Yuhan Enflu Capsule 75 mg (Oseltamivir Phosphate)

Adult dose

Treatment of 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; in some patients, tolerability may improve 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 the powder for oral suspension of this medicine. Patients with renal impairment (treatment): No dosage adjustment is necessary for 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 therapeutic plasma concentrations; treatment should not exceed 5 days. If influenza symptoms develop 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 less than 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment (treatment): No dosage adjustment is necessary for treatment of adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9). Immunocompromised patients (treatment): No dosage adjustment is necessary for treatment of immunocompromised patients; administration for 10 days is recommended. 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 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 taking this medicine. Patients with renal impairment (prevention): No dosage adjustment is necessary for 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 therapeutic plasma concentrations. 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 less than 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment (prevention): No dosage adjustment is necessary 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 year to 12 years: Pediatric patients weighing more than 40 kg who can swallow capsules may take 75mg capsules twice daily or 30mg and 45mg capsules twice daily instead of the recommended dose of this medicine as an oral suspension. Weight ≤ 15 kg: 30 mg per dose twice daily; oral suspension (6mg/mL) 5.0 mL per dose twice daily Weight 15 kg<, ≤ 23 kg: 45 mg per dose twice daily; oral suspension (6mg/mL) 7.5 mL per dose twice daily Weight 23 kg<, ≤ 40 kg: 60 mg per dose twice daily; oral suspension (6mg/mL) 10.0 mL per dose twice daily Weight > 40 kg: 75 mg per dose twice daily; oral suspension (6mg/mL) 12.5 mL per dose twice daily Children aged 2 weeks to less than 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. Weight 3 kg: 9 mg per dose twice daily; oral suspension (6mg/mL) 1.5 mL per dose twice daily Weight 4 kg: 12 mg per dose twice daily; oral suspension (6mg/mL) 2.0 mL per dose twice daily Weight 5 kg: 15 mg per dose twice daily; oral suspension (6mg/mL) 2.5 mL per dose twice daily Weight 6 kg: 18 mg per dose twice daily; oral suspension (6mg/mL) 3.0 mL per dose twice daily Weight 7 kg: 21 mg per dose twice daily; oral suspension (6mg/mL) 3.5 mL per dose twice daily Weight 8 kg: 24 mg per dose twice daily; oral suspension (6mg/mL) 4.0 mL per dose twice daily Weight 9 kg: 27 mg per dose twice daily; oral suspension (6mg/mL) 4.5 mL per dose twice daily Weight 10 kg: 30 mg per dose twice daily; oral suspension (6mg/mL) 5.0 mL per dose twice daily * This table does not include all possible weights in this patient group. For children under 1 year of age, a dose of 3mg/kg of this medicine is recommended. It is recommended that a pharmacist prepare the oral suspension of this medicine before administration to the patient. Prevention of influenza A and influenza B virus infections—children aged 1 year to 12 years: Pediatric patients weighing more than 40 kg who can 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 as an oral suspension. Weight ≤ 15 kg: 30 mg per dose once daily; oral suspension (6mg/mL) 5.0 mL per dose once daily Weight 15 kg<, ≤ 23 kg: 45 mg per dose once daily; oral suspension (6mg/mL) 7.5 mL per dose once daily Weight 23 kg<, ≤ 40 kg: 60 mg per dose once daily; oral suspension (6mg/mL) 10.0 mL per dose once daily Weight > 40 kg: 75 mg per dose once daily; oral suspension (6mg/mL) 12.5 mL per dose once daily It is recommended that a pharmacist prepare the oral suspension of this medicine before administration to the patient. The safety and efficacy of prevention of influenza A and B virus infections in children under 1 year of age have not been evaluated. Immunocompromised patients (prevention): No dosage adjustment is necessary for seasonal prevention in immunocompromised patients aged 1 year and older; administration for 12 weeks is recommended.

This medication cannot replace influenza vaccination and should be used separately from vaccination. This drug has only been proven effective against influenza A and B, and its safety and efficacy against other infections have not been confirmed. During treatment, especially in pediatric and adolescent patients, neuropsychiatric side effects such as convulsions and delirium have been reported; caregivers should monitor closely for any abnormal behavior. In children over 10 years of age, it should generally not be administered except in special cases, and they should not be left alone at least for 2 days after treatment initiation. Patients with hypersensitivity to this drug or its components should not be administered this medication. Renal impairment patients require dosage adjustment, and it is not recommended for those with end-stage renal failure. Caution should be exercised in administering to high-risk patients with asthma, chronic bronchitis, or immune suppression. The most common side effects include nausea, vomiting, and headache, which are mostly temporary and mild. Rarely, shock, anaphylaxis, hepatitis, mucocutaneous syndrome, acute renal failure, and neuropsychiatric symptoms may occur, and if any abnormal symptoms appear, immediate consultation with a healthcare provider is necessary. In pregnant or breastfeeding individuals, it should only be administered when the benefits of treatment outweigh the risks, as data on effects on the fetus or newborn is limited. Children can use this medication from 1 year of age; its safety and efficacy have not been established in children under 1 year. Elderly individuals may require careful monitoring during administration due to decreased bodily functions and multiple pre-existing conditions. In cases of overdose, most adverse reactions are mild, and it is crucial to adhere to the prescribed dosage. This drug has a low potential for drug interactions, but caution may be needed when combined with certain medications, so patients should inform their healthcare provider of any concurrent medications. No effects on driving or operating machinery have been reported, however, influenza itself may impair concentration, so caution is warranted. This medication may pose a risk of developing resistance to the influenza virus, particularly in patients with weakened immune systems and in young children where resistance rates may be higher. Thus, it is important to adhere to the appropriate dosage and instructions from healthcare providers when using this medication, and to seek immediate counsel if any adverse symptoms occur.

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

This drug should be stored in a tightly sealed container to protect it from air and humidity. Additionally, it is important to keep it in a cool place below 25 degrees Celsius to maintain its efficacy.

Appearance

Hard capsule with a yellowish upper part and gray lower part containing white or yellowish powder

Package unit

10 capsules (10 capsules/PTP packaging x 1)