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Outline
What is the generic name?
ZANAMIVIR
What is the Trade Name for ZANAMIVIR?
RELENZA
What are the Indications for ZANAMIVIR?
- 1 INDICATIONS AND USAGE RELENZA, an influenza virus neuraminidase inhibitor (NAI), is indicated for: Treatment of acute, uncomplicated influenza type A and B infections in patients aged 7 years and older who have been symptomatic for no more than 2 days. ( 1.1 ) Prophylaxis of influenza in patients aged 5 years and older. ( 1.2 ) Important Limitations of Use: Not recommended for treatment or prophylaxis of influenza in: ‚Ä¢ Individuals with underlying airways disease. ( 5.1 ) Not proven effective for: ‚Ä¢ Treatment in individuals with underlying airways disease. ( 1.3 ) ‚Ä¢ Prophylaxis in nursing home residents. ( 1.3 ) Not a substitute for annual influenza vaccination. ( 1.3 ) Consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use RELENZA. ( 1.3 ) 1.1 Treatment of Influenza RELENZA (zanamivir) inhalation powder is indicated for treatment of uncomplicated acute illness due to influenza A and B virus in adults and pediatric patients aged 7 years and older who have been symptomatic for no more than 2 days. 1.2 Prophylaxis of Influenza RELENZA is indicated for prophylaxis of influenza in adults and pediatric patients aged 5 years and older. 1.3 Important Limitations of Use ‚Ä¢ RELENZA is not recommended for treatment or prophylaxis of influenza in individuals with underlying airways disease (such as asthma or chronic obstructive pulmonary disease) due to risk of serious bronchospasm [see Warnings and Precautions ( 5.1 )] . ‚Ä¢ RELENZA has not been proven effective for treatment of influenza in individuals with underlying airways disease. ‚Ä¢ RELENZA has not been proven effective for prophylaxis of influenza in the nursing home setting. ‚Ä¢ RELENZA is not a substitute for early influenza vaccination on an annual basis as recommended by the Centers for Disease Control’s Immunization Practices Advisory Committee. ‚Ä¢ Influenza viruses change over time. Emergence of resistance mutations could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use RELENZA. ‚Ä¢ There is no evidence for efficacy of zanamivir in any illness caused by agents other than influenza virus A and B. ‚Ä¢ Patients should be advised that the use of RELENZA for treatment of influenza has not been shown to reduce the risk of transmission of influenza to others.
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References: https://open.fda.gov/
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