Yuhan Enflu Powder for Suspension 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; tolerability may improve in some patients when taken with food. 1) Adults and adolescents aged 13 years and older: The recommended dose is 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. 4) Patients with renal impairment: No dosage adjustment is necessary 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 30 mg 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 occur during the 48 hours between dialysis sessions, the dose may be administered before dialysis begins. For peritoneal dialysis, a single 30 mg 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. 5) Patients with hepatic impairment: No dosage adjustment is necessary 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 1) 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 after 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. 3) Patients with renal impairment: No dosage adjustment is necessary 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 once every other day is recommended. Patients receiving regular hemodialysis should receive a 30 mg dose of this medicine after every 2 dialysis sessions to maintain plasma concentrations within the therapeutic range. The first 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. 4) Patients with hepatic impairment: No dosage adjustment is necessary for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

1) 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 one 30mg capsule and one 45mg capsule twice daily instead of the recommended dose of this medicine. Treatment ≤ 15 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily Treatment 15 kg<, ≤ 23 kg: 45 mg twice daily; suspension (6mg/mL) 7.5 mL twice daily Treatment 23 kg<, ≤ 40 kg: 60 mg twice daily; suspension (6mg/mL) 10.0 mL twice daily Treatment > 40 kg: 75 mg twice daily; suspension (6mg/mL) 12.5 mL twice daily 3) Children 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 twice daily; suspension (6mg/mL) 1.5 mL twice daily 4 kg: 12 mg twice daily; suspension (6mg/mL) 2.0 mL twice daily 5 kg: 15 mg twice daily; suspension (6mg/mL) 2.5 mL twice daily 6 kg: 18 mg twice daily; suspension (6mg/mL) 3.0 mL twice daily 7 kg: 21 mg twice daily; suspension (6mg/mL) 3.5 mL twice daily 8 kg: 24 mg twice daily; suspension (6mg/mL) 4.0 mL twice daily 9 kg: 27 mg twice daily; suspension (6mg/mL) 4.5 mL twice daily 10 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL 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 children under 1 year of age. 2. Prevention of influenza A and influenza B virus infections 2) 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 one 30mg capsule and one 45mg capsule once daily for 10 days instead of the recommended dose of this medicine. Prevention ≤ 15 kg: 30 mg once daily; suspension (6mg/mL) 5.0 mL once daily Prevention 15 kg<, ≤ 23 kg: 45 mg once daily; suspension (6mg/mL) 7.5 mL once daily Prevention 23 kg<, ≤ 40 kg: 60 mg once daily; suspension (6mg/mL) 10.0 mL once daily Prevention > 40 kg: 75 mg once daily; suspension (6mg/mL) 12.5 mL once daily ※ The safety and efficacy of this medicine for the prevention of influenza A and B virus infections in children under 1 year of age have not been evaluated.

This medication cannot substitute for influenza vaccination and is used solely for treatment and prevention during flu virus outbreaks. Safety and efficacy have not been established for infections other than influenza A and B. Particular attention should be paid to observe for abnormal behavior or seizures in children and adolescents, where neuropsychiatric side effects have been reported, and children over 10 years old should not normally be used if they are not high-risk patients. Patients with hypersensitivity to this medication or its ingredients should not be administered. Dose adjustment is necessary for patients with renal failure or patients on dialysis, and it is not recommended for end-stage renal failure patients. Common side effects such as nausea, vomiting, headaches may occur, and rare side effects may include neuropsychiatric symptoms, skin rashes, liver dysfunction, acute renal failure, thus, immediate consultation with a physician is necessary if abnormal symptoms appear. This medication should be used cautiously in pregnant and breastfeeding women, and only when the therapeutic benefits outweigh the risks. Caution is needed for children, especially those under 1 year of age, as safety and efficacy have not been adequately established. Elderly patients should be carefully monitored during administration due to reduced bodily function. Serious side effects from overdose are rare, but if adverse reactions occur, medical personnel should be notified immediately. This drug contains sorbitol and is not suitable for patients with hereditary fructose intolerance. No particular effects have been reported during driving or operating machinery, but the potential for decreased ability due to influenza itself should be considered. This medication does not have significant interactions when used with various drugs, but caution is needed when combined with certain drugs affecting renal excretion. It is recommended not to use this drug simultaneously with the influenza vaccine, particularly live intranasal vaccines, with a certain interval between them. When taking this medicine, the suspension prepared by the pharmacist should be mixed correctly, and it should be stored out of the reach of children at the specified temperature.

• Nausea
• vomiting
• headache
• pain
• unstable angina
• anemia
• pseudomembranous colitis
• pneumonia
• peritonsillar abscess
• humeral fracture

This medication should be stored in a well-sealed container to prevent air or moisture from entering. Additionally, it is important to store it at a cool temperature below 25 degrees Celsius to maintain its efficacy.

Appearance

A suspension that consists of white to light yellow granules contained in a brown glass bottle.

Package unit

13g/bottle (65mL)