Tamiflu Capsule 30 mg (Oseltamivir Phosphate)

Adult dose

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. Treatment of influenza A and influenza B virus infections — 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 30mg 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 30mg 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). 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 30mg 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 30mg 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

Treatment 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 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. It is recommended that a pharmacist prepare this drug suspension before administration to the patient. 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 It is recommended that a pharmacist prepare this drug suspension before administration to the patient. ※ 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 cannot replace influenza vaccination and is only used for treatment and prevention during influenza virus epidemics. The efficacy and safety of this medication against infections other than influenza A and B have not been established. There may be rare occurrences of neuropsychiatric adverse reactions, especially in children and adolescents. Therefore, caregivers should monitor closely for unusual behavior. Patients with allergies to this medication should not use it, and patients with renal impairment or certain high-risk groups should take it with caution under medical supervision. Common side effects may include nausea, vomiting, and headache, but these are usually temporary. If severe adverse reactions occur, discontinue use and consult healthcare professionals immediately. Women who are pregnant or nursing should only use this medication if the benefits outweigh the risks, as its effects on fetuses or infants have not been sufficiently studied. This medication should be avoided in children under 1 year of age as its safety and efficacy have not been established. Elderly patients may have decreased physiological function, so their condition should be carefully monitored during use. Most reports indicate no serious side effects with overdose, but adherence to the prescribed dosage and regimen is important. This medication tends to have fewer drug interactions, but caution is necessary when used with certain medications, so inform your healthcare provider of any other medications you are taking. There is no impact on driving or operating machinery, but be aware of physical changes caused by influenza itself. Store in a place inaccessible to children and do not transfer to other containers for safety.

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

Store this medication in a closed container to protect it from air and moisture. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius. Proper storage helps to preserve the effectiveness of the medication.

Appearance

A hard capsule with yellow upper and lower parts containing white or light yellow powder

Package unit

10 capsules (10 capsules/PTP X 1)