Tamiflu Capsule 45 mg (Oseltamivir Phosphate)

Adult dose

1. Influenza A and influenza B virus infections: Begin treatment on the first or second day after the onset of influenza symptoms. This drug may be administered with or without food, although tolerability may improve in some patients when taken with food. Adults and adolescents aged 13 years or older: Administer oseltamivir 75 mg orally twice daily for 5 days. Adults and adolescents aged 13 years or older who have difficulty swallowing capsules should use this drug as a powder for suspension. Patients with renal impairment: No dose adjustment is required in patients with a creatinine clearance of 60 mL/min or greater. For patients with a creatinine clearance of 30 ~ 60 mL/min, reduction to 30 mg twice daily for 5 days is recommended. For patients with a creatinine clearance of 10 ~ 30 mL/min, reduction to 30 mg once daily for 5 days is recommended. Patients receiving periodic hemodialysis should receive a 30 mg dose of this drug after each dialysis session to maintain plasma concentrations within the therapeutic range; the treatment period 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 drug 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: No dose 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 or older: For those in close contact with an infected person, administer oseltamivir 75 mg orally once daily for 10 days. Begin administration within 2 days after 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 drug have been demonstrated for up to 6 weeks. The preventive effect continues while this drug is being taken. Patients with renal impairment: No dose adjustment is required in patients with a creatinine clearance of 60 mL/min or greater. For patients with a creatinine clearance of 30 ～ 60 mL/min, reduction to 30 mg once daily is recommended. For patients with a creatinine clearance of 10 ～ 30 mL/min, reduction to 30 mg once daily on alternate days is recommended. Patients receiving periodic hemodialysis should receive a 30 mg dose of this drug after every 2 dialysis sessions to maintain plasma concentrations within the therapeutic range. The initial dose may also be administered before the start of dialysis. For peritoneal dialysis, administration of 30 mg of this drug 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: No dose adjustment is required for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

1. 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 a 75mg capsule twice daily, or a 30mg capsule and a 45mg capsule twice daily, instead of the recommended dose of this drug suspension. ≤ 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 Infants aged 2 weeks to under 1 year: The recommended dose for pediatric patients aged 2 weeks to 12 months is 3mg/kg of this drug 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 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 * This table does not include all possible weights in this patient group. A dose of 3mg/kg of this drug is recommended for children under 1 year of age. 2. 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 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 drug suspension. ≤ 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 this drug for prevention of influenza A and B virus infections in children under 1 year of age have not been evaluated.

This medication is used to treat or prevent influenza virus infections, but it cannot replace influenza vaccinations. The preventive effect of this medication lasts only while it is being used and should only be used in areas where influenza virus is prevalent. Effectiveness has only been proven for influenza A and B viruses, and safety or efficacy has not been confirmed for other infections. In children and adolescents, rare neuropsychiatric adverse reactions may occur, and caregivers should carefully monitor for unusual behaviors. In principle, it should not be used in children over 10 years of age except in special cases. Patients with known allergic reactions to this medication or its components should not use it. Patients with reduced kidney function require dose adjustments, and it is not recommended for patients with end-stage renal disease. Use with caution in high-risk patients with asthma, chronic bronchitis, or immunosuppressive conditions. Common side effects during administration include nausea, vomiting, and headache, which are mostly mild and temporary. Rarely, shock, anaphylaxis, liver function abnormalities, skin rash, neuropsychiatric symptoms may occur, so if any unusual symptoms arise, immediate consultation with a healthcare professional is necessary. Pregnant or breastfeeding women should carefully consider the benefits and risks of using this medication. The safety and efficacy for young children, particularly those under 1 year of age, have not been sufficiently studied, so caution is needed for their use. Elderly patients do not require dosage adjustments, but should be monitored closely if they have decreased physical functioning or multiple conditions. This medication has a low potential for interactions with other medications, but caution may be needed when used in combination with certain drugs. Serious side effects are rarely reported even in cases of overdose, but any unusual symptoms should be reported to a healthcare professional immediately. Medications should be stored out of reach of children and should not be transferred to other containers.

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

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain a temperature between 1 to 30 degrees Celsius during storage.

Appearance

Gray hard capsule filled with white or light yellow powder

Package unit

10 capsules (10 capsules/PTPX1)