Fabiflu Capsule 75mg (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 administered with or without food; tolerability may improve 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 as an oral suspension. Patients with renal impairment: No dose adjustment is required in patients with creatinine clearance of 60 mL/min or higher. 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 plasma concentrations within the therapeutic range; treatment should not exceed 5 days. If influenza symptoms develop during the 48 hours between dialysis sessions, this medicine may also 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). 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 oseltamivir 75 mg 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 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 required in patients with creatinine clearance of 60 mL/min or higher. 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 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 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: No dose adjustment is required for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

1. Influenza A and influenza B virus infections Children aged 1 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 as an oral 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 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. 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 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 this medicine as an oral suspension before administration to the patient. 2. Prevention of influenza A and influenza B virus infections Children aged 1 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 as an oral 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 this medicine as an oral suspension before administration to the patient. ※ 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 should only be used for treatment and prevention during periods of influenza virus outbreaks. This drug has been proven effective only against influenza A and B, and safety and efficacy have not been established against other infections. In particular, neuropsychiatric adverse reactions have been reported in children and adolescents, and abnormal behaviors may occur, so caregivers should closely monitor the patient for 2 days after administration. Patients with a history of allergy to this medication or its components should not use it. Dose adjustment is required for patients with impaired kidney function or those undergoing dialysis, and it is not recommended for patients with end-stage renal failure. Caution should be exercised in high-risk patients such as those with asthma or chronic bronchitis. Common side effects such as nausea, vomiting, and headache may occur, but most are temporary. Rarely, anaphylaxis, liver dysfunction, skin reactions, acute renal failure, and psychiatric symptoms may develop, so patients should consult a doctor immediately if abnormal symptoms occur. This medication cannot replace influenza vaccines, and it is crucial to use it in conjunction with vaccinations. Pregnant or nursing women should use it with caution after consulting a physician, and safety and efficacy in children under 1 year old have not been established. The elderly should be monitored carefully due to the possibility of decreased physical function. Serious side effects from overdose have not been reported, but established dosages and administration should be followed. This medication has a low potential for drug interactions, but caution may be needed when co-administered with certain drugs. Caution should also be taken while driving or operating machinery due to the possibility of reduced capability from influenza symptoms. Keep out of reach of children, and do not transfer to other containers for safety.

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

This medication should be stored in a tightly sealed container to protect it from air and moisture and it is best to keep it at a cool temperature below 25 degrees Celsius. Proper storage helps maintain the medication's effectiveness for a longer period.

Appearance

A hard capsule with a light yellow upper part and gray lower part containing white or pale yellow powder.

Package unit

10 capsules/PTP