Oseltamivir Phosphate Capsule 45 mg

Adult dose

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. 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. No dose adjustment is required for treatment in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9). 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. 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. No dose adjustment is required for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

Age 1 to 12 years, ≤ 15 kg: 30 mg per dose twice daily for 5 days; 5.0 mL of suspension (6mg/mL) per dose twice daily Age 1 to 12 years, 15 kg<, ≤ 23 kg: 45 mg per dose twice daily for 5 days; 7.5 mL of suspension (6mg/mL) per dose twice daily Age 1 to 12 years, 23 kg<, ≤ 40 kg: 60 mg per dose twice daily for 5 days; 10.0 mL of suspension (6mg/mL) per dose twice daily Age 1 to 12 years, > 40 kg: 75 mg per dose twice daily for 5 days; 12.5 mL of suspension (6mg/mL) per dose twice daily. Pediatric patients weighing more than 40 kg who can swallow capsules 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. Age 2 weeks to less than 1 year: 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 A dose of 3mg/kg of this medicine is recommended for children younger than 1 year. Age 1 to 12 years, ≤ 15 kg: 30 mg per dose once daily for 10 days; 5.0 mL of suspension (6mg/mL) per dose once daily Age 1 to 12 years, 15 kg<, ≤ 23 kg: 45 mg per dose once daily for 10 days; 7.5 mL of suspension (6mg/mL) per dose once daily Age 1 to 12 years, 23 kg<, ≤ 40 kg: 60 mg per dose once daily for 10 days; 10.0 mL of suspension (6mg/mL) per dose once daily Age 1 to 12 years, > 40 kg: 75 mg per dose once daily for 10 days; 12.5 mL of suspension (6mg/mL) per dose once daily. Pediatric patients weighing more than 40 kg who can swallow capsules 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. 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 cannot replace influenza vaccination, and the use of this medication and influenza vaccination should be recognized as separate. This medication has been proven effective only against influenza A and B viruses, and its safety and efficacy have not been established for other infections. Neurological and psychiatric adverse reactions have been reported especially in children and adolescents; thus, care providers should monitor for abnormal behavior or seizures and take necessary actions if symptoms arise. Patients with hypersensitivity to this medication should not use it. Dose adjustment may be needed for patients with renal failure or certain high-risk groups, and caution should be exercised. Common side effects during treatment may include nausea, vomiting, and headache, which are mostly temporary and mild. Rarely, serious side effects such as allergic reactions, liver function abnormalities, neurological symptoms, and skin rashes may occur, and healthcare providers should be consulted immediately if symptoms occur. Pregnant or breastfeeding women should carefully consider the benefits and risks of using this medication and it is advisable to seek expert consultation if necessary. For children under 1 year old, safety and effectiveness have not been established, so caution is needed. Older adults generally do not require a dosage adjustment, but they should be monitored carefully due to potential decrements in physical function and underlying diseases. The possibility of drug interactions is low; however, caution may be needed in conjunction with certain medications, so inform your healthcare provider of any other medications being taken. This medication is effective when taken early in the course of influenza symptoms, and if a dose is missed, take it as soon as possible but not too close to the next dose. No effects on driving or machinery operation have been reported; however, influenza itself can affect physical capability, so caution is warranted. This medication should be stored out of reach of children, and it is advisable to avoid transferring it to other containers.

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

This medication should be stored in a sealed container to prevent air and moisture exposure, and it is recommended to keep the temperature below 25 degrees. Storing it this way can help maintain its effectiveness for a longer period.

Appearance

A light gray hard capsule containing a white or light yellow powder.

Package unit

10 capsules (10 capsules/PTP x 1)