Daewoong Bioflu Powder for Suspension 6mg/mL (Oseltamivir Phosphate)

Adult dose

1. Influenza A and influenza B virus infections: Start treatment on the first or second day after influenza symptoms appear. This medicine may be administered with or without food; some patients may tolerate it better when taken with food. Adults and adolescents 13 years and older: Administer 75 mg of oseltamivir orally twice daily for 5 days. Adults and adolescents 13 years and older who have difficulty swallowing capsules should use this medicine. Patients with renal impairment: No dose adjustment is necessary for patients with creatinine clearance of 60 mL/min or more. 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 30mg of this medicine after each dialysis session to maintain therapeutic plasma concentrations, and treatment 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 dose of 30mg 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: No dose adjustment is necessary 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 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 taking this medicine. Patients with renal impairment: No dose adjustment is necessary for patients with creatinine clearance of 60 mL/min or more. 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 30mg 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, 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: No dose adjustment is necessary for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

Children 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. ≤ 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 Infants aged 2 weeks to under 1 year: The recommended dose for infants 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 post-conceptional age of less than 36 weeks. 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 * This table does not include all possible weights in this patient group. A dose of 3mg/kg of this medicine is recommended for children under 1 year. Prevention of influenza A and influenza B virus infections Children 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. ≤ 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 prevention of influenza A and B virus infections in children under 1 year have not been evaluated.

This medication cannot replace influenza vaccinations and is used as a separate therapeutic agent from influenza vaccinations. This drug is effective only against influenza A and B viruses, and its safety and efficacy for the treatment of other infections has not been verified. Notably, neuropsychiatric adverse reactions, such as seizures or delirium, have been rarely reported in children and adolescents, so any unusual behavior should be closely monitored after administration. In principle, this medication should not be used in pediatric patients aged 10 years or older except in special cases. During the course of treatment, caregivers should ensure that children or adolescents do not remain alone to prevent any unusual behavior or incidents. Patients with hypersensitivity to this medication or its components should not use it. Dose adjustments are necessary for patients with impaired renal function or those undergoing dialysis, and it is not recommended for patients with end-stage renal failure. Caution should be exercised when administering to high-risk patients, such as those with asthma or chronic bronchitis. The most common side effects during treatment include nausea, vomiting, and headaches, which are usually transient and mild. Rarely, adverse reactions such as shock, anaphylaxis, hepatitis, Stevens-Johnson syndrome, acute renal failure, and neuropsychiatric symptoms may occur; any adverse symptoms should be reported to healthcare personnel immediately. Women who are pregnant or breastfeeding should use this medication only after carefully assessing the potential benefits and risks, as data on safety are limited. For children, safety and efficacy have not been established in those under 1 year of age, so use should be avoided. In elderly patients, no special dose adjustment is necessary, but they should be monitored for declining physical function. Reports of serious adverse reactions due to overdose are rare, but the recommended dosage and administration must be followed. This medication contains sorbitol and is not suitable for patients with hereditary fructose intolerance. The possibility of interactions with other commonly used medicines is low; however, caution may be needed when used in combination with specific medications. This medication should be spaced from the administration of influenza vaccines, particularly live attenuated vaccines, to avoid simultaneous use. It is essential to shake the suspension prepared by the pharmacist before administration and to store it out of reach of children and at the specified temperature.

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

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is recommended to maintain the storage temperature between 1°C and 30°C.

Appearance

A suspension consisting of white or light yellow granules contained in a brown glass bottle.

Package unit

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