Tamiflu Powder 30 mg (Oseltamivir Phosphate)

Adult dose

1. 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). 2. 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): 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. ≤ 15 kg: 30 mg (packet) twice daily, for 5 days 15 kg<, ≤ 23 kg: 45 mg (packet) twice daily, for 5 days 23 kg<, ≤ 40 kg: 60 mg (two 30mg packets) twice daily, for 5 days > 40 kg: 75 mg (packet) twice daily, for 5 days 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. Pediatric patients who have difficulty taking this medicine as a powder should use the suspension. 3 kg: 9 mg twice daily; suspension (6mg/mL) dose 1.5mL twice daily 4 kg: 12 mg twice daily; suspension (6mg/mL) dose 2.0mL twice daily 5 kg: 15 mg twice daily; suspension (6mg/mL) dose 2.5mL twice daily 6 kg: 18 mg twice daily; suspension (6mg/mL) dose 3.0mL twice daily 7 kg: 21 mg twice daily; suspension (6mg/mL) dose 3.5mL twice daily 8 kg: 24 mg twice daily; suspension (6mg/mL) dose 4.0mL twice daily 9 kg: 27 mg twice daily; suspension (6mg/mL) dose 4.5mL twice daily 10 kg: 30 mg twice daily; suspension (6mg/mL) dose 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): 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. ≤ 15 kg: 30 mg (packet) once daily, for 10 days 15 kg<, ≤ 23 kg: 45 mg (packet) once daily, for 10 days 23 kg<, ≤ 40 kg: 60 mg (two 30mg packets) once daily, for 10 days > 40 kg: 75 mg (packet) once daily, for 10 days ※ 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 cannot replace influenza vaccinations and should only be used for treatment and prevention when the influenza virus is prevalent. The safety and efficacy for infections other than influenza A and B have not been confirmed. Rare neuropsychiatric adverse reactions such as seizures and delirium have been reported, especially in children and adolescents, so close monitoring is needed for unusual behaviors. For pediatric patients over 10 years old, it is generally principled not to use this medication except in special cases due to the risks of unusual behaviors and thoughts. Because there is a risk of unusual behaviors while taking this medication, guardians should closely observe children or adolescents for more than 2 days to ensure they are not alone. This drug should not be administered to patients with hypersensitivity to this medication or its components. Patients with renal impairment or those on dialysis may require dose adjustment, and it is not recommended for patients with end-stage renal failure. Patients at high risk, such as those with asthma, chronic bronchitis, or immunosuppression, should be administered this medication with caution. Common side effects include nausea, vomiting, headache, and pain, but they are typically temporary. Rarely, symptoms such as shock, anaphylaxis, pneumonia, liver function abnormalities, skin symptoms, acute kidney failure, blood abnormalities, and neuropsychiatric symptoms may occur, so any unusual symptoms should be reported to a healthcare professional immediately. Pregnant or breastfeeding women should use this medication only if the therapeutic benefits outweigh the risks due to limited safety data. The safety and efficacy for children under 1 year of age have not been established, so care should be taken when using this medication in this age group. Generally, elderly patients do not need dose adjustments, but careful monitoring should be done considering body function decline and pre-existing conditions. Reports of special adverse reactions from overdose are limited, but dosages should be adhered to strictly. This medication should be stored out of reach of children, and care should be taken not to transfer it to other containers as it may impair quality.

• nausea
• vomiting
• headache
• pain
• unstable angina
• anemia
• pseudomembranous colitis
• pneumonia
• peritonsillar abscess
• humerus fracture

This medicine should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain a storage temperature between 1°C and 30°C.

Appearance

White or pale yellow powder

Package unit

10 packets per box