Tamiflu - Globally Endorsed in the Treatment and Prevention of Influenza

Roche®, based on its own production figures, estimates around 50 million people worldwide have been treated with Tamiflu. Influenza virus drug sensitivity monitoring has confirmed that current pandemic H1N1 and avian H5N1 strains remain sensitive to Tamiflu. Where practicable, in accordance with best practice guidelines, the prescription of anti-influenza drugs during seasonal influenza outbreaks should be guided by current local virus sensitivity data from the relevant authority (11).

Tamiflu® has been endorsed internationally as an effective and safe (7, 8, 9, 10, 11, 23, 24, 25, 26, 27, 28) anti-influenza agent with significant utility in both the treatment and prevention of Influenza A and Influenza B infection; this in the absence of a superior comparator, its ease of administration and simple dosing schedules have made Tamiflu® the drug of choice in the management and containment of Influenza throughout the world (11). Tamiflu® (oseltamivir phosphate ) Prescribing Data

Tamiflu® is presented as capsules containing 30mg (light yellow hard gel caps), 45mg (grey hard gel caps) or 75mg (grey/light yellow hard gel caps) of oseltamivir as the phosphate salt for oral administration. Roche and dosage are printed on each capsule in blue ink. Capsules are available as blister packages of 10 capsules. Tamiflu® is also available in bottles as a powder for reconstitution to an oral suspension, which when reconstituted with water as directed contains 12mg/mL of oseltamivir base. Not to be stored at ambient temperatures above 30°C.

Indications

Tamiflu® is indicated for the treatment and prevention of infections due to influenza Viruses of type A and B in adults and children one year of age or older.

Dosage

Treatment of Influenza in Adults and Adolescents aged 13 years or older: The recommended dose of Tamiflu® is 75mg twice daily for five days. Treatment should be commenced within 48hrs of onset of symptoms. Capsules may be taken with food

Prophylaxis of Influenza in Adults and Adolescents aged 13 years or older: The recommended dose of Tamiflu® is 75mg once daily for at least ten days. Treatment should commence within 48hrs of exposure. Safety and efficacy have been demonstrated for up to 6 weeks. The period of has protection as been determined to be as long as the dosing is continued. Capsules may be taken with food.

Treatment of Influenza in Paediatric Patients: The recommended dose of Tamiflu for children aged 1 yr or older is shown in Table 1. Tamiflu oral suspension may be used in patients unable to swallow a capsule. Table 1: Oral Dose of Tamiflu® for the Treatment of Influenza in Paediatric Patients by Weight Body Weight (kg) Body Weight (lbs) Recommended Dose for 5 Days No. Of Bottles of Tamiflu® Susp Needed for dose 5 Day Regimen No. Of Tamiflu® Capsules Required for a 5 Day Regimen ≤15kg ≤33lbs 30mg twice daily 1 10 Tamiflu® Caps (30mg) >15kg to 23kg >33lbs to 51lbs 45mg twice daily 2 10 Tamiflu® Caps (45mg) >23kg to 40kg >51lbs to 88lbs 60mg twice daily 2 20 Tamiflu® Caps (30mg) >40kg >88lbs 75mg twice daily 3 10 Tamiflu® Caps (75mg)

Prophylaxis of Influenza in Paediatric Patients: The recommended dose of Tamiflu® for children aged 1 year or older is shown in Table 2. Tamiflu® oral suspension may be used in patients unable to swallow a capsule. Table 2: Oral Dose of Tamiflu® for Prophylaxis of Influenza in Paediatric Patients by Weight. Body Weight (kg) Body Weight (lbs) Recommended Dose for 10 days No. Of Bottles of Tamiflu® Susp Needed for a 10 Day Regimen No. Of Tamiflu® Capsules Required for a 10 Day Regimen ≤15kg ≤33lbs 30mg once daily 1 10 Tamiflu® Caps (30mg) >15kg to 23kg >33lbs to 51lbs 45mg once daily 2 10 Tamiflu® Caps (45mg) >23kg to 40kg >51lbs to 88lbs 60 mg once daily 2 20 Tamiflu® Caps (30mg) >40kg >88lbs 75 mg once daily 3 10 Tamiflu® Caps (75mg)

Special Precautions and Dosage Instructions

Pregnancy and Nursing Mothers: To date research suggests that any risk associated with the use of Tamiflu® during pregnancy or nursing mothers to be extremely low. However, the use of Tamiflu® in these clinical instances is indicated only if the potential benefit justifies any potential risk to the foetus or breast-fed infant (11, 23).