Posology : מינונים

4.2   Posology and method of administration

Posology
75 mg doses can be administered as either
-    one 75 mg capsule or
-    one 30 mg capsule plus one 45 mg capsule or
-

Adults, and adolescents 13 years and over

Treatment: The recommended oral dose is 75 mg oseltamivir twice daily for 5 days for adolescents (13 to 17 years of age) and adults.

Body Weight                         Recommended dose for 5 days
> 40 kg                                75 mg twice daily

Treatment should be initiated as soon as possible within the first two days of onset of symptoms of influenza.
Post-exposure prevention: The recommended dose for prevention of influenza following close contact with an infected individual is 75 mg oseltamivir once daily for 10 days for adolescents (13 to 17 years of age) and adults.

Body Weight                        Recommended dose for 10 days
> 40 kg                               75 mg once daily

Therapy should begin as soon as possible within two days of exposure to an infected individual.
Prevention during an influenza epidemic in the community: The recommended dose for prevention of influenza during a community outbreak is 75 mg oseltamivir once daily for up to 6 weeks. Safety has been demonstrated for up to 12 weeks in immunocompromised patients. The duration of protection lasts for as long as dosing is continued.

Paediatric population

Children 1 to 12 years of age
Tamiflu 30 mg, 45 mg and 75 mg capsules are available for children 1 year of age or older 

Treatment: The following weight-adjusted dosing regimens are recommended for treatment of children 1 year of age or older:
Body Weight                     Recommended dose for 5 days
15 kg or less                             30 mg twice daily
> 15 kg to 23 kg                          45 mg twice daily
> 23 kg to 40 kg                          60 mg twice daily
> 40 kg                                   75 mg twice daily

Treatment should be initiated as soon as possible within the first two days of onset of symptoms of influenza.

Post-exposure prevention: The recommended post-exposure prevention dose of Tamiflu is: Body Weight                    Recommended dose for 10 days
15 kg or less                           30 mg once daily
> 15 kg to 23 kg                        45 mg once daily
> 23 kg to 40 kg                        60 mg once daily
> 40 kg                                 75 mg once daily

Prevention during an influenza epidemic in the community: For prophylaxis in pediatric patients during a community outbreak of oseltamivir susceptible influenza, dosing may be continued for up to 6 weeks.

Special populations

Hepatic impairment
No dose adjustment is required either for treatment or for prevention in patients with mild or moderate hepatic impairment (Child-Pugh score <9). The safety and pharmacokinetics in patients with severe hepatic impairment have not been evaluated.

Renal impairment
Treatment of influenza: Dose adjustment is recommended for adults and adolescents (13 to 17 years of age) with moderate or severe renal impairment. Recommended doses are detailed in the table below.
Creatinine clearance                               Recommended dose for treatment 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 patient not undergoing dialisis               Not recommended
ESRD Patients on Hemodialysis Creatinine           30 mg after each haemodialysis session Clearance ≤10 mL/min                               Treatment duration not to exceed 5 days* ESRD Patients on Continuous Ambulatory             30 mg single dose administered immediately Peritoneal Dialysis** Creatinine Clearance ≤10     after a dialysis exchange mL/min
*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.

Prevention of influenza: Dose adjustment is recommended for adults and adolescents (13 to 17 years of age) with moderate or severe renal impairment as detailed in the table below. The duration of prophylaxis is the same as recommended for patients with normal renal function.

Creatinine clearance                          Recommended dose for prevention 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 second day ESRD patient not undergoing dialisis                           Not recommended ESRD Patients on Hemodialysis Creatinine          30 mg after every second haemodialysis session* Clearance ≤10 mL/min


ESRD Patients on Continuous Ambulatory                30 mg once weekly immediately after dialysis Peritoneal Dialysis** Creatinine Clearance ≤10                          exchange mL/min
*An initial dose can be administered prior to the start of dialysis.
** Data derived from studies in continuous ambulatory peritoneal dialysis (CAPD) patients.

Elderly
No dose adjustment is required for geriatric patients.

Immunocompromised patients
Treatment: In immunocompromised patients the excretion of influenza virus is longer than in non- immunocompromised patients and it might be reduced by a 10-days treatment.
Seasonal prophylaxis: Safety has been demonstrated for up to 12 weeks in immunocompromised patients.

Method of administration
Oral use.