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What should I discuss with my healthcare provider before using levalbuterol inhalation (Xopenex, Xopenex Concentrate, Xopenex HFA)?

Before using levalbuterol inhalation, tell your doctor if you have

• heart disease, an irregular heartbeat, or high blood pressure;
• a seizure disorder;
• diabetes; or
• an overactive thyroid (hyperthyroidism).

You may not be able to use levalbuterol inhalation or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Levalbuterol inhalation is in the FDA pregnancy category C. This means that it is not known whether levalbuterol inhalation will be harmful to an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant.

It is not known whether levalbuterol passes into breast milk. Do not use levalbuterol inhalation without first talking to your doctor if you are breast-feeding a baby.

Levalbuterol inhalation is not approved for use by children younger than 6 years of age.

How should I use levalbuterol inhalation (Xopenex, Xopenex Concentrate, Xopenex HFA)?

Use levalbuterol inhalation exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

To use the solution for nebulization:

• Open one vial by tearing on the serrated edge along the seam of the foil pouch. Remove one unit-dose vial for immediate use. Keep the rest of the unused unit-dose vial in the foil pouch to protect them from light. Carefully twist open the top of one unit-dose vial and squeeze the entire contents into the nebulizer reservoir (drug chamber).
• Attach the nebulizer reservoir to the mouthpiece or face mask. Then, attach the nebulizer to the compressor. Sit upright, in a comfortable position, and put the mouthpiece into your mouth or put the face mask on, covering the nose and mouth. Turn on the compressor. Breathe slowly, deeply, and evenly until all of the medicine has been inhaled (usually 5 to 15 minutes). The treatment is complete when no more mist is formed by the nebulizer and the drug chamber is empty.
• Clean the nebulizer after a treatment as directed by the manufacturer.

If you also use a steroid inhaler, use your levalbuterol nebulization solution first to open up your airways, then use the steroid inhaler as directed.

Do not mix other medicines for nebulization with a dose of levalbuterol unless specifically directed to do so by your doctor.

It is very important that you use nebulized levalbuterol properly, so that the medicine gets into your lungs. Talk to your doctor about proper nebulizer use.

Do not use more of this medication, or use doses more frequently, than directed by your doctor. Seek medical attention if you notice that you require more than your usual or more than the maximum amount of any asthma medication in a 24-hour period. An increased need for medication could be an early sign of a serious asthma attack.

Store levalbuterol in the protective foil pouch at room temperature, protected from light and excessive heat. Once the foil pouch is opened, the vials should be used within two weeks. Once an individual vial is removed from the foil pouch, if it is not to be used immediately, it should be protected from light and used within one week. Once an individual vial is opened, it should be used immediately or discarded. Discard the vial if the solution is not colorless.

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