Tamiflu Suspension Powder (Oseltamivir Phosphate)

Adult dose

1. Influenza A and influenza B virus infections: Start treatment on the first or second day after the onset of influenza symptoms. This medicine may be taken with or without food; tolerability may improve in some patients when taken with food. 1) 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. 4) Patients with renal impairment No dose adjustment is required for patients with a creatinine clearance of 60 mL/min or more. For patients with a creatinine clearance of 30 ~ 60 mL/min, reduction to 30 mg twice daily for 5 days is recommended. For patients with a creatinine clearance of 10 ~ 30 mL/min, reduction to 30 mg once daily for 5 days is recommended. Patients receiving periodic hemodialysis should receive a 30mg dose of this medicine after each dialysis session to maintain plasma concentrations within the therapeutic range; the duration of administration should not exceed 5 days. If influenza symptoms occur during the 48-hour interval 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 below 10mL/min); therefore, no recommended dose is available for these patients. 5) Patients with hepatic impairment No dose adjustment is required for treatment in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9). 2. Prevention of influenza A and influenza B virus infections 1) 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 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 taking this medicine. 3) Patients with renal impairment No dose adjustment is required for patients with a creatinine clearance of 60 mL/min or more. For patients with a creatinine clearance of 30 ～ 60 mL/min, reduction to 30 mg once daily is recommended. For patients with a creatinine clearance of 10 ～ 30 mL/min, reduction to 30 mg once daily every other day is recommended. Patients receiving periodic hemodialysis should receive a 30mg dose of this medicine after every 2 dialysis sessions to maintain plasma concentrations within the therapeutic range. The first 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 below 10mL/min); therefore, no recommended dose is available for these patients. 4) Patients with hepatic impairment No dose adjustment is required for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

2) 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 per dose twice daily; suspension (6mg/mL) 5.0 mL per dose twice daily 15 kg<, ≤ 23 kg — 45 mg per dose twice daily; suspension (6mg/mL) 7.5 mL per dose twice daily 23 kg<, ≤ 40 kg — 60 mg per dose twice daily; suspension (6mg/mL) 10.0 mL per dose twice daily > 40 kg — 75 mg per dose twice daily; suspension (6mg/mL) 12.5 mL per dose twice daily 3) Infants aged 2 weeks to under 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. 3 kg — 9 mg per dose twice daily; suspension (6mg/mL) 1.5 mL per dose twice daily 4 kg — 12 mg per dose twice daily; suspension (6mg/mL) 2.0 mL per dose twice daily 5 kg — 15 mg per dose twice daily; suspension (6mg/mL) 2.5 mL per dose twice daily 6 kg — 18 mg per dose twice daily; suspension (6mg/mL) 3.0 mL per dose twice daily 7 kg — 21 mg per dose twice daily; suspension (6mg/mL) 3.5 mL per dose twice daily 8 kg — 24 mg per dose twice daily; suspension (6mg/mL) 4.0 mL per dose twice daily 9 kg — 27 mg per dose twice daily; suspension (6mg/mL) 4.5 mL per dose twice daily 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 under 1 year of age. It is recommended that a pharmacist prepare the suspension of this medicine before it is administered to the patient. 2) 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 per dose once daily; suspension (6mg/mL) 5.0 mL per dose once daily 15 kg<, ≤ 23 kg — 45 mg per dose once daily; suspension (6mg/mL) 7.5 mL per dose once daily 23 kg<, ≤ 40 kg — 60 mg per dose once daily; suspension (6mg/mL) 10.0 mL per dose once daily > 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 under 1 year of age have not been evaluated.

This drug is used for treating or preventing influenza virus infections, but it cannot replace influenza vaccinations. The preventive effect against influenza is only active while taking this drug, making annual influenza vaccination essential. The safety and effectiveness of this drug has not been confirmed for infections other than influenza A and B viruses. Especially in children and adolescents, seizures or abnormal neuropsychiatric behaviors have been reported following the use of this drug, and caregivers or medical personnel should be informed immediately if any abnormal behavior occurs. The use of this drug is generally not recommended for children over 10 years old except in specific cases, and caregivers should monitor children closely for at least 2 days following administration. Patients with known allergies to this drug or its components should not use it. Patients with reduced kidney function may require dose adjustments, and it is not recommended for patients with end-stage renal failure. Caution is advised for high-risk patients with asthma, chronic bronchitis, or immunosuppressed states. Common side effects include nausea, vomiting, headache, etc., and are usually transient. Rarely, shock, anaphylaxis, hepatitis, skin rash, and neuropsychiatric symptoms may occur; seek immediate consultation with a physician if symptoms arise. This drug contains sorbitol and is not suitable for patients with hereditary fructose intolerance. While significant interactions are not common with various drugs, caution may be needed with certain medications. Pregnant or nursing women should carefully weigh the risks and benefits of administering this drug and consult a physician if necessary. The effectiveness and safety of this drug have not been adequately confirmed for children under 1 year of age. Older adults may require careful observation for possible diminished bodily functions. There is no specific treatment for overdose, but if adverse effects occur, notify medical personnel immediately. Proper methods must be followed when preparing this drug as a suspension, and it should be stored at appropriate temperatures and kept out of reach of children. Lastly, this drug may lead to the emergence of resistant influenza virus; therefore, the local prevalence of influenza virus resistance should be considered during prescribing.

• Cramps
• delirium
• unusual behavior
• nausea
• vomiting
• headache
• pain
• unstable angina
• anemia
• membranous colitis

This drug must be stored in a tightly sealed container to protect it from air and moisture, and it is best kept at room temperature between 1°C and 30°C. Proper storage can help maintain the drug's effectiveness for a longer duration.

Appearance

A suspension prepared from white or light yellow granules contained in a brown glass bottle.

Package unit

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