Daewoong Bioflu Capsule 75 mg (Oseltamivir Phosphate)

Adult dose

Influenza A and influenza B virus infections: Initiate treatment on the first or second day after the onset of influenza symptoms. This medicine may be administered with or without food, although tolerability may improve in some patients when taken with food. Adults and adolescents 13 years of age and older: Administer oseltamivir 75 mg orally twice daily for 5 days. Adults and adolescents 13 years of age and older who have difficulty swallowing capsules should use this medicine as powder for suspension. Patients with renal impairment (treatment): No dose adjustment is required for patients with a creatinine clearance of 60 mL/min or higher. 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 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 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 below 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment (treatment): No dose adjustment is required 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 of age and older (following close contact with an infected person): Administer oseltamivir 75 mg 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 protective effect continues while this medicine is being taken. Patients with renal impairment (prevention): No dose adjustment is required for patients with a creatinine clearance of 60 mL/min or higher. 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 once daily 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 initial dose may 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 below 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment (prevention): 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 (treatment): Pediatric patients weighing more than 40 kg who can swallow capsules may take 75 mg capsules twice daily or 30 mg and 45 mg capsules twice daily instead of the recommended dose of this drug suspension. ≤ 15 kg (treatment): 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily 15 kg<, ≤ 23 kg (treatment): 45 mg twice daily; suspension (6mg/mL) 7.5 mL twice daily 23 kg<, ≤ 40 kg (treatment): 60 mg twice daily; suspension (6mg/mL) 10.0 mL twice daily > 40 kg (treatment): 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 drug orally twice daily for 5 days. This does not apply to infants with a postconceptional age of less than 36 weeks. 3 kg (treatment): 9 mg twice daily; suspension (6mg/mL) 1.5 mL twice daily 4 kg (treatment): 12 mg twice daily; suspension (6mg/mL) 2.0 mL twice daily 5 kg (treatment): 15 mg twice daily; suspension (6mg/mL) 2.5 mL twice daily 6 kg (treatment): 18 mg twice daily; suspension (6mg/mL) 3.0 mL twice daily 7 kg (treatment): 21 mg twice daily; suspension (6mg/mL) 3.5 mL twice daily 8 kg (treatment): 24 mg twice daily; suspension (6mg/mL) 4.0 mL twice daily 9 kg (treatment): 27 mg twice daily; suspension (6mg/mL) 4.5 mL twice daily 10 kg (treatment): 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 drug is recommended for children under 1 year of age. Children aged 1 to 12 years (prophylaxis): Pediatric patients weighing more than 40 kg who can swallow capsules may take 75 mg capsules once daily or 30 mg and 45 mg capsules once daily for 10 days instead of the recommended dose of this drug suspension. ≤ 15 kg (prophylaxis): 30 mg once daily; suspension (6mg/mL) 5.0 mL once daily 15 kg<, ≤ 23 kg (prophylaxis): 45 mg once daily; suspension (6mg/mL) 7.5 mL once daily 23 kg<, ≤ 40 kg (prophylaxis): 60 mg once daily; suspension (6mg/mL) 10.0 mL once daily > 40 kg (prophylaxis): 75 mg once daily; suspension (6mg/mL) 12.5 mL once daily ※ The safety and efficacy of preventing influenza A and B virus infections in children under 1 year of age have not been evaluated.

This medication cannot replace influenza vaccinations and should be used separately from the annual influenza vaccine. This drug is effective only against influenza A and B, and its safety and efficacy have not been confirmed for other infectious diseases. Neurological and psychiatric side effects may occur in children and adolescents, so parents should closely observe for unusual behaviors. In principle, this medication is not used for children aged 10 years and older, and it should be administered carefully only to high-risk patients. Patients with hypersensitivity to this medication should not take it. Patients with renal impairment require dosage adjustments and it is not recommended for patients with end-stage renal disease. It should be administered with caution in high-risk patients, such as those with asthma or chronic bronchitis. Common side effects include nausea, vomiting, and headache, which are mostly temporary. Rarely, shock, anaphylaxis, hepatitis, skin abnormalities, acute renal failure, and neuropsychiatric symptoms can occur, so immediate consultation with healthcare providers is necessary if symptoms appear. Pregnant or breastfeeding women should consult a doctor about the administration of this medication and should only use it when the therapeutic benefit outweighs the risks. In children under 1 year, safety and efficacy have not been established, so it is not used. Generally, elderly patients do not require dose adjustments, but careful observation is necessary due to possible declines in physical function. This medication typically has no significant interactions with other drugs, but caution may be needed when combined with specific drugs. If unusual behavior or severe side effects occur during administration, the medication should be discontinued immediately and healthcare providers informed. Keep this medication out of reach of children and do not transfer it to other containers. It is effective when taken early during the onset of influenza symptoms, and if a dose is missed, take it as soon as possible while maintaining regular intervals.

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

This medication should be stored in a sealed container to protect it from air and moisture. Also, it is important to store it at a cool temperature below 25 degrees Celsius to maintain its effectiveness.

Appearance

A hard capsule with a light yellow upper part and a light gray lower part containing a white or light yellow powder.

Package unit

10 capsules (10 capsules/PTP X 1)