Flubir Capsule 75 mg (Oseltamivir Phosphate)

Adult dose

Influenza A and influenza B virus infections: Initiate treatment on the first or second day after the onset of influenza symptoms. This medicine may be administered regardless of food intake, and tolerability may improve in some patients when taken with food. 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 a powder for suspension. Patients with renal impairment (treatment): No dose adjustment is necessary for patients with creatinine clearance of 60 mL/min or more. 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 plasma concentrations, and the treatment period should not exceed 5 days. If influenza symptoms develop during the 48 hours between dialysis sessions, the dose may also 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 less than 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment (treatment): No dose adjustment is necessary for treatment in adult patients 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. Begin administration within 2 days of contact with the infected person. The recommended dose for prevention during an influenza epidemic 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. Patients with renal impairment (prevention): No dose adjustment is necessary for patients with creatinine clearance of 60 mL/min or more. 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 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 plasma concentrations. The initial dose may also be administered before dialysis begins. For peritoneal dialysis, administration of 30mg of this medicine once weekly 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 (prevention): No dose adjustment is necessary for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

Children aged 1 to 12 years (treatment): Pediatric patients weighing more than 40 kg who can swallow capsules may take 75mg capsules twice daily, or 30mg and 45mg capsules 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 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 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 infants under 1 year. It is recommended that a pharmacist prepare this medicine as a suspension before administration to the patient. Children aged 1 to 12 years (prevention): Pediatric patients weighing more than 40 kg who can swallow capsules may take 75mg capsules once daily, or 30mg and 45mg capsules 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 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 this medicine as a suspension before administration to the patient. ※ The safety and efficacy of prevention of influenza A and B virus infections in infants under 1 year have not been evaluated.

This medication cannot replace influenza vaccination and is used separately from vaccination. This medication is only effective against influenza A and B and its safety and efficacy have not been confirmed for other infections. In particular, neuropsychiatric side effects, such as seizures or delirium, have been rarely reported in children and adolescents; thus, caregivers should monitor for abnormal behavior while taking this medication. Generally, it is recommended not to use this medication in children over 10 years of age except in special cases due to the risk of abnormal behavior associated with it. Patients with hypersensitivity to this medication should not use it. Patients with renal impairment should adjust the dosage of this medication, and it is not recommended for patients with end-stage renal failure. Caution is advised when administering this to high-risk patients with asthma, chronic bronchitis, or immunosuppressed conditions. Common side effects include nausea, vomiting, and headache, most of which are temporary and may not require discontinuation of treatment. Rarely, symptoms such as shock, anaphylaxis, hepatitis, pneumonia, skin abnormalities, acute renal failure, hematological abnormalities, and neuropsychiatric symptoms may occur; thus, if any abnormal symptoms occur, immediate medical attention should be sought. Due to insufficient data regarding use during pregnancy, pregnant women or those who may become pregnant should use this medication only when the benefits outweigh the risks. If a nursing mother takes this medication, a small amount of the drug may be excreted in breast milk, but it may be considered if the therapeutic benefits exceed the risks. The safety and efficacy for children under 1 year of age have not been established, and a similar safety profile has been observed in children over 1 year and adults. Elderly patients should be closely monitored during administration as they may have decreased physical function and underlying diseases. Reported adverse reactions from overdose are similar to common side effects, and immediate consultation with medical professionals is advised. This medication has a low potential for interaction with other drugs; however, caution may be required when used in combination with specific drugs. Effects on the ability to drive or operate machinery have not been reported, but influenza itself can impair these abilities, so caution is advised. After using this medication, it should be stored out of reach of children, and it is advisable not to transfer it to another container.

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

This medication should be kept in a tightly closed container to protect it from air and moisture. The storage temperature should be maintained between 1 and 30 degrees Celsius. This helps to maintain the efficacy and safety of the medication.

Appearance

A hard capsule with gray lower part and light yellow upper part containing white or light yellow powder

Package unit

10 capsules/PTP