Genewon Oseltamivir Suspension Powder 6 mg/mL (Oseltamivir Phosphate)

Adult dose

Treatment of 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 administered with or without food; tolerability may improve in some patients when it is taken with food. Adults and adolescents aged 13 years and older: Administer 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 medicine. Patients with renal impairment (treatment): No dose adjustment is necessary in 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 therapeutic blood concentrations; treatment should not exceed 5 days. If influenza symptoms develop during the 48 hours between dialysis sessions, the dose may also be administered 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 undergoing dialysis (e.g., creatinine clearance less than 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment (treatment): No dose adjustment is necessary for treatment in adults with mild to moderate hepatic impairment (Child-Pugh score ≤ 9). Prevention of influenza A and influenza B virus infections—Adults and adolescents aged 13 years and older: For close contacts of an infected person, administer 75 mg of oseltamivir orally once daily for 10 days. Initiate administration 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 protective effect continues while this medicine is being taken. Patients with renal impairment (prevention): No dose adjustment is necessary in 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 therapeutic blood concentrations. The initial dose may also be administered before dialysis begins. For peritoneal dialysis, administration of 30mg of this medicine once weekly after dialysis is recommended. The pharmacokinetics of oseltamivir have not been studied in patients with end-stage renal disease who are not undergoing dialysis (e.g., creatinine clearance less than 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment (prevention): No dose adjustment is necessary for prevention in adults with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

Treatment of influenza A and influenza B virus infections—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. Aged 1 year to 12 years, weight ≤ 15 kg: 30 mg per dose twice daily; suspension (6mg/mL) 5.0 mL per dose twice daily. Aged 1 year to 12 years, weight 15 kg<, ≤ 23 kg: 45 mg per dose twice daily; suspension (6mg/mL) 7.5 mL per dose twice daily. Aged 1 year to 12 years, weight 23 kg<, ≤ 40 kg: 60 mg per dose twice daily; suspension (6mg/mL) 10.0 mL per dose twice daily. Aged 1 year to 12 years, weight > 40 kg: 75 mg per dose twice daily; suspension (6mg/mL) 12.5 mL per dose twice daily. 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 medicine orally twice daily for 5 days. This does not apply to children with a postconceptional age of less than 36 weeks. Aged 2 weeks to less than 1 year, weight 3 kg: 9 mg per dose twice daily; suspension (6mg/mL) 1.5 mL per dose twice daily. Aged 2 weeks to less than 1 year, weight 4 kg: 12 mg per dose twice daily; suspension (6mg/mL) 2.0 mL per dose twice daily. Aged 2 weeks to less than 1 year, weight 5 kg: 15 mg per dose twice daily; suspension (6mg/mL) 2.5 mL per dose twice daily. Aged 2 weeks to less than 1 year, weight 6 kg: 18 mg per dose twice daily; suspension (6mg/mL) 3.0 mL per dose twice daily. Aged 2 weeks to less than 1 year, weight 7 kg: 21 mg per dose twice daily; suspension (6mg/mL) 3.5 mL per dose twice daily. Aged 2 weeks to less than 1 year, weight 8 kg: 24 mg per dose twice daily; suspension (6mg/mL) 4.0 mL per dose twice daily. Aged 2 weeks to less than 1 year, weight 9 kg: 27 mg per dose twice daily; suspension (6mg/mL) 4.5 mL per dose twice daily. Aged 2 weeks to less than 1 year, weight 10 kg: 30 mg per dose twice daily; suspension (6mg/mL) 5.0 mL per dose 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 younger than 1 year. It is recommended that a pharmacist prepare the suspension of this medicine before it is administered to the patient. Prevention of influenza A and influenza B virus infections—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. Aged 1 year to 12 years, weight ≤ 15 kg: 30 mg per dose once daily; suspension (6mg/mL) 5.0 mL per dose once daily. Aged 1 year to 12 years, weight 15 kg<, ≤ 23 kg: 45 mg per dose once daily; suspension (6mg/mL) 7.5 mL per dose once daily. Aged 1 year to 12 years, weight 23 kg<, ≤ 40 kg: 60 mg per dose once daily; suspension (6mg/mL) 10.0 mL per dose once daily. Aged 1 year to 12 years, weight > 40 kg: 75 mg per dose once daily; suspension (6mg/mL) 12.5 mL per dose once daily. It is recommended that a pharmacist prepare the suspension of this medicine before it is administered to the patient. 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 must be used separately from vaccination. This medication is effective only against influenza A and B viruses, and its safety and efficacy have not been established for other infections. Rarely, neuropsychiatric adverse reactions may occur in children and adolescents, such as seizures or delirium, so patients in this age group should be closely monitored. In principle, use in pediatric patients over 10 years old is not recommended except in special cases due to the risk of abnormal behavior and thoughts. Abnormal behavior may occur during the duration of treatment, so caregivers should ensure children or adolescents are not left alone for at least 2 days. Patients allergic to this medication or its components, or those with certain genetic lactose metabolism disorders, should not take this medication. Patients with impaired kidney function or those on dialysis require dose adjustments, and it is not recommended for patients with end-stage renal failure. Caution is required when administering this medication to patients with asthma, chronic bronchitis, or immunosuppressive states. Common side effects may include nausea, vomiting, and headache, which are mostly temporary and mild. Rarely, symptoms such as shock, anaphylaxis, liver function abnormalities, skin reactions, acute renal failure, blood disorders, and neuropsychiatric symptoms may occur, and immediate consultation with a physician is required if any unusual symptoms arise. Pregnant or breastfeeding women should carefully consider the benefits and risks of using this medication and consult a doctor if necessary. Safety and efficacy in children under 1 year of age have not been established, so use is not recommended. Elderly patients do not require special dose adjustments, but careful monitoring is necessary due to potential decline in physical function and underlying diseases. The potential for interactions with other medications is low, but caution may be needed when used with certain medications, so patients should inform their healthcare provider about any medications they are taking. This medication can be used with the influenza vaccine, but a certain interval must be maintained with live vaccines. In case of overdose, symptoms similar to common adverse effects may occur, so immediate medical attention is required. This medication in suspension form must be used according to specified temperature and duration after preparation, and should be kept out of reach of children. For effective use, this medication should be taken at the early onset of influenza symptoms, and if a dose is missed, it should be taken as soon as possible, but skipped if the next dose is too close to the scheduled time. There is no special effect on driving or operating machinery, but caution is required due to the symptoms of influenza itself.

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

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

Appearance

A white to off-white powder or powder with clumps in a brown glass bottle

Package unit

10g/bottle (50mL)