Samjin Flu Capsule 30 mg (Oseltamivir Phosphate)

Adult dose

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). 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

Influenza A and influenza B virus infections: Treatment — 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. Weight ≤ 15 kg: 30 mg per dose twice daily for 5 days; suspension (6mg/mL) 5.0 mL per dose twice daily Weight 15 kg<, ≤ 23 kg: 45 mg per dose twice daily for 5 days; suspension (6mg/mL) 7.5 mL per dose twice daily Weight 23 kg<, ≤ 40 kg: 60 mg per dose twice daily for 5 days; suspension (6mg/mL) 10.0 mL per dose twice daily Weight > 40 kg: 75 mg per dose twice daily for 5 days; 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. Weight 3 kg: 9 mg per dose twice daily for 5 days; suspension (6mg/mL) 1.5 mL per dose twice daily Weight 4 kg: 12 mg per dose twice daily for 5 days; suspension (6mg/mL) 2.0 mL per dose twice daily Weight 5 kg: 15 mg per dose twice daily for 5 days; suspension (6mg/mL) 2.5 mL per dose twice daily Weight 6 kg: 18 mg per dose twice daily for 5 days; suspension (6mg/mL) 3.0 mL per dose twice daily Weight 7 kg: 21 mg per dose twice daily for 5 days; suspension (6mg/mL) 3.5 mL per dose twice daily Weight 8 kg: 24 mg per dose twice daily for 5 days; suspension (6mg/mL) 4.0 mL per dose twice daily Weight 9 kg: 27 mg per dose twice daily for 5 days; suspension (6mg/mL) 4.5 mL per dose twice daily Weight 10 kg: 30 mg per dose twice daily for 5 days; 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. 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. Weight ≤ 15 kg: 30 mg per dose once daily for 10 days; suspension (6mg/mL) 5.0 mL per dose once daily Weight 15 kg<, ≤ 23 kg: 45 mg per dose once daily for 10 days; suspension (6mg/mL) 7.5 mL per dose once daily Weight 23 kg<, ≤ 40 kg: 60 mg per dose once daily for 10 days; suspension (6mg/mL) 10.0 mL per dose once daily Weight > 40 kg: 75 mg per dose once daily for 10 days; suspension (6mg/mL) 12.5 mL per dose 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 is used for the treatment and prevention of influenza virus infections. However, it cannot replace influenza vaccinations and should be used separately from them. It has proven effectiveness only against influenza A and B viruses, and safety and efficacy for other infections have not been established. Especially in children and adolescents, there have been reports of seizures and neuropsychiatric abnormalities after taking this medication, so careful observation is required in this age group. Generally, it is not used in children over 10 years of age except in special cases, and caregivers should closely monitor patients during treatment. Patients with allergies to this medication or its components should not use it. Dose adjustment is required for patients with poor kidney function, and it is not recommended for patients with end-stage renal failure. Caution is advised when administering this medication to high-risk patients with asthma, chronic bronchitis, or immunosuppression. Taking this medication may cause symptoms such as nausea, vomiting, headache, pain, and most are temporary and mild. Rarely, serious adverse reactions such as skin rash, liver function abnormalities, acute renal failure, and neuropsychiatric symptoms can occur; therefore, if any unusual symptoms appear, immediate consultation with a physician is necessary. Pregnant or breastfeeding women should carefully consider the therapeutic effects and risks of this medication, and it is important to consult a doctor due to limited clinical data. In children under 1 year of age, safety and efficacy have not been established, so caution is needed for use. Elderly patients may have decreased physical functions and comorbidities, so careful observation is required during administration. This medication has a low potential for drug interactions, but caution may be needed when used in combination with certain medications, so inform your doctor of any medications currently being taken. Store the medication out of reach of children and do not transfer it to another container. When taking, it is best to start as early as possible with the appearance of symptoms; if a dose is missed, take it as soon as possible but skip it if it's too close to the next dose time. No special effects have been reported when driving or operating machinery, but influenza itself can impair abilities, so caution is advised.

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

Store this medication in a tightly sealed container to prevent air or moisture from entering, and it is advisable to keep it at a cool temperature below 25 degrees. Storing it this way helps maintain the effectiveness of the medication for a longer time.

Appearance

Hard capsules with a light yellow shell containing white or pale yellow powder

Package unit

10 capsules (10 capsules/PTP*1)