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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 taking this medication, some individuals may experience common side effects that are generally mild. For those aged 12 and older, these can include asthma (9%), sore throat (8%), runny nose (7%), body pain (4%), and dizziness (3%). Children between the ages of 4 and 11 might experience vomiting (11%), sore throat (7%), and bronchitis (3%). While these symptoms are typically not severe, if they persist or become bothersome, it is advisable to consult with a healthcare provider for guidance.

There are also other side effects reported by some users, such as asthma, sore throat, runny nose, body pain, and dizziness. These are usually not alarming, but should be monitored, and medical advice should be sought if they worsen.

However, there are rare but serious side effects that require immediate medical attention. These include vomiting, sore throat, and bronchitis. Should any of these severe symptoms occur, it is crucial to seek urgent medical care to ensure safety and well-being.