Zanamivir dosage and administration: Difference between revisions
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{{CMG}}; {{AE}} {{SS}} | {{CMG}}; {{AE}} {{SS}} | ||
==Dosage | ==Dosage and Administration== | ||
===Dosing Considerations=== | ===Dosing Considerations=== | ||
*RELENZA is for administration to the respiratory tract by oral inhalation only, using the DISKHALER® device provided [see Warnings and Precautions (5.6)]. | * RELENZA is for administration to the respiratory tract by oral inhalation only, using the DISKHALER® device provided [see Warnings and Precautions (5.6)]. | ||
* The 10-mg dose is provided by 2 inhalations (one 5-mg blister per inhalation).*Patients should be instructed in the use of the delivery system. Instructions should include a demonstration whenever possible. If RELENZA is prescribed for children, it should be used only under adult supervision and instruction, and the supervising adult should first be instructed by a healthcare professional [see Patient Counseling Information (17)].*Patients scheduled to use an inhaled bronchodilator at the same time as RELENZA should use their bronchodilator before taking RELENZA [see Patient Counseling Information (17)]. | |||
===Treatment of Influenza=== | ===Treatment of Influenza=== | ||
*The recommended dose of RELENZA for treatment of influenza in adults and pediatric patients aged 7 years and older is 10 mg twice daily (approximately 12 hours apart) for 5 days. | |||
*Two doses should be taken on the first day of treatment whenever possible provided there is at least 2 hours between doses. | * The recommended dose of RELENZA for treatment of influenza in adults and pediatric patients aged 7 years and older is 10 mg twice daily (approximately 12 hours apart) for 5 days. | ||
*On subsequent days, doses should be about 12 hours apart (e.g., morning and evening) at approximately the same time each day. | |||
*The safety and efficacy of repeated treatment courses have not been studied. | * Two doses should be taken on the first day of treatment whenever possible provided there is at least 2 hours between doses. | ||
* On subsequent days, doses should be about 12 hours apart (e.g., morning and evening) at approximately the same time each day. | |||
* The safety and efficacy of repeated treatment courses have not been studied. | |||
===Prophylaxis of Influenza=== | ===Prophylaxis of Influenza=== | ||
====Household Setting==== | ====Household Setting==== | ||
*The recommended dose of RELENZA for prophylaxis of influenza in adults and pediatric patients aged 5 years and older in a household setting is 10 mg once daily for 10 days. | * The recommended dose of RELENZA for prophylaxis of influenza in adults and pediatric patients aged 5 years and older in a household setting is 10 mg once daily for 10 days. | ||
*The dose should be administered at approximately the same time each day. | |||
*There are no data on the effectiveness of prophylaxis with RELENZA in a household setting when initiated more than 1.5 days after the onset of signs or symptoms in the index case. | * The dose should be administered at approximately the same time each day. | ||
* There are no data on the effectiveness of prophylaxis with RELENZA in a household setting when initiated more than 1.5 days after the onset of signs or symptoms in the index case. | |||
====Community Outbreaks==== | ====Community Outbreaks==== | ||
*The recommended dose of RELENZA for prophylaxis of influenza in adults and adolescents in a community setting is 10 mg once daily for 28 days. | * The recommended dose of RELENZA for prophylaxis of influenza in adults and adolescents in a community setting is 10 mg once daily for 28 days. | ||
*The dose should be administered at approximately the same time each day. | * The dose should be administered at approximately the same time each day. | ||
*There are no data on the effectiveness of prophylaxis with RELENZA in a community outbreak when initiated more than 5 days after the outbreak was identified in the community. | * There are no data on the effectiveness of prophylaxis with RELENZA in a community outbreak when initiated more than 5 days after the outbreak was identified in the community. | ||
*The safety and effectiveness of prophylaxis with RELENZA have not been evaluated for longer than 28 days’ duration.<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> | * The safety and effectiveness of prophylaxis with RELENZA have not been evaluated for longer than 28 days’ duration.<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== | ||
| Line 38: | Line 46: | ||
{{FDA}} | {{FDA}} | ||
[[Category: | [[Category:Antibiotics]] | ||
[[Category:Wikinfect]] | [[Category:Wikinfect]] | ||
Latest revision as of 23:56, 2 January 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]
Dosage and Administration
Dosing Considerations
- RELENZA is for administration to the respiratory tract by oral inhalation only, using the DISKHALER® device provided [see Warnings and Precautions (5.6)].
- The 10-mg dose is provided by 2 inhalations (one 5-mg blister per inhalation).*Patients should be instructed in the use of the delivery system. Instructions should include a demonstration whenever possible. If RELENZA is prescribed for children, it should be used only under adult supervision and instruction, and the supervising adult should first be instructed by a healthcare professional [see Patient Counseling Information (17)].*Patients scheduled to use an inhaled bronchodilator at the same time as RELENZA should use their bronchodilator before taking RELENZA [see Patient Counseling Information (17)].
Treatment of Influenza
- The recommended dose of RELENZA for treatment of influenza in adults and pediatric patients aged 7 years and older is 10 mg twice daily (approximately 12 hours apart) for 5 days.
- Two doses should be taken on the first day of treatment whenever possible provided there is at least 2 hours between doses.
- On subsequent days, doses should be about 12 hours apart (e.g., morning and evening) at approximately the same time each day.
- The safety and efficacy of repeated treatment courses have not been studied.
Prophylaxis of Influenza
Household Setting
- The recommended dose of RELENZA for prophylaxis of influenza in adults and pediatric patients aged 5 years and older in a household setting is 10 mg once daily for 10 days.
- The dose should be administered at approximately the same time each day.
- There are no data on the effectiveness of prophylaxis with RELENZA in a household setting when initiated more than 1.5 days after the onset of signs or symptoms in the index case.
Community Outbreaks
- The recommended dose of RELENZA for prophylaxis of influenza in adults and adolescents in a community setting is 10 mg once daily for 28 days.
- The dose should be administered at approximately the same time each day.
- There are no data on the effectiveness of prophylaxis with RELENZA in a community outbreak when initiated more than 5 days after the outbreak was identified in the community.
- The safety and effectiveness of prophylaxis with RELENZA have not been evaluated for longer than 28 days’ duration.[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.