Zanamivir indications and usage: Difference between revisions
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{{CMG}}; {{AE}} {{SS}} | {{CMG}}; {{AE}} {{SS}} | ||
==Indications | ==Indications and Usage== | ||
===Treatment of Influenza=== | ===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. | 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. | ||
===Prophylaxis of Influenza=== | ===Prophylaxis of Influenza=== | ||
RELENZA is indicated for prophylaxis of influenza in adults and pediatric patients aged 5 years and older. | RELENZA is indicated for prophylaxis of influenza in adults and pediatric patients aged 5 years and older. | ||
===Important Limitations on Use of RELENZA=== | ===Important Limitations on Use of RELENZA=== | ||
*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)]. | * 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)]. | ||
*RELENZA has not been proven effective for treatment of influenza in individuals with underlying airways disease.*RELENZA has not been proven effective for prophylaxis of influenza in the nursing home setting. | |||
* RELENZA has not been proven effective for treatment of influenza in individuals with underlying airways disease.*RELENZA has not been proven effective for prophylaxis of influenza in the nursing home setting. | |||
*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.*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.*There is no evidence for efficacy of zanamivir in any illness caused by agents other than influenza virus A and B.*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.<ref>{{Cite web | last = | first =|title = http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021036s019lbl.pdf | url =http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021036s019lbl.pdf | publisher = |date = | accessdate = }}</ref> | * 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.*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.*There is no evidence for efficacy of zanamivir in any illness caused by agents other than influenza virus A and B.*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.<ref>{{Cite web | last = | first =|title = http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021036s019lbl.pdf | url =http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021036s019lbl.pdf | publisher = |date = | accessdate = }}</ref> | ||
==References== | ==References== | ||
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{{FDA}} | {{FDA}} | ||
[[Category: | [[Category:Antibiotics]] | ||
[[Category:Wikinfect]] | [[Category:Wikinfect]] | ||
Latest revision as of 23:52, 2 January 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]
Indications and Usage
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.
Prophylaxis of Influenza
RELENZA is indicated for prophylaxis of influenza in adults and pediatric patients aged 5 years and older.
Important Limitations on Use of RELENZA
- 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)].
- RELENZA has not been proven effective for treatment of influenza in individuals with underlying airways disease.*RELENZA has not been proven effective for prophylaxis of influenza in the nursing home setting.
- 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.*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.*There is no evidence for efficacy of zanamivir in any illness caused by agents other than influenza virus A and B.*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.[1]
References
- ↑ "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021036s019lbl.pdf" (PDF). External link in
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Adapted from the FDA Package Insert.