Boryung Tamiflu 45 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; in some patients, taking it with food may improve tolerability. Adults and adolescents 13 years of age and older: The recommended dose is 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. Patients with renal impairment: No dosage adjustment is required for patients with a creatinine clearance of 60 mL/min or higher. 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 regular hemodialysis should receive a 30mg dose of this medicine after each dialysis session to maintain therapeutic blood concentrations, and treatment should not exceed 5 days. If influenza symptoms develop during the 48-hour interval 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. Patients with hepatic impairment: No dosage adjustment is necessary for the treatment of adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9). 2. Prevention of influenza A and influenza B virus infections Adults and adolescents 13 years of age and older: For close contact with 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 influenza outbreaks 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. Patients with renal impairment: No dosage adjustment is required for patients with a creatinine clearance of 60 mL/min or higher. 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 every other day is recommended. Patients receiving regular hemodialysis should receive a 30mg dose of this medicine after every 2 dialysis sessions to maintain therapeutic blood concentrations. The initial dose may also be administered 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. Patients with hepatic impairment: No dosage adjustment is necessary for the prevention of influenza in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

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 (sachet) twice daily 15 kg<, ≤ 23 kg: 45 mg (sachet) twice daily 23 kg<, ≤ 40 kg: 60 mg (two 30mg sachets) twice daily > 40 kg: 75 mg (sachet) twice daily Children 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. 3 kg: 9 mg twice daily; suspension (6mg/mL), 1.5mL twice daily 4 kg: 12 mg twice daily; suspension (6mg/mL), 2.0mL twice daily 5 kg: 15 mg twice daily; suspension (6mg/mL), 2.5mL twice daily 6 kg: 18 mg twice daily; suspension (6mg/mL), 3.0mL twice daily 7 kg: 21 mg twice daily; suspension (6mg/mL), 3.5mL twice daily 8 kg: 24 mg twice daily; suspension (6mg/mL), 4.0mL twice daily 9 kg: 27 mg twice daily; suspension (6mg/mL), 4.5mL twice daily 10 kg: 30 mg twice daily; suspension (6mg/mL), 5.0mL twice daily 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 (sachet) once daily 15 kg<, ≤ 23 kg: 45 mg (sachet) once daily 23 kg<, ≤ 40 kg: 60 mg (two 30mg sachets) once daily > 40 kg: 75 mg (sachet) once daily

This medication is used to treat or prevent infections caused by influenza viruses. However, it cannot replace influenza vaccinations and must be used separately from vaccinations. This medication has been proven effective only for influenza A and B viruses, and its safety and efficacy have not been confirmed for other types of infections. Rarely, neuropsychiatric adverse reactions such as seizures or delirium have been reported in children and adolescents, so caregivers should closely monitor for unusual behaviors. It is recommended not to use this medication in pediatric patients over 10 years old except in special cases due to the risk of accidents due to unusual behavior. Those with a known allergy to this medication or its components should not use it. Dose adjustment is needed for patients with reduced kidney function or those on dialysis, and it is not recommended for patients with end-stage renal failure. Caution should be exercised when administering to high-risk patients such as those with asthma or chronic bronchitis. Common side effects may include nausea, vomiting, and headache, which are mostly temporary and mild. Rarely, symptoms such as shock, anaphylaxis, liver dysfunction, skin rash, acute renal failure, blood disorders, and neuropsychiatric symptoms may occur, so patients should consult a physician immediately if unusual symptoms develop. Pregnant or nursing women should consult with a physician before using this medication, as data on fetal or infant effects are limited. The safety and efficacy of this medication in children under 1 year old have not been sufficiently established, so caution is required in its use. Elderly patients may have decreased physical function, so their condition should be closely monitored during administration. When taking the medication, the prescribed use and dosage must be followed; if a dose is missed, it should be taken as soon as possible, but if it is less than 2 hours until the next dose, it is advisable to skip it. This medication contains sorbitol, so it is not suitable for patients with fructose intolerance. The possibility of interactions with other drugs is low, but caution may be needed when used in combination with certain medications, so inform your physician or pharmacist of any medications being taken.

• nausea
• vomiting
• headache
• pain
• unstable angina
• anemia
• pseudomembranous colitis
• pneumonia
• peritonsillar abscess
• humeral fracture

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. The recommended storage temperature is room temperature between 1 and 30 degrees Celsius.

Appearance

White or yellowish powder

Package unit

10 packets per box