Shinpoong Flu Suspension Powder 6mg/mL (Oseltamivir Phosphate)

Adult dose

1. Influenza A and influenza B virus infection: Initiate treatment on the first or second day after the onset of influenza symptoms. This drug may be taken with or without food; in some patients, taking it with food may improve tolerability. Adults and adolescents aged 13 years or older: Administer 75 mg of oseltamivir orally twice daily for 5 days. Adults and adolescents aged 13 years or older who have difficulty swallowing capsules should use this drug. Patients with renal impairment: 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 intermittent hemodialysis should receive a 30 mg 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 be administered before the start of dialysis. For peritoneal dialysis, a single 30 mg 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 undergoing 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 necessary for treatment in adults with mild to moderate hepatic impairment (Child-Pugh score ≤ 9). 2. Prevention of influenza A and influenza B virus infection Adults and adolescents aged 13 years or older: For close contacts of an infected person, administer 75 mg of oseltamivir orally once daily for 10 days. Initiate treatment 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 drug have been demonstrated for up to 6 weeks. The preventive effect continues while taking this drug. Patients with renal impairment: 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 intermittent hemodialysis should receive a 30 mg 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, a 30 mg dose 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 undergoing 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 necessary for prevention in adults with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

1. Influenza A and influenza B virus infection 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 drug. ≤ 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 children aged 2 weeks to 12 months is 3mg/kg of this drug orally twice daily for 5 days. This does not apply to children with a postconceptional 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 every possible weight in this patient group. A dose of 3mg/kg of this drug is recommended for children under 1 year of age. It is recommended that a pharmacist prepare the suspension of this drug before it is administered to the patient. 2. Prevention of influenza A and influenza B virus infection 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 drug. ≤ 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 drug before it is administered to the patient. ※ The safety and efficacy of this drug for the prevention of influenza A and B virus infection in children under 1 year of age have not been evaluated.

This medication cannot replace influenza vaccination and should only be used for treatment and prevention during influenza outbreaks. Safety and efficacy have not been established for infections other than influenza A and B. Reports of abnormal behavior, seizures, and delirium associated with neuropsychiatric adverse reactions have been noted in children and adolescents; caution should be exercised in this age group, and guardians should ensure that patients are not left alone for at least 2 days. Patients with known allergies to this medication or its components should not use it, and patients with genetic metabolic disorders such as lactose intolerance should also avoid it. Dosing adjustments are needed for patients with impaired renal function or those on dialysis; it is not recommended for patients with end-stage renal failure. Caution should be exercised when prescribing to high-risk patients with asthma, chronic bronchitis, or immunocompromised status. While taking this medication, common and transient mild side effects may include nausea, vomiting, headache, and pain. Rarely, symptoms such as shock, anaphylaxis, liver function abnormalities, skin abnormalities, acute renal failure, leukopenia, and neuropsychiatric symptoms may occur. In such cases, administration should be stopped immediately and healthcare professionals should be consulted. Pregnant or breastfeeding women should only use this medication if the benefits outweigh the risks; caution is warranted due to limited safety information regarding the fetus or neonate. Safety and efficacy have not been established in children under 1 year of age, and its use is not recommended. Elderly patients typically do not require dose adjustments, but they should be carefully monitored for any decline in physical function. This medication has a low potential for drug interactions, but caution may be needed with certain drugs; always inform healthcare professionals of any medications being taken. When taking this medication, adhere strictly to the prescribed dosage and timing; if a dose is missed, take it as soon as possible unless it is close to the next scheduled dose, in which case skip the missed dose. This medication is most effective when taken early during treatment for influenza, and delays in administration may reduce efficacy. Though no effects on driving or operating machinery have been reported, consider the potential impairment due to influenza itself. Preparation of the suspension must be done accurately, and after preparation, it should be stored at designated temperatures for the specified duration, out of reach of children.

• Convulsions
• delirium
• abnormal 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. The storage temperature should be maintained between 1 degree and 30 degrees Celsius.

Appearance

White to pale yellow powder or clumped powder in a brown glass bottle

Package unit

10g/bottle (50mL), 13g/bottle (65mL), 15g/bottle (75mL)