Fluone Suspension Powder 6 mg/mL (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, although tolerability may improve in some patients when it is 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. Patients with renal impairment (treatment): No dosage adjustment is required 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 regular hemodialysis should receive a 30mg dose of this medicine after each dialysis session to maintain blood 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 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 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: In individuals who have been in close contact with 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 this medicine is being taken. Patients with renal impairment (prevention): No dosage adjustment is required 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 regular hemodialysis should receive a 30mg dose of this medicine after every 2 dialysis sessions to maintain blood 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 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 less than 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment (prevention): 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 to 12 years (treatment): Pediatric patients weighing more than 40 kg who can swallow capsules may take a 75mg capsule twice daily or a 30mg capsule and a 45mg capsule twice daily instead of the recommended dose of this medicine. Age 1 to 12 years, weight ≤ 15 kg (treatment): 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily Age 1 to 12 years, weight 15 kg<, ≤ 23 kg (treatment): 45 mg twice daily; suspension (6mg/mL) 7.5 mL twice daily Age 1 to 12 years, weight 23 kg<, ≤ 40 kg (treatment): 60 mg twice daily; suspension (6mg/mL) 10.0 mL twice daily Age 1 to 12 years, weight > 40 kg (treatment): 75 mg twice daily; suspension (6mg/mL) 12.5 mL twice daily Infants 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. A dose of 3mg/kg of this medicine is recommended for infants under 1 year of age. Age 2 weeks to less than 1 year, weight 3 kg (treatment): 9 mg twice daily; suspension (6mg/mL) 1.5 mL twice daily Age 2 weeks to less than 1 year, weight 4 kg (treatment): 12 mg twice daily; suspension (6mg/mL) 2.0 mL twice daily Age 2 weeks to less than 1 year, weight 5 kg (treatment): 15 mg twice daily; suspension (6mg/mL) 2.5 mL twice daily Age 2 weeks to less than 1 year, weight 6 kg (treatment): 18 mg twice daily; suspension (6mg/mL) 3.0 mL twice daily Age 2 weeks to less than 1 year, weight 7 kg (treatment): 21 mg twice daily; suspension (6mg/mL) 3.5 mL twice daily Age 2 weeks to less than 1 year, weight 8 kg (treatment): 24 mg twice daily; suspension (6mg/mL) 4.0 mL twice daily Age 2 weeks to less than 1 year, weight 9 kg (treatment): 27 mg twice daily; suspension (6mg/mL) 4.5 mL twice daily Age 2 weeks to less than 1 year, weight 10 kg (treatment): 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily Children aged 1 to 12 years (prevention): Pediatric patients weighing more than 40 kg who can swallow capsules may take a 75mg capsule once daily or a 30mg capsule and a 45mg capsule once daily for 10 days instead of the recommended dose of this medicine. Age 1 to 12 years, weight ≤ 15 kg (prevention): 30 mg once daily; suspension (6mg/mL) 5.0 mL once daily Age 1 to 12 years, weight 15 kg<, ≤ 23 kg (prevention): 45 mg once daily; suspension (6mg/mL) 7.5 mL once daily Age 1 to 12 years, weight 23 kg<, ≤ 40 kg (prevention): 60 mg once daily; suspension (6mg/mL) 10.0 mL once daily Age 1 to 12 years, weight > 40 kg (prevention): 75 mg once daily; suspension (6mg/mL) 12.5 mL once daily The safety and efficacy of this medicine 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 is used for treatment and prevention purposes only during periods when the influenza virus is prevalent. Safety and efficacy have not been established for infections other than influenza A and B. Rarely, neuropsychiatric effects such as seizures, delirium, and abnormal behavior may occur in children and adolescents, so it is generally advised not to use in children over 10 years of age except in special cases. There is a risk of abnormal behavior during treatment with this medication, so children and adolescents should not be left alone for at least 2 days after starting treatment, and caregivers should monitor them closely. Patients with allergies to this medication or its components, lactose intolerance, or specific metabolic disorders should not use it. Patients with renal impairment or those undergoing dialysis may require dose adjustments, and it is not recommended for patients with end-stage renal failure. Patients with asthma, chronic bronchitis, or immunosuppressive conditions should use it cautiously. Common side effects such as nausea, vomiting, and headache may occur, but they are mostly transient and mild. Rarely, serious side effects such as shock, anaphylaxis, liver function abnormalities, skin rashes, acute renal failure, and neuropsychiatric symptoms may occur, so if any abnormal symptoms appear, consult a healthcare provider immediately. Pregnant or breastfeeding women should use this medication only if the benefits outweigh the risks, as its effects on the fetus or infant are not clearly established. Safety and efficacy for children under 1 year of age have not been sufficiently established, so its use is not recommended. Elderly patients should be monitored closely considering physiological decline and multiple comorbidities, and dose adjustments are generally not necessary. This medication has few interactions with other drugs, but caution may be needed when used with specific medications, so be sure to inform healthcare providers of any medications being taken. When taking, the medication should be prepared accurately, kept out of the reach of children, and stored in accordance with the recommended temperature and duration. This medication should be taken as soon as possible after influenza symptoms begin, and if a dose is missed, it should be taken as soon as possible, but if less than 2 hours remain until the next dose, it is advisable to skip it. No effects on driving or operating machinery have been reported, but since influenza itself can impair concentration, caution should be exercised.

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

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. Additionally, it should be stored at room temperature (between 1°C and 30°C), which is not too high or too low. This will help maintain the effectiveness of the medication over time.

Appearance

White to pale yellow powder or powder with lumps contained in a brown glass bottle

Package unit

10 g/bottle (50 mL), 13 g/bottle (65 mL)