Xopenex®
Brand Name: Xopenex®
Active Ingredient:   levalbuterol HCl
Strength(s): 0.63mg/3ml & 1.25mg/3ml unit dose vials
Dosage Form(s):   Inhalation solution
Availability:         Prescription only
Company Name:    Sepracor Inc.
*Date Approved by FDA:   March 25, 1999
*Approval by FDA does not mean that a new drug will be immediately marketed and available to consumers.

What is Xopenex used for? Xopenex is used to treat or prevent narrowing of the airways, (bronchospasm), in adults and children 12 years of age and older with reversible obstructive airway disease, e.g., asthma. The safety and effectiveness of Xopenex in children less than 12 years of age has not been established.

Who should not take Xopenex?

You should not take Xopenex if you have had any type of reaction to medicines containing levalbuterol or albuterol.

Special Warnings with Xopenex:

  • Xopenex can produce a narrowing of the airways called paradoxical bronchospasm in some patients, which may be life threatening. If pardoxical bronchospasm occurs, you should stop taking Xopenex, use an alternate treatment, and contact your doctor immediately.
  • If you begin to need more doses of Xopenex than usual, it may be a sign of worsening asthma, and you should contact your doctor.
  • Your doctor may need to prescribe other medications in addition to Xopenex to help control your asthma. Do not stop taking other asthma medications unless advised by your doctor.
  • Xopenex can cause significant heart-related side effects, such as an increase in pulse, blood pressure, and/or related symptoms. If you have a heart condition, your doctor will determine if Xopenex is right for you.
  • Do not use more Xopenex than is recommended by your doctor. Deaths have been reported with similar inhaled medications in asthma patients who use too much

General Precautions with Xopenex: 

If you currently have, or have a history of the following conditions, your health care provider will evaluate you to decide if Xopenex is right for you:

  • Heart disease, (e.g., reduced heart circulation, high blood pressure, and irregular heartbeat)
  • Seizures
  • High levels of thyroid hormone
  • Diabetes
  • Reactions to medications similar to Xopenex

How should I take Xopenex?

A nebulizer is used to administer Xopenex inhalation solution. Do not drink Xopenex.

Before using Xopenex, be sure you read the Patient’s Instructions for Use leaflet.

Take Xopenex as directed by your doctor. Do not increase your dose or the number of times you use Xopenex without advice from your doctor. If the dose you are taking does not provide the relief you expect, contact your doctor immediately, because this could be a sign of worsening asthma.

Unused vials of Xopenex should be stored in their protective foil pouch. Once the foil pouch is opened, the remaining vials should be used within 2 weeks. Vials removed from the pouch, if not used immediately they should be protected from light and heat and used within 2 weeks. Throw away any vials of Xopenex solution that are not colorless.

Do not mix Xopenex with other drugs in your nebulizer. Talk to your doctor before mixing any medications in your nebulizer.

What should I avoid while taking Xopenex?

Because certain other medications can interact with Xopenex, review all medications that you are taking with your doctor, including those that you take without a prescription.

The effect of Xopenex may last up to 8 hours in some patients. If you feel that Xopenex is not providing the relief you expect, your symptoms become worse, and/or you need to use Xopenex more often than usual, do not increase the dose or increase the number of doses of Xopenex you use without first talking to your doctor.

Tell your doctor if you are trying to become pregnant, are already pregnant, or are breast-feeding.

What are some possible side effects of Xopenex? (This is NOT a complete list of side effects reported with Xopenex. Your health care provider can discuss with you a more complete list of side effects.)

Side effects of Xopenex may depend on the dose. Xopenex may result in some temporary increase in heart rate, tremor, and nervousness.

For more detailed information about Xopenex, ask your health care provider.

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Posted 4/20/99