Youngjin Oseltamivir Capsule 75 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 administered regardless of food intake, although tolerability may improve in some patients 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 formulation of this medicine. Patients with renal impairment: No dose adjustment is needed 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 periodic hemodialysis should receive a 30mg dose of this medicine after each dialysis session to maintain therapeutic plasma concentrations; 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 on 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 needed for treatment in adult patients 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 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 this medicine is being taken. Patients with renal impairment: No dose adjustment is needed 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 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 the start of dialysis. For peritoneal dialysis, administration of 30mg of this medicine once weekly after dialysis is recommended. The pharmacokinetics of oseltamivir have not been studied in patients with end-stage renal disease who are not on 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 needed for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

Children aged 1 year to 12 years: Pediatric patients weighing more than 40 kg who are able to swallow capsules may take 75mg capsules twice daily or 30mg capsules and 45mg capsules twice daily instead of the recommended dose of this medicine 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 Infants 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 infants 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 Children aged 1 year to 12 years: Pediatric patients weighing more than 40 kg who are able to swallow capsules may take 75mg capsules once daily or 30mg capsules and 45mg capsules once daily for 10 days instead of the recommended dose of this medicine 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 ※ 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 cannot replace influenza vaccinations and should be used in conjunction with vaccinations for effectiveness. This drug is effective only against influenza A and B and its safety and efficacy against other infections have not been confirmed. Rarely, neuropsychiatric adverse reactions may occur in children and adolescents, so careful observation for unusual behavior is necessary in this age group. In particular, it is generally not used in children over 10 years of age due to reports of the risk of accidents stemming from unusual behaviors, except in high-risk patients. There is a risk of unusual behavior occurring while taking this drug, so caregivers should not leave patients alone for at least 2 days. Patients with allergies to this drug or its components should not be administered. Patients with impaired renal function may require dose adjustments and it is not recommended for end-stage renal failure patients. Caution is advised for high-risk groups such as asthma or chronic bronchitis patients, or those in immunocompromised states. Common side effects that may occur include nausea, vomiting, headache, and most are temporary. Rarely, skin rashes, liver function abnormalities, neuropsychiatric symptoms, acute renal failure, etc. can occur, so immediate consultation with a healthcare professional is required if unusual symptoms arise. This drug has a low potential for interactions with other drugs, but caution may be necessary when combined with certain medications. If pregnant or breastfeeding, careful use after consulting with a physician is essential, as safety for the fetus or infant has not been fully established. The efficacy and safety in children under 1 year of age have not been established, so it is better not to use it. Elderly patients do not require dose adjustments but should be observed carefully considering their physical function decline. In case of overdose, there are no specific antidotes, so immediate consultation with a medical institution is needed for appropriate measures. Keep out of reach of children and do not transfer to another container for safety. This drug is used for the treatment and prevention of influenza and is effective when taken early in the onset of symptoms. If a dose is missed, take it as soon as possible but be careful not to take two doses too close together.

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

This medication should be stored in a sealed container to protect it from air and moisture. Furthermore, it is important to store it in a cool place below 25 degrees to maintain its effectiveness.

Appearance

A hard capsule with a light yellow upper part and a light gray lower part filled with a white or light yellow powder.

Package unit

10 capsules (10 capsules/PTPx1)