Oseltamivir Phosphate Powder 75 mg

Adult dose

1. 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 taken with or without food; tolerability may be improved in some patients when taken with food. 1) Adults and adolescents aged 13 years and older: Administer oseltamivir 75 mg orally twice daily for 5 days. Adults and adolescents aged 13 years and older who have difficulty swallowing capsules should use this medicine for dosing. 4) Patients with renal impairment No dose adjustment is required for patients with a creatinine clearance of 60 mL/min or more. 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 periodic hemodialysis should receive a 30mg dose of this medicine after each dialysis session to maintain plasma concentrations within the therapeutic range, and the treatment period should not exceed 5 days. If influenza symptoms occur 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. 5) Patients with hepatic impairment No dose adjustment is required 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 1) Adults and adolescents aged 13 years and older: For those in close contact with an infected person, administer oseltamivir 75 mg orally once daily for 10 days. Initiate treatment within 2 days of contact with the infected person. The recommended dose for prevention during an influenza epidemic 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. 3) Patients with renal impairment No dose adjustment is required for patients with a creatinine clearance of 60 mL/min or more. 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 every other day is recommended. Patients receiving periodic hemodialysis should receive a 30mg dose of this medicine after every 2 dialysis sessions to maintain plasma concentrations within the therapeutic range. The initial dose may also be administered before the start of dialysis. 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 below 10mL/min); therefore, no recommended dose is available for these patients. 4) Patients with hepatic impairment No dose adjustment is required for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

1. Influenza A and influenza B virus infections 2) Children aged 1 year 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 (sachet) per dose twice daily 15 kg<, ≤ 23 kg — 45 mg (sachet) per dose twice daily 23 kg<, ≤ 40 kg — 60 mg (two 30mg sachets) per dose twice daily > 40 kg — 75 mg (sachet) per dose twice daily 3) 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 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 per dose twice daily; 1.5mL twice daily 4 kg — 12 mg per dose twice daily; 2.0mL twice daily 5 kg — 15 mg per dose twice daily; 2.5mL twice daily 6 kg — 18 mg per dose twice daily; 3.0mL twice daily 7 kg — 21 mg per dose twice daily; 3.5mL twice daily 8 kg — 24 mg per dose twice daily; 4.0mL twice daily 9 kg — 27 mg per dose twice daily; 4.5mL twice daily 10 kg — 30 mg per dose twice daily; 5.0mL twice daily * This table does not include all possible body weights in this patient group. A dose of 3mg/kg of this medicine is recommended for infants under 1 year of age. 2. Prevention of influenza A and influenza B virus infections 2) Children aged 1 year 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 (sachet) per dose once daily 15 kg<, ≤ 23 kg — 45 mg (sachet) per dose once daily 23 kg<, ≤ 40 kg — 60 mg (two 30mg sachets) per dose once daily > 40 kg — 75 mg (sachet) per dose 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 medicine is used to treat or prevent influenza viruses. However, this medicine cannot replace influenza vaccination, and it is important to use it alongside vaccination. Effectiveness has only been proven against influenza viruses A and B, and safety or efficacy has not been confirmed for other infections. In particular, unusual behavior or neuropsychiatric adverse reactions have been reported in children and adolescents after taking this medicine, requiring careful observation by caregivers in this age group. Patients with allergies to this medicine or its components should not use it. Patients with reduced kidney function or those receiving dialysis need dose adjustments, and it is not recommended for patients with end-stage renal failure. Caution should be exercised in high-risk patients with asthma, chronic bronchitis, or immunosuppressed states. Side effects such as nausea, vomiting, and headaches may occur, but most are temporary. Rarely, symptoms such as shock, anaphylaxis, abnormal liver function, skin symptoms, acute renal failure, blood abnormalities, and neuropsychiatric symptoms may occur, and immediate consultation with medical personnel should be sought for any unusual symptoms. In pregnant or breastfeeding women, the benefits and risks of using this medicine should be carefully considered before use. Safety and efficacy in infants under 1 year have not been established, so caution is necessary when using it. No dose adjustments are required for the elderly, but careful observation considering reduced physical function is advised. Severe side effects from overdose are rare, but if unusual symptoms occur, immediate medical attention should be sought. This medicine contains sorbitol, so patients with fructose intolerance should not take it. While drug interactions are not significant, caution may be needed when combined with certain medications, so it is essential to inform about any medications being taken. While taking this medicine, caution may be needed while driving or operating machinery, so patients should closely monitor their condition. Keep this medicine out of the reach of children, and it is advisable not to transfer it to another container.

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

This medicine should be stored in a tightly sealed container to prevent air or moisture from entering, and it is advisable to keep the temperature between 1 to 30 degrees Celsius at room temperature. Storing it this way helps maintain the effectiveness of the medicine.

Appearance

White or yellowish powder

Package unit

10 packets/box