Fluone Capsule 30 mg (Oseltamivir Phosphate)

Adult dose

1. Influenza A and influenza B virus infections: Treatment should be initiated 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 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 as a powder for oral suspension. Patients with renal impairment: No dose 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 30 mg dose of this medicine after each dialysis session to maintain plasma concentrations within the therapeutic range; the treatment duration should not exceed 5 days. If influenza symptoms develop during the 48 hours between dialysis sessions, this medicine may be administered before the start of dialysis. For peritoneal dialysis, a single 30 mg 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 dose 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 individuals in close contact with an infected person, administer 75 mg of oseltamivir 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 preventive effect continues while taking this medicine. Patients with renal impairment: No dose 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 every other day is recommended. Patients receiving regular hemodialysis should receive a 30 mg dose of this medicine 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, administration of 30 mg 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 dose adjustment is required for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

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. ≤ 15 kg — 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily 15 kg<, ≤ 23 kg — 45 mg twice daily; suspension (6mg/mL) 7.5 mL twice daily 23 kg<, ≤ 40 kg — 60 mg twice daily; suspension (6mg/mL) 10.0 mL twice daily > 40 kg — 75 mg twice daily; 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 medicine 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; suspension (6mg/mL) 1.5 mL twice daily 4 kg — 12 mg twice daily; suspension (6mg/mL) 2.0 mL twice daily 5 kg — 15 mg twice daily; suspension (6mg/mL) 2.5 mL twice daily 6 kg — 18 mg twice daily; suspension (6mg/mL) 3.0 mL twice daily 7 kg — 21 mg twice daily; suspension (6mg/mL) 3.5 mL twice daily 8 kg — 24 mg twice daily; suspension (6mg/mL) 4.0 mL twice daily 9 kg — 27 mg twice daily; suspension (6mg/mL) 4.5 mL twice daily 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. For children younger than 1 year, a dose of 3mg/kg of this medicine is recommended. It is recommended that a pharmacist prepare the suspension of this medicine before it is administered to the patient. 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. ≤ 15 kg — 30 mg once daily; suspension (6mg/mL) 5.0 mL once daily 15 kg<, ≤ 23 kg — 45 mg once daily; suspension (6mg/mL) 7.5 mL once daily 23 kg<, ≤ 40 kg — 60 mg once daily; suspension (6mg/mL) 10.0 mL once daily > 40 kg — 75 mg once daily; suspension (6mg/mL) 12.5 mL once daily It is recommended that a pharmacist prepare the suspension of this medicine before it is administered to the patient. ※ The safety and efficacy of this medicine for the prevention of influenza A and B virus infections in children younger than 1 year have not been evaluated.

This medication cannot replace influenza vaccination and must be used separately from it. It is effective only against influenza A and B viruses, and its safety and effectiveness against other infections have not been established. Particularly in children and adolescents, neuropsychiatric adverse reactions have been reported, and symptoms such as abnormal behavior or convulsions may occur, so guardians should closely monitor during use. Generally, the use of this medication in children over 10 years of age is not recommended unless under special circumstances. Do not take this medication if you are allergic to it or its components. Patients with renal failure or on dialysis require dosage adjustment, and it is not recommended for end-stage renal failure patients. Caution should be exercised in high-risk patients with asthma, chronic bronchitis, or immunocompromised status. Common side effects include nausea, vomiting, headache, and pain, most of which are transient and mild. Rarely, shock, anaphylaxis, liver dysfunction, skin rash, acute renal failure, or neuropsychiatric issues may occur, so unusual symptoms should be reported to healthcare providers immediately. Pregnant or breastfeeding women should use this medication only when its benefits outweigh the risks, and adequate data on its effects on fetuses or infants are not yet available. Safety and efficacy in children under 1 year have not been established. Elderly patients may have reduced physiological functions, so they should be monitored carefully during use, although dosage adjustment is not necessary. Overdose is generally not reported to cause serious side effects, but the prescribed dosage should be strictly followed. This medication has a low likelihood of drug interactions, but caution may be necessary when combined with certain medications. No special effects have been reported when driving vehicles or operating machinery, but the impairment caused by influenza itself should be noted. Keep this product out of reach of children and do not transfer it to other containers.

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

This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. Additionally, it is important to store it at room temperature between 1 degree and 30 degrees Celsius to maintain its efficacy.

Appearance

Hard capsule with yellowish upper and lower parts containing white or light yellow powder

Package unit

10 capsules (10 capsules/PTP X 1)