Hanmi Flu Capsule 45mg (Oseltamivir)

Adult dose

1. Influenza A and influenza B virus infections: Initiate 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 an oral suspension prepared from the powder. Patients with renal impairment: No dosage adjustment is required for patients with a creatinine clearance of 60 mL/min or greater. 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 medicine after each dialysis session to maintain plasma concentrations within the therapeutic range, and 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 less than 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment: No dosage adjustment is required 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 13 years of age and older: For those in close contact with an infected person, administer oseltamivir 75 mg orally once daily for 10 days. Initiate 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 protective effect continues while this medicine is being taken. Patients with renal impairment: No dosage adjustment is required for patients with a creatinine clearance of 60 mL/min or greater. 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 once daily every other day is recommended. Patients receiving regular hemodialysis should receive a 30mg dose of this medicine 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 medicine 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 less than 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment: No dosage adjustment is required for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

Children aged 1 year to 12 years, treatment: 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 drug suspension. Weight ≤ 15 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily Weight 15 kg<, ≤ 23 kg: 45 mg twice daily; suspension (6mg/mL) 7.5 mL twice daily Weight 23 kg<, ≤ 40 kg: 60 mg twice daily; suspension (6mg/mL) 10.0 mL twice daily Weight > 40 kg: 75 mg twice daily; suspension (6mg/mL) 12.5 mL twice daily 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 postconceptional age of less than 36 weeks. Weight 3 kg: 9 mg twice daily; suspension (6mg/mL) 1.5 mL twice daily Weight 4 kg: 12 mg twice daily; suspension (6mg/mL) 2.0 mL twice daily Weight 5 kg: 15 mg twice daily; suspension (6mg/mL) 2.5 mL twice daily Weight 6 kg: 18 mg twice daily; suspension (6mg/mL) 3.0 mL twice daily Weight 7 kg: 21 mg twice daily; suspension (6mg/mL) 3.5 mL twice daily Weight 8 kg: 24 mg twice daily; suspension (6mg/mL) 4.0 mL twice daily Weight 9 kg: 27 mg twice daily; suspension (6mg/mL) 4.5 mL twice daily Weight 10 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL 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 it is administered to the patient. Children aged 1 year to 12 years, prevention: 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 drug suspension. Weight ≤ 15 kg: 30 mg once daily; suspension (6mg/mL) 5.0 mL once daily Weight 15 kg<, ≤ 23 kg: 45 mg once daily; suspension (6mg/mL) 7.5 mL once daily Weight 23 kg<, ≤ 40 kg: 60 mg once daily; suspension (6mg/mL) 10.0 mL once daily Weight > 40 kg: 75 mg once daily; suspension (6mg/mL) 12.5 mL once daily It is recommended that a pharmacist prepare this drug suspension before it is administered 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 cannot replace influenza vaccination and should be used separately from vaccination. It is only effective against Influenza A and B, and its safety and efficacy have not been established for other infections. Especially in children and adolescents, neuropsychiatric adverse reactions have been reported; unusual behavior or seizures may occur, so caregivers should observe them carefully. The principle is to avoid using this medication in children over 10 years old except in special cases. Patients with impaired kidney function or those on dialysis require dosage adjustment and it is not recommended for patients with end-stage renal failure. Careful administration is required in high-risk patients with asthma, chronic bronchitis, or immunocompromised states. Common side effects include nausea, vomiting, headache, and pain, most of which are mild and temporary. Rarely, allergic reactions, liver dysfunction, skin rashes, neuropsychiatric disorders, and hemorrhagic colitis may occur; consult a physician immediately if any abnormal symptoms appear. The effects of this medication on the fetus or infant during pregnancy or breastfeeding are unclear, so it should be used only when the therapeutic benefits outweigh the risks. It is preferable to avoid use in infants under 1 year of age, as safety and efficacy have not been established. Elderly patients do not require dose adjustments, but should be monitored closely considering decreased physical function and various health conditions. When taking medication, it is essential to follow the prescribed dosage and timings accurately; if a dose is missed, take it as soon as possible, but skip it if it's close to the next dose. This medication interacts minimally with other drugs, but caution is needed when used with drugs that affect renal excretion. There have been no reports of specific effects when driving or operating machinery, but since influenza can impair physical abilities, caution is necessary. Store out of reach of children and do not transfer to other containers for safety.

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

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

Appearance

A white to light yellow powder filled hard capsule with a white upper and lower part.

Package unit

10 capsules/box [10 capsules/PTP x 1]