Tamiflu Capsule 45 mg (Oseltamivir Phosphate)

Adult dose

1. Treatment of influenza A and influenza B virus infections Treatment should be initiated on the first or second day after the onset of influenza symptoms. This medication may be administered regardless of food intake, and tolerability may improve in some patients when taken with food. Adults and adolescents aged 13 years and older: Administer 75 mg of oseltamivir orally twice daily for 5 days. Adults and adolescents aged 13 years and older who have difficulty swallowing capsules should use this medication as a powder for suspension. Patients with renal impairment: No dosage adjustment is required for patients with a creatinine clearance of 60 mL/min or more. 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 regular hemodialysis should receive a 30mg dose of this medication after each dialysis session to maintain therapeutic plasma concentrations, and the duration of administration should not exceed 5 days. If influenza symptoms develop during the 48 hours between dialysis sessions, the dose may also be administered before the start of dialysis. For peritoneal dialysis, a single 30mg dose of this medication 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 in 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 aged 13 years and older: For individuals in close contact with 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 medication have been demonstrated for up to 6 weeks. The preventive effect continues while taking this medication. Patients with renal impairment: No dosage adjustment is required for patients with a creatinine clearance of 60 mL/min or more. 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 regular hemodialysis should receive a 30mg dose of this medication after every 2 dialysis sessions to maintain therapeutic plasma concentrations. The initial dose may also be administered before the start of dialysis. For peritoneal dialysis, administration of 30mg of this medication once weekly 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 prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

1. Treatment of influenza A and influenza B virus infections Children aged 1 year 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 suspension. ≤ 15 kg: 30 mg twice daily for 5 days; suspension (6mg/mL) 5.0 mL twice daily 15 kg<, ≤ 23 kg: 45 mg twice daily for 5 days; suspension (6mg/mL) 7.5 mL twice daily 23 kg<, ≤ 40 kg: 60 mg twice daily for 5 days; suspension (6mg/mL) 10.0 mL twice daily > 40 kg: 75 mg twice daily for 5 days; suspension (6mg/mL) 12.5 mL twice daily Children aged 2 weeks to under 1 year: The recommended dose for pediatric patients aged 2 weeks to 12 months is 3mg/kg of this medicine, administered orally twice daily for 5 days. This does not apply to infants with a postconceptional age of less than 36 weeks. 3 kg: 9 mg twice daily for 5 days; suspension (6mg/mL) 1.5 mL twice daily 4 kg: 12 mg twice daily for 5 days; suspension (6mg/mL) 2.0 mL twice daily 5 kg: 15 mg twice daily for 5 days; suspension (6mg/mL) 2.5 mL twice daily 6 kg: 18 mg twice daily for 5 days; suspension (6mg/mL) 3.0 mL twice daily 7 kg: 21 mg twice daily for 5 days; suspension (6mg/mL) 3.5 mL twice daily 8 kg: 24 mg twice daily for 5 days; suspension (6mg/mL) 4.0 mL twice daily 9 kg: 27 mg twice daily for 5 days; suspension (6mg/mL) 4.5 mL twice daily 10 kg: 30 mg twice daily for 5 days; 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 children under 1 year of age. It is recommended that a pharmacist prepare this medicine suspension before administration to the patient. 2. Prevention of influenza A and influenza B virus infections Children aged 1 year 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 suspension. ≤ 15 kg: 30 mg once daily for 10 days; suspension (6mg/mL) 5.0 mL once daily 15 kg<, ≤ 23 kg: 45 mg once daily for 10 days; suspension (6mg/mL) 7.5 mL once daily 23 kg<, ≤ 40 kg: 60 mg once daily for 10 days; suspension (6mg/mL) 10.0 mL once daily > 40 kg: 75 mg once daily for 10 days; suspension (6mg/mL) 12.5 mL once daily It is recommended that a pharmacist prepare this medicine suspension before administration to the patient. ※ The safety and efficacy of prevention of influenza A and B virus infections in children under 1 year of age have not been evaluated.

This medication cannot replace influenza vaccinations and should be used separately from vaccinations. This medication is effective only against influenza viruses A and B; safety and efficacy against other types of infections have not been established. In rare cases, neuropsychiatric adverse reactions such as convulsions or delirium may occur in pediatric and adolescent patients, so careful observation is needed to ensure no abnormal behavior occurs. Especially in children and adolescents aged 10 years and older, there have been reports of abnormal behavior and risk of incidents after taking this medication; therefore, it is not recommended for use if they are not at high risk. During the use of this medication, caregivers should monitor the child or adolescent for at least 2 days to ensure they are not alone. Patients with a history of allergic reactions to this medication should not use it. Patients with reduced kidney function require dosage adjustment, and it is not recommended for patients with end-stage renal failure. This medication should be administered with caution in patients with asthma, chronic bronchitis, or immunosuppressive conditions. The most common side effects include nausea, vomiting, and headache, which are usually temporary and mild. Serious side effects may rarely include shock, anaphylaxis, liver function abnormalities, skin and mucous membrane syndrome, acute renal failure, neuropsychiatric abnormalities, and hemorrhagic colitis; any unusual symptoms should be reported to healthcare professionals immediately. This medication should only be used in pregnant or lactating women when the benefits outweigh the risks, as data on effects on the fetus or neonate is limited. It can be used in children aged 1 year and older; safety and efficacy in children under 1 year have not been established. Elderly patients can use it without special dosage adjustments; however, careful observation is needed if they have reduced physical function or co-morbid conditions. Serious side effects have been reported rarely in cases of overdose, but it is important to inform healthcare professionals immediately if symptoms occur. This medication has a low potential for interactions with other medications; however, caution may be needed when taken with certain medications, so patients should inform healthcare professionals of any other medications they are taking. The effect on driving or operating machinery is unknown, but influenza itself can impair these abilities, so caution is advised.

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

This medication should be stored in a tightly sealed container to prevent air and moisture ingress, and kept in a cool place below 25 degrees for optimal effectiveness.

Appearance

A hard capsule that is light gray with a white or light yellow powder inside.

Package unit

10 capsules/PTP