Oseltamivir Capsule 45 mg (Oseltamivir Phosphate)

Adult dose

1. Influenza A and influenza B virus infections: Begin treatment on the first or second day after the onset of influenza symptoms. This medicine may be taken with or without food; in some patients, tolerability may improve 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 this medicine as powder for oral suspension. Patients with renal impairment: No dose adjustment is required in patients with creatinine clearance of 60 mL/min or greater. 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 therapeutic plasma concentrations; treatment should not exceed 5 days. If influenza symptoms occur 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: No dose adjustment is required 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 13 years of age and older: For close contacts of an infected person, administer 75 mg of oseltamivir orally once daily for 10 days. Begin 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 in patients with creatinine clearance of 60 mL/min or greater. 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 therapeutic plasma concentrations. The initial dose may be administered before the start of dialysis. 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 receiving dialysis (e.g., creatinine clearance below 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment: No dose adjustment is required for prevention in adults with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

1. Influenza A and influenza B virus infections Children 1 to 12 years of age: 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 an oral suspension. Body weight ≤ 15 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily Body weight 15 kg<, ≤ 23 kg: 45 mg twice daily; suspension (6mg/mL) 7.5 mL twice daily Body weight 23 kg<, ≤ 40 kg: 60 mg twice daily; suspension (6mg/mL) 10.0 mL twice daily Body weight > 40 kg: 75 mg twice daily; suspension (6mg/mL) 12.5 mL twice daily Children 2 weeks to less than 1 year of age: 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. Not applicable 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 Body weight 4 kg: 12 mg twice daily; suspension (6mg/mL) 2.0 mL twice daily Body weight 5 kg: 15 mg twice daily; suspension (6mg/mL) 2.5 mL twice daily Body weight 6 kg: 18 mg twice daily; suspension (6mg/mL) 3.0 mL twice daily Body weight 7 kg: 21 mg twice daily; suspension (6mg/mL) 3.5 mL twice daily Body weight 8 kg: 24 mg twice daily; suspension (6mg/mL) 4.0 mL twice daily Body weight 9 kg: 27 mg twice daily; suspension (6mg/mL) 4.5 mL twice daily Body weight 10 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily * This table does not include every possible body weight 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 an oral suspension before administration to the patient. 2. Prevention of influenza A and influenza B virus infections Children 1 to 12 years of age: 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 an oral suspension. Body weight ≤ 15 kg: 30 mg once daily; suspension (6mg/mL) 5.0 mL once daily Body weight 15 kg<, ≤ 23 kg: 45 mg once daily; suspension (6mg/mL) 7.5 mL once daily Body weight 23 kg<, ≤ 40 kg: 60 mg once daily; suspension (6mg/mL) 10.0 mL once daily Body weight > 40 kg: 75 mg once daily; suspension (6mg/mL) 12.5 mL once daily It is recommended that a pharmacist prepare this medicine as an oral 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 should not be used as a substitute for influenza vaccination, and vaccination and the use of this medication should be understood as separate actions. The efficacy of this medication has only been established against influenza A and B viruses, and its safety and efficacy have not been proven for other infections. In children and adolescents aged 10 years and older, reports of unusual behavior and thoughts have been noted, so it should be avoided in patients who are not at high risk, and a guardian should remain with them for at least 2 days after taking. This medication should not be used by individuals allergic to the drug or its components. Patients with impaired kidney function require dosage adjustments and it is not recommended for patients with end-stage renal failure. Caution is advised for patients with asthma or chronic bronchitis and those in an immunosuppressive state. Common side effects include nausea, vomiting, and headache, and most are temporary and mild symptoms. Rarely, symptoms like shock, anaphylaxis, liver function abnormalities, skin rashes, acute renal failure, blood abnormalities, and neurological symptoms can occur, so immediate consultation with a physician is necessary if any abnormal symptoms appear. In children, vomiting is the most common side effect, and safety has not been established for children under 1 year old. Women who are pregnant or nursing should only use this medication when the benefits of treatment outweigh the risks, as the effects on the fetus or infant are not well-defined; avoidance of use while breastfeeding is recommended. Elderly patients may have decreased physical function and various comorbidities, requiring careful observation during administration. Serious side effects from overdose are rare, but if any abnormal symptoms appear, medical personnel should be informed immediately. This medication should be stored out of the reach of children and should not be transferred to other containers. The potential for drug interactions is low with this medication, however, caution is needed when used with certain drugs excreted through the kidneys. The effects on the ability to drive or operate machinery are not known, but the possibility of impaired function due to influenza itself should be considered. This medication may lead to the development of resistance to the influenza virus, so it is essential to follow the prescribed dosage and administration guidelines from the physician.

• Nausea
• vomiting
• headache
• pain
• unstable angina
• anemia
• pseudomembranous colitis
• pneumonia
• peritonsillar abscess
• humeral fracture

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture and should ideally be kept at a cool temperature below 25 degrees Celsius.

Appearance

Gray hard capsule containing white or pale yellow powder

Package unit

10 capsules/PTP - 10 capsules/PTP