Utaflu Capsule 30 mg (Oseltamivir Phosphate)

Adult dose

1. Treatment of 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 taken 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 a powder for suspension. Patients with renal impairment: No dosage adjustment is needed 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 undergoing periodic 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 occur during the 48 hours between dialysis sessions, the dose 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 undergoing dialysis (e.g., creatinine clearance below 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment: No dosage adjustment is needed for treatment in adults 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 persons in close contact with an infected individual, administer oseltamivir 75 mg 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 dosage adjustment is needed 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 once daily every other day is recommended. Patients undergoing periodic hemodialysis should receive a 30mg 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 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 undergoing dialysis (e.g., creatinine clearance below 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment: No dosage adjustment is needed for prevention in adults with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

Children aged 1 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 a suspension. ≤ 15 kg: 30 mg per dose twice daily; suspension (6mg/mL) 5.0 mL per dose twice daily 15 kg<, ≤ 23 kg: 45 mg per dose twice daily; suspension (6mg/mL) 7.5 mL per dose twice daily 23 kg<, ≤ 40 kg: 60 mg per dose twice daily; suspension (6mg/mL) 10.0 mL per dose twice daily > 40 kg: 75 mg per dose twice daily; suspension (6mg/mL) 12.5 mL per dose twice daily Infants 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. 3 kg: 9 mg per dose twice daily; suspension (6mg/mL) 1.5 mL per dose twice daily 4 kg: 12 mg per dose twice daily; suspension (6mg/mL) 2.0 mL per dose twice daily 5 kg: 15 mg per dose twice daily; suspension (6mg/mL) 2.5 mL per dose twice daily 6 kg: 18 mg per dose twice daily; suspension (6mg/mL) 3.0 mL per dose twice daily 7 kg: 21 mg per dose twice daily; suspension (6mg/mL) 3.5 mL per dose twice daily 8 kg: 24 mg per dose twice daily; suspension (6mg/mL) 4.0 mL per dose twice daily 9 kg: 27 mg per dose twice daily; suspension (6mg/mL) 4.5 mL per dose twice daily 10 kg: 30 mg per dose twice daily; suspension (6mg/mL) 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 the suspension of this medicine before administration to the patient. Children aged 1 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 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 It is recommended that a pharmacist prepare the 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.

This medication cannot replace influenza vaccination and must be used separately from vaccination. It is effective only against influenza A and B viruses, and its safety or efficacy for other infections has not been established. Particular attention should be paid to children and adolescents as neuropsychiatric adverse reactions have been reported; guardians should closely monitor for abnormal behaviors. Dose adjustment may be necessary for patients with reduced kidney function or specific high-risk groups, or use may not be recommended. Side effects such as nausea, vomiting, headache may occur; if severe allergic reactions, liver function abnormalities, or skin abnormalities develop, immediate medical attention should be sought. The use of this medication in pregnant or breastfeeding women should be limited to situations where the benefits outweigh the risks, as its impact on the fetus or infant has not been sufficiently studied. Caution is required in children, especially those under 1 year, as safety and efficacy have not been established. Elderly patients should be closely observed as doses may need to be adjusted considering decreased physiological function and multiple comorbidities. Drug interactions are relatively few, but caution is needed when used with drugs that may affect renal excretion. If abnormal behavior or neurological symptoms occur during treatment, ingestion should be stopped immediately and consulted with a healthcare provider. The medication should be stored out of reach of children, and should not be transferred to other containers. Dosing should ideally commence at the earliest signs of symptoms, and if a dose is missed, it should be taken immediately within 2 hours, maintaining defined intervals thereafter.

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

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. Additionally, it is important to store it in a cool place below 25 degrees Celsius to maintain its efficacy.

Appearance

A hard capsule with the upper part opaque turquoise and the lower part opaque yellow containing white or pale yellow powder.

Package unit

10 capsules (10 capsules/PTP×1)