Tamiflu Capsule 45 mg (Oseltamivir Phosphate)

Adult dose

Treatment of 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 with or without food; in some patients, taking it with food may improve tolerability. Adults and adolescents 13 years of age and older: Administer oseltamivir 75 mg 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 powder for suspension. Patients with renal impairment (treatment): No dose adjustment is required for patients with creatinine clearance of 60 mL/min or greater. 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 therapeutic plasma concentrations; the treatment duration 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 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 (treatment): No dose adjustment is required for treatment in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9). Immunocompromised patients (treatment): No dose adjustment is required for treatment in immunocompromised patients; administration for 10 days is recommended. Prevention of influenza A and influenza B virus infections—Adults and adolescents 13 years of age and older: If in close contact with 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 taking this medicine. Patients with renal impairment (prevention): No dose adjustment is required for patients with creatinine clearance of 60 mL/min or greater. 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 therapeutic plasma concentrations. The first dose may also be administered before the start of dialysis. 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 (prevention): No dose 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 1 to 12 years of age: Pediatric patients weighing more than 40 kg who can swallow capsules may take 75mg capsules twice daily, or 30mg capsules and 45mg capsules twice daily, instead of the recommended dose of this medicine as a suspension. Body weight ≤ 15 kg: 30 mg per dose twice daily for 5 days; suspension (6mg/mL) 5.0 mL per dose twice daily. 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. 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. Body weight > 40 kg: 75 mg per dose twice daily for 5 days; suspension (6mg/mL) 12.5 mL per dose twice daily. Infants 2 weeks to less than 1 year of age: The recommended dose for infants 2 weeks to 12 months of age 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. Body weight 3 kg: 9 mg per dose twice daily for 5 days; suspension (6mg/mL) 1.5 mL per dose twice daily. Body weight 4 kg: 12 mg per dose twice daily for 5 days; suspension (6mg/mL) 2.0 mL per dose twice daily. Body weight 5 kg: 15 mg per dose twice daily for 5 days; suspension (6mg/mL) 2.5 mL per dose twice daily. Body weight 6 kg: 18 mg per dose twice daily for 5 days; suspension (6mg/mL) 3.0 mL per dose twice daily. Body weight 7 kg: 21 mg per dose twice daily for 5 days; suspension (6mg/mL) 3.5 mL per dose twice daily. Body weight 8 kg: 24 mg per dose twice daily for 5 days; suspension (6mg/mL) 4.0 mL per dose twice daily. Body weight 9 kg: 27 mg per dose twice daily for 5 days; suspension (6mg/mL) 4.5 mL per dose twice daily. 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 weights in this patient group. A dose of 3mg/kg of this medicine is recommended for children less than 1 year of age. It is recommended that a pharmacist prepare the suspension of this medicine before administration to the patient. Prevention of influenza A and influenza B virus infections—Children 1 to 12 years of age: Pediatric patients weighing more than 40 kg who can swallow capsules may take 75mg capsules once daily, or 30mg capsules and 45mg capsules once daily for 10 days, instead of the recommended dose of this medicine as a suspension. Body weight ≤ 15 kg: 30 mg per dose once daily for 10 days; suspension (6mg/mL) 5.0 mL per dose once daily. 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. 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. Body weight > 40 kg: 75 mg per dose once daily for 10 days; suspension (6mg/mL) 12.5 mL per dose once daily. It is recommended that a pharmacist prepare the suspension of this medicine before administration to the patient. The safety and efficacy of this medicine for prevention of influenza A and B virus infections in children less than 1 year of age have not been evaluated. Immunocompromised patients (prevention): No dose adjustment is required for seasonal prevention in immunocompromised patients 1 year of age and older; administration for 12 weeks is recommended.

This medication cannot substitute for influenza vaccination and should be used separately from vaccination. It is effective only against influenza A and B viruses, and safety and efficacy for other infections have not been confirmed. Neuropsychiatric adverse reactions, such as seizures or delirium, have been reported rarely in children and adolescents, so these patients should be closely monitored for abnormal behavior. Specifically, children over 10 years old may have an increased risk of abnormal behavior, thus it is generally advised not to use this medication in non-high-risk cases. Abnormal behavior may occur while taking this medication, so caregivers should be present for at least 2 days to ensure children and adolescents do not remain alone. Patients with allergies to this medication or its components should not use it. Patients with renal impairment may require dose adjustments, and it is not recommended for end-stage renal failure patients. Caution is advised for high-risk patients with asthma or chronic bronchitis, or those with immunosuppression. Side effects such as nausea, vomiting, and headaches are common but usually temporary. Rarely, severe side effects such as anaphylaxis, liver function abnormalities, skin rashes, and neurological disorders may occur, and if any unusual symptoms arise, immediate medical attention should be sought. Women who are pregnant or nursing should use this medication only when the therapeutic benefits outweigh the risks, as data on its effects on the fetus or infant is limited. Safety and efficacy have not been established for infants under 1 year of age, and its use is not recommended. Generally, elderly patients do not need dose adjustments, but should be closely monitored for declines in physical function or underlying conditions. Serious adverse reactions from overdose have been reported infrequently, but it is essential to follow the recommended usage and dosage. While this medication has a low potential for drug interactions, it is advisable to consult healthcare professionals for any concerns about using it with other medications. The effects on driving or operating machinery have not been reported, but one should consider the possible impairment of capabilities due to influenza itself. This medication may lead to resistance against influenza viruses, so caution is necessary during outbreaks of resistant viruses.

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

Store this medication in a tightly sealed container to protect it from air and moisture, and it is best kept in a cool place below 25 degrees Celsius. This helps maintain the efficacy of the medication for an extended period.

Appearance

Gray hard capsule containing white or pale yellow powder

Package unit

10 capsules (10 capsules/PTP packaging x 1)