Hanmi Flu Capsule 30mg (Oseltamivir)

Adult dose

1. Influenza A and influenza B virus infections: Treatment should be started on the first or second day after the onset of influenza symptoms. This medicine may be administered regardless of food intake, and tolerability may improve in some patients when it is taken with food. Adults and adolescents aged 13 years and older: Administer oseltamivir 75 mg orally twice daily for 5 days. Adults and adolescents aged 13 years and older who have difficulty swallowing capsules should use this medicine as a powder for suspension. 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 duration of administration should not exceed 5 days. If influenza symptoms develop during the 48-hour interval between dialysis sessions, this medicine 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 aged 13 years and older: For close contacts of 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 an influenza epidemic 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 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

1. Influenza A and influenza B virus infections Children aged 1 year to 12 years: Pediatric patients weighing more than 40 kg who can swallow capsules may take a 75 mg capsule twice daily or one 30 mg capsule and one 45 mg capsule twice daily instead of the recommended dose of this drug suspension. ≤ 15 kg: 30 mg twice daily; 5.0 mL twice daily 15 kg<, ≤ 23 kg: 45 mg twice daily; 7.5 mL twice daily 23 kg<, ≤ 40 kg: 60 mg twice daily; 10.0 mL twice daily > 40 kg: 75 mg twice daily; 12.5 mL twice daily Children aged 2 weeks to less than 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. 3 kg: 9 mg twice daily; 1.5 mL twice daily 4 kg: 12 mg twice daily; 2.0 mL twice daily 5 kg: 15 mg twice daily; 2.5 mL twice daily 6 kg: 18 mg twice daily; 3.0 mL twice daily 7 kg: 21 mg twice daily; 3.5 mL twice daily 8 kg: 24 mg twice daily; 4.0 mL twice daily 9 kg: 27 mg twice daily; 4.5 mL twice daily 10 kg: 30 mg twice daily; 5.0 mL twice daily * This table does not include all possible body weights in this patient group. A dose of 3mg/kg of this drug is recommended for children younger than 1 year. It is recommended that a pharmacist prepare this drug suspension before it is administered to the patient. 2. Prevention of influenza A and influenza B virus infections Children aged 1 year to 12 years: Pediatric patients weighing more than 40 kg who can swallow capsules may take a 75 mg capsule once daily or one 30 mg capsule and one 45 mg capsule once daily for 10 days instead of the recommended dose of this drug suspension. ≤ 15 kg: 30 mg once daily; 5.0 mL once daily 15 kg<, ≤ 23 kg: 45 mg once daily; 7.5 mL once daily 23 kg<, ≤ 40 kg: 60 mg once daily; 10.0 mL once daily > 40 kg: 75 mg once daily; 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 preventing influenza A and B virus infections in children younger than 1 year have not been evaluated.

This medication cannot replace influenza vaccination and should only be used for treatment and prevention during seasons when the influenza virus is prevalent. This medication is effective only against influenza A and B viruses, and safety and effectiveness for other infections have not been established. In particular, neuropsychiatric adverse reactions have been reported in children and adolescents, and abnormal behavior or seizures may occur, so caregivers should carefully monitor patients after administration. It is generally recommended not to use this medication in children over 10 years old except in special cases. Patients with hypersensitivity to this medication or any of its components should not use it. Dose adjustments are necessary for patients with impaired kidney function, and it is not recommended for patients with end-stage renal failure. Caution should be applied in high-risk patients with asthma, chronic bronchitis, or immune suppression. The most common side effects include nausea, vomiting, headache, and are mostly temporary. Rarely, serious allergic reactions, liver dysfunction, skin rashes, acute renal failure, and neuropsychiatric symptoms may occur, so if abnormalities appear, immediate consultation with a physician is essential. This medication can be used with the influenza vaccine, but there should be a certain interval with live vaccines, and there are generally few drug interactions with various common medications. Pregnant or breastfeeding women should carefully weigh the benefits and risks when using this medication. Safety and efficacy have not been established for children under 1 year of age, so it is advisable to avoid use in this group. In elderly patients, dosage adjustments are generally not required, but careful monitoring is important considering physical functions. Serious side effects from overdose are rare, but it is vital to adhere to the prescribed dosages and regimens. Store out of reach of children and avoid transferring to other containers. If abnormal behavior or neuropsychiatric symptoms occur during treatment with this medication, immediate consultation with healthcare professionals is necessary, and caregivers should closely monitor the patient.

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

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is best to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance

A hard capsule filled with a white to light yellow powder, with light yellow caps and bottoms.

Package unit

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