Flurex 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; 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 oral suspension. Patients with renal impairment (treatment): No dosage adjustment is required in 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 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 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 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 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 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 dosage adjustment is required in 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 blood concentrations within the therapeutic range. 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 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 adult patients 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 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. Weight ≤ 15 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily Weight 15 kg<, ≤ 23 kg: 45 mg twice daily; suspension (6mg/mL) 7.5 mL twice daily Weight 23 kg<, ≤ 40 kg: 60 mg twice daily; suspension (6mg/mL) 10.0 mL twice daily Weight > 40 kg: 75 mg twice daily; suspension (6mg/mL) 12.5 mL twice daily Children aged 2 weeks to under 1 year: The recommended dose for children 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. Weight 3 kg: 9 mg twice daily; suspension (6mg/mL) 1.5 mL twice daily Weight 4 kg: 12 mg twice daily; suspension (6mg/mL) 2.0 mL twice daily Weight 5 kg: 15 mg twice daily; suspension (6mg/mL) 2.5 mL twice daily Weight 6 kg: 18 mg twice daily; suspension (6mg/mL) 3.0 mL twice daily Weight 7 kg: 21 mg twice daily; suspension (6mg/mL) 3.5 mL twice daily Weight 8 kg: 24 mg twice daily; suspension (6mg/mL) 4.0 mL twice daily Weight 9 kg: 27 mg twice daily; suspension (6mg/mL) 4.5 mL twice daily Weight 10 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily Children under 1 year: This table does not include all possible weights in this patient group. The recommended dose for children under 1 year is 3mg/kg of this medicine. 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 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. Weight ≤ 15 kg: 30 mg once daily; suspension (6mg/mL) 5.0 mL once daily Weight 15 kg<, ≤ 23 kg: 45 mg once daily; suspension (6mg/mL) 7.5 mL once daily Weight 23 kg<, ≤ 40 kg: 60 mg once daily; suspension (6mg/mL) 10.0 mL once daily Weight > 40 kg: 75 mg once daily; suspension (6mg/mL) 12.5 mL once daily Children under 1 year: 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 medication cannot replace influenza vaccination and is only used for treatment and prevention during periods when the influenza virus is prevalent. The safety and efficacy of this drug have not been established for infections other than Influenza A and B. In particular, neurological and psychiatric adverse reactions, such as seizures or delirium, have been rarely reported, and caregivers should closely monitor for unusual behavior in children and adolescents, and it is advisable to avoid use in children over 10 years old as a principle. People with hypersensitivity to this drug or its components should not take it. Patients with impaired renal function or those on dialysis may require dosage adjustment, and it is not recommended for patients with end-stage renal disease. Caution should be taken when administered to high-risk patients with asthma, chronic bronchitis, or immunosuppressive states. The most common side effects during use include nausea, vomiting, and headache, which are generally temporary and mild. Rarely, shock, anaphylaxis, hepatic dysfunction, skin and mucous membrane syndrome, acute renal failure, blood abnormalities, or neurological symptoms may occur, and if any unusual symptoms occur, immediate consultation with a physician is recommended. This medication is not a substitute for the influenza vaccine, so vaccination must be conducted, and starting treatment within 40 hours of symptom onset is effective. Its effect on driving or operating machinery is minimal, but caution is needed because influenza itself can impair physical function. Drug interactions are minimal, but caution is needed when used with drugs that may affect renal excretion. Pregnant or breastfeeding women should consider the limited data on the effects of this medication on the fetus or infant and carefully weigh the benefits and risks of treatment. It is advisable not to use in infants under 1 year of age as safety and efficacy have not been established. An elderly person does not require special dosage adjustments, but careful monitoring is necessary due to physical function decline and pre-existing conditions. Severe side effects have been rarely reported in cases of overdose, but if any unusual symptoms appear, immediate consultation with medical personnel is necessary. This drug should be stored out of reach of children and should not be transferred to another container.

• Cramps
• delirium
• abnormal behavior
• nausea
• vomiting
• headache
• pain
• unstable angina
• anemia
• membrane colitis

This medication should be stored in a tightly closed container, protected from air and moisture. Additionally, it should be kept away from extremely hot or cold places, ideally at room temperature between 1°C and 30°C.

Appearance

Hard capsules with a gray lower part and a light yellow upper part containing a white or light yellow powder

Package unit

10 capsules/PTP