Bisel Flu Suspension Powder 6mg/mL (Oseltamivir Phosphate)

Adult dose

Influenza A and influenza B virus infections: Start treatment on the first or second day after the onset of influenza symptoms. This drug may be taken with or without food; tolerability may improve in some patients when taken with food. Adults and adolescents aged 13 years and older: Take 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 drug. Patients with renal impairment (treatment): No dose adjustment is necessary for patients with creatinine clearance of 60 mL/min or higher. 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 drug after each dialysis session to maintain therapeutic blood concentrations; the duration of administration should not exceed 5 days. If influenza symptoms develop during the 48 hours between dialysis sessions, the dose may also be given before dialysis begins. For peritoneal dialysis, a single 30mg dose of this drug 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 below 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 aged 13 years and older: For close contacts of an infected person, take 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 drug have been demonstrated for up to 6 weeks. The preventive effect continues while taking this drug. Patients with renal impairment (prevention): No dose adjustment is necessary for patients with creatinine clearance of 60 mL/min or higher. 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 once daily every other day is recommended. Patients receiving regular hemodialysis should receive a 30mg dose of this drug after every 2 dialysis sessions to maintain therapeutic blood concentrations. The initial dose may also be given before dialysis begins. For peritoneal dialysis, administration of 30mg of this drug 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 below 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 a 75mg capsule twice daily, or 30mg and 45mg capsules twice daily, instead of the recommended dose of this drug. ≤ 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 Infants 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 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 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 the suspension of this drug 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 a 75mg capsule once daily, or 30mg and 45mg capsules once daily for 10 days, instead of the recommended dose of this drug. ≤ 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 the suspension of this drug before it is administered to the patient. ※ The safety and efficacy of this drug for prevention of influenza A and B virus infections in children under 1 year of age have not been evaluated.

This medication is used to treat or prevent influenza virus infections but cannot replace influenza vaccinations. It is effective only against influenza A and B viruses, and its safety and efficacy against other types of infections have not been established. Particularly in children and adolescents, abnormal behavior or neuropsychiatric adverse reactions have been reported; thus, careful observation is necessary in this age group, and guardians should ensure that they are not left alone for 2 days. Individuals allergic to this drug or its components should not take it. Dose adjustment is required for patients with impaired kidney function or those undergoing dialysis, and it is not recommended for patients with severe renal failure. Caution is required for high-risk patients with asthma, chronic bronchitis, or immunosuppressive conditions. Common side effects include nausea, vomiting, and headache, which are mostly temporary and mild. Rarely, shock, anaphylaxis, abnormal liver function, skin rash, acute renal failure, and neuropsychiatric symptoms may occur, and if any abnormal symptoms arise, immediate consultation with a medical professional is necessary. The effects of this medication on fetuses or infants during pregnancy or breastfeeding have not been adequately studied, so a careful decision should be made after consulting a doctor. The safety and effectiveness for children, especially infants under 1 year old, have not been established, so it is advisable to avoid use. Elderly individuals do not require dose adjustment, but careful observation is necessary due to possible decline in physical function and underlying diseases. When taking this medication, the prescribed method and dosage must be strictly followed, and if a dose is missed, it should be taken as soon as possible, but care should be taken not to take it too close to the next dose. This medication has a low potential for interaction with specific drugs, but caution is warranted when used with agents affecting renal excretion. When storing this medication, keep it in a cool place out of reach of children, and use it within the specified period after preparation; it is advisable not to transfer it to another container. This medication is not suitable for patients with hereditary fructose intolerance.

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

This medication should be stored in a tightly sealed container to prevent air or moisture from entering and should be kept at room temperature between 1 degree and 30 degrees Celsius. Storing it this way will help maintain its efficacy and prevent deterioration.

Appearance

A suspension that dissolves when used, consisting of white or light yellow granules in a brown glass bottle.

Package unit

10 grams/bottle [(50 mL)]