Tamiflu Capsule 45 mg (Oseltamivir Phosphate)

Adult dose

Influenza A and influenza B virus infections: Initiate treatment on the first or second day after the onset of influenza symptoms. This medicine may be taken with or without food; in some patients, taking it with food may improve tolerability. Adults and adolescents aged 13 years and older: Administer oseltamivir 75 mg orally twice daily for 5 days. Adults and adolescents aged 13 years and older who have difficulty swallowing capsules should use this medicine as powder for suspension. Patients with renal impairment: No dosage adjustment is required for patients with creatinine clearance ≥ 60 mL/min. 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 30 mg dose of this medicine after each dialysis session to maintain therapeutic plasma concentrations; treatment 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 30 mg 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 in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9). Prevention of influenza A and influenza B virus infections Adults and adolescents aged 13 years and older: For close contacts of an infected person, administer oseltamivir 75 mg orally once daily for 10 days. Start administration within 2 days of contact with the infected person. The recommended dose for prevention during influenza outbreaks 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 this medicine is being taken. Patients with renal impairment: No dosage adjustment is required for patients with creatinine clearance ≥ 60 mL/min. 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 every other day is recommended. Patients receiving periodic hemodialysis should receive a 30 mg dose of this medicine 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 30 mg 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

Treatment of influenza A and influenza B virus infections — children aged 1 to 12 years, body weight ≤ 15 kg: 30 mg per dose twice daily for 5 days; suspension (6mg/mL) 5.0 mL per dose twice daily. Treatment of influenza A and influenza B virus infections — children aged 1 to 12 years, body weight 15 kg<, ≤ 23 kg: 45 mg per dose twice daily for 5 days; suspension (6mg/mL) 7.5 mL per dose twice daily. Treatment of influenza A and influenza B virus infections — children aged 1 to 12 years, body weight 23 kg<, ≤ 40 kg: 60 mg per dose twice daily for 5 days; suspension (6mg/mL) 10.0 mL per dose twice daily. Treatment of influenza A and influenza B virus infections — children aged 1 to 12 years, body weight > 40 kg: 75 mg per dose twice daily for 5 days; suspension (6mg/mL) 12.5 mL per dose twice daily. Children aged 1 to 12 years: 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 as a suspension. Children aged 2 weeks to less than 1 year: The recommended dose for pediatric patients 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 of less than 36 weeks. Children aged 2 weeks to less than 1 year, body weight 3 kg: 9 mg per dose twice daily for 5 days; suspension (6mg/mL) 1.5 mL per dose twice daily. Children aged 2 weeks to less than 1 year, body weight 4 kg: 12 mg per dose twice daily for 5 days; suspension (6mg/mL) 2.0 mL per dose twice daily. Children aged 2 weeks to less than 1 year, body weight 5 kg: 15 mg per dose twice daily for 5 days; suspension (6mg/mL) 2.5 mL per dose twice daily. Children aged 2 weeks to less than 1 year, body weight 6 kg: 18 mg per dose twice daily for 5 days; suspension (6mg/mL) 3.0 mL per dose twice daily. Children aged 2 weeks to less than 1 year, body weight 7 kg: 21 mg per dose twice daily for 5 days; suspension (6mg/mL) 3.5 mL per dose twice daily. Children aged 2 weeks to less than 1 year, body weight 8 kg: 24 mg per dose twice daily for 5 days; suspension (6mg/mL) 4.0 mL per dose twice daily. Children aged 2 weeks to less than 1 year, body weight 9 kg: 27 mg per dose twice daily for 5 days; suspension (6mg/mL) 4.5 mL per dose twice daily. Children aged 2 weeks to less than 1 year, body weight 10 kg: 30 mg per dose twice daily for 5 days; suspension (6mg/mL) 5.0 mL per dose twice daily. * This table does not include all possible body weights in this patient group. A dose of 3mg/kg of this medicine is recommended for children under 1 year of age. Prevention of influenza A and influenza B virus infections — children aged 1 to 12 years, body weight ≤ 15 kg: 30 mg per dose once daily for 10 days; suspension (6mg/mL) 5.0 mL per dose once daily. Prevention of influenza A and influenza B virus infections — children aged 1 to 12 years, body weight 15 kg<, ≤ 23 kg: 45 mg per dose once daily for 10 days; suspension (6mg/mL) 7.5 mL per dose once daily. Prevention of influenza A and influenza B virus infections — children aged 1 to 12 years, body weight 23 kg<, ≤ 40 kg: 60 mg per dose once daily for 10 days; suspension (6mg/mL) 10.0 mL per dose once daily. Prevention of influenza A and influenza B virus infections — children aged 1 to 12 years, body weight > 40 kg: 75 mg per dose once daily for 10 days; suspension (6mg/mL) 12.5 mL per dose once daily. Children aged 1 to 12 years: 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 as a suspension. ※ The safety and efficacy of preventing influenza A and B virus infections in children under 1 year of age have not been evaluated.

This medication is used for the treatment and prevention of influenza virus infections and cannot replace the influenza vaccine. Therefore, it is important to receive an annual influenza vaccination even if this medication is used. This drug has been proven effective only against Influenza A and B viruses, and its safety and efficacy have not been confirmed for other infections. Particularly, abnormal behavior or neuropsychiatric adverse reactions have been reported infrequently in pediatric and adolescent patients, so patients in this age group should be closely monitored for unusual behavior during treatment. For at least 2 days after administration, caregivers should ensure the patient is not left alone. Those with allergies to this drug or its components should not use it. Patients with impaired kidney function or those on dialysis may need dose adjustments, and it is not recommended for end-stage renal failure patients. Patients in high-risk groups, such as those with asthma or chronic bronchitis or those in immunocompromised states, should use this drug cautiously. Common side effects may include nausea, vomiting, headache, and pain, most of which are transient. In case of severe allergic reactions, liver function abnormalities, skin rashes, acute renal failure, blood abnormalities, or neuropsychiatric symptoms, it is necessary to immediately consult a healthcare professional. This medication has not been reported to have significant interactions with multiple drugs, but caution may be required when used with certain medications, so it is vital to inform about any ongoing medications. Pregnant or lactating women should carefully consider the risks and benefits of using this drug and follow the instructions provided by their doctors when treatment is required. For children, it is recommended not to use this medication under 1 year of age, as safety and efficacy have not been established. The elderly may have decreased bodily functions, so it is important to monitor closely during administration. This medication should be stored out of reach of children, and it is preferable not to transfer it to another container. Starting treatment as early as possible when symptoms appear can be effective, and if a dose is missed, it is advisable to take it as soon as possible, except if more than 2 hours have passed since the scheduled time. There have been no direct reports of impact on driving or operating machinery, but influenza itself can affect 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 exposure, ideally in a cool place below 25 degrees Celsius. This storage method can help preserve the drug's efficacy for a longer time.

Appearance

A hard capsule in light gray upper and lower parts containing white or pale yellow powder

Package unit

10 capsules/box [10 capsules/PTP], 30 capsules/box [10 capsules/PTP X 3]