Tamiflu Suspension Powder 6mg/mL (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

1. Influenza A and influenza B virus infections 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; 5.0 mL per dose twice daily 15 kg<, ≤ 23 kg — 45 mg per dose twice daily; 7.5 mL per dose twice daily 23 kg<, ≤ 40 kg — 60 mg per dose twice daily; 10.0 mL per dose twice daily > 40 kg — 75 mg per dose twice daily; 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; 1.5 mL per dose twice daily 4 kg — 12 mg per dose twice daily; 2.0 mL per dose twice daily 5 kg — 15 mg per dose twice daily; 2.5 mL per dose twice daily 6 kg — 18 mg per dose twice daily; 3.0 mL per dose twice daily 7 kg — 21 mg per dose twice daily; 3.5 mL per dose twice daily 8 kg — 24 mg per dose twice daily; 4.0 mL per dose twice daily 9 kg — 27 mg per dose twice daily; 4.5 mL per dose twice daily 10 kg — 30 mg per dose twice daily; 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. Prevention of influenza A and influenza B virus infections 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; 5.0 mL per dose once daily 15 kg<, ≤ 23 kg — 45 mg per dose once daily; 7.5 mL per dose once daily 23 kg<, ≤ 40 kg — 60 mg per dose once daily; 10.0 mL per dose once daily > 40 kg — 75 mg per dose once daily; 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 to treat or prevent infections caused by the influenza virus. However, it cannot replace the influenza vaccine, and it is important to use it alongside the influenza vaccine. This drug is effective only against influenza A and B viruses, and its safety and efficacy have not been established for other types of infections. Rare instances of neuropsychiatric side effects, such as seizures or delirium, have been reported in children and adolescents, so caution is needed in this age group as unusual behavior may occur. Caregivers should closely observe the patient for at least 2 days after treatment initiation to reduce the risk of unusual behavior or accidents. This medication should not be administered to patients with an allergy to this drug or its components. Dose adjustments are necessary for patients with impaired renal function or those undergoing dialysis, and it is not recommended for patients with end-stage renal disease. It should also be administered cautiously to high-risk patients with asthma, chronic bronchitis, or immunosuppressive conditions. During treatment with this drug, side effects such as nausea, vomiting, headache, dizziness, etc., may occur, but most are temporary and mild. However, rarely, anaphylaxis, liver function abnormalities, skin rashes, acute renal failure, and neuropsychiatric symptoms may occur, so if unusual symptoms arise, consult a healthcare professional immediately. Women who are pregnant or breastfeeding should carefully consider the benefits and risks of using this drug, and there is limited safety data for pregnant women, so it is advisable to consult with healthcare professionals. The safety and efficacy of this drug have not been established in children under 1 year of age; therefore, its use should be avoided. When taking this medication, the prescribed dosage and administration should be adhered to, and if a dose is missed, take it as soon as possible but should not take it if the next dosing time is very near. No effects on driving or operating machinery have been reported, but influenza itself can impair concentration, so caution is recommended. This drug contains sorbitol, so it is advisable for patients with genetically determined fructose intolerance to avoid using it. While the potential for drug interactions is low, caution is needed when used concurrently with certain drugs that share the renal excretion pathway. It should also be administered with a certain period of separation from live vaccines. This drug should be stored in a tightly closed container to protect it from air and moisture. It is preferable to store it at room temperature between 1°C and 30°C, not in too hot or too cold locations.

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

This medication should be stored in a tightly closed container to avoid exposure to air or moisture. Additionally, it is best to store the drug at room temperature between 1°C and 30°C, not in excessively hot or cold conditions.

Appearance

A suspension that dissolves before use, containing white or light yellow granules in a brown glass bottle

Package unit

10 grams/bottle [50mL]