Yuhan Enflu Capsule 45 mg (Oseltamivir Phosphate)

Adult dose

Influenza A and influenza B virus infections: Begin treatment on the first or second day after the onset of influenza symptoms. This medicine may be administered regardless of food intake; in some patients, taking it with food may improve tolerability. Adults and adolescents aged 13 years and older: Administer 75 mg of oseltamivir orally 2 times daily for 5 days. Adults and adolescents aged 13 years and older who have difficulty swallowing capsules should use this medicine as suspension powder. Patients with renal impairment: No dose adjustment is required for patients with creatinine clearance of 60 mL/min or more. For patients with creatinine clearance of 30 ~ 60 mL/min, a reduced dose of 30 mg 2 times 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, 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 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 dose adjustment is required for treatment in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9). Immunocompromised patients: No dose adjustment is required for treatment in 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 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 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: No dose adjustment is required for patients with creatinine clearance of 60 mL/min or more. 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 dialysis begins. 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 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 2 times daily or a 30mg capsule and a 45mg capsule 2 times daily instead of the recommended dose of this medicine as a suspension. ≤ 15 kg: 30 mg per dose 2 times daily; suspension (6mg/mL) 5.0 mL per dose 2 times daily 15 kg<, ≤ 23 kg: 45 mg per dose 2 times daily; suspension (6mg/mL) 7.5 mL per dose 2 times daily 23 kg<, ≤ 40 kg: 60 mg per dose 2 times daily; suspension (6mg/mL) 10.0 mL per dose 2 times daily > 40 kg: 75 mg per dose 2 times daily; suspension (6mg/mL) 12.5 mL per dose 2 times daily 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, administered orally 2 times daily for 5 days. This does not apply to children with a postconceptional age of less than 36 weeks. 3 kg: 9 mg per dose 2 times daily; suspension (6mg/mL) 1.5 mL per dose 2 times daily 4 kg: 12 mg per dose 2 times daily; suspension (6mg/mL) 2.0 mL per dose 2 times daily 5 kg: 15 mg per dose 2 times daily; suspension (6mg/mL) 2.5 mL per dose 2 times daily 6 kg: 18 mg per dose 2 times daily; suspension (6mg/mL) 3.0 mL per dose 2 times daily 7 kg: 21 mg per dose 2 times daily; suspension (6mg/mL) 3.5 mL per dose 2 times daily 8 kg: 24 mg per dose 2 times daily; suspension (6mg/mL) 4.0 mL per dose 2 times daily 9 kg: 27 mg per dose 2 times daily; suspension (6mg/mL) 4.5 mL per dose 2 times daily 10 kg: 30 mg per dose 2 times daily; suspension (6mg/mL) 5.0 mL per dose 2 times 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. 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 a suspension. ≤ 15 kg: 30 mg per dose once daily; suspension (6mg/mL) 5.0 mL per dose once daily 15 kg<, ≤ 23 kg: 45 mg per dose once daily; suspension (6mg/mL) 7.5 mL per dose once daily 23 kg<, ≤ 40 kg: 60 mg per dose once daily; suspension (6mg/mL) 10.0 mL per dose once daily > 40 kg: 75 mg per dose once daily; suspension (6mg/mL) 12.5 mL per dose once daily ※ 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: No dose adjustment is required 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 only be used for treatment and prevention during the period when influenza viruses are circulating. Safety and effectiveness have not been established for infections other than influenza A and B viruses. Particularly in children and adolescents, neurological and psychiatric adverse reactions such as seizures and delirium have been reported, so caregivers should carefully observe for abnormal behavior. Children over the age of 10 should generally avoid using this medication except in special cases. Patients with allergic reactions to this medication should not take it, and dose adjustments may be necessary for patients with impaired kidney function. Nausea, vomiting, and headaches can occur as common side effects, but most of them are temporary. Serious allergic reactions, liver function abnormalities, skin reactions, acute renal failure, and central nervous system symptoms may occur, and if any of these occur, immediate consultation with medical personnel is essential. Women who are pregnant or breastfeeding should carefully consider the risks and benefits of using this medication. Safety and effectiveness in children under 1 year of age have not been sufficiently confirmed, so caution is necessary in their use. Elderly patients can use this medication without special dose adjustments, but observation of physical function deterioration is necessary. This medication has a low likelihood of drug interactions; however, caution may be needed when used with certain medications. Serious side effects are not common even in cases of overdose, but if any abnormal symptoms occur, it is necessary to visit a hospital immediately. Keep out of reach of children and avoid transferring to other containers. This medication has the potential for the emergence of resistance in influenza viruses, particularly in immunocompromised patients or young children, where resistant viruses may occur more frequently.

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

This medication should be stored in a tightly closed container to protect it from air and moisture, and it is best stored at a cool temperature below 25 degrees Celsius. This way, the effectiveness of the medication can be maintained for a long period.

Appearance

A gray hard capsule filled with a white or yellowish powder

Package unit

10 capsules (10 capsules/PTP packaging x1)