Hana Flu 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 taken with or without food; tolerability may improve in some patients when taken with food. 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 in powder form for suspension. Patients with renal impairment (treatment): No dose adjustment is necessary in patients with creatinine clearance of 60 mL/min or more. 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 intermittent hemodialysis should receive a 30mg dose of this medicine after each dialysis session to maintain therapeutic plasma concentrations; 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 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 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 adults 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 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 taking this medicine. Patients with renal impairment (prevention): No dose adjustment is necessary in patients with creatinine clearance of 60 mL/min or more. 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 once daily every other day is recommended. Patients receiving intermittent hemodialysis should receive a 30mg dose of this medicine after every 2 dialysis sessions to maintain therapeutic plasma concentrations. The initial 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 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 adults 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 75mg capsules twice daily or 30mg and 45mg capsules twice daily instead of the recommended dose of this medicine as a suspension. Treatment, body weight ≤ 15 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily, for 5 days. Treatment, body weight 15 kg<, ≤ 23 kg: 45 mg twice daily; suspension (6mg/mL) 7.5 mL twice daily, for 5 days. Treatment, body weight 23 kg<, ≤ 40 kg: 60 mg twice daily; suspension (6mg/mL) 10.0 mL twice daily, for 5 days. Treatment, body weight > 40 kg: 75 mg twice daily; suspension (6mg/mL) 12.5 mL twice daily, for 5 days. 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 medicine orally twice daily for 5 days. This does not apply to infants with a postconceptional age of less than 36 weeks. Treatment, body weight 3 kg: 9 mg twice daily; suspension (6mg/mL) 1.5 mL twice daily, for 5 days. Treatment, body weight 4 kg: 12 mg twice daily; suspension (6mg/mL) 2.0 mL twice daily, for 5 days. Treatment, body weight 5 kg: 15 mg twice daily; suspension (6mg/mL) 2.5 mL twice daily, for 5 days. Treatment, body weight 6 kg: 18 mg twice daily; suspension (6mg/mL) 3.0 mL twice daily, for 5 days. Treatment, body weight 7 kg: 21 mg twice daily; suspension (6mg/mL) 3.5 mL twice daily, for 5 days. Treatment, body weight 8 kg: 24 mg twice daily; suspension (6mg/mL) 4.0 mL twice daily, for 5 days. Treatment, body weight 9 kg: 27 mg twice daily; suspension (6mg/mL) 4.5 mL twice daily, for 5 days. Treatment, body weight 10 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily, for 5 days. 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 75mg capsules once daily or 30mg and 45mg capsules once daily for 10 days instead of the recommended dose of this medicine as a suspension. Prevention, body weight ≤ 15 kg: 30 mg once daily; suspension (6mg/mL) 5.0 mL once daily, for 10 days. Prevention, body weight 15 kg<, ≤ 23 kg: 45 mg once daily; suspension (6mg/mL) 7.5 mL once daily, for 10 days. Prevention, body weight 23 kg<, ≤ 40 kg: 60 mg once daily; suspension (6mg/mL) 10.0 mL once daily, for 10 days. Prevention, body weight > 40 kg: 75 mg once daily; suspension (6mg/mL) 12.5 mL once daily, for 10 days. The safety and efficacy of prevention of influenza A and B virus infections in children under 1 year of age have not been evaluated.

This medicine is used for the treatment and prevention of influenza virus infections. However, this medicine cannot replace influenza vaccination and should be used separately from vaccination. Effectiveness has only been proven for influenza A and B viruses, and safety and efficacy have not been established for other infections. Especially in children and adolescents, rare neurological and psychiatric side effects such as seizures, delirium, and abnormal behavior may occur, so patients in this age group must be closely monitored for abnormal behavior after medication administration. People who are allergic to this medicine or its ingredients should not take it. Patients with impaired kidney function or those undergoing dialysis require dosage adjustment, and it is not recommended for patients with end-stage renal failure. Caution should be exercised in high-risk patients with asthma, chronic bronchitis, or immunosuppressive conditions. Generally, the most common side effects are nausea, vomiting, and headache, which are usually temporary and mild. However, there may rarely be instances of anaphylaxis, liver dysfunction, skin rash, acute kidney failure, and neuropsychiatric symptoms, and if unusual symptoms occur, it is essential to consult a doctor immediately. Pregnant or breastfeeding women should only use this medicine when the therapeutic benefits outweigh potential risks, as data on its effects on the fetus or newborn are limited. The safety and efficacy of this medicine have not been adequately established in children, especially in those under 1 year of age. Elderly patients typically do not require dosage adjustment, but must be monitored carefully considering decreased bodily functions and underlying diseases. This medicine has relatively few drug interactions, but caution may be needed when used in combination with specific medications. Be sure to follow the prescribed dosage and usage accurately, and inform medical personnel immediately if any abnormal behavior or side effects occur. Keep this medicine out of the reach of children and do not transfer it to other containers.

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

This medicine may be sensitive to air or moisture, so it should be stored in a tightly sealed container. Additionally, to maintain the efficacy of the medication, it is important to store it at a cool temperature below 25 degrees.

Appearance

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

Package unit

10 capsules/PTP