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Oseltamivir carboxylate - Tamiflu®

Usual Dosing (Adults)


Treatment of influenza
  • Adults and adolescents (13 years and older): 75 mg twice daily for 5 days
  • Pediatric patients 1 to 12 years of age: Based on weight twice daily for 5 days
  • Pediatric patients 2 weeks to less than 1 year of age: 3mg/kg twice daily for 5 days.
  • Renally impaired adult patients (creatinine clearance >30-60 mL/min): Reduce to 30 mg twice daily for 5 days
  • Renally impaired adult patients (creatinine clearance >10-30 mL/min): Reduce to 30 mg once daily for 5 days
  • ESRD patients on hemodialysis: Reduce to 30 mg after every hemodialysis cycle. Treatment duration not to exceed 5 days
  • ESRD patients on CAPD: Reduce to a single 30 mg dose administered immediately after a dialysis exchange
Prophylaxis of influenza
  • Adults and adolescents (13 years and older): 75 mg once daily for at least 10 days
    Community outbreak: 75 mg once daily for up to 6 weeks
  • Pediatric patients 1 to 12 years of age: Based on weight once daily for 10 days
    Community outbreak: Based on weight once daily for up to 6 weeks
  • Renally impaired adult patients (creatinine clearance >30-60 mL/min): Reduce to 30 mg once daily
  • Renally impaired adult patients (creatinine clearance >10-30 mL/min): Reduce to 30 mg once every other day
  • ESRD patients on hemodialysis: Reduce to 30 mg after alternate hemodialysis cycles for the recommended duration of prophylaxis
  • ESRD patients on CAPD: Reduce to 30 mg once weekly immediately after dialysis exchange for the recommended duration of prophylaxis

Renal Dosing

dialysis Treatment of Influenza
Dose adjustment is recommended for adult patients with creatinine clearance between 10 and 60 mL/min and patients with end-stage renal disease (ESRD) undergoing hemodialysis or continuous peritoneal dialysis receiving TAMIFLU for the treatment of influenza. TAMIFLU is not recommended for patients with ESRD not undergoing dialysis. The recommended doses are detailed in Table 2 below.

Table 2 Recommended Dose Adjustments for Treatment of Influenza in Adult Patients with Renal Impairment or End Stage Renal Disease (ESRD) on Dialysis
Renal Impairment/Creatinine Clearance Recommended Treatment Regimen*
Mild
Creatinine Clearance >60-90 mL/min
75 mg twice daily for 5 days
Moderate
Creatinine Clearance >30-60 mL/min
30 mg twice daily for 5 days
Severe
Creatinine Clearance >10-30 mL/min
30 mg once daily for 5 days
ESRD Patients on Hemodialysis
Creatinine Clearance leq10 mL/min
30 mg after every hemodialysis cycle. Treatment duration not to exceed 5 days†
ESRD Patients on Continuous Ambulatory Peritoneal Dialysis‡
Creatinine Clearance leq10 mL/min
A single 30 mg dose administered immediately after a dialysis exchange
*Capsules or suspension can be used for 30 mg dosing.

Assuming three hemodialysis sessions are performed in the 5-day period. Treatment can be initiated immediately if influenza symptoms develop during the 48 hours between hemodialysis sessions; however, the post-hemodialysis dose should still be administered independently of time of administration of the initial dose.

Data derived from studies in continuous ambulatory peritoneal dialysis (CAPD) patients.

Prophylaxis of Influenza
For the prophylaxis of influenza, dose adjustment is recommended for adult patients with creatinine clearance between 10 and 60 mL/min and patients with end-stage renal disease (ESRD) undergoing hemodialysis or continuous peritoneal dialysis receiving TAMIFLU [see Clinical Pharmacology (12.3)]. The duration of prophylaxis is the same as recommended for patients with normal renal function. TAMIFLU is not recommended for patients with ESRD not undergoing dialysis. The recommended doses are detailed in Table 3 below.

Table 3 Recommended Dose Adjustments for Prophylaxis of Influenza in Adult Patients with Renal Impairment or End Stage Renal Disease (ESRD) on Dialysis
Renal Impairment/Creatinine Clearance Recommended Prophylaxis Regimen*
Mild
Creatinine Clearance >60-90 mL/min
75 mg once daily
Moderate
Creatinine Clearance >30-60 mL/min
30 mg once daily
Severe
Creatinine Clearance >10-30 mL/min
30 mg every other day
ESRD Patients on Hemodialysis
Creatinine Clearance leq10 mL/min
30 mg after alternate hemodialysis cycles†
ESRD Patients on Continuous Ambulatory Peritoneal Dialysis‡
Creatinine Clearance leq10 mL/min
30 mg once weekly immediately after dialysis exchange
*Capsules or suspension can be used for 30 mg dosing.
†An initial dose can be administered prior to the start of dialysis.
‡Data derived from studies in continuous ambulatory peritoneal dialysis (CAPD) patients.


Hemodialysis

dialysis See above

Reference(s)

National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Please review the latest applicable package insert for additional information and possible updates.  A local search option of this data can be found here.

Disclaimer

The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.   Read the disclaimer
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