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

Adult dose

Influenza A and influenza B virus infections: Initiate treatment on the first or second day after the onset of influenza symptoms. This drug may be administered with or without food; in some patients, taking it with food may improve tolerability. 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 product. Patients with renal impairment: No dosage 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 be given a 30mg dose of this drug after each dialysis session to maintain plasma concentrations within the therapeutic range; treatment should not exceed 5 days. If influenza symptoms develop during the 48 hours between dialysis sessions, the dose may also be administered before the start of dialysis. For peritoneal dialysis, a single 30mg dose of this drug 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: 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: For close contacts of an infected person, administer oseltamivir 75 mg orally once daily for 10 days. Start administration within 2 days of contact with the infected person. The recommended dose for prevention during influenza outbreaks is 75 mg once daily. The safety and efficacy of this drug have been demonstrated for up to 6 weeks. The preventive effect continues while this drug is being taken. Patients with renal impairment: No dosage 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 once every other day is recommended. Patients receiving regular hemodialysis should be given a 30mg dose of this drug 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 drug 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: 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 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 product. ≤ 15 kg : 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily 15 kg<, ≤ 23 kg : 45 mg twice daily; suspension (6mg/mL) 7.5 mL twice daily 23 kg<, ≤ 40 kg : 60 mg twice daily; suspension (6mg/mL) 10.0 mL twice daily > 40 kg : 75 mg twice daily; suspension (6mg/mL) 12.5 mL 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 product orally twice daily for 5 days. This does not apply to infants with a postmenstrual age of less than 36 weeks. 3 kg : 9 mg twice daily; suspension (6mg/mL) 1.5 mL twice daily 4 kg : 12 mg twice daily; suspension (6mg/mL) 2.0 mL twice daily 5 kg : 15 mg twice daily; suspension (6mg/mL) 2.5 mL twice daily 6 kg : 18 mg twice daily; suspension (6mg/mL) 3.0 mL twice daily 7 kg : 21 mg twice daily; suspension (6mg/mL) 3.5 mL twice daily 8 kg : 24 mg twice daily; suspension (6mg/mL) 4.0 mL twice daily 9 kg : 27 mg twice daily; suspension (6mg/mL) 4.5 mL twice daily 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 product is recommended for children under 1 year of age. It is recommended that a pharmacist prepare the suspension of this product before it is administered to the patient. 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 product. ≤ 15 kg : 30 mg once daily; suspension (6mg/mL) 5.0 mL once daily 15 kg<, ≤ 23 kg : 45 mg once daily; suspension (6mg/mL) 7.5 mL once daily 23 kg<, ≤ 40 kg : 60 mg once daily; suspension (6mg/mL) 10.0 mL once daily > 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 product before it is administered to the patient. The safety and efficacy of 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 should be used separately from vaccination. This drug is only effective against influenza A and B viruses, and its safety and efficacy for other infections have not been established. When children and adolescents take this medication, there may be rare neuropsychiatric adverse effects, thus caregivers must monitor closely for abnormal behavior. In particular, there have been reports of accidents due to abnormal behavior in children over 10 years old, and it is advisable to refrain from use unless the patient is at high risk. Patients with a known hypersensitivity to this drug should not use it, and dosage adjustment may be needed for patients with impaired renal function. Caution is warranted for high-risk patients, such as those with asthma or chronic bronchitis and immunosuppressed patients. Common side effects include nausea, vomiting, and headache, which are mostly transient and mild. Rarely, serious adverse effects such as shock, anaphylaxis, hepatic dysfunction, skin rash, acute renal failure, or neurological symptoms may occur, and if any unusual symptoms arise, immediate consultation with healthcare professionals is advised. Consultation with a physician is recommended before use during pregnancy or breastfeeding, only if the benefits outweigh the risks. The safety and efficacy of this drug have not been sufficiently established in infants under 1 year; therefore, its use is not recommended. Although special dosage adjustments are generally not needed for the elderly, careful observation is necessary if body function is impaired. Severe adverse effects are rare in cases of overdose, but if any unusual reactions occur, the patient should visit a medical facility immediately. This drug should be stored as a suspension in the refrigerator after preparation and kept out of the reach of children. Interactions with other medications currently being taken are rare; however, caution is advised when used concurrently with medications affecting renal excretion. No impact on driving or operating machinery has been reported, but the potential for functional impairments due to influenza itself must be considered.

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

This medication should be stored in a tightly sealed container to protect it from air and moisture and is best stored at room temperature between 1 to 30 degrees Celsius. Storing it this way helps to maintain the medication's efficacy for a longer duration.

Appearance

A powder of white or pale yellow granules in a brown glass bottle for reconstitution

Package unit

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