Boryeong 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 medicine 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: 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. Patients with renal impairment (treatment): No dosage adjustment is necessary for patients with creatinine clearance of 60 mL/min or higher. For patients with creatinine clearance of 30 ~ 60 mL/min, reduction to 30 mg twice daily for 5 days is recommended. For patients with creatinine clearance of 10 ~ 30 mL/min, reduction to 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 therapeutic plasma concentrations, and the treatment period should not exceed 5 days. If influenza symptoms occur during the 48 hours between dialysis sessions, the dose may also be given 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 below 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment (treatment): No dosage 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, 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 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 (prevention): No dosage adjustment is necessary for patients with creatinine clearance of 60 mL/min or higher. For patients with creatinine clearance of 30 ～ 60 mL/min, reduction to 30 mg once daily is recommended. For patients with creatinine clearance of 10 ～ 30 mL/min, reduction to 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 therapeutic plasma concentrations. The first dose may also be given 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 below 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment (prevention): No dosage 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 a 30mg capsule and a 45mg capsule twice daily instead of the recommended dose of this medicine. Weight ≤ 15 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily Weight 15 kg<, ≤ 23 kg: 45 mg twice daily; suspension (6mg/mL) 7.5 mL twice daily Weight 23 kg<, ≤ 40 kg: 60 mg twice daily; suspension (6mg/mL) 10.0 mL twice daily Weight > 40 kg: 75 mg twice daily; suspension (6mg/mL) 12.5 mL twice daily Children aged 2 weeks to under 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. Weight 3 kg: 9 mg twice daily; suspension (6mg/mL) 1.5 mL twice daily Weight 4 kg: 12 mg twice daily; suspension (6mg/mL) 2.0 mL twice daily Weight 5 kg: 15 mg twice daily; suspension (6mg/mL) 2.5 mL twice daily Weight 6 kg: 18 mg twice daily; suspension (6mg/mL) 3.0 mL twice daily Weight 7 kg: 21 mg twice daily; suspension (6mg/mL) 3.5 mL twice daily Weight 8 kg: 24 mg twice daily; suspension (6mg/mL) 4.0 mL twice daily Weight 9 kg: 27 mg twice daily; suspension (6mg/mL) 4.5 mL twice daily Weight 10 kg: 30 mg twice daily; suspension (6mg/mL) 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 medicine is recommended for children under 1 year of age. 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 a 30mg capsule and a 45mg capsule once daily for 10 days instead of the recommended dose of this medicine. Weight ≤ 15 kg: 30 mg once daily; suspension (6mg/mL) 5.0 mL once daily Weight 15 kg<, ≤ 23 kg: 45 mg once daily; suspension (6mg/mL) 7.5 mL once daily Weight 23 kg<, ≤ 40 kg: 60 mg once daily; suspension (6mg/mL) 10.0 mL once daily Weight > 40 kg: 75 mg once daily; suspension (6mg/mL) 12.5 mL once daily ※ The safety and efficacy of prevention of influenza A and B virus infections in children under 1 year of age have not been evaluated.

This drug cannot replace influenza vaccination and is used only for treatment and prevention during periods when influenza viruses are circulating. The safety and efficacy of this drug have not been confirmed for infections other than influenza A and B. In children and adolescents, rare neurological and psychiatric adverse reactions such as seizures or delirium may occur, so guardians should carefully monitor for unusual behavior. In principle, this drug should not be used in children over 10 years old, except in special cases, due to the risk of unusual behavior and accidents. Patients with allergies to this drug or its ingredients should not use it. Patients with impaired kidney function or those on dialysis require dosage adjustments, and it is not recommended for patients with end-stage renal failure. It should be administered cautiously to high-risk patients with asthma, chronic bronchitis, or immunosuppressed states. Common side effects include nausea, vomiting, headache, and are mostly temporary and mild. Rarely, shock, anaphylaxis, liver dysfunction, rashes, acute renal failure, and neurological symptoms may occur, so if any unusual symptoms arise, consult a doctor immediately. This drug contains sorbitol and is not suitable for patients with hereditary fructose intolerance. There is minimal interaction with other medications, but caution is required when used with certain medications affecting renal excretion. Pregnant or nursing women should carefully consider the risks and benefits of administering this drug. In children, especially under 1 year old, the safety and efficacy of this drug have not been sufficiently established, so its use is not recommended. For the elderly, dosage adjustments are not required, but careful monitoring should be conducted considering physical decline and underlying conditions. There are rarely reports of severe side effects even in cases of overdose, but if any unusual symptoms appear, visit a medical institution immediately. This drug should be stored in a tightly sealed container to avoid exposure to air or moisture. It is recommended to keep it stored at room temperature between 1 to 30 degrees Celsius.

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

This drug must be stored in a tightly sealed container to prevent exposure to air or moisture. It is advisable to keep the storage temperature between 1 and 30 degrees Celsius.

Appearance

A suspension that dissolves for use, consisting of white or light yellow granules packed in a brown glass bottle.

Package unit

10g/bottle (50mL)