AhnGuk Oseltamivir 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 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). 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

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 75mg capsules twice daily or 30mg and 45mg capsules twice daily instead of the recommended dose of this medicine as a suspension. Body weight ≤ 15 kg: 30 mg per dose twice daily; suspension (6mg/mL) 5.0 mL per dose twice daily Body weight 15 kg<, ≤ 23 kg: 45 mg per dose twice daily; suspension (6mg/mL) 7.5 mL per dose twice daily Body weight 23 kg<, ≤ 40 kg: 60 mg per dose twice daily; suspension (6mg/mL) 10.0 mL per dose twice daily Body weight > 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. Body weight 3 kg: 9 mg per dose twice daily; suspension (6mg/mL) 1.5 mL per dose twice daily Body weight 4 kg: 12 mg per dose twice daily; suspension (6mg/mL) 2.0 mL per dose twice daily Body weight 5 kg: 15 mg per dose twice daily; suspension (6mg/mL) 2.5 mL per dose twice daily Body weight 6 kg: 18 mg per dose twice daily; suspension (6mg/mL) 3.0 mL per dose twice daily Body weight 7 kg: 21 mg per dose twice daily; suspension (6mg/mL) 3.5 mL per dose twice daily Body weight 8 kg: 24 mg per dose twice daily; suspension (6mg/mL) 4.0 mL per dose twice daily Body weight 9 kg: 27 mg per dose twice daily; suspension (6mg/mL) 4.5 mL per dose twice daily Body weight 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. It is recommended that a pharmacist prepare this medicine as a suspension before administration to the patient. 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. Body weight ≤ 15 kg: 30 mg per dose once daily; suspension (6mg/mL) 5.0 mL per dose once daily Body weight 15 kg<, ≤ 23 kg: 45 mg per dose once daily; suspension (6mg/mL) 7.5 mL per dose once daily Body weight 23 kg<, ≤ 40 kg: 60 mg per dose once daily; suspension (6mg/mL) 10.0 mL per dose once daily Body weight > 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 this medicine as a suspension 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 should only be used for treatment and prevention during influenza virus outbreaks. Safety and efficacy have not been established for infections other than influenza A and B. Neuropsychiatric adverse reactions may occur rarely in pediatric and adolescent patients, therefore careful observation for behavioral abnormalities is necessary, especially in children over 10 years old. This medication should not be administered to patients who are hypersensitive to it or its components. Patients with impaired kidney function require dosage adjustment, and it is not recommended for patients with end-stage renal failure. It should be used cautiously in high-risk patients, such as those with asthma, chronic bronchitis, or immunosuppressed states. The most common side effects include nausea, vomiting, headache, etc., and these are mostly temporary and mild. Serious adverse reactions such as shock, anaphylaxis, liver function abnormalities, skin rashes, acute renal failure, and neuropsychiatric symptoms may occur infrequently, so consultation with a healthcare professional should be sought immediately if such symptoms arise. When administered to children, a caregiver should stay with them for at least 2 days after the start of treatment to reduce the risk of abnormal behavior or accidents. Pregnant or breastfeeding women should carefully consider the benefits and risks of treatment as the effects of this medication on the fetus or infant have not been sufficiently studied. Elderly patients require caution due to decreased physical function and various co-morbidities, but dosage adjustment is generally not necessary. This medication has a low potential for drug interactions, however caution is advised when used in combination with certain medications. No serious adverse reactions have been reported for overdose, but if symptoms occur, healthcare professionals should be notified immediately. This medication should be stored out of reach of children, and it is advisable not to transfer it to another container.

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

This medication should be stored in a tightly sealed container to keep out air and moisture. Additionally, it is best to store the medication at a cool temperature below 25 degrees Celsius. This will help maintain the medication's effectiveness for a longer period.

Appearance

Light yellow hard capsule with a light yellow upper part and light gray lower part containing a white or light yellow powder

Package unit

10 capsules (10 capsules/PTP x 1)