Daewoong Bioflu Capsule 30 mg (Oseltamivir Phosphate)

Adult dose

Treatment of influenza A and influenza B virus infections: Start treatment on the first or second day after influenza symptoms appear. This medicine may be taken with or without food; taking it with food may improve tolerability in some patients. 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 an oral suspension powder. Patients with renal impairment (treatment): No dosage adjustment is needed in patients with creatinine clearance ≥ 60 mL/min. 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; treatment should not exceed 5 days. If influenza symptoms develop during the 48 hours between dialysis sessions, the dose may also be administered before dialysis begins. 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 needed 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 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 needed in patients with creatinine clearance ≥ 60 mL/min. 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 two dialysis sessions to maintain blood concentrations within the therapeutic range. The first dose may also be administered before dialysis begins. 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 needed 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 75mg capsules twice daily or 30mg and 45mg capsules twice daily instead of the recommended dose of this medicine as an oral 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 children with a post-conceptional age of less than 36 weeks. A dose of 3mg/kg of this medicine is recommended for children younger than 1 year. 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 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 75mg capsules once daily or 30mg and 45mg capsules once daily for 10 days instead of the recommended dose of this medicine as an oral 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 The safety and efficacy of preventing influenza A and B virus infections in children younger than 1 year have not been evaluated.

This drug is used for the treatment and prevention of influenza infections and cannot replace the influenza vaccine. This drug has been proven effective only against influenza A and B viruses, and its safety and efficacy have not been established for other infections. Rarely, in children and adolescents, neuropsychiatric adverse reactions such as seizures or delirium may occur, so guardians should observe carefully if unusual behaviors arise during treatment. The principle is to avoid using this drug in pediatric patients aged 10 years and older without special risk factors. Patients with hypersensitivity to this drug or its components should not take it. Patients with decreased renal function require dose adjustments, and it is not recommended for patients with end-stage renal disease. High-risk patients such as those with asthma, chronic bronchitis, or immunosuppressive states should be administered with caution. Common side effects include nausea, vomiting, and headache, which are mostly transient and mild symptoms. Rarely, allergic reactions, liver function abnormalities, skin rashes, acute renal failure, and neuropsychiatric symptoms may occur, so immediate consultation with healthcare professionals is advised if any adverse symptoms arise. This drug has low interaction potential with other medications; however, caution may be required when used in combination with specific drugs. Pregnant or nursing women should only use it when the benefits of treatment outweigh the risks, and consultation with a specialist is important. Safety and efficacy in pediatric patients under 1 year have not been established. While elderly patients do not require dose adjustments, they should be monitored closely considering potential declines in bodily function. Although serious adverse reactions are rarely reported in cases of overdose, it is important to adhere to the recommended doses. This drug should be kept out of the reach of children and should not be transferred to other containers. It is effective to start taking at the onset of influenza symptoms, and if a dose is missed, it should be taken as soon as possible while maintaining an appropriate interval before the next scheduled dose. No influence on driving or operating machinery has been reported, however, caution is necessary due to symptoms caused by influenza itself.

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

This drug may be sensitive to air and moisture, so it should be stored in a tightly closed container. It is important to store it in a cool place below 25 degrees Celsius to maintain its efficacy and safety.

Appearance

Light yellow hard gelatin capsule containing white or light yellow powder

Package unit

10 capsules (10 capsules/PTP x 1)