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Relenza®

Brand Name: Relenza®
Active Ingredient:   zanamivir for inhalation
Dosage Form(s):   Relenza Rotadisk with Diskhaler Inhalation Device
Company Name:    Glaxo Wellcome Inc.
Availability:         Prescription only
*Date Approved by the FDA:   July 26, 1999
*Approval by FDA does not mean that the drug is available for consumers at this time.




What is Relenza used for?

Relenza is used to treat uncomplicated illness due to influenza virus in people 7 years and older who have been symptomatic for no more than 2 days.

Special Warnings with Relenza:

Some patients have had bronchospasm (wheezing) or serious breathing problems when they used Relenza. Many but not all of these patients had previous asthma or chronic obstructive pulmonary disease. Relenza has not been shown to shorten the duration of influenza in people with these diseases. Because of the risk of side effects and because it has not been shown to help them, Relenza is not generally recommended for people with chronic respiratory disease such as asthma or chronic obstructive pulmonary disease.
  • If you have lung disease you should have a fast-acting inhaled bronchodilator available while being treated with Relenza. If your breathing worsens, stop using Relenza and call your health care provider.
  • General Precautions with Relenza:

  • Relenza is not used to prevent the flu or to decrease the risk of transmitting the virus to others.
  • Relenza has not been shown to treat flu-like illnesses caused by any virus other than influenza A and B (e.g., stomach flu, common cold, or other respiratory illnesses not caused by influenza).
  • Stop taking Relenza and contact your health care provider if you experience signs or symptoms of an allergic reaction such as shortness of breath, swelling of eyelids, face, or lips or a skin rash.
  • Other kinds of infections can appear like influenza or occur along with influenza, and need different types of treatment. Contact your health care provider if you feel worse or develop new symptoms during or after treatment, or if your influenza symptoms do not start to get better.
  • Taking Relenza should not affect your decision to have an annual influenza vaccination.
  • The safety and efficacy of repeated courses of treatment have not been established.
  • If you use a bronchodilator and are scheduled to use it at the same time as Relenza, use your bronchodilator first before using Relenza.
  • What should I tell my doctor or health care provider?

    Tell your health care provider if you:

    are taking any other medications
  • have chronic lung disease such as asthma or chronic obstructive pulmonary disease.
  • are trying to become pregnant, are already pregnant, or are breast-feeding.
  • What are some possible side effects of Relenza? (This list is NOT a complete list of side effects reported with Relenza. Your health care provider can discuss with you a more complete list of side effects.)

    See the "Warnings" and "Precautions" sections for information about the risk of bronchospasm and allergic-like reactions.

    Other side effects may include:

    • headache
    • diarrhea
    • nausea
    • vomiting
    • nasal irritation
    • bronchitis
    • cough
    • sinus inflammation
    • ear, nose and throat infections
    • dizziness

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

    http://www.fda.gov/cder/foi/label/1999/21036lbl.pdf    Link to Relenza's approved label and patient information 

    Updated 10/5/00

     

    Back to Drug Side Effects


    source: FDA


    last update: December 2004





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