Tamiflu Powder 75 mg (Oseltamivir Phosphate)

Adult dose

1. Influenza A and influenza B virus infections: Start treatment on the first or second day after influenza symptoms appear. This medicine may be taken with or without food; taking it with food may improve tolerability in some patients. 1) Adults and adolescents 13 years of age and older: Administer 75 mg of oseltamivir orally twice daily for 5 days. Adults and adolescents 13 years of age and older who have difficulty swallowing capsules should use this medicine for dosing. 4) Patients with renal impairment: No dosage adjustment is required for patients with a creatinine clearance of 60 mL/min or greater. For patients with a creatinine clearance of 30 ~ 60 mL/min, a reduced dose of 30 mg twice daily for 5 days is recommended. For patients with a 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 30mg dose of this medicine after each dialysis session to maintain blood concentrations within the therapeutic range, and treatment should not exceed 5 days. If influenza symptoms develop during the 48 hours between dialysis sessions, the dose may be given before dialysis begins. 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. 5) Patients with hepatic impairment: No dosage adjustment is required for treatment of 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 13 years of age 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 the medicine is being taken. 3) Patients with renal impairment: No dosage adjustment is required for patients with a creatinine clearance of 60 mL/min or greater. For patients with a creatinine clearance of 30 ～ 60 mL/min, a reduced dose of 30 mg once daily is recommended. For patients with a creatinine clearance of 10 ～ 30 mL/min, a reduced dose of 30 mg once daily every other day is recommended. Patients receiving intermittent hemodialysis should receive a 30mg dose of this medicine after every 2 dialysis sessions to maintain blood concentrations within the therapeutic range. The first dose may also be given before dialysis begins. 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 less than 10mL/min); therefore, no recommended dose is available for these patients. 4) 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

1. Influenza A and influenza B virus infections 2) Children 1 to 12 years of age: 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 (packet) twice daily 15 kg<, ≤ 23 kg: 45 mg (packet) twice daily 23 kg<, ≤ 40 kg: 60 mg (two 30mg packets) twice daily > 40 kg: 75 mg (packet) twice daily 3) Infants 2 weeks to less than 1 year of age: The recommended dose for pediatric patients 2 weeks to 12 months of age 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. Pediatric patients who have difficulty taking this medicine as a powder should use the suspension. 3 kg: 9 mg twice daily; suspension (6mg/mL) dose 1.5mL twice daily 4 kg: 12 mg twice daily; suspension (6mg/mL) dose 2.0mL twice daily 5 kg: 15 mg twice daily; suspension (6mg/mL) dose 2.5mL twice daily 6 kg: 18 mg twice daily; suspension (6mg/mL) dose 3.0mL twice daily 7 kg: 21 mg twice daily; suspension (6mg/mL) dose 3.5mL twice daily 8 kg: 24 mg twice daily; suspension (6mg/mL) dose 4.0mL twice daily 9 kg: 27 mg twice daily; suspension (6mg/mL) dose 4.5mL twice daily 10 kg: 30 mg twice daily; suspension (6mg/mL) dose 5.0mL twice daily * This table does not include all possible weights for this patient group. A dose of 3mg/kg of this medicine is recommended for children younger than 1 year. 2. Prevention of influenza A and influenza B virus infections 2) Children 1 to 12 years of age: 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 (packet) once daily 15 kg<, ≤ 23 kg: 45 mg (packet) once daily 23 kg<, ≤ 40 kg: 60 mg (two 30mg packets) once daily > 40 kg: 75 mg (packet) once daily ※ The safety and efficacy of prevention of influenza A and B virus infections in children younger than 1 year have not been evaluated.

This medication is used for the treatment and prevention of patients infected with influenza viruses A and B and cannot substitute for influenza vaccinations. This medication should only be used during outbreaks of the influenza virus, and safety or efficacy has not been confirmed for infections other than influenza. Particularly in pediatric and adolescent patients, reports of seizures or neuropsychiatric abnormal behaviors have been noted, and caregivers should closely observe for the potential occurrence of abnormal behaviors. Generally, it is not used in children over the age of 10 except in special cases, and caregivers should be present for at least 2 days after treatment begins to prevent accidents due to abnormal behaviors. Patients who have allergic reactions to this medication or its components should not use it, and patients with reduced kidney function or certain chronic conditions may require dose adjustments or careful administration. Common side effects may include nausea, vomiting, headaches, and pains, which are mostly transient and mild symptoms. Serious side effects such as shock, anaphylaxis, liver dysfunction, skin rashes, acute renal failure, blood abnormalities, and neuropsychiatric symptoms may occur occasionally, and if any unusual symptoms appear, consult a doctor immediately. Pregnant or nursing women should carefully consider the benefits and risks of using this medication, and safety and efficacy have not been established for children under 1 year old. Elderly patients may require special caution due to possible decline in physical function and accompanying various diseases. This medication is unlikely to interact with other drugs; however, caution may be needed when combined with certain medications, so inform your doctor of any other medications you are taking. Dosage and administration must be strictly followed, and if a dose is missed, take it as soon as possible; however, if it is within 2 hours before the next dose, skip it. This medication contains sorbitol and is not suitable for patients with fructose intolerance. Keep out of reach of children and do not transfer to other containers.

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

This medication should be stored in a tightly closed container to prevent air exposure and is best kept at room temperature between 1 to 30 degrees Celsius. Proper storage will help safely maintain the medication's effectiveness.

Appearance

A white or off-white powder

Package unit

10 packets/box