Home FDA labels e4dcd277-102e-c367-e053-2a95a90a188d FDA label e4dcd277-102e-c367-e053-2a95a90a188d openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
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warnings and cautions 5 WARNINGS AND PRECAUTIONS Life-threatening paradoxical bronchospasm may occur. Discontinue levalbuterol inhalation solution immediately and treat with alternative therapy. ( 5.1 ) Need for more doses of levalbuterol inhalation solution than usual may be a sign of deterioration of asthma and requires reevaluation of treatment. ( 5.2 ) Levalbuterol inhalation solution is not a substitute for corticosteroids. ( 5.3 ) Cardiovascular effects may occur. Consider discontinuation of levalbuterol inhalation solution if these effects occur. Use with caution in patients with underlying cardiovascular disorders. ( 5.4 ) Excessive use may be fatal. Do not exceed recommended dose. ( 5.5 ) Immediate hypersensitivity reactions may occur. Discontinue levalbuterol inhalation solution immediately. ( 5.6 ) Hypokalemia and changes in blood glucose may occur. ( 5.7 , 5.8 ) 5.1 Paradoxical Bronchospasm Levalbuterol inhalation solution can produce paradoxical bronchospasm, which may be life-threatening. If paradoxical bronchospasm occurs, levalbuterol inhalation solution should be discontinued immediately and alternative therapy instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new vial. 5.2 Deterioration of Asthma Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient needs more doses of levalbuterol inhalation solution than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids. 5.3 Use of Anti-Inflammatory Agents Levalbuterol inhalation solution is not a substitute for corticosteroids. The use of beta-adrenergic agonists alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids, to the therapeutic regimen. 5.4 Cardiovascular Effects Levalbuterol inhalation solution, 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 inhalation solution at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the t-wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown. Therefore, levalbuterol inhalation solution, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. 5.5 Do Not Exceed Recommended Dose Do not exceed the recommended dose. 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 an unexpected development of a severe acute asthmatic crisis and subsequent hypoxia is suspected. 5.6 Immediate Hypersensitivity Reactions Immediate hypersensitivity reactions may occur after administration of levalbuterol or racemic albuterol. Reactions have included urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema. The potential for hypersensitivity must be considered in the clinical evaluation of patients who experience immediate hypersensitivity reactions while receiving levalbuterol inhalation solution. 5.7 Coexisting Conditions Levalbuterol inhalation solution, 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 the use of any beta-adrenergic bronchodilator. Changes in blood glucose may occur. Large doses of intravenous racemic albuterol have been reported to aggravate preexisting diabetes mellitus and ketoacidosis. 5.8 Hypokalemia As with other beta-adrenergic agonist medications, levalbuterol inhalation solution may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects. The decrease is usually transient, not requiring supplementation.
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adverse reactions table <table><caption>Table 3: Most Frequently Reported Adverse Reactions (≥ 2% in Any Treatment Group) and Those Reported More Frequently Than in Placebo During the Double-Blind Period (ITT Population, 6 to 11 Years Old)</caption><col/><col/><col/><col/><col/><col/><thead><tr><th styleCode=" Botrule Toprule " valign="bottom"><content styleCode="bold">Body System </content> <content styleCode="bold"> Preferred Term</content></th><th align="center" styleCode=" Botrule Toprule " valign="bottom"><content styleCode="bold">Placebo</content> <content styleCode="bold">(n = 59)</content></th><th align="center" styleCode=" Botrule Toprule " valign="bottom"><content styleCode="bold">Levalbuterol</content> <content styleCode="bold">0.31 mg</content> <content styleCode="bold">(n = 66)</content></th><th align="center" styleCode=" Botrule Toprule " valign="bottom"><content styleCode="bold">Levalbuterol </content> <content styleCode="bold">0.63 mg</content> <content styleCode="bold">(n = 67)</content></th><th align="center" styleCode=" Botrule Toprule " valign="bottom"><content styleCode="bold">Racemic albuterol </content> <content styleCode="bold">1.25 mg</content> <content styleCode="bold">(n = 64)</content></th><th align="center" styleCode=" Botrule Toprule " valign="bottom"><content styleCode="bold">Racemic albuterol </content> <content styleCode="bold">2.5 mg</content> <content styleCode="bold">(n = 60)</content></th></tr></thead><tbody><tr><td styleCode=" Toprule " valign="bottom"/><td align="center" colspan="5" styleCode=" Botrule Toprule " valign="bottom"><paragraph>Percent of Patients</paragraph></td></tr><tr><td valign="top"><paragraph>Body as a Whole</paragraph></td><td valign="top"/><td valign="top"/><td valign="top"/><td valign="top"/><td valign="top"/></tr><tr><td valign="top"><paragraph> Abdominal pain</paragraph></td><td align="center" valign="top"><paragraph>3.4</paragraph></td><td align="center" valign="top"><paragraph>0</paragraph></td><td align="center" valign="top"><paragraph>1.5</paragraph></td><td align="center" valign="top"><paragraph>3.1</paragraph></td><td align="center" valign="top"><paragraph>6.7</paragraph></td></tr><tr><td valign="top"><paragraph> Accidental injury</paragraph></td><td align="center" valign="top"><paragraph>3.4</paragraph></td><td align="center" valign="top"><paragraph>6.1</paragraph></td><td align="center" valign="top"><paragraph>4.5</paragraph></td><td align="center" valign="top"><paragraph>3.1</paragraph></td><td align="center" valign="top"><paragraph>5.0</paragraph></td></tr><tr><td valign="top"><paragraph> Asthenia</paragraph></td><td align="center" valign="top"><paragraph>0</paragraph></td><td align="center" valign="top"><paragraph>3.0</paragraph></td><td align="center" valign="top"><paragraph>3.0</paragraph></td><td align="center" valign="top"><paragraph>1.6</paragraph></td><td align="center" valign="top"><paragraph>1.7</paragraph></td></tr><tr><td valign="top"><paragraph> Fever</paragraph></td><td align="center" valign="top"><paragraph>5.1</paragraph></td><td align="center" valign="top"><paragraph>9.1</paragraph></td><td align="center" valign="top"><paragraph>3.0</paragraph></td><td align="center" valign="top"><paragraph>1.6</paragraph></td><td align="center" valign="top"><paragraph>6.7</paragraph></td></tr><tr><td valign="top"><paragraph> Headache</paragraph></td><td align="center" valign="top"><paragraph>8.5</paragraph></td><td align="center" valign="top"><paragraph>7.6</paragraph></td><td align="center" valign="top"><paragraph>11.9</paragraph></td><td align="center" valign="top"><paragraph>9.4</paragraph></td><td align="center" valign="top"><paragraph>3.3</paragraph></td></tr><tr><td valign="top"><paragraph> Pain</paragraph></td><td align="center" valign="top"><paragraph>3.4</paragraph></td><td align="center" valign="top"><paragraph>3.0</paragraph></td><td align="center" valign="top"><paragraph>1.5</paragraph></td><td align="center" valign="top"><paragraph>4.7</paragraph></td><td align="center" valign="top"><paragraph>6.7</paragraph></td></tr><tr><td valign="top"><paragraph> Viral infection</paragraph></td><td align="center" valign="top"><paragraph>5.1</paragraph></td><td align="center" valign="top"><paragraph>7.6</paragraph></td><td align="center" valign="top"><paragraph>9.0</paragraph></td><td align="center" valign="top"><paragraph>4.7</paragraph></td><td align="center" valign="top"><paragraph>8.3</paragraph></td></tr><tr><td valign="top"><paragraph>Digestive System</paragraph></td><td valign="top"/><td valign="top"/><td valign="top"/><td valign="top"/><td valign="top"/></tr><tr><td valign="top"><paragraph> Diarrhea</paragraph></td><td align="center" valign="top"><paragraph>0</paragraph></td><td align="center" valign="top"><paragraph>1.5</paragraph></td><td align="center" valign="top"><paragraph>6.0</paragraph></td><td align="center" valign="top"><paragraph>1.6</paragraph></td><td align="center" valign="top"><paragraph>0</paragraph></td></tr><tr><td valign="top"><paragraph>Hemic and Lymphatic</paragraph></td><td valign="top"/><td valign="top"/><td valign="top"/><td valign="top"/><td valign="top"/></tr><tr><td valign="top"><paragraph> Lymphadenopathy</paragraph></td><td align="center" valign="top"><paragraph>0</paragraph></td><td align="center" valign="top"><paragraph>3.0</paragraph></td><td align="center" valign="top"><paragraph>0</paragraph></td><td align="center" valign="top"><paragraph>1.6</paragraph></td><td align="center" valign="top"><paragraph>0</paragraph></td></tr><tr><td valign="top"><paragraph>Musculoskeletal System</paragraph></td><td valign="top"/><td valign="top"/><td valign="top"/><td valign="top"/><td valign="top"/></tr><tr><td valign="top"><paragraph> Myalgia</paragraph></td><td align="center" valign="top"><paragraph>0</paragraph></td><td align="center" valign="top"><paragraph>0</paragraph></td><td align="center" valign="top"><paragraph>1.5</paragraph></td><td align="center" valign="top"><paragraph>1.6</paragraph></td><td align="center" valign="top"><paragraph>3.3</paragraph></td></tr><tr><td valign="top"><paragraph>Respiratory System</paragraph></td><td valign="top"/><td valign="top"/><td valign="top"/><td valign="top"/><td valign="top"/></tr><tr><td valign="top"><paragraph> Asthma</paragraph></td><td align="center" valign="top"><paragraph>5.1</paragraph></td><td align="center" valign="top"><paragraph>9.1</paragraph></td><td align="center" valign="top"><paragraph>9.0</paragraph></td><td align="center" valign="top"><paragraph>6.3</paragraph></td><td align="center" valign="top"><paragraph>10.0</paragraph></td></tr><tr><td valign="top"><paragraph> Pharyngitis</paragraph></td><td align="center" valign="top"><paragraph>6.8</paragraph></td><td align="center" valign="top"><paragraph>3.0</paragraph></td><td align="center" valign="top"><paragraph>10.4</paragraph></td><td align="center" valign="top"><paragraph>0</paragraph></td><td align="center" valign="top"><paragraph>6.7</paragraph></td></tr><tr><td valign="top"><paragraph> Rhinitis</paragraph></td><td align="center" valign="top"><paragraph>1.7</paragraph></td><td align="center" valign="top"><paragraph>6.1</paragraph></td><td align="center" valign="top"><paragraph>10.4</paragraph></td><td align="center" valign="top"><paragraph>3.1</paragraph></td><td align="center" valign="top"><paragraph>5.0</paragraph></td></tr><tr><td valign="top"><paragraph>Skin and Appendages</paragraph></td><td valign="top"/><td valign="top"/><td valign="top"/><td valign="top"/><td valign="top"/></tr><tr><td valign="top"><paragraph> Eczema</paragraph></td><td align="center" valign="top"><paragraph>0</paragraph></td><td align="center" valign="top"><paragraph>0</paragraph></td><td align="center" valign="top"><paragraph>0</paragraph></td><td align="center" valign="top"><paragraph>0</paragraph></td><td align="center" valign="top"><paragraph>3.3</paragraph></td></tr><tr><td valign="top"><paragraph> Rash</paragraph></td><td align="center" valign="top"><paragraph>0</paragraph></td><td align="center" valign="top"><paragraph>0</paragraph></td><td align="center" valign="top"><paragraph>7.5</paragraph></td><td align="center" valign="top"><paragraph>1.6</paragraph></td><td align="center" valign="top"><paragraph>0</paragraph></td></tr><tr><td valign="top"><paragraph> Urticaria</paragraph></td><td align="center" valign="top"><paragraph>0</paragraph></td><td align="center" valign="top"><paragraph>0</paragraph></td><td align="center" valign="top"><paragraph>3.0</paragraph></td><td align="center" valign="top"><paragraph>0</paragraph></td><td align="center" valign="top"><paragraph>0</paragraph></td></tr><tr><td valign="top"><paragraph>Special Senses</paragraph></td><td valign="top"/><td valign="top"/><td valign="top"/><td valign="top"/><td valign="top"/></tr><tr><td styleCode=" Botrule " valign="top"><paragraph> Otitis media</paragraph></td><td align="center" styleCode=" Botrule " valign="top"><paragraph>1.7</paragraph></td><td align="center" styleCode=" Botrule " valign="top"><paragraph>0</paragraph></td><td align="center" styleCode=" Botrule " valign="top"><paragraph>0</paragraph></td><td align="center" styleCode=" Botrule " valign="top"><paragraph>0</paragraph></td><td align="center" styleCode=" Botrule " valign="top"><paragraph>3.3</paragraph></td></tr></tbody></table>
adverse reactions table <table><caption>Table 4: Mean Changes from Baseline Heart Rate at 30 Minutes and Glucose and Potassium at 1 Hour after First Dose (Day 1) and Last Dose (Day 21) in Children 6 to 11 Years Old</caption><col width="50%"/><col width="18%"/><col width="15%"/><col width="17%"/><tbody><tr><td styleCode=" Toprule " valign="top"/><td align="center" colspan="3" styleCode=" Botrule Toprule " valign="top"><paragraph>Mean Changes (Day 1)</paragraph></td></tr><tr><td styleCode=" Botrule " valign="bottom"><paragraph> Treatment </paragraph></td><td align="center" styleCode=" Botrule " valign="top"><paragraph>Heart Rate (bpm) </paragraph></td><td align="center" styleCode=" Botrule " valign="top"><paragraph>Glucose (mg/dL) </paragraph></td><td align="center" styleCode=" Botrule " valign="top"><paragraph>Potassium (mEq/L) </paragraph></td></tr><tr><td valign="top"><paragraph>Levalbuterol 0.31 mg, n = 66</paragraph></td><td align="center" valign="top"><paragraph>0.8</paragraph></td><td align="center" valign="top"><paragraph>4.9</paragraph></td><td align="center" valign="top"><paragraph>-0.31</paragraph></td></tr><tr><td valign="top"><paragraph>Levalbuterol 0.63 mg, n = 67</paragraph></td><td align="center" valign="top"><paragraph>6.7</paragraph></td><td align="center" valign="top"><paragraph>5.2</paragraph></td><td align="center" valign="top"><paragraph>-0.36</paragraph></td></tr><tr><td valign="top"><paragraph>Racemic albuterol 1.25 mg, n = 64</paragraph></td><td align="center" valign="top"><paragraph>6.4</paragraph></td><td align="center" valign="top"><paragraph>8.0</paragraph></td><td align="center" valign="top"><paragraph>-0.27</paragraph></td></tr><tr><td valign="top"><paragraph>Racemic albuterol 2.5 mg, n = 60</paragraph></td><td align="center" valign="top"><paragraph>10.9</paragraph></td><td align="center" valign="top"><paragraph>10.8</paragraph></td><td align="center" valign="top"><paragraph>-0.56</paragraph></td></tr><tr><td styleCode=" Botrule " valign="top"><paragraph>Placebo, n = 59</paragraph></td><td align="center" styleCode=" Botrule " valign="top"><paragraph>-1.8</paragraph></td><td align="center" styleCode=" Botrule " valign="top"><paragraph>0.6</paragraph></td><td align="center" styleCode=" Botrule " valign="top"><paragraph>-0.05</paragraph></td></tr><tr><td valign="top"/><td align="center" colspan="3" styleCode=" Botrule " valign="top"><paragraph>Mean Changes (Day 21)</paragraph></td></tr><tr><td styleCode=" Botrule " valign="bottom"><paragraph> Treatment </paragraph></td><td align="center" styleCode=" Botrule " valign="top"><paragraph>Heart Rate (bpm) </paragraph></td><td align="center" styleCode=" Botrule " valign="top"><paragraph>Glucose (mg/dL) </paragraph></td><td align="center" styleCode=" Botrule " valign="top"><paragraph>Potassium (mEq/L) </paragraph></td></tr><tr><td valign="top"><paragraph>Levalbuterol 0.31 mg, n = 60</paragraph></td><td align="center" valign="top"><paragraph>0</paragraph></td><td align="center" valign="top"><paragraph>2.6</paragraph></td><td align="center" valign="top"><paragraph>-0.32</paragraph></td></tr><tr><td valign="top"><paragraph>Levalbuterol 0.63 mg, n = 66</paragraph></td><td align="center" valign="top"><paragraph>3.8</paragraph></td><td align="center" valign="top"><paragraph>5.8</paragraph></td><td align="center" valign="top"><paragraph>-0.34</paragraph></td></tr><tr><td valign="top"><paragraph>Racemic albuterol 1.25 mg, n = 62</paragraph></td><td align="center" valign="top"><paragraph>5.8</paragraph></td><td align="center" valign="top"><paragraph>1.7</paragraph></td><td align="center" valign="top"><paragraph>-0.18</paragraph></td></tr><tr><td valign="top"><paragraph>Racemic albuterol 2.5 mg, n = 54</paragraph></td><td align="center" valign="top"><paragraph>5.7</paragraph></td><td align="center" valign="top"><paragraph>11.8</paragraph></td><td align="center" valign="top"><paragraph>-0.26</paragraph></td></tr><tr><td styleCode=" Botrule " valign="top"><paragraph>Placebo, n = 55</paragraph></td><td align="center" styleCode=" Botrule " valign="top"><paragraph>-1.7</paragraph></td><td align="center" styleCode=" Botrule " valign="top"><paragraph>1.1</paragraph></td><td align="center" styleCode=" Botrule " valign="top"><paragraph>-0.04</paragraph></td></tr></tbody></table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.