Oseltamivir Phosphate Capsule 75 mg

Adult dose

Influenza A and influenza B virus infections: Start treatment on the first or second day after the onset of influenza symptoms. This medicine may be administered with or without food; taking it with food may improve tolerability in some patients. 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 this medicine as an oral suspension prepared from the powder. Patients with renal impairment (treatment): 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 regular hemodialysis should receive a 30mg dose of this medicine after each dialysis session to maintain plasma concentrations within the therapeutic range, and the treatment duration 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 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 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 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 (prevention): 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 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 initial 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 receiving 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

Treatment, children 1 to 12 years of age: Pediatric patients weighing more than 40 kg may take a 75mg capsule twice daily or one 30mg capsule and one 45mg capsule twice daily instead of the recommended dose of this medicine oral suspension. ≤ 15 kg: 30 mg per dose twice daily for 5 days; 5.0 mL of suspension (6mg/mL) per dose twice daily 15 kg<, ≤ 23 kg: 45 mg per dose twice daily for 5 days; 7.5 mL of suspension (6mg/mL) per dose twice daily 23 kg<, ≤ 40 kg: 60 mg per dose twice daily for 5 days; 10.0 mL of suspension (6mg/mL) per dose twice daily > 40 kg: 75 mg per dose twice daily for 5 days; 12.5 mL of suspension (6mg/mL) per dose twice daily Treatment, infants younger than 1 year and at least 2 weeks old: The recommended dose for pediatric patients 2 weeks to 12 months of age 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 for 5 days; 1.5 mL of suspension (6mg/mL) per dose twice daily 4 kg: 12 mg per dose twice daily for 5 days; 2.0 mL of suspension (6mg/mL) per dose twice daily 5 kg: 15 mg per dose twice daily for 5 days; 2.5 mL of suspension (6mg/mL) per dose twice daily 6 kg: 18 mg per dose twice daily for 5 days; 3.0 mL of suspension (6mg/mL) per dose twice daily 7 kg: 21 mg per dose twice daily for 5 days; 3.5 mL of suspension (6mg/mL) per dose twice daily 8 kg: 24 mg per dose twice daily for 5 days; 4.0 mL of suspension (6mg/mL) per dose twice daily 9 kg: 27 mg per dose twice daily for 5 days; 4.5 mL of suspension (6mg/mL) per dose twice daily 10 kg: 30 mg per dose twice daily for 5 days; 5.0 mL of suspension (6mg/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 younger than 1 year. It is recommended that a pharmacist prepare the suspension of this medicine before it is administered to the patient. Prevention, children 1 to 12 years of age: Pediatric patients weighing more than 40 kg may take a 75mg capsule once daily or one 30mg capsule and one 45mg capsule once daily for 10 days instead of the recommended dose of this medicine oral suspension. ≤ 15 kg: 30 mg per dose once daily for 10 days; 5.0 mL of suspension (6mg/mL) per dose once daily 15 kg<, ≤ 23 kg: 45 mg per dose once daily for 10 days; 7.5 mL of suspension (6mg/mL) per dose once daily 23 kg<, ≤ 40 kg: 60 mg per dose once daily for 10 days; 10.0 mL of suspension (6mg/mL) per dose once daily > 40 kg: 75 mg per dose once daily for 10 days; 12.5 mL of suspension (6mg/mL) per dose once daily It is recommended that a pharmacist prepare the suspension of this medicine before it is administered to the patient. ※ The safety and efficacy of prevention of influenza A and B virus infections in children younger than 1 year have not been evaluated.

This medication is used for the treatment and prevention of influenza virus infections. However, it cannot replace influenza vaccination and is most effective when used in conjunction with the influenza vaccine. It is effective only against influenza A and B viruses, and safety and efficacy have not been confirmed for other infections. Particularly, unusual behavior or neuropsychiatric adverse reactions have been reported after medication in children and adolescents, so caregivers should carefully observe patients in this age group. Patients with allergies to this medication or its components should not take it. Dose adjustment is necessary for patients with diminished renal function, and it is not recommended for patients with end-stage renal disease. Caution is required for high-risk patients with asthma, chronic bronchitis, or immunosuppressive conditions. Common side effects may include nausea, vomiting, headache, and pain, but most are temporary. Rarely, anaphylaxis, liver function abnormalities, skin rashes, acute renal failure, and neuropsychiatric adverse reactions may occur, and if any abnormal symptoms occur, consultation with a physician should be sought immediately. Pregnant or breastfeeding women should consider the therapeutic benefits and risks before consulting with a physician regarding administration. The safety and efficacy of this medication in children under 1 year of age have not been established, so caution is needed for use. For elderly patients, dose adjustment is not required, but careful observation is advised considering potential decline in physical function. If any abnormal behavior or neurological symptoms occur during administration, treatment should be immediately discontinued and medical personnel notified. Drug interactions are minimal, but caution is needed when combined with certain medications, and consultation with medical personnel is advised during administration due to potential interference with vaccination. During administration, keep out of the reach of children and do not transfer into other containers.

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

This medication should be stored in a tightly closed container to prevent air and moisture from entering, and it is recommended to store it at a cool temperature below 25 degrees Celsius. This helps maintain the effectiveness of the medication for a longer period.

Appearance

Capsule with white or light yellow powder in a soft yellow upper part and light gray lower part.

Package unit

10 capsules (10 capsules/PTPx1)