Oseltamivir Suspension Powder 6mg/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 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 take this medicine. Patients with renal impairment (treatment): No dose adjustment is required for 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 therapeutic plasma concentrations; treatment 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 dose 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: 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 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 taking this medicine. Patients with renal impairment (prevention): No dose adjustment is required for 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 therapeutic plasma concentrations. The initial dose may also be administered before the start of dialysis. 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 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 dose adjustment is required for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

Treatment of influenza A and influenza B virus infections — Children aged 1 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 twice daily; suspension (6mg/mL) 5.0 mL twice daily, for 5 days. 15 kg<, ≤ 23 kg: 45 mg twice daily; suspension (6mg/mL) 7.5 mL twice daily, for 5 days. 23 kg<, ≤ 40 kg: 60 mg twice daily; suspension (6mg/mL) 10.0 mL twice daily, for 5 days. > 40 kg: 75 mg twice daily; suspension (6mg/mL) 12.5 mL twice daily, for 5 days. Infants aged 2 weeks to less than 1 year: The recommended dose for infants 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. A dose of 3mg/kg of this medicine is recommended for infants younger than 1 year. 3 kg: 9 mg twice daily; suspension (6mg/mL) 1.5 mL twice daily, for 5 days. 4 kg: 12 mg twice daily; suspension (6mg/mL) 2.0 mL twice daily, for 5 days. 5 kg: 15 mg twice daily; suspension (6mg/mL) 2.5 mL twice daily, for 5 days. 6 kg: 18 mg twice daily; suspension (6mg/mL) 3.0 mL twice daily, for 5 days. 7 kg: 21 mg twice daily; suspension (6mg/mL) 3.5 mL twice daily, for 5 days. 8 kg: 24 mg twice daily; suspension (6mg/mL) 4.0 mL twice daily, for 5 days. 9 kg: 27 mg twice daily; suspension (6mg/mL) 4.5 mL twice daily, for 5 days. 10 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily, for 5 days. This table does not include all possible body weights in this patient group. It is recommended that a pharmacist prepare the suspension before it is administered to the patient. Prevention of influenza A and influenza B virus infections — Children aged 1 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 once daily; suspension (6mg/mL) 5.0 mL once daily, for 10 days. 15 kg<, ≤ 23 kg: 45 mg once daily; suspension (6mg/mL) 7.5 mL once daily, for 10 days. 23 kg<, ≤ 40 kg: 60 mg once daily; suspension (6mg/mL) 10.0 mL once daily, for 10 days. > 40 kg: 75 mg once daily; suspension (6mg/mL) 12.5 mL once daily, for 10 days. It is recommended that a pharmacist prepare the suspension 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 younger than 1 year have not been evaluated.

This medication cannot replace influenza vaccination and should be used separately. It is effective only against influenza A and B viruses, and its safety and efficacy have not been established for other infections. Rare neuropsychiatric adverse reactions such as seizures or delirium have been reported in children and adolescents, so use in children over 10 years of age should be avoided if they are not in high-risk groups. Abnormal behaviors may occur after taking this medication; therefore, caregivers should ensure that children and adolescents are not left alone for at least 2 days after treatment initiation. It should not be administered to patients with known allergies to this medication or its ingredients. Dose adjustment is necessary for patients with renal impairment, and it is not recommended for patients with end-stage renal disease. Caution should be exercised when administering to patients with asthma, chronic bronchitis, or immunosuppressed conditions. Common side effects include nausea, vomiting, headache, and are mostly mild and temporary. Rarely, symptoms such as shock, anaphylaxis, liver dysfunction, skin abnormalities, acute renal failure, blood abnormalities, and neurological symptoms may occur; immediate medical attention should be sought if any unusual symptoms appear. This medication contains sorbitol and is not suitable for patients with hereditary fructose intolerance. Interactions with other drugs are generally low, but caution may be needed when used in combination with certain medications. Pregnant or breastfeeding women should only use this medication when the benefits outweigh the risks, as its effects on the fetus or infant are not clearly established. Safety and efficacy in children under 1 year have not been established. Older adults do not require dose adjustment, but should be monitored carefully considering the possibility of decreased physical function. In case of overdose, consult a healthcare professional immediately for appropriate measures. This medication should be used within a certain period after preparation as a suspension, and should be kept out of reach of children. When taking, it is advisable to start as early as possible when symptoms appear, and if a dose is missed, it should be taken as soon as possible, but if it is within 2 hours of the next dose, it should be skipped. Caution should be exercised for potential impairment of driving or operating machinery due to influenza symptoms.

• 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 recommended to maintain room temperature between 1 and 30 degrees Celsius.

Appearance

A suspension preparation in a brown glass bottle containing white or light yellow granules to be dissolved before use.

Package unit

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