Oseltamivir Capsule 75 mg (Oseltamivir Phosphate)

Adult dose

Influenza A and influenza B virus infections: Start treatment on the first or second day after the onset of influenza symptoms. This medication may be administered with or without food, and tolerability may improve in some patients when taken with food. Adults and adolescents 13 years of age and older: Administer 75 mg of oseltamivir orally twice daily for 5 days. Adults and adolescents 13 years of age and older who have difficulty swallowing capsules should use the powder for oral suspension of this medication. Patients with renal impairment (treatment): No dose adjustment is required 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 regular hemodialysis should receive a 30mg dose of this medication after each dialysis session to maintain therapeutic plasma concentrations; treatment should not exceed 5 days. If influenza symptoms develop during the 48 hours between dialysis sessions, the dose may be administered before the start of dialysis. For peritoneal dialysis, a single 30mg dose of this medication 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 (treatment): 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 13 years of age 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 epidemic is 75 mg once daily. The safety and efficacy of this medication have been demonstrated for up to 6 weeks. The preventive effect continues while taking this medication. Patients with renal impairment (prevention): No dose adjustment is required 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 every other day is recommended. Patients undergoing regular hemodialysis should receive a 30mg dose of this medication after every 2 dialysis sessions to maintain therapeutic plasma concentrations. The first dose may also be administered before the start of dialysis. For peritoneal dialysis, administration of 30mg of this medication once weekly 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 (prevention): No dose adjustment is required for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

Children 1 to 12 years of age (treatment): Pediatric patients weighing more than 40 kg who are able to swallow capsules may take 75mg capsules twice daily or 30mg and 45mg capsules twice daily instead of the recommended dose of this medication as a suspension. ≤ 15 kg : 30 mg per dose twice daily for 5 days; suspension (6mg/mL) 5.0 mL per dose twice daily 15 kg<, ≤ 23 kg : 45 mg per dose twice daily for 5 days; suspension (6mg/mL) 7.5 mL per dose twice daily 23 kg<, ≤ 40 kg : 60 mg per dose twice daily for 5 days; suspension (6mg/mL) 10.0 mL per dose twice daily > 40 kg : 75 mg per dose twice daily for 5 days; suspension (6mg/mL) 12.5 mL per dose twice daily Children 2 weeks to under 1 year of age: The recommended dose for pediatric patients aged 2 weeks to 12 months is 3mg/kg of this medication orally twice daily for 5 days. This does not apply to children with a post-conceptional age of less than 36 weeks. 3 kg : 9 mg per dose twice daily for 5 days; suspension (6mg/mL) 1.5 mL per dose twice daily 4 kg : 12 mg per dose twice daily for 5 days; suspension (6mg/mL) 2.0 mL per dose twice daily 5 kg : 15 mg per dose twice daily for 5 days; suspension (6mg/mL) 2.5 mL per dose twice daily 6 kg : 18 mg per dose twice daily for 5 days; suspension (6mg/mL) 3.0 mL per dose twice daily 7 kg : 21 mg per dose twice daily for 5 days; suspension (6mg/mL) 3.5 mL per dose twice daily 8 kg : 24 mg per dose twice daily for 5 days; suspension (6mg/mL) 4.0 mL per dose twice daily 9 kg : 27 mg per dose twice daily for 5 days; suspension (6mg/mL) 4.5 mL per dose twice daily 10 kg : 30 mg per dose twice daily for 5 days; 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 medication is recommended for children under 1 year of age. It is recommended that a pharmacist prepare the suspension of this medication before it is administered to the patient. Children 1 to 12 years of age (prevention): Pediatric patients weighing more than 40 kg who are able to 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 medication as a suspension. ≤ 15 kg : 30 mg per dose once daily for 10 days; suspension (6mg/mL) 5.0 mL per dose once daily 15 kg<, ≤ 23 kg : 45 mg per dose once daily for 10 days; suspension (6mg/mL) 7.5 mL per dose once daily 23 kg<, ≤ 40 kg : 60 mg per dose once daily for 10 days; suspension (6mg/mL) 10.0 mL per dose once daily > 40 kg : 75 mg per dose once daily for 10 days; suspension (6mg/mL) 12.5 mL per dose once daily It is recommended that a pharmacist prepare the suspension of this medication before it is administered 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 substitute for influenza vaccination and should only be used during periods of influenza virus outbreaks. This drug is effective only for Influenza A and B, and safety and efficacy for other infections have not been confirmed. Especially reports of neuropsychiatric adverse reactions in children and adolescents indicate that patients in this age group should be closely monitored for unusual behaviors. Patients with hypersensitivity to this medication should not be administered it. Dose adjustment is necessary for patients with renal impairment, 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 immunosuppressive conditions. Nausea, vomiting, headache, and other symptoms may commonly occur during use, but most are temporary. Severe allergic reactions, liver function abnormalities, and major adverse reactions such as skin rashes may occur; therefore, patients should consult healthcare professionals immediately if unusual symptoms occur. Pregnant and nursing women should be administered only if necessary and with caution, as safety for the fetus or infant has not been adequately established. This medication is not recommended for children under 1 year of age; it can be administered to the elderly without dosage adjustment but should be monitored carefully. Drug interactions are relatively minimal, but caution is needed when combined with certain medications. Attention is required when driving or operating machinery due to influenza symptoms during treatment. Keep this medication out of reach of children and adhere to the prescribed dosage and administration.

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

This medication should be kept in a tightly sealed container to prevent air or moisture from entering, and should be stored in a cool place below 25 degrees Celsius. Proper storage can help maintain the drug's effectiveness for a long time.

Appearance

A hard capsule with a yellowish-brown upper part and a gray lower part filled with white or yellowish powder

Package unit

10 capsules/PTP