Boryung Tamiflu Capsule 30mg (Oseltamivir Phosphate)

Adult dose

Influenza A and influenza B virus infections: Initiate treatment on the first or second day after the onset of influenza symptoms. This drug 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 oseltamivir 75 mg orally twice daily for 5 days. Adults and adolescents aged 13 years and older who have difficulty swallowing capsules should use this drug as a powder for suspension. Patients with renal impairment: No dose adjustment is required for patients with a creatinine clearance of 60 mL/min or more. For patients with a creatinine clearance of 30 ~ 60 mL/min, a reduced dose of 30 mg twice daily for 5 days is recommended. For patients with a 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 drug after each dialysis session to maintain plasma concentrations within the therapeutic range; the duration of administration 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 drug 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 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 adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9). Prevention of influenza A and influenza B virus infections Adults and adolescents aged 13 years and older: For those in close contact with an infected person, administer oseltamivir 75 mg 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 drug have been demonstrated for up to 6 weeks. The preventive effect continues while this drug is being taken. Patients with renal impairment: No dose adjustment is required for patients with a creatinine clearance of 60 mL/min or more. For patients with a creatinine clearance of 30 ～ 60 mL/min, a reduced dose of 30 mg once daily is recommended. For patients with a creatinine clearance of 10 ～ 30 mL/min, a reduced dose of 30 mg once daily on alternate days is recommended. Patients receiving regular hemodialysis should receive a 30mg dose of this drug after every 2 dialysis sessions to maintain plasma concentrations within the therapeutic range. The initial dose may be administered before the start of dialysis. For peritoneal dialysis, administration of 30mg of this drug 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 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 adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

Influenza A and influenza B virus infections Children aged 1 to 12 years: 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 drug suspension. ≤ 15 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily 15 kg<, ≤ 23 kg: 45 mg twice daily; suspension (6mg/mL) 7.5 mL twice daily 23 kg<, ≤ 40 kg: 60 mg twice daily; suspension (6mg/mL) 10.0 mL twice daily > 40 kg: 75 mg twice daily; suspension (6mg/mL) 12.5 mL twice daily Children aged 2 weeks to under 1 year: The recommended dose for pediatric patients aged 2 weeks to 12 months is 3mg/kg of this drug, administered orally twice daily for 5 days. This does not apply to children with a postconceptional age of less than 36 weeks. 3 kg: 9 mg twice daily; suspension (6mg/mL) 1.5 mL twice daily 4 kg: 12 mg twice daily; suspension (6mg/mL) 2.0 mL twice daily 5 kg: 15 mg twice daily; suspension (6mg/mL) 2.5 mL twice daily 6 kg: 18 mg twice daily; suspension (6mg/mL) 3.0 mL twice daily 7 kg: 21 mg twice daily; suspension (6mg/mL) 3.5 mL twice daily 8 kg: 24 mg twice daily; suspension (6mg/mL) 4.0 mL twice daily 9 kg: 27 mg twice daily; suspension (6mg/mL) 4.5 mL twice daily 10 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily * This table does not include all possible weights in this patient group. A dose of 3mg/kg of this drug is recommended for children under 1 year of age. It is recommended that a pharmacist prepare this drug suspension before it is administered 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 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 drug suspension. ≤ 15 kg: 30 mg once daily; suspension (6mg/mL) 5.0 mL once daily 15 kg<, ≤ 23 kg: 45 mg once daily; suspension (6mg/mL) 7.5 mL once daily 23 kg<, ≤ 40 kg: 60 mg once daily; suspension (6mg/mL) 10.0 mL once daily > 40 kg: 75 mg once daily; suspension (6mg/mL) 12.5 mL once daily It is recommended that a pharmacist prepare this drug suspension before it is administered to the patient. ※ The safety and efficacy of preventing influenza A and B virus infections in children under 1 year of age have not been evaluated.

This drug is used for the treatment and prevention of influenza virus infections. This drug cannot replace the influenza vaccination and should be used separately from it. It has been proven effective only against Influenza A and B viruses; its safety and efficacy against other infections are not established. Particularly in children and adolescents, there are reports of neuropsychiatric adverse reactions such as abnormal behavior, seizures, and delirium, so caution is needed. During the administration of this drug, caregivers should carefully observe the patient, and if abnormal behavior occurs, they should consult medical personnel immediately. It should not be administered to patients with a hypersensitivity to this drug or its components. Patients with impaired kidney function or those undergoing dialysis require dose adjustments, and it is not recommended for patients with end-stage renal failure. Caution is necessary when administering this drug to at-risk patients with asthma, chronic bronchitis, or immune suppression. The most common side effects during administration are nausea, vomiting, and headache, which are usually temporary. Rarely, symptoms such as shock, hepatitis, skin hypersensitivity reactions, acute renal failure, and neuropsychiatric symptoms may occur; if these symptoms appear, administration should be stopped immediately, and medical personnel should be informed. Women who are pregnant or breastfeeding should use this drug only after carefully weighing the risks and benefits. Caution is needed for children, especially for those under 1 year old, as safety and efficacy have not been adequately established for this group. Elderly individuals require careful observation during administration due to potential decline in physical functions and multiple existing diseases. This drug has low potential for interactions with other medications; however, caution is required when used in combination with certain drugs. During administration, careful monitoring for abnormal behavior or neuropsychiatric symptoms, allergic reactions, and liver and kidney abnormalities should be observed. This drug should be stored out of the reach of children and should not be kept in a different container.

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

This drug is sensitive to air and moisture; therefore, it must be stored in a tightly sealed container. Additionally, avoid storing in extremely hot or cold locations and preferably keep at room temperature between 1°C to 30°C.

Appearance

A yellow hard capsule containing a white or light yellow powder

Package unit

10 capsules/PTP