Boryung Tamiflu Capsule 45 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 taken with or without food; in some patients, tolerability may improve when taken with food. 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 the powder for suspension of this medicine. Patients with renal impairment: No dose adjustment is necessary in 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 periodic 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 develop during the 48 hours 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 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 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: For close contacts of an infected person, administer 75 mg of oseltamivir orally once daily for 10 days. Initiate administration within 2 days of contact with the infected person. The recommended dose for prevention during an influenza epidemic 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 necessary in 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 once daily every other day is recommended. Patients receiving periodic hemodialysis should receive a 30mg dose of this medicine after every 2 dialysis sessions to maintain therapeutic plasma concentrations. The initial 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 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 necessary for prevention in adults with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

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

This medication is used to treat and prevent influenza infections. This medication cannot replace the influenza vaccine and must be used alongside vaccination. This medication has been proven effective only against influenza A and B viruses; its safety and efficacy against other infections have not been confirmed. Particularly in children and adolescents, rare abnormal behaviors or neuropsychiatric abnormalities may occur after taking this medication, so caregivers should observe closely during treatment. Patients with reduced kidney function or dialysis patients require dosage adjustments, and it is not recommended for patients with end-stage renal failure. Common side effects include nausea, vomiting, and headache, but most are temporary. Rarely, serious side effects such as allergic reactions, liver dysfunction, skin rashes, neuropsychiatric abnormalities, and hemorrhagic colitis may occur, and if any unusual symptoms arise, immediate consultation with medical personnel is advised. If pregnant or nursing, this medication should only be used when the therapeutic benefits outweigh the risks, and it is recommended for children over 1 year of age. Elderly individuals do not require dose adjustments but should be observed carefully due to decreased body functions. This medication has low potential for drug interactions, but caution may be needed when used in combination with certain drugs. When taking this medication, store it out of reach of children, stick to the prescribed dosing schedule, and if a dose is missed, take it as soon as possible, but skip it if it is within 2 hours of the next scheduled dose. No special effects have been reported when driving or operating machinery, but influenza itself may impair such abilities, so caution is advised.

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

Keep this medication in a tightly sealed container to avoid exposure to air or moisture. It is important to maintain storage temperatures between 1 degree and 30 degrees Celsius. Storing it this way will help maintain the medication's efficacy and safety.

Appearance

Gray hard capsule containing white or light yellow powder

Package unit

10 capsules/PTP