Aflu Capsule 75 mg (Oseltamivir Phosphate)

Adult dose

Influenza A and influenza B virus infections: Treatment should be initiated on the first or second day after the onset of influenza symptoms. 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 take this medication using the powder for oral suspension. Patients with renal impairment (treatment): No dose adjustment is necessary for patients with a creatinine clearance of 60 mL/min or higher. For patients with a creatinine clearance of 30 ~ 60 mL/min, a reduced dose of 30 mg twice daily for 5 days is recommended. For patients with a 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 medication 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 also be administered before the start of dialysis. For peritoneal dialysis, a single 30mg dose of this medication 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 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 13 years of age and older: For close contacts of 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 outbreak is 75 mg once daily. The safety and efficacy of this medication have been demonstrated for up to 6 weeks. The preventive effect continues while taking this medication. Patients with renal impairment (prevention): No dose adjustment is necessary for patients with a creatinine clearance of 60 mL/min or higher. For patients with a creatinine clearance of 30 ～ 60 mL/min, a reduced dose of 30 mg once daily is recommended. For patients with a 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 medication after every 2 dialysis sessions to maintain plasma concentrations within the therapeutic range. The first dose may also be administered before the start of dialysis. For peritoneal dialysis, 30mg of this medication once weekly 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 (prevention): No dose adjustment is necessary 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 a 75mg capsule twice daily or a 30mg capsule and a 45mg capsule twice daily instead of the recommended dose of this medication as an oral 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 2 weeks to under 1 year of age: The recommended dose for pediatric patients 2 weeks to 12 months of age is 3mg/kg of this medication 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 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 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 medication as an oral 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

This medicine cannot replace influenza vaccinations and is only used for treatment and prevention during the seasonal outbreak of influenza. The safety and efficacy of this medicine have not been established for infections other than influenza A and B. Particularly in pediatric and adolescent patients, neuropsychiatric adverse effects have been reported and careful observation by guardians is necessary if abnormal behavior occurs. Those allergic to this drug or its components should not use it. Patients with renal failure require dosage adjustments, and it is not recommended for patients with end-stage renal failure. Caution should be exercised when administering to patients with asthma, chronic bronchitis, or immunocompromised states. Nausea, vomiting, headache, and other side effects may commonly occur upon administration, but most are temporary. Rarely, serious allergic reactions, liver dysfunction, skin abnormalities, and psychiatric symptoms may occur, requiring immediate consultation with healthcare professionals in case of abnormal symptoms. It should be used during pregnancy or breastfeeding only after careful consideration of therapeutic benefits and risks. Safety and efficacy in children under 1 year of age have not been established, hence caution is required. Elderly patients do not require dosage adjustments, but close monitoring is requested due to potential bodily function decline. Although drug interactions are rare, caution is needed when co-administering with certain medications. It is most effective when taken early during the onset of influenza symptoms; if a dose is missed, take it as soon as possible, but skip it if it is too close to the next dose. Effects on driving or operating machinery have not been reported, but influenza itself may affect such abilities, thus caution is advised. Keep this medicine out of children's reach and avoid transferring it to other containers.

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

This medicine should be stored in a tightly sealed container to prevent exposure to air and moisture, preferably at a cool temperature below 25 degrees Celsius. This will help maintain the efficacy of the drug for a longer period.

Appearance

Hard capsule with a soft yellow top and light gray bottom filled with white or light yellow powder

Package unit

10 capsules (10 capsules/PTP×1)