Fluone Capsule 75 mg (Oseltamivir Phosphate)

Adult dose

Treatment of influenza A and influenza B virus infections: Begin 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 it is taken with food. Adults and adolescents 13 years and older: Administer 75 mg of oseltamivir orally twice daily for 5 days. Adults and adolescents 13 years and older who have difficulty swallowing capsules should use this medicine as an oral suspension. Patients with renal impairment (treatment): No dose adjustment is necessary in patients with creatinine clearance of 60 mL/min or greater. 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 periodic hemodialysis should receive a 30mg dose of this medicine after each dialysis session to maintain therapeutic blood concentrations, and the treatment period should not exceed 5 days. If influenza symptoms develop during the 48-hour period between dialysis sessions, the dose may 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 (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 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 medicine have been demonstrated for up to 6 weeks. The preventive effect continues while this medicine is being taken. Patients with renal impairment (prevention): No dose adjustment is necessary in patients with creatinine clearance of 60 mL/min or greater. 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 every other day is recommended. Patients receiving periodic hemodialysis should receive a 30mg dose of this medicine after every 2 dialysis sessions to maintain therapeutic blood concentrations. 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 (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 aged 1 to 12 years: Pediatric patients weighing more than 40 kg who can swallow capsules may take 75 mg capsules twice daily or 30 mg capsules and 45 mg capsules twice daily instead of the recommended dose of this drug suspension. ≤ 15 kg: 30 mg twice daily for 5 days; suspension (6mg/mL) 5.0 mL twice daily 15 kg<, ≤ 23 kg: 45 mg twice daily for 5 days; suspension (6mg/mL) 7.5 mL twice daily 23 kg<, ≤ 40 kg: 60 mg twice daily for 5 days; suspension (6mg/mL) 10.0 mL twice daily > 40 kg: 75 mg twice daily for 5 days; suspension (6mg/mL) 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 children with a postconceptional age of less than 36 weeks. 3 kg: 9 mg twice daily for 5 days; suspension (6mg/mL) 1.5 mL twice daily 4 kg: 12 mg twice daily for 5 days; suspension (6mg/mL) 2.0 mL twice daily 5 kg: 15 mg twice daily for 5 days; suspension (6mg/mL) 2.5 mL twice daily 6 kg: 18 mg twice daily for 5 days; suspension (6mg/mL) 3.0 mL twice daily 7 kg: 21 mg twice daily for 5 days; suspension (6mg/mL) 3.5 mL twice daily 8 kg: 24 mg twice daily for 5 days; suspension (6mg/mL) 4.0 mL twice daily 9 kg: 27 mg twice daily for 5 days; suspension (6mg/mL) 4.5 mL twice daily 10 kg: 30 mg twice daily for 5 days; 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. 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 75 mg capsules once daily or 30 mg capsules and 45 mg capsules once daily for 10 days instead of the recommended dose of this drug suspension. ≤ 15 kg: 30 mg once daily for 10 days; suspension (6mg/mL) 5.0 mL once daily 15 kg<, ≤ 23 kg: 45 mg once daily for 10 days; suspension (6mg/mL) 7.5 mL once daily 23 kg<, ≤ 40 kg: 60 mg once daily for 10 days; suspension (6mg/mL) 10.0 mL once daily > 40 kg: 75 mg once daily for 10 days; 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 medicine cannot replace influenza vaccination and its preventive effect lasts only during its use. Safety and efficacy have not been established for infections other than influenza A and B. Abnormal behavior or neuropsychiatric reactions have been reported in children and adolescents taking this medicine, so it should be used cautiously in children aged 10 and above only when necessary. People with an allergy to this medicine or its components should not take it. Patients with impaired kidney function require dosage adjustments, and it is not recommended for patients with end-stage renal failure. Caution should be exercised when administering to high-risk patients with asthma, chronic bronchitis, or immunosuppressed conditions. Nausea, vomiting, headache, etc., are common side effects and mostly temporary. Rarely, symptoms such as shock, anaphylaxis, pneumonia, liver dysfunction, skin abnormalities, acute renal failure, hematological abnormalities, and neuropsychiatric symptoms may occur, so consult healthcare professionals immediately if any of these symptoms appear. This medicine does not replace the influenza vaccine and is effective when taken early after the onset of flu symptoms. The potential for drug interactions is low, but caution is needed when used with drugs that may affect renal excretion. Pregnant or breastfeeding women should carefully consider the risks and benefits of using this medicine. Safety and efficacy in children under 1 year old have not been established, so caution is needed. Elderly patients require careful monitoring during administration due to decreased body function and various underlying diseases. In case of overdose, symptoms similar to commonly known side effects may occur, so adherence to the prescribed dosage and administration is essential. Keep out of reach of children and do not transfer to another container.

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

This medicine may be sensitive to air and moisture, so it should be stored in a tightly closed container. In addition, storing it at a temperature between 1 and 30 degrees Celsius is important to maintain its effectiveness.

Appearance

Hard capsule with gray lower part and light yellow upper part containing white or light yellow powder

Package unit

10 capsules (10 capsules/PTP X 1)