Tamiflu Capsule 75 mg (Oseltamivir Phosphate)

Adult dose

Influenza A and influenza B virus infections: Start treatment on the first or second day after the onset of influenza symptoms. This medicine may be administered regardless of food intake, although tolerability may improve in some patients when taken with food. 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 as a powder for suspension. Patients with renal impairment (treatment): No dose adjustment is necessary in patients with creatinine clearance of 60 mL/min or more. 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 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 develop during the 48 hours between dialysis sessions, the dose may be administered 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 below 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment (treatment): No dose adjustment is necessary 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 contact with an infected person, administer 75 mg of oseltamivir orally once daily for 10 days. Begin administration within 2 days of contact with the infected person. The recommended dose for prevention during an influenza epidemic 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 taking this medicine. Patients with renal impairment (prevention): No dose adjustment is necessary in patients with creatinine clearance of 60 mL/min or more. 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 once daily every other day is recommended. Patients receiving periodic hemodialysis should receive a 30mg dose of this medicine after every 2 dialysis sessions to maintain plasma concentrations within the therapeutic range. The initial dose may also be administered 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 below 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment (prevention): No dose adjustment is necessary for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

Influenza A and influenza B virus infections—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 this medicine as a suspension. ≤ 15 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily 15 kg<, ≤ 23 kg: 45 mg twice daily; suspension (6mg/mL) 7.5 mL twice daily 23 kg<, ≤ 40 kg: 60 mg twice daily; suspension (6mg/mL) 10.0 mL twice daily > 40 kg: 75 mg twice daily; suspension (6mg/mL) 12.5 mL twice daily Infants aged 2 weeks to under 1 year: The recommended dose for infants 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 below 36 weeks. 3 kg: 9 mg twice daily; suspension (6mg/mL) 1.5 mL twice daily 4 kg: 12 mg twice daily; suspension (6mg/mL) 2.0 mL twice daily 5 kg: 15 mg twice daily; suspension (6mg/mL) 2.5 mL twice daily 6 kg: 18 mg twice daily; suspension (6mg/mL) 3.0 mL twice daily 7 kg: 21 mg twice daily; suspension (6mg/mL) 3.5 mL twice daily 8 kg: 24 mg twice daily; suspension (6mg/mL) 4.0 mL twice daily 9 kg: 27 mg twice daily; suspension (6mg/mL) 4.5 mL twice daily 10 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily Prevention of influenza A and influenza B virus infections—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 this medicine as a suspension. ≤ 15 kg: 30 mg once daily; suspension (6mg/mL) 5.0 mL once daily 15 kg<, ≤ 23 kg: 45 mg once daily; suspension (6mg/mL) 7.5 mL once daily 23 kg<, ≤ 40 kg: 60 mg once daily; suspension (6mg/mL) 10.0 mL once daily > 40 kg: 75 mg once daily; suspension (6mg/mL) 12.5 mL once daily The safety and efficacy of prevention of influenza A and B virus infections in infants under 1 year of age have not been evaluated.

This medication is used to treat or prevent influenza virus infection but cannot replace influenza vaccinations. It is important to receive the influenza vaccine annually. This medication is effective only against Influenza A and B viruses, and its safety and effectiveness have not been established for other types of infections. Particularly in children and adolescents, there may be neuropsychiatric side effects such as seizures, delirium, or abnormal behavior, so careful observation is necessary. Pediatric patients over 10 years old have been reported to have falls due to abnormal behaviors, and it is advised not to use it unless there are no special risk factors. Because there is a risk of abnormal behavior during the use of this medication, caregivers should ensure that children and adolescents are not left alone for at least 2 days. Patients who have an allergy to this medication or any of its components should not use it. Patients with decreased renal function or those receiving dialysis may require dose adjustment and are not recommended for patients with severe renal impairment. It should be administered cautiously to high-risk patients with asthma, chronic bronchitis, or immunosuppressive conditions. Common side effects include nausea, vomiting, headache, and pain, which are mostly temporary. Rarely, shock, anaphylaxis, hepatitis, skin reactions, acute renal failure, and neuropsychiatric symptoms may occur, and immediate medical attention should be sought if any unusual symptoms appear. Women who are pregnant or breastfeeding should only be administered this medication if the benefits of treatment outweigh the risks. The safety and efficacy in children, especially infants under 1 year of age, have not been sufficiently studied, so caution is needed. Elderly patients generally do not require dose adjustment, but careful observation is necessary considering physical function decline and underlying diseases. This medication has a low potential for drug interactions, but caution is needed when used with drugs that affect renal excretion. During administration, it is effective to take it early during the onset of influenza symptoms, and if a dose is missed, it should be taken as soon as possible, but not too close to the next dose time. It should be stored out of the reach of children, and it is safe 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 prevent air or moisture from entering, and it is advisable to keep it at a cool temperature below 25 degrees. This will help maintain the medication's efficacy for a longer period.

Appearance

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

Package unit

10 capsules/PTP X 1