Zanamivir dosage and administration

Zanamivir
RELENZA® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Overdosage
Clinical Studies
Dosage and Administration
Directions for Use
How Supplied
Labels and Packages

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.

References

Adapted from the FDA Package Insert.