Flurex Capsule 30 mg (Oseltamivir Phosphate)

Adult dose

1. Influenza A and influenza B virus infections: Initiate treatment on the first or second day 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 use the powder for suspension. 4) Patients with renal impairment No dose adjustment is necessary for patients with creatinine clearance of 60 mL/min or greater. 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 undergoing regular hemodialysis should receive a 30mg dose of this medicine after each dialysis session to maintain blood concentrations within the therapeutic range; 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 undergoing dialysis (e.g., creatinine clearance less than 10mL/min); therefore, no recommended dose is available for these patients. 5) Patients with hepatic impairment No dose adjustment is necessary for treatment in adults 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. Begin 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 this medicine is being taken. 3) Patients with renal impairment No dose adjustment is necessary for patients with creatinine clearance of 60 mL/min or greater. 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 daily every other day is recommended. Patients undergoing regular hemodialysis should receive a 30mg dose of this medicine after every 2 dialysis sessions to maintain blood concentrations within the therapeutic range. The initial dose may also be given before dialysis begins. For peritoneal dialysis, a 30mg dose 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 undergoing dialysis (e.g., creatinine clearance less than 10mL/min); therefore, no recommended dose is available for these patients. 4) Patients with hepatic impairment No dose adjustment is necessary for prevention in adults 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 are able to swallow capsules may take 75mg capsules twice daily or 30mg and 45mg capsules twice daily instead of the recommended dose of this medicine suspension. ≤ 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 less than 1 year: The recommended dose for 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 body 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 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 are able to 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 suspension. ≤ 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 before it is administered to the patient. ※ The safety and efficacy of this medicine for prevention of influenza A and B virus infections in children under 1 year of age have not been evaluated.

This medication cannot replace influenza vaccination and is used as a separate treatment. Its efficacy has only been proven against influenza A and B viruses, and safety and efficacy have not been confirmed for other infections. Neuropsychiatric adverse reactions such as seizures or abnormal behavior have been rarely reported in children and adolescents after taking this medication, so caution is especially necessary in children over 10 years old. As unusual behavior may appear while taking this medication, children and adolescents should be monitored by a guardian for at least 2 days for safety. Patients allergic to this medication or its components should not take it. Dose adjustment is necessary for patients with reduced kidney function, and it is not recommended for patients with end-stage renal failure. Caution should be exercised for high-risk groups with asthma, chronic bronchitis, or immunosuppressive conditions. Commonly occurring side effects include nausea, vomiting, headache, etc., which are mostly temporary. However, serious side effects such as skin rash, liver dysfunction, neurological symptoms, and acute renal failure may occur rarely, so medical attention should be sought immediately if unusual symptoms arise. Pregnant or breastfeeding women should weigh the risks and benefits of this medication carefully, and safety and efficacy have not been established for children, especially those under 1 year old. For the elderly, no special dose adjustment is needed, but careful observation should be made for possible decline in bodily functions. The possibility of drug interactions with this medication is low, but caution may be needed when combined with certain other drugs. During the course of treatment, it is advisable to maintain an interval from the influenza vaccine. Serious side effects are rare in cases of overdose, but if unusual symptoms occur, medical attention should be sought immediately. Store out of reach of children and be careful not to transfer to another container.

• Convulsions
• 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 at room temperature between 1 to 30 degrees Celsius. Storing it this way can maintain the effectiveness of the medication for a longer period.

Appearance

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

Package unit

10 capsules/PTP