FluRex Suspension Powder 6mg/mL (Oseltamivir Phosphate)

Adult dose

1. 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 taken with or without food. In some patients, taking it with food may improve tolerability. 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 this medicine. Patients with renal impairment: No dosage adjustment is required for patients with a creatinine clearance of 60 mL/min or greater. For patients with a creatinine clearance of 30 ~ 60 mL/min, a reduced dose of 30 mg twice daily for 5 days is recommended. For patients with a 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 be given 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 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 below 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment: No dosage adjustment is required for treatment in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9). 2. 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 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: No dosage adjustment is required for patients with a creatinine clearance of 60 mL/min or greater. For patients with a creatinine clearance of 30 ～ 60 mL/min, a reduced dose of 30 mg once daily is recommended. For patients with a creatinine clearance of 10 ～ 30 mL/min, a reduced dose of 30 mg every other day is recommended. Patients receiving regular hemodialysis should be given 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, 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 receiving dialysis (e.g., creatinine clearance below 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment: No dosage adjustment is required for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

1) Children aged 1 year or older and 12 years or younger, treatment: Pediatric patients weighing more than 40 kg who can swallow capsules may take 75mg capsules twice daily or 30mg capsules and 45mg capsules twice daily instead of the recommended dose of this drug. ≤ 15 kg: 30 mg twice daily for 5 days; suspension (6mg/mL) 5.0 mL twice daily 15 kg<, ≤ 23 kg: 45 mg twice daily for 5 days; suspension (6mg/mL) 7.5 mL twice daily 23 kg<, ≤ 40 kg: 60 mg twice daily for 5 days; suspension (6mg/mL) 10.0 mL twice daily > 40 kg: 75 mg twice daily for 5 days; suspension (6mg/mL) 12.5 mL twice daily 2) Children aged 2 weeks or older and younger than 1 year: The recommended dose for pediatric patients aged 2 weeks to 12 months is 3mg/kg of this drug orally twice daily for 5 days. This does not apply to children with a postconceptional age of less than 36 weeks. 3 kg: 9 mg twice daily for 5 days; suspension (6mg/mL) 1.5 mL twice daily 4 kg: 12 mg twice daily for 5 days; suspension (6mg/mL) 2.0 mL twice daily 5 kg: 15 mg twice daily for 5 days; suspension (6mg/mL) 2.5 mL twice daily 6 kg: 18 mg twice daily for 5 days; suspension (6mg/mL) 3.0 mL twice daily 7 kg: 21 mg twice daily for 5 days; suspension (6mg/mL) 3.5 mL twice daily 8 kg: 24 mg twice daily for 5 days; suspension (6mg/mL) 4.0 mL twice daily 9 kg: 27 mg twice daily for 5 days; suspension (6mg/mL) 4.5 mL twice daily 10 kg: 30 mg twice daily for 5 days; suspension (6mg/mL) 5.0 mL twice daily * This table does not include all possible weights in this patient group. A dose of 3mg/kg of this drug is recommended for children younger than 1 year. 2. Prevention of influenza A and influenza B virus infections Children aged 1 year or older and 12 years or younger: Pediatric patients weighing more than 40 kg who can swallow capsules may take 75mg capsules once daily or 30mg capsules and 45mg capsules once daily for 10 days instead of the recommended dose of this drug. ≤ 15 kg: 30 mg once daily for 10 days; suspension (6mg/mL) 5.0 mL once daily 15 kg<, ≤ 23 kg: 45 mg once daily for 10 days; suspension (6mg/mL) 7.5 mL once daily 23 kg<, ≤ 40 kg: 60 mg once daily for 10 days; suspension (6mg/mL) 10.0 mL once daily > 40 kg: 75 mg once daily for 10 days; suspension (6mg/mL) 12.5 mL once daily ※ The safety and efficacy of preventing influenza A and B virus infections in children younger than 1 year have not been evaluated.

This medication cannot replace the influenza vaccination and is only to be used for treatment and prevention during influenza virus outbreaks. Safety and efficacy have not been established for infections other than influenza A and B. Neuropsychiatric adverse effects such as unusual behavior, seizures, and delirium may occur, particularly in children and adolescents, so careful monitoring is required. For children over 10 years old, this medication is generally not recommended except in special cases. There is a risk of unusual behavior during treatment, so caregivers should not leave patients alone for at least 2 days after starting treatment. Patients with an allergy to this medication or its components should not be administered this medication. Dosage adjustments are needed for patients with decreased kidney function, and it is not recommended for patients with end-stage renal failure. Caution is necessary for high-risk patients such as those with asthma, chronic bronchitis, or immunosuppressive conditions. Common side effects include nausea, vomiting, headache, etc., which are mostly temporary and mild. Rarely, shock, anaphylaxis, liver dysfunction, skin reactions, acute renal failure, and neurological symptoms may occur, so any abnormal signs should be reported to healthcare professionals immediately. Children can be treated from 1 year of age, but safety and efficacy have not been established for those under 1 year old. Women who are pregnant or nursing should only use this medication if the therapeutic benefits outweigh the risks, and they should consult with a specialist. Elderly patients should be monitored closely considering the possibility of decreased bodily functions and multiple underlying diseases. Serious adverse effects due to overdose are rare, but if unusual reactions occur, healthcare providers should be informed immediately. This medication contains sorbitol and is not suitable for patients with hereditary fructose intolerance. The possibility of drug interactions is low; however, caution is needed when used with certain medications that share the same renal excretion pathway. This medication can be used alongside the influenza vaccine without interfering with vaccination effectiveness, but it must be spaced appropriately from live vaccines. This medication should be properly mixed before administration, and the storage period and methods after preparation should be adhered to. It is recommended to keep it out of reach of children and not to transfer it to other containers.

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

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. The storage temperature should maintain room temperature between 1°C and 30°C. This helps to maintain the effectiveness of the medication for a longer period.

Appearance

A suspension powder in a light brown glass bottle containing white or light yellow granules for reconstitution.

Package unit

10g/bottle (50mL), 13g/bottle (65mL)