Oseltamivir Phosphate Powder for Suspension 6mg/mL

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 medicine may be administered 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 administration. Patients with renal impairment: No dose adjustment is required 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 a 30mg dose of this medicine after each dialysis session to maintain plasma concentrations within the therapeutic range, and the treatment duration 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 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. 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 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 taking this medicine. Patients with renal impairment: No dose adjustment is required 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 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. 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 Children aged 1 to 12 years: Pediatric patients weighing more than 40 kg who are able to 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 medication. Weight ≤ 15 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily, for 5 days Weight 15 kg<, ≤ 23 kg: 45 mg twice daily; suspension (6mg/mL) 7.5 mL twice daily, for 5 days Weight 23 kg<, ≤ 40 kg: 60 mg twice daily; suspension (6mg/mL) 10.0 mL twice daily, for 5 days Weight > 40 kg: 75 mg twice daily; suspension (6mg/mL) 12.5 mL twice daily, for 5 days 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 medication orally twice daily for 5 days. This does not apply to children with a postconceptional age of less than 36 weeks. Weight 3 kg: 9 mg twice daily; suspension (6mg/mL) 1.5 mL twice daily, for 5 days Weight 4 kg: 12 mg twice daily; suspension (6mg/mL) 2.0 mL twice daily, for 5 days Weight 5 kg: 15 mg twice daily; suspension (6mg/mL) 2.5 mL twice daily, for 5 days Weight 6 kg: 18 mg twice daily; suspension (6mg/mL) 3.0 mL twice daily, for 5 days Weight 7 kg: 21 mg twice daily; suspension (6mg/mL) 3.5 mL twice daily, for 5 days Weight 8 kg: 24 mg twice daily; suspension (6mg/mL) 4.0 mL twice daily, for 5 days Weight 9 kg: 27 mg twice daily; suspension (6mg/mL) 4.5 mL twice daily, for 5 days Weight 10 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily, for 5 days This table does not include all possible weights in this patient group. The recommended dose for children under 1 year of age is 3mg/kg of this medication. 2. Prevention of influenza A and influenza B virus infections Children aged 1 to 12 years: Pediatric patients weighing more than 40 kg who are able to 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 medication. Weight ≤ 15 kg: 30 mg once daily; suspension (6mg/mL) 5.0 mL once daily, for 10 days Weight 15 kg<, ≤ 23 kg: 45 mg once daily; suspension (6mg/mL) 7.5 mL once daily, for 10 days Weight 23 kg<, ≤ 40 kg: 60 mg once daily; suspension (6mg/mL) 10.0 mL once daily, for 10 days Weight > 40 kg: 75 mg once daily; suspension (6mg/mL) 12.5 mL once daily, for 10 days The safety and efficacy of this medication for the prevention of influenza A and B virus infections in children under 1 year of age have not been evaluated.

This medication cannot replace influenza vaccination and must be used separately. Its safety and efficacy have not been confirmed in infections other than Influenza A and B. Rare neurological and psychiatric adverse reactions such as seizures and delirium may occur in children and adolescents, and careful observation for abnormal behaviors is advised. Particularly, children over 10 years have reported a risk of accidents due to abnormal behaviors, and as a principle, it is not used. During treatment with this medication, the risk of abnormal behaviors should be communicated, and guardians should not leave children unattended for 2 days. Patients who have an allergic reaction to this medication or are hypersensitive to any of its components should not take it. Patients with impaired kidney function or those undergoing dialysis may require dose adjustment, and it is not recommended for patients with end-stage renal failure. It should be cautiously administered in high-risk patients such as those with asthma, chronic bronchitis, or immunosuppressed conditions. Common side effects of this medication include nausea, vomiting, headache, and pain, most of which are temporary. Rarely, serious side effects may occur such as shock, anaphylaxis, hepatitis, skin reactions, acute renal failure, and neurological symptoms, and if any abnormal symptoms appear, administration should be stopped immediately and medical consultation sought. This medication contains sorbitol and is not suitable for patients with hereditary fructose intolerance. There are minimal interactions with other drugs, but caution may be needed with certain medications. Use in pregnant or lactating women should only occur when the benefits of treatment outweigh the risks. Safety and efficacy in children under 1 year have not been sufficiently studied, so its use is not recommended. Elderly patients do not require dose adjustment but should be closely monitored due to decreased physical function. Reported adverse reactions in cases of overdose are similar to general side effects, and since there is no specific antidote, appropriate treatment should be provided based on symptoms. The suspension should be stored according to the preparation period and methods, and kept out of reach of children.

• Nausea
• vomiting
• headache
• pain
• unstable angina
• anemia
• pseudomembranous colitis
• pneumonia
• peritonsillar abscess
• humeral fracture

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain a room temperature between 1 to 30 degrees Celsius. This helps to preserve the medication's effectiveness for a longer duration.

Appearance

A suspension that dissolves when used, consisting of granules that are white or light yellow, contained in a brown glass bottle.

Package unit

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