Tamiflu Capsule 75 mg (Oseltamivir Phosphate)

Adult dose

1. Influenza A and influenza B virus infections: Start treatment on the first or second day after influenza symptoms appear. This medicine may be taken with or without food; taking it with food may improve tolerability in some patients. 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 medicine as an oral suspension powder. Patients with renal impairment: No dosage adjustment is needed in 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 regular hemodialysis should receive a 30mg dose of this medicine after each dialysis session to maintain blood 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 also 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 less than 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment: No dosage adjustment is needed 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 close contacts of 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 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 needed in 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 regular hemodialysis should receive a 30mg dose of this medicine after every two dialysis sessions to maintain blood concentrations within the therapeutic range. The first 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 less than 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment: No dosage adjustment is needed for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

Treatment — Children aged 1 year to 12 years: Pediatric patients weighing more than 40 kg who are able to swallow capsules may take 75 mg capsules twice daily or 30 mg capsules and 45 mg capsules twice daily instead of the recommended dose of this drug suspension. Treatment — Weight ≤ 15 kg: 30 mg twice daily; suspension (6mg/ml) 5.0 mL twice daily. Treatment — Weight 15 kg<, ≤ 23 kg: 45 mg twice daily; suspension (6mg/ml) 7.5 mL twice daily. Treatment — Weight 23 kg<, ≤ 40 kg: 60 mg twice daily; suspension (6mg/ml) 10.0 mL twice daily. Treatment — Weight > 40 kg: 75 mg twice daily; suspension (6mg/ml) 12.5 mL twice daily. Treatment — 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 drug, administered orally twice daily for 5 days. This does not apply to infants with a post-conceptional age of less than 36 weeks. Treatment — Weight 3 kg: 9 mg twice daily; suspension (6mg/mL) 1.5 mL twice daily. Treatment — Weight 4 kg: 12 mg twice daily; suspension (6mg/mL) 2.0 mL twice daily. Treatment — Weight 5 kg: 15 mg twice daily; suspension (6mg/mL) 2.5 mL twice daily. Treatment — Weight 6 kg: 18 mg twice daily; suspension (6mg/mL) 3.0 mL twice daily. Treatment — Weight 7 kg: 21 mg twice daily; suspension (6mg/mL) 3.5 mL twice daily. Treatment — Weight 8 kg: 24 mg twice daily; suspension (6mg/mL) 4.0 mL twice daily. Treatment — Weight 9 kg: 27 mg twice daily; suspension (6mg/mL) 4.5 mL twice daily. Treatment — Weight 10 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily. Treatment — * 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. It is recommended that a pharmacist prepare this drug suspension before administration to the patient. Prevention — Children aged 1 year to 12 years: Pediatric patients weighing more than 40 kg who are able to swallow capsules may take 75 mg capsules once daily or 30 mg capsules and 45 mg capsules once daily for 10 days instead of the recommended dose of this drug suspension. Prevention — Weight ≤ 15 kg: 30 mg once daily; suspension (6mg/mL) 5.0 mL once daily. Prevention — Weight 15 kg<, ≤ 23 kg: 45 mg once daily; suspension (6mg/mL) 7.5 mL once daily. Prevention — Weight 23 kg<, ≤ 40 kg: 60 mg once daily; suspension (6mg/mL) 10.0 mL once daily. Prevention — Weight > 40 kg: 75 mg once daily; suspension (6mg/mL) 12.5 mL once daily. Prevention — It is recommended that a pharmacist prepare this drug suspension before administration to the patient. * The safety and efficacy of this drug for the 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 infections caused by the influenza virus. This medication does not substitute for influenza vaccination, and it is important to use it in conjunction with vaccination. This medication should only be used in areas where influenza viruses are currently circulating, and its effectiveness has only been confirmed against influenza A and B viruses. It is recommended not to use this medication in children under 1 year of age, as safety and efficacy have not been established. During the course of taking this medication, unusual behavior, seizures, delirium, and other neuropsychiatric side effects may particularly occur in children and adolescents, so caregivers should observe them closely. It is recommended not to use this medication in pediatric patients over 10 years of age, except in special cases. Individuals with hypersensitivity to this medication should not be administered this drug. Patients with impaired renal function or those on dialysis may require dosage adjustments, and it is not recommended for patients with end-stage renal disease. Caution should be exercised when administering this medication to patients with asthma, chronic bronchitis, or immunosuppressive conditions. The most common side effects include nausea, vomiting, and headaches, most of which are temporary and disappear quickly. Rarely, shock, anaphylaxis, liver function abnormalities, skin rashes, acute renal failure, and neuropsychiatric symptoms may occur, and any abnormal symptoms should be reported to medical personnel immediately. Pregnant or breastfeeding women should carefully consider the risks and benefits of taking this medication, as safety data in pregnant women is limited. Elderly patients generally do not require dosage adjustments; however, they should be observed carefully if they have impaired bodily functions. Drug interactions have not been widely reported; however, caution may be needed when used in combination with certain drugs. This medication should be kept out of reach of children and should not be transferred to different containers. When taking, start as early as possible after the onset of symptoms; if a dose is missed and it is within 2 hours of the next scheduled dose, take it quickly; otherwise, take it at the next scheduled time. The effects on driving or operating machinery are not clear; however, since influenza itself can affect bodily functions, caution should be exercised.

• Area
• vomiting
• headache
• pain
• unstable angina
• anemia
• pseudomembranous colitis
• pneumonia
• peritonsillar abscess
• humeral fracture

This medication should be stored in a tightly closed container to prevent air and moisture from entering. It is also important to store it at a cool temperature below 25 degrees to maintain its efficacy and safety.

Appearance

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

Package unit

10 capsules (10 capsules/PTP×1)