Seltaplu Suspension Powder 6 mg/mL (Oseltamivir Phosphate)

Adult dose

Influenza A and influenza B virus infections: Treatment should be initiated on the first or second day after the onset of influenza symptoms. This medicine may be administered regardless of food intake, although 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 dosage adjustment is required in patients with creatinine clearance of 60 mL/min or greater. 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 blood concentrations within the therapeutic range, and the treatment period 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 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 in adult patients 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: In individuals who have been in close contact with 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 this medicine is being taken. Patients with renal impairment (prevention): No dosage adjustment is required in patients with creatinine clearance of 60 mL/min or greater. 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 blood 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 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

Children aged 1 to 12 years (treatment): 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. Weight ≤ 15 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily Weight 15 kg<, ≤ 23 kg: 45 mg twice daily; suspension (6mg/mL) 7.5 mL twice daily Weight 23 kg<, ≤ 40 kg: 60 mg twice daily; suspension (6mg/mL) 10.0 mL twice daily Weight > 40 kg: 75 mg twice daily; suspension (6mg/mL) 12.5 mL twice daily Infants 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 infants with a postconceptional age of less than 36 weeks. Weight 3 kg: 9 mg twice daily; suspension (6mg/mL) 1.5 mL twice daily Weight 4 kg: 12 mg twice daily; suspension (6mg/mL) 2.0 mL twice daily Weight 5 kg: 15 mg twice daily; suspension (6mg/mL) 2.5 mL twice daily Weight 6 kg: 18 mg twice daily; suspension (6mg/mL) 3.0 mL twice daily Weight 7 kg: 21 mg twice daily; suspension (6mg/mL) 3.5 mL twice daily Weight 8 kg: 24 mg twice daily; suspension (6mg/mL) 4.0 mL twice daily Weight 9 kg: 27 mg twice daily; suspension (6mg/mL) 4.5 mL twice daily Weight 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 medicine is recommended for infants under 1 year of age. It is recommended that a pharmacist prepare the suspension of this medicine before it is administered to the patient. Children aged 1 to 12 years (prevention): 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. Weight ≤ 15 kg: 30 mg once daily; suspension (6mg/mL) 5.0 mL once daily Weight 15 kg<, ≤ 23 kg: 45 mg once daily; suspension (6mg/mL) 7.5 mL once daily Weight 23 kg<, ≤ 40 kg: 60 mg once daily; suspension (6mg/mL) 10.0 mL once daily Weight > 40 kg: 75 mg once daily; suspension (6mg/mL) 12.5 mL 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 this medicine for the prevention of influenza A and B virus infections in children under 1 year of age have not been evaluated.

This drug is used for the treatment and prevention of influenza virus infections. However, it cannot replace influenza vaccination; therefore, it is important to receive the influenza vaccine every year. This drug has only been shown to be effective against influenza A and B viruses, and its safety or efficacy has not been verified for other types of infections. Especially in children and adolescents, rare neuropsychiatric adverse reactions may occur, so patients in this age group should be carefully monitored for unusual behavior or seizures. If unusual behavior occurs, caregivers should ensure that the patient is not left alone. Since this drug contains lactose, it should not be administered to patients with lactose intolerance or related genetic diseases. Patients with decreased renal function or those undergoing hemodialysis may require dose adjustments, and it is not recommended for patients with end-stage renal failure. Additionally, it should be used with caution in high-risk patients with conditions such as asthma, chronic bronchitis, or immunosuppression. The most common side effects include nausea, vomiting, and headache, which are generally mild and temporary. Rarely, serious adverse reactions may occur, such as rash, liver function abnormalities, neuropsychiatric symptoms, and acute renal failure; if any symptoms arise, immediate consultation with a healthcare professional is necessary. Pregnant or nursing women should use this medication only when the benefits outweigh the risks, as the effects on the fetus or infant are not fully understood. The safety and efficacy of this drug in children under 1 year of age have not been established, so it is best not to use it in this age group. Elderly patients require caution due to decreased bodily functions and various comorbidities, although generally, dose adjustments are not necessary. Drug interactions are relatively limited; however, caution is needed when co-administering with other drugs excreted by the kidneys, and it should be administered with some interval from certain vaccines. Serious side effects from overdose are rare, but if adverse reactions occur, immediate medical attention should be sought. This drug should be shaken well before administration as a suspension, and care should be taken regarding the storage period and temperature after preparation. It is important to keep it out of reach of children.

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

This drug should be stored in a tightly closed container to prevent exposure to air or moisture. It is best to maintain storage temperatures between 1°C and 30°C. Proper storage will help to safely maintain the drug's efficacy.

Appearance

White to off-white powder or powder with lumps in a brown glass bottle

Package unit

10 grams/bottle [50 mL], 15 grams/bottle [75 mL]