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Xopenex Patient, Information, Instructions - Levalbuterol

Xopenex Patient, Information, Instructions - Levalbuterol

PATIENT INFORMATION

The action of Xopenex (levalbuterol HCl) Inhalation Solution may last up to 8 hours. Xopenex Inhalation Solution should not be used more frequently than recommended. Do not increase the dose or frequency of dosing of Xopenex Inhalation Solution without consulting your physician. If you find that treatment with Xopenex Inhalation Solution becomes less effective for symptomatic relief, your symptoms become worse, and/or you need to use the product more frequently than usual, you should seek medical attention immediately. While you are taking Xopenex Inhalation Solution, other inhaled drugs and asthma medications should be taken only as directed by your physician. Common adverse effects include palpitations, chest pain, rapid heart rate, headache, dizziness, and tremor or nervousness. If you are pregnant or nursing, contact your physician about the use of Xopenex Inhalation Solution.

Effective and safe use of Xopenex Inhalation Solution requires consideration of the following information in addition to that provided under Patient’s Instructions for Use:

Xopenex Inhalation Solution single-use low-density polyethylene (LDPE) vials should be protected from light and excessive heat. Store in the protective foil pouch between 15°C and 25°C (59°F and 77°F). Do not use after the expiration date stamped on the container. Unused vials should be stored in the protective foil pouch. Once the foil pouch is opened, the vials should be used within two weeks. Discard if the solution is not colorless.

The drug compatibility (physical and chemical), efficacy, and safety of Xopenex Inhalation Solution when mixed with other drugs in a nebulizer have not been established.

Read complete instructions carefully before using.

  1. Open 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 vials in the foil pouch to protect them from light.
  2. Carefully twist open the top of one unit-dose vial and squeeze the entire contents into the nebulizer reservoir.
  3. Connect the nebulizer reservoir to the mouthpiece or face mask.
  4. Connect the nebulizer to the compressor.
  5. Sit in a comfortable, upright position. Place the mouthpiece in your mouth (or put on the face mask) and turn on the compressor.
  6. Breathe as calmly, deeply, and evenly as possible until no more mist is formed in the nebulizer reservoir (about 5 to 15 minutes). At this point, the treatment is finished.
  7. Clean the nebulizer (see manufacturer’s instructions).

Note: Xopenex (levalbuterol HCl) Inhalation Solution should be used in a nebulizer only under the direction of a physician. More frequent administration or higher doses are not recommended. This solution should not be injected or administered orally. Protect from light and excessive heat. Store in the protective foil pouch between 15°C and 25°C (59°F and 77°F). Keep unopened vials in the foil pouch. 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.

The safety and effectiveness of Xopenex Inhalation Solution have not been determined when one or more drugs are mixed with it in a nebulizer. Check with your doctor before mixing any medication in your nebulizer.

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