Samjin Flu Capsule 75mg (Oseltamivir Phosphate)

Adult dose

1. Influenza A and influenza B virus infections: Start treatment on the first or second day of influenza symptoms. This medicine may be administered regardless of food intake; 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 medicine's powder for suspension. Patients with renal impairment: No dose adjustment is necessary 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 therapeutic blood concentrations, and treatment should not exceed 5 days. If influenza symptoms develop during the 48-hour interval between dialysis sessions, the dose may 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 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 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 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 influenza season 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 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 therapeutic blood concentrations. The first dose may also be administered before dialysis begins. For peritoneal dialysis, administration of 30mg of this medicine after once-weekly 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 prevention in adults with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

1. Treatment of influenza A and influenza B virus infections Children aged 1 to 12 years: 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's suspension. ≤ 15 kg: 30 mg per dose twice daily; suspension (6mg/mL) 5.0 mL per dose twice daily 15 kg<, ≤ 23 kg: 45 mg per dose twice daily; suspension (6mg/mL) 7.5 mL per dose twice daily 23 kg<, ≤ 40 kg: 60 mg per dose twice daily; suspension (6mg/mL) 10.0 mL per dose twice daily > 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 per dose 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 per dose twice daily; suspension (6mg/mL) 1.5 mL per dose twice daily 4 kg: 12 mg per dose twice daily; suspension (6mg/mL) 2.0 mL per dose twice daily 5 kg: 15 mg per dose twice daily; suspension (6mg/mL) 2.5 mL per dose twice daily 6 kg: 18 mg per dose twice daily; suspension (6mg/mL) 3.0 mL per dose twice daily 7 kg: 21 mg per dose twice daily; suspension (6mg/mL) 3.5 mL per dose twice daily 8 kg: 24 mg per dose twice daily; suspension (6mg/mL) 4.0 mL per dose twice daily 9 kg: 27 mg per dose twice daily; suspension (6mg/mL) 4.5 mL per dose twice daily 10 kg: 30 mg per dose twice daily; suspension (6mg/mL) 5.0 mL per dose twice daily * This table does not include all possible weights 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's suspension before administration to the patient. 2. Prevention of influenza A and influenza B virus infections Children aged 1 to 12 years: 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's suspension. ≤ 15 kg: 30 mg per dose once daily; suspension (6mg/mL) 5.0 mL per dose once daily 15 kg<, ≤ 23 kg: 45 mg per dose once daily; suspension (6mg/mL) 7.5 mL per dose once daily 23 kg<, ≤ 40 kg: 60 mg per dose once daily; suspension (6mg/mL) 10.0 mL per dose once daily > 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 this medicine's 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 drug cannot replace influenza vaccinations and should be used separately from vaccinations. This drug has only been proven effective against influenza A and B, and its safety and efficacy have not been established for other infections. Particularly in children and adolescents, rare neuropsychiatric reactions have been reported, and if abnormal behavior occurs, it should be closely monitored by guardians. It should not be taken if there is an allergy to this drug or its components. Patients with renal impairment will need dose adjustments, and it is not recommended for patients with end-stage renal failure. Caution should be exercised in high-risk patients such as those with asthma or chronic bronchitis and immunosuppressed individuals. The most common side effects include nausea, vomiting, and headaches, which mostly occur early in treatment and resolve quickly. Rarely, shock, anaphylaxis, abnormal liver function, skin rashes, acute renal failure, and neuropsychiatric symptoms may occur, and if symptoms appear, the medication should be stopped immediately, and a healthcare provider should be consulted. Pregnant or nursing women should consider the benefits and risks of this drug thoroughly as data on its effects on fetuses or infants is limited. Use in children is recommended only for those aged 1 year and older, as safety and efficacy have not been established in children under 1 year. Generally, elderly patients do not require dose adjustments but should be observed for declining bodily functions. Serious side effects from overdose are rare, but patients should inform healthcare providers of any unusual symptoms. This drug has a low potential for interactions with other medications; however, caution is advised when used with certain drugs that affect renal excretion. There have been no reports of effects on driving or machine operation, but caution should be taken regarding the effects caused by influenza itself. This drug should be stored out of reach of children, and it is safe not to transfer it to another container.

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

This drug should be stored in a tightly sealed container to avoid exposure to air or moisture, and it is best kept in a cool place at a temperature below 25 degrees Celsius. Storing it this way will help maintain its effectiveness for a longer period.

Appearance

Hard capsule with a light yellow upper part and a light gray lower part containing a white or light yellow powder

Package unit

10 capsules (10 capsules/PTP*1)