Tamifu Powder 45 mg (Oseltamivir Phosphate)

Adult dose

Influenza A and influenza B virus infections: Start treatment on the first or second day after influenza symptoms appear. This medicine may be taken with or without food; taking it with food may improve tolerability in some patients. 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 for dosing. Patients with renal impairment: No dosage adjustment is required for patients with a creatinine clearance of 60 mL/min or greater. For patients with a creatinine clearance of 30 ~ 60 mL/min, a reduced dose of 30 mg twice daily for 5 days is recommended. For patients with a creatinine clearance of 10 ~ 30 mL/min, a reduced dose of 30 mg once daily for 5 days is recommended. Patients receiving intermittent hemodialysis should receive a 30mg dose of this medicine after each dialysis session to maintain blood concentrations within the therapeutic range, and treatment should not exceed 5 days. If influenza symptoms develop during the 48 hours between dialysis sessions, the dose may be given 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 less than 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment: No dosage adjustment is required 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 contacts of an infected person, administer 75 mg of oseltamivir orally once daily for 10 days. Start administration within 2 days of contact with the infected person. The recommended dose for prevention during an influenza outbreak 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 the medicine is being taken. Patients with renal impairment: No dosage adjustment is required for patients with a creatinine clearance of 60 mL/min or greater. For patients with a creatinine clearance of 30 ～ 60 mL/min, a reduced dose of 30 mg once daily is recommended. For patients with a creatinine clearance of 10 ～ 30 mL/min, a reduced dose of 30 mg once daily every other day is recommended. Patients receiving intermittent hemodialysis should receive a 30mg dose of this medicine after every 2 dialysis sessions to maintain blood concentrations within the therapeutic range. The first dose may also be given 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 less than 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment: No dosage adjustment is required for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

Children 1 to 12 years of age, treatment: Weight ≤ 15 kg — 30 mg (packet) twice daily Children 1 to 12 years of age, treatment: Weight 15 kg<, ≤ 23 kg — 45 mg (packet) twice daily Children 1 to 12 years of age, treatment: Weight 23 kg<, ≤ 40 kg — 60 mg (two 30mg packets) twice daily Children 1 to 12 years of age, treatment: Weight > 40 kg — 75 mg (packet) twice daily Children 1 to 12 years of age, treatment: Pediatric patients weighing more than 40 kg who can swallow capsules may take a 75mg capsule twice daily or a 30mg capsule and a 45mg capsule twice daily instead of the recommended dose of this medicine. Infants 2 weeks to less than 1 year of age: The recommended dose for pediatric patients 2 weeks to 12 months of age is 3mg/kg of this medicine orally twice daily for 5 days. This does not apply to infants with a postconceptional age of less than 36 weeks. Infants 2 weeks to less than 1 year of age, weight 3 kg — 9 mg twice daily; suspension (6mg/mL) dose (for suspension formulation only): 1.5mL twice daily Infants 2 weeks to less than 1 year of age, weight 4 kg — 12 mg twice daily; suspension (6mg/mL) dose (for suspension formulation only): 2.0mL twice daily Infants 2 weeks to less than 1 year of age, weight 5 kg — 15 mg twice daily; suspension (6mg/mL) dose (for suspension formulation only): 2.5mL twice daily Infants 2 weeks to less than 1 year of age, weight 6 kg — 18 mg twice daily; suspension (6mg/mL) dose (for suspension formulation only): 3.0mL twice daily Infants 2 weeks to less than 1 year of age, weight 7 kg — 21 mg twice daily; suspension (6mg/mL) dose (for suspension formulation only): 3.5mL twice daily Infants 2 weeks to less than 1 year of age, weight 8 kg — 24 mg twice daily; suspension (6mg/mL) dose (for suspension formulation only): 4.0mL twice daily Infants 2 weeks to less than 1 year of age, weight 9 kg — 27 mg twice daily; suspension (6mg/mL) dose (for suspension formulation only): 4.5mL twice daily Infants 2 weeks to less than 1 year of age, weight 10 kg — 30 mg twice daily; suspension (6mg/mL) dose (for suspension formulation only): 5.0mL twice daily * This table does not include all possible weights for this patient group. A dose of 3mg/kg of this medicine is recommended for children younger than 1 year. Children 1 to 12 years of age, prevention: Weight ≤ 15 kg — 30 mg (packet) once daily Children 1 to 12 years of age, prevention: Weight 15 kg<, ≤ 23 kg — 45 mg (packet) once daily Children 1 to 12 years of age, prevention: Weight 23 kg<, ≤ 40 kg — 60 mg (two 30mg packets) once daily Children 1 to 12 years of age, prevention: Weight > 40 kg — 75 mg (packet) once daily Children 1 to 12 years of age, prevention: Pediatric patients weighing more than 40 kg who can swallow capsules may take a 75mg capsule once daily or a 30mg capsule and a 45mg capsule once daily for 10 days instead of the recommended dose of this medicine. ※ The safety and efficacy of prevention of influenza A and B virus infections in children younger than 1 year have not been evaluated.

This medication is used for the treatment and prevention of influenza virus infections and cannot replace influenza vaccines. Therefore, annual influenza vaccination must be received, and this medication is to be used only during influenza outbreaks. This medication has been proven effective only against influenza A and B viruses, and safety and efficacy have not been confirmed for other infections. Particularly in children and adolescents, neuropsychiatric adverse reactions such as seizures, delirium, and abnormal behavior have been reported; if abnormal behavior appears after taking this medication, immediate observation and necessary actions should be taken by guardians. Use is not recommended in children and adolescents aged 10 years and older unless there are no special risk factors. Individuals with an allergy to this medication or its components should not take it. Patients with impaired kidney function may require dosage adjustment, and it is not recommended for patients with end-stage renal disease. Caution should be exercised in administering to high-risk patients with asthma, chronic bronchitis, or immunosuppressed states. Common side effects may include nausea, vomiting, headache, and pain, most of which are transient and mild. However, rare but serious side effects such as shock, anaphylaxis, liver function abnormalities, skin rashes, acute renal failure, neurological abnormalities, and hemorrhagic colitis can occur, so immediate consultation with a healthcare provider is necessary if abnormal symptoms appear. Women who are pregnant or may become pregnant should carefully weigh the benefits and risks of using this medication, and nursing mothers should exercise caution when using it. Safety and efficacy in children under 1 year of age have not been adequately established, so it is advisable not to use it. Elderly individuals may have decreased physical function and existing health conditions, so they should be closely monitored when administered. If any abnormal behaviors or uncomfortable symptoms occur during use, consult a physician immediately, and children should take the medication under the supervision of a guardian. Additionally, this medication has not shown significant interactions with specific drugs, but caution may be needed when used concurrently with drugs excreted through the kidneys. This medication contains sorbitol, so those with fructose intolerance should not take it, and it should be kept out of reach of children.

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

This medication is sensitive to air and moisture, so it should be stored in a tightly sealed container. It is best to maintain the storage temperature between 1 to 30 degrees Celsius.

Appearance

White or yellowish powder

Package unit

10 packets/box