Flutacapsule 75 milligrams (Oseltamivir Phosphate)

Adult dose

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 aged 13 years and older: Administer oseltamivir 75 mg orally twice daily for 5 days. Adults and adolescents aged 13 years and older who have difficulty swallowing capsules should use this medicine as powder for suspension. Patients with renal impairment (treatment): No dosage adjustment is required in patients with creatinine clearance of 60 mL/min or higher. 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 regular hemodialysis should receive a 30mg dose of this medicine after each dialysis session to maintain therapeutic blood concentrations; treatment should not exceed 5 days. If influenza symptoms develop during the 48-hour interval between dialysis sessions, the dose may be administered 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 below 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment (treatment): No dosage adjustment is required for treatment in adults with mild to moderate hepatic impairment (Child-Pugh score ≤ 9). Prevention of influenza A and influenza B virus infections—Adults and adolescents aged 13 years and older: For close contacts of an infected person, administer oseltamivir 75 mg orally once daily for 10 days. Start administration within 2 days after 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 this medicine is being taken. Patients with renal impairment (prevention): No dosage adjustment is required in patients with creatinine clearance of 60 mL/min or higher. 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 once 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 first 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 below 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment (prevention): No dosage adjustment is required for prevention in adults with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

Influenza A and influenza B virus infections—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 as a suspension. ≤ 15 kg: 30 mg per dose twice daily; suspension (6mg/mL) 5.0 mL per dose twice daily, for 5 days. 15 kg<, ≤ 23 kg: 45 mg per dose twice daily; suspension (6mg/mL) 7.5 mL per dose twice daily, for 5 days. 23 kg<, ≤ 40 kg: 60 mg per dose twice daily; suspension (6mg/mL) 10.0 mL per dose twice daily, for 5 days. > 40 kg: 75 mg per dose twice daily; suspension (6mg/mL) 12.5 mL per dose twice daily, for 5 days. Children 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, for 5 days. 4 kg: 12 mg per dose twice daily; suspension (6mg/mL) 2.0 mL per dose twice daily, for 5 days. 5 kg: 15 mg per dose twice daily; suspension (6mg/mL) 2.5 mL per dose twice daily, for 5 days. 6 kg: 18 mg per dose twice daily; suspension (6mg/mL) 3.0 mL per dose twice daily, for 5 days. 7 kg: 21 mg per dose twice daily; suspension (6mg/mL) 3.5 mL per dose twice daily, for 5 days. 8 kg: 24 mg per dose twice daily; suspension (6mg/mL) 4.0 mL per dose twice daily, for 5 days. 9 kg: 27 mg per dose twice daily; suspension (6mg/mL) 4.5 mL per dose twice daily, for 5 days. 10 kg: 30 mg per dose twice daily; suspension (6mg/mL) 5.0 mL per dose twice daily, for 5 days. This table does not include all possible weights in this patient group. For children under 1 year, a dose of 3mg/kg of this medicine is recommended. It is recommended that a pharmacist prepare the suspension before administration to the patient. Prevention of influenza A and influenza B virus infections—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 as a suspension. ≤ 15 kg: 30 mg per dose once daily; suspension (6mg/mL) 5.0 mL per dose once daily, for 10 days. 15 kg<, ≤ 23 kg: 45 mg per dose once daily; suspension (6mg/mL) 7.5 mL per dose once daily, for 10 days. 23 kg<, ≤ 40 kg: 60 mg per dose once daily; suspension (6mg/mL) 10.0 mL per dose once daily, for 10 days. > 40 kg: 75 mg per dose once daily; suspension (6mg/mL) 12.5 mL per dose once daily, for 10 days. It is recommended that a pharmacist prepare the suspension before administration to the patient. The safety and efficacy of this medicine for prevention of influenza A and B virus infections in children under 1 year have not been evaluated.

This drug cannot replace the influenza vaccine and should only be used for treatment and prevention when influenza viruses are prevalent. The safety and efficacy of this medication have not been established for infections other than influenza A and B. Especially in children and adolescents, rare neuropsychiatric adverse reactions such as abnormal behavior, seizures, and delirium have been reported after taking this medication, requiring caution during administration. Generally, it should not be used in pediatric patients over 10 years old, and when used, guardians should carefully observe for the risk of abnormal behavior. Patients with allergies to this drug or its components should not use it. Patients with impaired kidney function or those on dialysis may require dose adjustments, and it is not recommended for patients with end-stage renal failure. Caution should be exercised when administering it to high-risk patients with asthma, chronic bronchitis, or immunosuppression. Common side effects may include nausea, vomiting, and headache, which are usually temporary. Rarely, shock, anaphylaxis, liver function abnormalities, skin rash, acute renal failure, and neuropsychiatric symptoms may occur. If any unusual symptoms arise, inform the medical staff immediately. Pregnant or breastfeeding women should consider the therapeutic benefits and risks carefully before administration. Usage is recommended for children over 1 year of age, and safety and efficacy have not been established for children under 1 year. The elderly can be administered without special dose adjustments, but should be monitored carefully considering physical decline and multiple diseases. Most adverse reactions are not reported in the event of overdose, but adherence to the recommended dosage is important. This drug is unlikely to interact with other medications; however, caution may be needed when used with certain drugs. There have been no observed effects on driving or operating machinery; however, influenza itself may impair these abilities, so caution is advised. Store out of reach of children and avoid transferring to other containers.

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

This medication should be stored in a tightly sealed container to prevent air or moisture from entering, and the safe temperature range is between 1°C and 30°C at room temperature. Storing it this way can maintain the effectiveness of the drug and prevent deterioration.

Appearance

A hard capsule with a gray bottom and light yellow top filled with white or light yellow powder

Package unit

10 capsules/PTP