Tamiflu Capsule 75 mg (Oseltamivir Phosphate)

Adult dose

1. Influenza A and influenza B virus infection: Initiate treatment on the first or second day after the onset of influenza symptoms. This medicine may be administered with or without food; in some patients, tolerability may improve 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 the powder for oral suspension of this medicine. Patients with renal impairment No dose adjustment is necessary in patients with creatinine clearance of 60 mL/min or higher. 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 regular 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 occur during the 48 hours between dialysis sessions, the dose may be administered before the start of dialysis. 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 on dialysis (e.g., creatinine clearance below 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment No dose adjustment is necessary for treatment in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9). 2. Prevention of influenza A and influenza B virus infection Adults and adolescents aged 13 years and older: For close contacts of an infected person, administer 75 mg of oseltamivir orally once daily for 10 days. Initiate treatment 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 this medicine is being taken. Patients with renal impairment No dose adjustment is necessary in patients with creatinine clearance of 60 mL/min or higher. 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 regular hemodialysis should receive a 30mg dose of this medicine after every 2 dialysis sessions to maintain plasma concentrations within the therapeutic range. The first dose may also be administered before the start of dialysis. For peritoneal dialysis, 30mg of this medicine once weekly after dialysis is recommended. The pharmacokinetics of oseltamivir have not been studied in patients with end-stage renal disease who are not on dialysis (e.g., creatinine clearance below 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment No dose adjustment is necessary for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

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 the suspension of this medicine. ≤ 15 kg : 30 mg per dose twice daily; suspension (6mg/mL) 5.0 mL per dose twice daily 15 kg<, ≤ 23 kg : 45 mg per dose twice daily; suspension (6mg/mL) 7.5 mL per dose twice daily 23 kg<, ≤ 40 kg : 60 mg per dose twice daily; suspension (6mg/mL) 10.0 mL per dose twice daily > 40 kg : 75 mg per dose twice daily; suspension (6mg/mL) 12.5 mL per dose 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 orally twice daily for 5 days. This does not apply to children with a postconceptional age under 36 weeks. 3 kg : 9 mg per dose twice daily; suspension (6mg/mL) 1.5 mL per dose twice daily 4 kg : 12 mg per dose twice daily; suspension (6mg/mL) 2.0 mL per dose twice daily 5 kg : 15 mg per dose twice daily; suspension (6mg/mL) 2.5 mL per dose twice daily 6 kg : 18 mg per dose twice daily; suspension (6mg/mL) 3.0 mL per dose twice daily 7 kg : 21 mg per dose twice daily; suspension (6mg/mL) 3.5 mL per dose twice daily 8 kg : 24 mg per dose twice daily; suspension (6mg/mL) 4.0 mL per dose twice daily 9 kg : 27 mg per dose twice daily; suspension (6mg/mL) 4.5 mL per dose twice daily 10 kg : 30 mg per dose twice daily; suspension (6mg/mL) 5.0 mL per dose twice daily 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 the suspension of this medicine. ≤ 15 kg : 30 mg per dose once daily; suspension (6mg/mL) 5.0 mL per dose once daily 15 kg<, ≤ 23 kg : 45 mg per dose once daily; suspension (6mg/mL) 7.5 mL per dose once daily 23 kg<, ≤ 40 kg : 60 mg per dose once daily; suspension (6mg/mL) 10.0 mL per dose once daily > 40 kg : 75 mg per dose once daily; suspension (6mg/mL) 12.5 mL per dose once daily ※ The safety and efficacy of prevention of influenza A and B virus infection in children under 1 year of age have not been evaluated.

This medication is used for the treatment and prevention of influenza virus infections. It cannot substitute for influenza vaccination, so it is important to receive the influenza vaccine annually. Its effectiveness has been proved only against influenza A and B viruses, and it is not used for other infections. Neurological and psychiatric adverse reactions, such as seizures, delirium, and abnormal behavior, have been reported in children and adolescents taking this medication, so especially patients in this age group should be closely monitored for unusual behavior. Children over 10 years old are generally not to be treated with this medication unless they are in specific high-risk groups, and caregivers should be cautious not to leave the patient unattended for at least 2 days after treatment starts. This medication should not be administered to patients who have hypersensitivity to it. Patients with renal failure must have their dosage adjusted, and it is not recommended for those with end-stage renal disease. Patients at high risk with asthma, chronic bronchitis, or immunocompromised conditions should be administered cautiously. Common side effects during treatment may include nausea, vomiting, headache, and pain, but these are usually transient and mild. Serious adverse reactions may rarely occur, such as shock, anaphylaxis, abnormal liver function, Stevens-Johnson syndrome, acute renal failure, and neurological symptoms, so any unusual symptoms should be reported to a healthcare professional immediately. The use by pregnant or breastfeeding women should be carefully evaluated to determine if the therapeutic benefits outweigh the risks. Safety and efficacy for children under 1 year of age have not been established, hence its use is not recommended. Elderly patients do not require special dosage adjustments but should be carefully monitored considering diminished physical function and underlying illnesses. This medication has a low likelihood of interactions with other drugs, but it may still require caution when used with specific drugs, so patients should inform their healthcare provider of any medications they are taking. Dosage should be followed as indicated, and if a dose is missed, it should be taken as soon as possible unless it is close to the next dose time, in which case it should be skipped. Keep this medication out of the reach of children and be careful not to transfer it to another container.

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

This medication should be stored in a tightly sealed container to protect it from air and moisture and kept at a cool temperature below 25 degrees Celsius. Storing it this way can maintain the medication's effectiveness for a longer time.

Appearance

A hard capsule with a pale yellow upper and gray lower section containing a white or light yellow powder.

Package unit

10 capsules (10 capsules/PTPX1)