria. In addition, Levalbuterol tartrate HFA inhalation aerosol, like other sympathomimetic agents, can cause adverse reactions such as hypertension, angina, vertigo, central nervous system stimulation, sleeplessness, headache, and drying or irritation of oropharynx.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

EFFECTIVENESS

Results from clinical trials in adults show levalbuterol tartrate to be as effective as albuterol in improving lung function as measured by percent change in forced expiratory volume in one second. 1 2 duration of action is approximately four hours in most people and is similar to that of alcohol Improve lung function is sustained over at least two months of continuous dosing. Base on one small study, effects in children seem to be similar. 1 pre-dose FEV 1 values during chronic dosing have been significantly lower in patients receiving racemic albuterol compared with levalbuterol tartrate, suggesting the role of S-isomer in declining lung function observed during albuterol therapy. 3 no research has compared levalbuterol tartrate inhalers and albuterol inhalers with regard to reduction in acute exacerbations, normalization of physical activity, symptom-free days, improvements in quality of life, control of airway hyperresponsiveness, normalization of chronic airway inflammation, or avoidance of adverse effects. However, there are studies that show comparable effectiveness in nebulized forms of levalbuterol and albuterol.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Warnings

Levalbuterol tartrate HFA inhalation aerosol can produce paradoxical bronchospasm, which may be life-threatening. If paradoxical bronchospasm occurs, Levalbuterol tartrate HFA inhalation aerosol should be discontinued immediately and alternative therapy institute. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with first use of new canister. Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If a patient needs more doses of Levalbuterol tartrate HFA inhalation aerosol than usual, this may be a marker of destabilization of asthma and require reevaluation of patient and treatment regimen, giving special consideration to possible need for anti-inflammatory treatment, eg, corticosteroids. Use of beta-adrenergic agonist alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, eg, corticosteroids, to therapeutic regimen. Levalbuterol tartrate HFA inhalation aerosol, like other beta-adrenergic agonists, can produce clinically significant cardiovascular effects in some patients, as measured by heart rate, blood pressure, and symptoms. Although such effects are uncommon after administration of Levalbuterol tartrate HFA inhalation aerosol at recommended doses, if they occur, drug may need to be discontinue. In addition, beta-agonists have been reported to produce electrocardiogram changes, such as flattening of T-wave, prolongation of QTc interval, and segment depression. The clinical significance of these findings is unknown. Therefore, Levalbuterol tartrate HFA inhalation aerosol, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma. The exact cause of death is unknown, but cardiac arrest following unexpected development of severe acute asthmatic crisis and subsequent hypoxia is suspect. Immediate hypersensitivity reactions may occur after administration of racemic albuterol, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema. The Potential for hypersensitivity must be considered in clinical evaluation of patients who experience immediate hypersensitivity reactions while receiving Levalbuterol tartrate HFA inhalation aerosol. Levalbuterol tartrate HFA inhalation aerosol, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, hypertension, and cardiac arrhythmias; in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus; and in patients who are unusually responsive to sympathomimetic amines. Clinically significant changes in systolic and diastolic blood pressure have been seen in individual patients and could be expected to occur in some patients after use of any beta-adrenergic bronchodilator. Large doses of intravenous racemic albuterol have been reported to aggravate preexisting diabetes mellitus and ketoacidosis. As with other beta-adrenergic agonist medications, Levalbuterol tartrate HFA inhalation aerosol may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has potential to produce adverse cardiovascular effects. A Decrease is usually transient, not require supplementation.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Pregnancy & Lactation

Congenital anomalies, including cleft palate and limb defects, have been reported in newborns of women treated with Racemic Albuterol, which contains Levalbuterol isomer. In animal studies, oral administration of this drug to pregnant rabbits showed no evidence of teratogenicity at approximately 108 times the maximum recommended daily inhalation dose of this drug. However, other studies demonstrate that Racemic Albuterol sulfate was teratogenic in mice and rabbits at doses comparable to human therapeutic range. Pregnant mice administered Racemic Albuterol sulfate subcutaneously had dose-relate increased incidence of cleft palate in their fetuses. In addition, oral administration of Racemic Albuterol sulfate to pregnant rabbits results in increased incidence of cranioschisis in fetuses. There are no adequate and well controlled studies of this drug in pregnant women. Us FDA pregnancy category C: Animal reproduction studies have shown adverse effect on fetus and there are no adequate and well-control studies in humans, but potential benefits may warrant use of drug in pregnant women despite potential risks. This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus. Us FDA pregnancy category: C Comments:-potential beta adrenergic agonist effect of this drug can interfere with uterine contractility.-This Drug is not approved for management of preterm labor.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Pharmacology

A population pharmacokinetic model was developed USING plasma concentrations of Albuterol obtained from 632 asthmatic patients aged 4 to 81 years in three large trials. For Adolescent and adult Patients 12 Years and Older, following 90 mcg dose of XOPENEX HFA, yields mean peak plasma concentrations and systemic exposure of approximately 199 pg / mL and 695 pgh / mL, respectively, compared to approximately 238 pg / mL and 798 pgh / mL, respectively, following 180 mcg dose of Racemic Albuterol HFA meter-dose inhaler. For Pediatric Patients from 4 To 11 Years of Age, following 90 mcg dose of XOPENEX HFA, yield Cmax and AUC0-6 of approximately 163 pg / mL and 579 pgh / mL, respectively, compared to approximately 238 pg / mL and 828 pgh / mL, respectively, following 180 mcg dose of Racemic Albuterol HFA meter-dose inhaler. These pharmacokinetic data indicate that mean exposure to-albuterol was 13% to 16% less in adults and 30% to 32% less in Pediatric Patients given XOPENEX HFA as compared to those given comparable dose of Racemic Albuterol. When compared to adult patients, pediatric patients given 90 mcg of Levalbuterol have 17% lower mean exposure to-albuterol.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

INDICATIONS

Levalbuterol is used to prevent and treat wheezing and shortness of breath caused by breathing problems. It is a quick-relief drug. Levalbuterol belongs to class of drugs know as bronchodilators. It works by relaxing muscles around airways so that they open up and you can breathe more easily. Controlling symptoms of breathing problems can decrease time lost from work or school. This drug is not approved for use in children younger than 4 years due to increased risk of side effects. Ask your doctor or pharmacist for details. Read the Patient Information Leaflet provided by your pharmacist before you start using this medication and each time you get a refill. Follow illustrated directions for proper use of this medication and proper cleaning of mouthpiece. If you have any questions, ask your doctor or pharmacist. Shake canister well before using. It Follow instructions for testing sprays in the air if you are using a canister for the first time or if you have not used it for 3 days or more. A fine mist is a sign that the inhaler is working properly. Avoid spraying medication on your eyes. Inhale this medication by mouth as direct by your doctor, usually every 4 to 6 hours as needed. If two inhalations are prescribe, wait at least 1 minute between them. Dosage is based on your medical condition and response to treatment. Do not increase your dose or use this drug more often than prescribed without your doctor's approval. Using too much of this medication will increase your risk of serious side effects. Using spacer device with inhaler may help you use this medication properly. Ask your doctor or pharmacist for more information. If a child is using this medication, parents or other responsible adults may need to help the child use inhaler properly. If you are using other inhalers at the same time, wait at least 1 minute between use of each medication. Always have this quick-relief inhaler with you. Keep track of the number of inhalations you use, and discard inhalers after you have used label number of inhalations on the product package. Also, count test sprays used to prime inhaler.S Do not float metal canister in water to test if any more drug is left in the canister. Learn which of your inhalers you should use every day and which you should use if your breathing suddenly worsen. Ask your doctor ahead of time what you should do if you have new or worsening cough or shortness of breath, wheezing, increased sputum, worsening peak flow meter readings, waking up at night with trouble breathing, if you use your quick-relief inhaler more often, or if your quick-relief inhaler does not seem to be Working well. Learn when you can treat sudden breathing problems by yourself and when you must get medical help right away. Tell your doctor if your symptoms do not improve or if they worsen.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

DOSAGE AND ADMINISTRATION

Table 2: Adverse Event Incidence (% of Patients) in Two 8-Week Clinical Trials in Adults and Adolescents 12 Years of Age

Body System Preferred TermXOPENEX HFA Inhalation Aerosol 90 mcg (n=403)Racemic Albuterol HFA 180 mcg (n=179)Placebo (n=166)
Body as a Whole
Pain4.03.43.6
Central Nervous System
Dizziness2.70.61.8
Respiratory System
Asthma9.47.36.0
Pharyngitis7.92.22.4
Rhinitis7.42.23.0

63 mg inhaled via nebulization 3 times per day, give every 6 TO 8 hours, as NEED FOR bronchospasm. Patients with more severe Asthma or patients who do not respond adequately MAY benefit FROM dosage OF 1. 25 mg by nebulization 3 times per day. For acute asthma exacerbations, National Asthma Education and Prevention Program Expert Panel recommends 1. 25 TO 2. 5 mg every 20 minutes FOR 3 doses, then 1. 25 TO 5 mg every 1 TO 4 hours as NEED. Initiate dosage AT lower end OF range FOR geriatric patients; IF clinically indicate, dosage MAY BE increased as tolerate, UP TO maximum adult dosage. Patients receiving higher doses SHOULD BE monitored closely FOR ADVERSE systemic effects, and risks OF such effects SHOULD BE balanced against the potential FOR improved efficacy. 2 puffs every 4 TO 6 hours is NEED FOR bronchospasm; in some patients, 1 puff every 4 hours MAY BE sufficient. More frequent administration or larger number OF INHALATIONS IS not routinely recommend. For acute asthma exacerbations, National Asthma Education and Prevention Program Expert Panel recommends 4 TO 8 puffs every 20 minutes FOR UP TO 4 hours, then decrease TO every 1 TO 4 hours as NEED. 2 INHALATIONS administered 15 minutes BEFORE exercise. The American Thoracic Society strongly recommends administration OF inhaled short-acting beta-2 agonist 15 minutes BEFORE exercise FOR Prevention. Efficacy OF Levalbuterol FOR Prevention OF EIB was assessed in a randomized, double-blind, placebo-control, cross over study in 15 asthmatic adults with stable Asthma and EIB. Patients were required TO HAVE 2050% decrease in FEV1 following exercise challenge and dose OF placebo meter dose INHALER. Low or moderate dose leukotriene inhibitors and inhaled corticosteroids were allowed IF patient was stable on Drug 30 days prior TO entry; montelukast, inhaled steroids, and antihistamines were USE in 6. 7%, 33. 3%, and 13. 3% of patients, respectively. The primary endpoint was maximum percent decrease in FEV1 FROM baseline. The study consisted of 3 visits; baseline values and EIB diagnosis were confirmed during visit 1, randomization occurred AT visit 2 followed by exercise, and patients were crossed over TO opposite treatment AT visit 3, followed by exercise. The maximum percent FEV1 decrease was significantly less when patients receive Levalbuterol compared TO placebo. Following exercise challenge with Levalbuterol prophylaxis, NO patients require rescue MEDICATION, WHILE 3 patients require rescue MEDICATION following placebo prophylaxis.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

Table 3: Adverse Event Incidence (% of Patients) in a 4-Week Trial in Children Aged 4-11 Years

Body System Preferred TermXOPENEX HFA Inhalation Aerosol 90 mcg (n=76)Racemic Albuterol HFA 180 mcg (n=39)Placebo (n=35)
Body as a Whole
Accidental injury9.210.35.7
Digestive System
Vomiting10.57.75.7
Respiratory System
Bronchitis2.600
Pharyngitis6.612.85.7
* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

PATIENT INFORMATION

Table 2: Adverse Event Incidence (% of Patients) in Two 8-Week Clinical Trials in Adults and Adolescents 12 Years of Age

Body System Preferred TermXOPENEX HFA Inhalation Aerosol 90 mcg (n=403)Racemic Albuterol HFA 180 mcg (n=179)Placebo (n=166)
Body as a Whole
Pain4.03.43.6
Central Nervous System
Dizziness2.70.61.8
Respiratory System
Asthma9.47.36.0
Pharyngitis7.92.22.4
Rhinitis7.42.23.0

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

Table 3: Adverse Event Incidence (% of Patients) in a 4-Week Trial in Children Aged 4-11 Years

Body System Preferred TermXOPENEX HFA Inhalation Aerosol 90 mcg (n=76)Racemic Albuterol HFA 180 mcg (n=39)Placebo (n=35)
Body as a Whole
Accidental injury9.210.35.7
Digestive System
Vomiting10.57.75.7
Respiratory System
Bronchitis2.600
Pharyngitis6.612.85.7
* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Sources

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

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