Fluphid Powder 30 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 taken with or without food; tolerability may be improved 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 for dosing. Patients with renal impairment: No dose adjustment is required for patients with a creatinine clearance of 60 mL/min or more. 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 periodic hemodialysis should receive a 30mg dose of this medicine after each dialysis session to maintain plasma concentrations within the therapeutic range, and the treatment period should not exceed 5 days. If influenza symptoms occur during the 48 hours between dialysis sessions, the dose may be administered before the start of dialysis. 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 dose 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 those in close contact with an infected person, administer oseltamivir 75 mg orally once daily for 10 days. Initiate treatment 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 this medicine is being taken. Patients with renal impairment: No dose adjustment is required for patients with a creatinine clearance of 60 mL/min or more. 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 once every other day is recommended. Patients receiving periodic hemodialysis should receive a 30mg dose of this medicine after every 2 dialysis sessions to maintain plasma concentrations within the therapeutic range. The initial dose may also be administered before the start of dialysis. For peritoneal dialysis, administration of 30mg 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 dose adjustment is required for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

Treatment — Children aged 1 year to 12 years: Pediatric patients weighing more than 40 kg who can 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. ≤ 15 kg: 30 mg (sachet) per dose twice daily 15 kg<, ≤ 23 kg: 45 mg (sachet) per dose twice daily 23 kg<, ≤ 40 kg: 60 mg (two 30mg sachets) per dose twice daily > 40 kg: 75 mg (sachet) per dose twice daily Treatment — 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. Pediatric patients who have difficulty taking this medicine as a powder should use the suspension for dosing. 3 kg: 9 mg per dose twice daily; suspension (6mg/mL) dose 1.5mL twice daily 4 kg: 12 mg per dose twice daily; suspension (6mg/mL) dose 2.0mL twice daily 5 kg: 15 mg per dose twice daily; suspension (6mg/mL) dose 2.5mL twice daily 6 kg: 18 mg per dose twice daily; suspension (6mg/mL) dose 3.0mL twice daily 7 kg: 21 mg per dose twice daily; suspension (6mg/mL) dose 3.5mL twice daily 8 kg: 24 mg per dose twice daily; suspension (6mg/mL) dose 4.0mL twice daily 9 kg: 27 mg per dose twice daily; suspension (6mg/mL) dose 4.5mL twice daily 10 kg: 30 mg per dose twice daily; suspension (6mg/mL) dose 5.0mL 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 infants under 1 year of age. Prevention — Children aged 1 year to 12 years: Pediatric patients weighing more than 40 kg who can 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. ≤ 15 kg: 30 mg (sachet) per dose once daily 15 kg<, ≤ 23 kg: 45 mg (sachet) per dose once daily 23 kg<, ≤ 40 kg: 60 mg (two 30mg sachets) per dose once daily > 40 kg: 75 mg (sachet) per dose once daily ※ The safety and efficacy of preventing 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 only used for treatment or prevention during influenza virus outbreaks. Safety and efficacy for infections other than influenza A and B have not been established. Particularly in children and adolescents, rare occurrences of seizures or psychological disturbances have been noted after taking this medication; therefore, guardians should carefully monitor for abnormal behaviors. Individuals allergic to this medication or any of its components should not use it. Patients with poor renal function or those on dialysis may require dosage adjustments, and it is not recommended for patients with end-stage renal failure. Use with caution in high-risk patients with asthma, chronic bronchitis, or immunosuppressive conditions. Common side effects include nausea, vomiting, headache, and pain, which are mostly temporary and mild. Rarely, serious allergic reactions such as shock or anaphylaxis, liver dysfunction, skin rash, acute renal failure, and neuropsychiatric symptoms may occur, so immediate consultation with healthcare professionals should occur if such symptoms arise. There is insufficient data regarding the safety of this medication in pregnant or breastfeeding women; it should only be used when the benefits of treatment outweigh the risks. Safety and efficacy for children under the age of 1 have not been established, and use is not recommended. Elderly patients generally do not require dosage adjustments; however, careful monitoring is required for those with reduced bodily function or chronic diseases. This medication has a low potential for drug interactions, but caution may be needed when used in combination with certain medications, so it is essential to inform healthcare professionals of any other medications being taken. If abnormal behaviors or severe side effects occur while taking this medication, discontinue immediately and notify healthcare professionals. Keep out of reach of children and avoid transferring to another container.

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

This medication should be stored in a sealed container to prevent exposure to air or moisture. It is best to maintain storage temperatures between 1 and 30 degrees Celsius in a cool, dry place.

Appearance

White or yellowish powder

Package unit

10 packets/box