Oseltamivir Capsule 75 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, taking it with food may improve tolerability. 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 necessary in patients with creatinine clearance ≥ 60 mL/min. 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 regular hemodialysis should receive a 30mg dose of this medicine after each dialysis session to maintain plasma concentrations within the therapeutic range; treatment must not exceed 5 days. If influenza symptoms develop during the 48-hour interval between dialysis sessions, the dose may also 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 undergoing 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 necessary 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: Following close contact with 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 this medicine is being taken. Patients with renal impairment: No dose adjustment is necessary in patients with creatinine clearance ≥ 60 mL/min. 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 regular 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 dialysis begins. For peritoneal dialysis, a 30mg dose 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 less than 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment: No dose adjustment is necessary 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 a 75mg capsule twice daily or a 30mg capsule and a 45mg capsule twice daily instead of the recommended dose of this medicine as a suspension. Body weight ≤ 15 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily, for 5 days Body weight 15 kg<, ≤ 23 kg: 45 mg twice daily; suspension (6mg/mL) 7.5 mL twice daily, for 5 days Body weight 23 kg<, ≤ 40 kg: 60 mg twice daily; suspension (6mg/mL) 10.0 mL twice daily, for 5 days Body weight > 40 kg: 75 mg twice daily; suspension (6mg/mL) 12.5 mL twice daily, for 5 days 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 twice daily; suspension (6mg/mL) 1.5 mL twice daily, for 5 days Body weight 4 kg: 12 mg twice daily; suspension (6mg/mL) 2.0 mL twice daily, for 5 days Body weight 5 kg: 15 mg twice daily; suspension (6mg/mL) 2.5 mL twice daily, for 5 days Body weight 6 kg: 18 mg twice daily; suspension (6mg/mL) 3.0 mL twice daily, for 5 days Body weight 7 kg: 21 mg twice daily; suspension (6mg/mL) 3.5 mL twice daily, for 5 days Body weight 8 kg: 24 mg twice daily; suspension (6mg/mL) 4.0 mL twice daily, for 5 days Body weight 9 kg: 27 mg twice daily; suspension (6mg/mL) 4.5 mL twice daily, for 5 days Body weight 10 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily, for 5 days * 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 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. Body weight ≤ 15 kg: 30 mg once daily; suspension (6mg/mL) 5.0 mL once daily, for 10 days Body weight 15 kg<, ≤ 23 kg: 45 mg once daily; suspension (6mg/mL) 7.5 mL once daily, for 10 days Body weight 23 kg<, ≤ 40 kg: 60 mg once daily; suspension (6mg/mL) 10.0 mL once daily, for 10 days Body weight > 40 kg: 75 mg once daily; suspension (6mg/mL) 12.5 mL once daily, for 10 days 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 drug cannot replace influenza vaccination and should be used separately from the vaccination. It is recommended for use only for influenza A and B, and safety and efficacy have not been established for other infections. Particularly, neuropsychiatric adverse reactions have been reported in children and adolescents, where unusual behavior or seizures may occur, so guardians should carefully observe after administration. Patients with a known allergy to this medication or its components should not take it. Patients with impaired kidney function require dosage adjustment and it is not recommended for patients with end-stage renal failure. Caution should be exercised when administering to high-risk patients with asthma, chronic bronchitis, or immunosuppressive conditions. Common side effects during administration include nausea, vomiting, headache, etc., and most are temporary. Rarely, shock, anaphylaxis, liver dysfunction, skin abnormalities, acute renal failure, blood abnormalities, neurological symptoms, etc., may occur, and if such symptoms appear, a doctor should be consulted immediately. Pregnant or breastfeeding women should use this drug only after consulting with a physician and considering the risks and benefits. The safety and efficacy of this drug have not been established in children under 1 year of age. Elderly patients can use it without special dosage adjustments, but careful monitoring is recommended due to decreased physiological function. Serious adverse reactions are rare even in cases of overdose, but if suspected, medical attention should be sought immediately. This drug has a low interaction potential with other medications, although caution may be needed when used with certain drugs. No specific effects have been reported while driving or operating machinery, but influenza symptoms may themselves pose a risk, so caution is advised. This drug should be kept out of the reach of children and should not be transferred to other containers.

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

This drug should be stored in a tightly sealed container to prevent exposure to air and moisture, preferably in a cool place below 25 degrees. Storing it this way can help maintain its effectiveness over a longer period.

Appearance

A hard capsule with a light yellow upper part and a light gray lower part containing white or pale yellow powder.

Package unit

10 capsules (10 capsules/PTPx1)