AhnGuk Oseltamivir Capsule 30 mg (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; in some patients, tolerability may be improved when taken with food. Adults and adolescents aged 13 years and older: Administer 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 as powder for suspension. 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 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 periodic hemodialysis should receive a 30mg dose of this medicine after each dialysis session to maintain therapeutic plasma concentrations, and treatment should not exceed 5 days. If influenza symptoms develop 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 receiving dialysis (e.g., creatinine clearance less than 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 75 mg of oseltamivir 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 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 once daily every other day is recommended. Patients receiving periodic hemodialysis should receive a 30mg dose of this medicine after every 2 dialysis sessions to maintain therapeutic plasma concentrations. The first dose may 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 receiving dialysis (e.g., creatinine clearance less than 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 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 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; 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 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 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 ※ 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 be used as a substitute for the influenza vaccine and should be used separately from the vaccine. Its safety and efficacy have not been confirmed for infections other than Influenza A and B. Particularly, abnormal behaviors, seizures, and delirium have been reported as neuropsychiatric adverse reactions in children and adolescents, so caution is necessary. The guardian should observe the patient closely for 2 days after taking this medication. It should not be administered to patients with hypersensitivity to this medication or its components. Dosage adjustment is necessary for patients with renal failure or those on dialysis, and it is not recommended for patients with end-stage renal failure. Caution should be exercised in high-risk patients with asthma, chronic bronchitis, or immunosuppression. Common adverse reactions include nausea, vomiting, and headache, which are usually temporary and mild. Rarely, symptoms such as shock, anaphylaxis, hepatitis, epidermal necrolysis, acute renal failure, and neuropsychiatric symptoms may occur, so immediate notification to medical personnel is necessary if symptoms appear. Pregnant or breastfeeding women should use this medication only when the therapeutic benefits outweigh the risks due to unclear impacts on fetuses or infants. Use is only recommended in children aged 1 year and older; safety and efficacy have not been established for infants under 1 year. No special dosage adjustments are necessary for the elderly; however, careful monitoring is essential due to potential decline in physical function. In case of overdose, adverse reactions may worsen, and immediate consultation with medical personnel is recommended. The interaction potential with other medications is low; however, caution may be required when combined with specific drugs. Caution should be exercised when driving or operating machinery, noting the potential impairment of ability due to influenza symptoms. This medication should be kept out of reach of children and should not be transferred to other containers.

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

This medication is sensitive to air and moisture, so it should be stored in a tightly closed container. It is also important to keep it at a cool temperature below 25 degrees Celsius to maintain its effectiveness.

Appearance

Soft gelatin capsules with a pale yellow body and cap containing white or light yellow powder

Package unit

10 capsules (10 capsules/PTPx1)