Tamiflu Oral Suspension Powder 6 mg/mL (Oseltamivir Phosphate)

Adult dose

Influenza A and influenza B virus infections: Start treatment on the first or second day after the onset of influenza symptoms. This medicine may be administered regardless of food intake, although tolerability may improve in some patients when taken with food. Adults and adolescents 13 years of age and older: Administer 75 mg of oseltamivir orally twice daily for 5 days. Adults and adolescents 13 years of age and older who have difficulty swallowing capsules should use this medicine. Patients with renal impairment (treatment): No dose adjustment is necessary in patients with creatinine clearance of 60 mL/min or more. For patients with creatinine clearance of 30 ~ 60 mL/min, a reduced dose of 30 mg twice daily for 5 days is recommended. For patients with creatinine clearance of 10 ~ 30 mL/min, a reduced dose of 30 mg once daily for 5 days is recommended. Patients receiving periodic hemodialysis should receive a 30mg dose of this medicine after each dialysis session to maintain plasma concentrations within the therapeutic range; treatment should not exceed 5 days. If influenza symptoms develop during the 48 hours between dialysis sessions, the dose may be administered before dialysis begins. For peritoneal dialysis, a single 30mg dose of this medicine after dialysis is recommended. The pharmacokinetics of oseltamivir have not been studied in patients with end-stage renal disease who are not receiving dialysis (e.g., creatinine clearance below 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment (treatment): No dose adjustment is necessary for treatment of adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9). Prevention of influenza A and influenza B virus infections Adults and adolescents 13 years of age and older: For close contact with an infected person, administer 75 mg of oseltamivir orally once daily for 10 days. Begin administration within 2 days of contact with the infected person. The recommended dose for prevention during an influenza epidemic is 75 mg once daily. The safety and efficacy of this medicine have been demonstrated for up to 6 weeks. The preventive effect continues while taking this medicine. Patients with renal impairment (prevention): No dose adjustment is necessary in patients with creatinine clearance of 60 mL/min or more. For patients with creatinine clearance of 30 ～ 60 mL/min, a reduced dose of 30 mg once daily is recommended. For patients with creatinine clearance of 10 ～ 30 mL/min, a reduced dose of 30 mg once daily every other day is recommended. Patients receiving periodic hemodialysis should receive a 30mg dose of this medicine after every 2 dialysis sessions to maintain plasma concentrations within the therapeutic range. The initial dose may also be administered before dialysis begins. For peritoneal dialysis, administration of 30mg of this medicine after dialysis once weekly is recommended. The pharmacokinetics of oseltamivir have not been studied in patients with end-stage renal disease who are not receiving dialysis (e.g., creatinine clearance below 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment (prevention): No dose adjustment is necessary for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

Treatment of influenza A and influenza B virus infections — Children aged 1 to 12 years: Pediatric patients weighing more than 40 kg who can swallow capsules may take 75mg capsules twice daily or 30mg and 45mg capsules twice daily instead of the recommended dose of this medicine. Children aged 1 to 12 years, body weight ≤ 15 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily Children aged 1 to 12 years, body weight 15 kg<, ≤ 23 kg: 45 mg twice daily; suspension (6mg/mL) 7.5 mL twice daily Children aged 1 to 12 years, body weight 23 kg<, ≤ 40 kg: 60 mg twice daily; suspension (6mg/mL) 10.0 mL twice daily Children aged 1 to 12 years, body weight > 40 kg: 75 mg twice daily; suspension (6mg/mL) 12.5 mL twice daily Infants aged 2 weeks to under 1 year: The recommended dose for infants aged 2 weeks to 12 months is 3mg/kg of this medicine orally twice daily for 5 days. This does not apply to infants with a postconceptional age below 36 weeks. Infants aged 2 weeks to under 1 year, body weight 3 kg: 9 mg twice daily; suspension (6mg/mL) 1.5 mL twice daily Infants aged 2 weeks to under 1 year, body weight 4 kg: 12 mg twice daily; suspension (6mg/mL) 2.0 mL twice daily Infants aged 2 weeks to under 1 year, body weight 5 kg: 15 mg twice daily; suspension (6mg/mL) 2.5 mL twice daily Infants aged 2 weeks to under 1 year, body weight 6 kg: 18 mg twice daily; suspension (6mg/mL) 3.0 mL twice daily Infants aged 2 weeks to under 1 year, body weight 7 kg: 21 mg twice daily; suspension (6mg/mL) 3.5 mL twice daily Infants aged 2 weeks to under 1 year, body weight 8 kg: 24 mg twice daily; suspension (6mg/mL) 4.0 mL twice daily Infants aged 2 weeks to under 1 year, body weight 9 kg: 27 mg twice daily; suspension (6mg/mL) 4.5 mL twice daily Infants aged 2 weeks to under 1 year, body weight 10 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily * This table does not include all possible weights in this patient group. A dose of 3mg/kg of this medicine is recommended for infants under 1 year of age. It is recommended that a pharmacist prepare this medicine as a suspension before administration to the patient. Prevention of influenza A and influenza B virus infections — Children aged 1 to 12 years: Pediatric patients weighing more than 40 kg who can swallow capsules may take 75mg capsules once daily or 30mg and 45mg capsules once daily for 10 days instead of the recommended dose of this medicine. Children aged 1 to 12 years, body weight ≤ 15 kg: 30 mg once daily; suspension (6mg/mL) 5.0 mL once daily Children aged 1 to 12 years, body weight 15 kg<, ≤ 23 kg: 45 mg once daily; suspension (6mg/mL) 7.5 mL once daily Children aged 1 to 12 years, body weight 23 kg<, ≤ 40 kg: 60 mg once daily; suspension (6mg/mL) 10.0 mL once daily Children aged 1 to 12 years, body weight > 40 kg: 75 mg once daily; suspension (6mg/mL) 12.5 mL once daily It is recommended that a pharmacist prepare this medicine as a suspension before administration to the patient. The safety and efficacy of prevention of influenza A and B virus infections in infants under 1 year of age have not been evaluated.

This drug cannot replace influenza vaccinations, and should only be used for treatment and prevention during influenza outbreaks. This drug has been proven effective only against influenza A and B viruses, and its safety and efficacy have not been established for other infections. In pediatric and adolescent patients, neuropsychiatric adverse reactions, such as seizures or abnormal behavior, may occur after taking this medication, therefore close observation by guardians is required if abnormal behaviors arise. It should not be used in patients with an allergy to this drug or its components, or in patients with lactose intolerance or relevant genetic disorders. Patients with impaired renal function may require dose adjustment and it is not recommended for patients with severe renal failure. This drug may have mild side effects such as nausea, vomiting, and headache, but most are temporary and do not require discontinuation of treatment. Rarely, anaphylaxis, liver dysfunction, skin rashes, acute renal failure, and neuropsychiatric symptoms may occur, so any abnormal symptoms should be reported to a healthcare provider immediately. It should only be used during pregnancy or while nursing if the therapeutic benefits outweigh the risks, as complete safety data is lacking. Caution is needed when used in children under 1 year of age as safety and efficacy have not been established. No dose adjustment is needed for the elderly; however, careful observation is necessary regarding potential adverse reactions due to decreased body function. This drug generally has few interactions with other medications, but caution may be necessary when co-administered with certain drugs, so any other medications being taken should be reported. Serious side effects from overdose are rare, but any adverse reactions should be reported to a healthcare provider immediately. It is important to prepare and store the medication precisely as directed, and keep it out of the reach of children.

• Cramps
• delirium
• abnormal behavior
• nausea
• vomiting
• headache
• pain
• unstable angina
• anemia
• pseudomembranous colitis

This drug is sensitive to air and moisture, so it should be stored in a tightly sealed container. It is important to maintain a storage temperature between 1 and 30 degrees Celsius to ensure the longevity of the drug's efficacy.

Appearance

White to off-white powder or granules in a brown glass bottle

Package unit

10g/bottle (50mL)