N-Pflu Suspended Powder (Oseltamivir Phosphate)

Adult dose

1. Influenza A and influenza B virus infections: Start treatment on the first or second day after the onset of influenza symptoms. This drug 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: Take 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 drug. Patients with renal impairment: No dose adjustment is necessary for patients with creatinine clearance of 60 mL/min or higher. 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 drug after each dialysis session to maintain therapeutic blood concentrations; the duration of administration should not exceed 5 days. If influenza symptoms develop during the 48 hours between dialysis sessions, the dose may also be given before dialysis begins. For peritoneal dialysis, a single 30mg dose of this drug 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 aged 13 years and older: For close contacts of an infected person, take 75 mg of oseltamivir orally once daily for 10 days. Begin 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 drug have been demonstrated for up to 6 weeks. The preventive effect continues while taking this drug. Patients with renal impairment: No dose adjustment is necessary for patients with creatinine clearance of 60 mL/min or higher. 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 once daily every other day is recommended. Patients receiving regular hemodialysis should receive a 30mg dose of this drug after every 2 dialysis sessions to maintain therapeutic blood concentrations. The initial dose may also be given before dialysis begins. For peritoneal dialysis, administration of 30mg of this drug 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 aged 1 to 12 years weighing more than 40 kg: A 75mg capsule may be taken twice daily, or 30mg and 45mg capsules may be taken twice daily. ≤ 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 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: 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 drug is recommended for children under 1 year of age. Prevention of influenza A and influenza B virus infections Children aged 1 to 12 years weighing more than 40 kg: A 75mg capsule may be taken once daily, or 30mg and 45mg capsules may be taken once daily for 10 days. ≤ 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 this drug for prevention of influenza A and B virus infections in children under 1 year of age have not been evaluated.

This drug cannot substitute for influenza vaccination and is recommended to be used only during influenza outbreaks. The safety and efficacy of this drug have not been established for infections other than influenza A and B. Rarely, seizures or abnormal behavior may occur during treatment with this drug in children and adolescents, so those in this age group should be closely monitored for unusual behavior. For pediatric patients aged 10 years and older, it is generally recommended not to use this drug except in special cases, and caregivers should ensure not to leave the patient unattended for at least 2 days during treatment. This drug should not be administered to patients with hypersensitivity to it. Dosing adjustments are necessary for patients with impaired kidney function or those undergoing dialysis, and it is not recommended for patients with end-stage renal failure. Use with caution in high-risk patients with asthma, chronic bronchitis, or immunocompromised conditions. During treatment with this drug, side effects such as nausea, vomiting, headache, etc., may commonly occur, but most of these are temporary and not severe. Rarely, symptoms such as shock, anaphylaxis, liver function abnormalities, skin rashes, acute renal failure, blood dyscrasias, and neuropsychiatric symptoms may occur, so if any unusual symptoms appear, immediate consultation with a healthcare professional is required. The safety and efficacy of this drug have not been established in children under 1 year of age, so it should be avoided for use in this group. Women who are pregnant or breastfeeding should carefully consider the benefits and risks of using this drug and consult a doctor if necessary. This drug has a low potential for interactions with other medications; however, caution may be warranted when taking certain drugs, so the patient's current medications should be disclosed. This drug contains sorbitol, making it unsuitable for patients with hereditary fructose intolerance. While taking this drug, unusual behavior or neurological symptoms may emerge, so precautions should be taken when driving or operating machinery. After compounding the suspension, it must be stored at the recommended temperature and duration, and kept out of reach of children.

• Convulsion
• 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 recommended to maintain storage temperatures between 1 and 30 degrees Celsius. This will help preserve the drug's effectiveness over time.

Appearance

A suspension preparation in a brown glass bottle containing white or pale yellow granules for reconstitution before use.

Package unit

10 grams/bottle [50 mL], 13 grams/bottle [65 mL]