Flurex Capsule 45 mg (Oseltamivir Phosphate)

Adult dose

Treatment of 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. 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. 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. Patients with hepatic impairment: No dose adjustment is necessary 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 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. 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. 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

Treatment of influenza A and influenza B virus infections — 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. Body weight ≤ 15 kg: 30 mg per dose twice daily; suspension(6mg/mL) 5.0 mL per dose twice daily Body weight 15 kg<, ≤ 23 kg: 45 mg per dose twice daily; suspension(6mg/mL) 7.5 mL per dose twice daily Body weight 23 kg<, ≤ 40 kg: 60 mg per dose twice daily; suspension(6mg/mL) 10.0 mL per dose twice daily Body weight > 40 kg: 75 mg per dose twice daily; suspension(6mg/mL) 12.5 mL per dose twice daily 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. Body weight 3 kg: 9 mg per dose twice daily; suspension(6mg/mL) 1.5 mL per dose twice daily Body weight 4 kg: 12 mg per dose twice daily; suspension(6mg/mL) 2.0 mL per dose twice daily Body weight 5 kg: 15 mg per dose twice daily; suspension(6mg/mL) 2.5 mL per dose twice daily Body weight 6 kg: 18 mg per dose twice daily; suspension(6mg/mL) 3.0 mL per dose twice daily Body weight 7 kg: 21 mg per dose twice daily; suspension(6mg/mL) 3.5 mL per dose twice daily Body weight 8 kg: 24 mg per dose twice daily; suspension(6mg/mL) 4.0 mL per dose twice daily Body weight 9 kg: 27 mg per dose twice daily; suspension(6mg/mL) 4.5 mL per dose twice daily Body weight 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 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. Prevention of influenza A and influenza B virus infections — 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. Body weight ≤ 15 kg: 30 mg per dose once daily; suspension(6mg/mL) 5.0 mL per dose once daily Body weight 15 kg<, ≤ 23 kg: 45 mg per dose once daily; suspension(6mg/mL) 7.5 mL per dose once daily Body weight 23 kg<, ≤ 40 kg: 60 mg per dose once daily; suspension(6mg/mL) 10.0 mL per dose once daily Body weight > 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 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 substitute for influenza vaccination, so it is important to use it in conjunction with influenza vaccination. Effectiveness has only been proven against influenza A and B viruses, and safety and efficacy have not been confirmed for other infections. Rarely, children and adolescents may experience seizures or abnormal behavior, so caregivers should closely monitor these age groups for any unusual behavior. It is generally advisable not to use this medication for pediatric patients over 10 years old unless there are no special risks. For at least 2 days after starting treatment, caregivers should ensure that the patient is not left alone and should report any unusual behavior immediately. Patients with allergies to this medication or its ingredients should not use it. Dose adjustments are necessary for patients with impaired renal function, and it is not recommended for patients with end-stage renal failure. Caution is advised for high-risk patients such as those with asthma, chronic bronchitis, or immunosuppressive conditions. Commonly reported side effects may include nausea, vomiting, and headache, and they are mostly temporary. Rarely, symptoms such as skin rash, liver function abnormalities, acute renal failure, and neurological symptoms may occur, so if any abnormal symptoms arise, consult medical personnel immediately. Evidence is limited regarding the effects of this medication on pregnant or breastfeeding individuals, so it should only be used if the therapeutic benefits outweigh the risks. For children, safety and efficacy have not been established for those under 1 year of age, while children over 1 year may use it at appropriate doses. Elderly patients should be monitored for potential declines in physical functions, but generally, dose adjustments are not necessary. No specific treatment exists for overdose, but any adverse reactions should be reported to medical personnel immediately. This medication should be stored out of the reach of children and should not be transferred to other containers. The potential for interaction with other medications is low; however, caution is needed when used in combination with specific drugs, so always inform medical personnel. No effects on driving or operating machinery have been reported, but influenza itself may affect these abilities, so caution is advised.

• Convulsions
• 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 or moisture intrusion. Additionally, it is recommended to store it at room temperature between 1°C and 30°C. This helps maintain the medication's effectiveness for a long time.

Appearance

A hard capsule with a gray color containing white or light yellow powder.

Package unit

10 capsules/PTP