EasyFlu Powder 75 mg (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 taken with or without food; taking it with food may improve tolerability in some patients. Adults and adolescents 13 years of age and older: Administer 75 mg of oseltamivir orally twice daily for 5 days. Adults and adolescents 13 years of age and older who have difficulty swallowing capsules should use this medicine for dosing. 2. Prevention of influenza A and influenza B virus infections Adults and adolescents 13 years of age 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 the medicine is being taken. Patients with renal impairment (treatment): No dosage adjustment is required for patients with a creatinine clearance of 60 mL/min or greater. 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 intermittent hemodialysis should receive a 30mg dose of this medicine after each dialysis session to maintain blood concentrations within the therapeutic range, and treatment should not exceed 5 days. If influenza symptoms develop during the 48 hours between dialysis sessions, the dose may be given 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 required for treatment of adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9). Patients with renal impairment (prevention): No dosage adjustment is required for patients with a creatinine clearance of 60 mL/min or greater. 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 intermittent hemodialysis should receive a 30mg dose of this medicine after every 2 dialysis sessions to maintain blood concentrations within the therapeutic range. The first dose may also be given 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 required 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 1 to 12 years of age: 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 (packet) twice daily 15 kg<, ≤ 23 kg: 45 mg (packet) twice daily 23 kg<, ≤ 40 kg: 60 mg (two 30mg packets) twice daily > 40 kg: 75 mg (packet) twice daily Infants 2 weeks to less than 1 year of age: The recommended dose for pediatric patients 2 weeks to 12 months of age 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. 3 kg: 9 mg twice daily; suspension (6mg/mL) dose 1.5mL twice daily 4 kg: 12 mg twice daily; suspension (6mg/mL) dose 2.0mL twice daily 5 kg: 15 mg twice daily; suspension (6mg/mL) dose 2.5mL twice daily 6 kg: 18 mg twice daily; suspension (6mg/mL) dose 3.0mL twice daily 7 kg: 21 mg twice daily; suspension (6mg/mL) dose 3.5mL twice daily 8 kg: 24 mg twice daily; suspension (6mg/mL) dose 4.0mL twice daily 9 kg: 27 mg twice daily; suspension (6mg/mL) dose 4.5mL twice daily 10 kg: 30 mg twice daily; suspension (6mg/mL) dose 5.0mL twice daily * This table does not include all possible weights for this patient group. A dose of 3mg/kg of this medicine is recommended for children younger than 1 year. Pediatric patients who have difficulty taking this medicine as a powder should use the suspension. Prevention of influenza A and influenza B virus infections — Children 1 to 12 years of age: 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 (packet) once daily 15 kg<, ≤ 23 kg: 45 mg (packet) once daily 23 kg<, ≤ 40 kg: 60 mg (two 30mg packets) once daily > 40 kg: 75 mg (packet) once daily ※ The safety and efficacy of prevention of influenza A and B virus infections in children younger than 1 year have not been evaluated.

This medication cannot replace influenza vaccination and should be used separately from influenza vaccination. Its efficacy has only been confirmed against influenza A and B viruses, and its safety and efficacy for other infections are not known. Particularly in children and adolescents, abnormal behavior or neuropsychiatric adverse reactions may occur, so caregivers must observe them closely during administration. Patients allergic to this medication should not use it. Patients with impaired kidney function or those on dialysis need dosage adjustments, and it is not recommended for patients with severe renal failure. During treatment with this medication, side effects such as nausea, vomiting, headache, and pain may occur, but most are temporary. Rarely, serious side effects such as shock, anaphylaxis, liver dysfunction, skin reactions, acute renal failure, and neuropsychiatric abnormalities may occur, so any abnormal symptoms should be reported to medical personnel immediately. Pregnant or breastfeeding women should carefully consider the risks and benefits of using this medication. Safety and efficacy in children, especially infants under 1 year old, have not been established. Elderly patients can use it without special dosage adjustments, but their overall physical condition should be observed closely. This medication has a low possibility of drug interactions, but caution is needed when taken with some drugs related to renal excretion. When driving or operating machinery, patients should be cautious of the impairment caused by influenza symptoms. Store it in a safe place out of reach of children and do not transfer to other containers.

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

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is best stored at room temperature between 1 and 30 degrees.

Appearance

White or yellowish powder

Package unit

10 sachets/box