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This document outlines essential safety and warning information related to the use of levalbuterol (Xopenex HFA). Please read the following information carefully and consult your healthcare provider if you have any concerns or questions.

• Breathing Problems: In rare cases, levalbuterol (Xopenex HFA) can induce a bronchospasm, which may result in breathing difficulties, wheezing, coughing, and chest discomfort. Seek immediate medical attention if you experience trouble breathing immediately after using the medication.

• Heart Problems: This medication can potentially affect your blood pressure, heart rate, and heart rhythm, though such effects are unlikely if used as directed. If you have pre-existing heart conditions or hypertension, your healthcare provider may recommend regular monitoring of your blood pressure and heart rate at home. Avoid exceeding the recommended dosage. Report any symptoms such as dizziness, fatigue, tremors, rapid heartbeat, or weakness to your provider. Risks include high blood pressure, heart failure, and irregular heart rhythms.

• Allergic Reactions: There is a possibility of allergic reactions, including severe reactions such as facial swelling, anaphylaxis, or shock. Immediate medical attention is required if you experience symptoms like hives, rash, swelling of the lips or tongue, or difficulty breathing.

• Low Potassium Levels: Overuse of levalbuterol (Xopenex HFA) can lead to reduced potassium levels in the blood, presenting symptoms like fatigue, muscle cramps, a rapid heartbeat, and tingling sensations in the extremities. These symptoms are usually mild and resolve over time. Consult your healthcare provider if you find the need to use the medication more frequently than advised. They may need to adjust your asthma treatment plan.

• Contraindications: Do not use levalbuterol (Xopenex HFA) if you have an allergy to it or its related compound, albuterol. Always consult with your healthcare provider before starting this medication if any of these conditions apply to you.

When using Xopenex HFA (levalbuterol), it's important to be aware of potential interactions with other medications:

• Other Short-Acting Bronchodilators or Epinephrine: Using Xopenex HFA alongside other short-acting bronchodilators or epinephrine can increase the risk of cardiovascular side effects. If additional adrenergic drugs are necessary, they should be used cautiously.

• Beta-Blockers: Beta-blockers, commonly prescribed for heart conditions, can reduce the effectiveness of Xopenex HFA and may lead to severe bronchospasm in individuals with asthma. Therefore, beta-blockers are generally not recommended for asthma patients. In situations where their use is unavoidable, cardioselective beta-blockers may be considered with caution.

• Diuretics: Non-potassium-sparing diuretics, such as loop and thiazide diuretics, can cause changes in heart rhythm or lower potassium levels. These effects may be intensified when combined with Xopenex HFA. Monitoring potassium levels is advisable when these medications are used together.

• Digoxin: Studies have shown that using albuterol (a drug similar to levalbuterol) with digoxin can decrease digoxin levels in the body. While the significance of this interaction with Xopenex HFA is not fully understood, it's prudent to monitor digoxin levels if both medications are used concurrently.

• Monoamine Oxidase Inhibitors (MAOIs) and Tricyclic Antidepressants: These types of antidepressants can enhance the cardiovascular effects of Xopenex HFA. It's recommended to avoid using Xopenex HFA if you are currently taking, or have recently stopped taking, MAOIs or tricyclic antidepressants within the past two weeks.

• Stimulants: Medications like Methylphenidate (used for ADHD) can increase blood pressure and heart rate. Combining these with Xopenex HFA may amplify these effects. Consult your doctor before using these medications together.

• Thyroid Hormone Replacements: Drugs such as Levothyroxine can also raise heart rate and blood pressure. Using them with Xopenex HFA may further increase these effects. Discuss with your healthcare provider if you are on thyroid hormone therapy.

• Pseudoephedrine: Commonly found in decongestants, pseudoephedrine can elevate heart rate and blood pressure. Using it alongside Xopenex HFA may enhance these effects. Seek medical advice before combining these medications.

• Theophylline: Used for respiratory diseases, theophylline can interact with Xopenex HFA, potentially increasing side effects like nervousness or heart palpitations. Consult your doctor if you are prescribed both medications.

Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking to ensure safe and effective use of Xopenex HFA.