Samjin Flu Capsule 45 mg (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

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. Treatment, weight ≤ 15 kg: 30 mg per dose twice daily; suspension (6mg/mL) 5.0 mL per dose twice daily. Treatment, weight 15 kg<, ≤ 23 kg: 45 mg per dose twice daily; suspension (6mg/mL) 7.5 mL per dose twice daily. Treatment, weight 23 kg<, ≤ 40 kg: 60 mg per dose twice daily; suspension (6mg/mL) 10.0 mL per dose twice daily. 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 per dose orally twice daily for 5 days. This does not apply to children with a postconceptional age of less than 36 weeks. Treatment, weight 3 kg: 9 mg per dose twice daily; suspension (6mg/mL) 1.5 mL per dose twice daily. Treatment, weight 4 kg: 12 mg per dose twice daily; suspension (6mg/mL) 2.0 mL per dose twice daily. Treatment, weight 5 kg: 15 mg per dose twice daily; suspension (6mg/mL) 2.5 mL per dose twice daily. Treatment, weight 6 kg: 18 mg per dose twice daily; suspension (6mg/mL) 3.0 mL per dose twice daily. Treatment, weight 7 kg: 21 mg per dose twice daily; suspension (6mg/mL) 3.5 mL per dose twice daily. Treatment, weight 8 kg: 24 mg per dose twice daily; suspension (6mg/mL) 4.0 mL per dose twice daily. Treatment, weight 9 kg: 27 mg per dose twice daily; suspension (6mg/mL) 4.5 mL per dose twice daily. Treatment, weight 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. Prevention, 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. Prevention, weight ≤ 15 kg: 30 mg per dose once daily; suspension (6mg/mL) 5.0 mL per dose once daily. Prevention, weight 15 kg<, ≤ 23 kg: 45 mg per dose once daily; suspension (6mg/mL) 7.5 mL per dose once daily. Prevention, weight 23 kg<, ≤ 40 kg: 60 mg per dose once daily; suspension (6mg/mL) 10.0 mL per dose once daily. 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 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 medication cannot replace influenza vaccinations and is used only for treatment and prevention during the season when the flu virus is prevalent. This medicine is effective only against influenza A and B viruses, and its safety and efficacy against other infections have not been confirmed. Caution is needed as neuropsychiatric side effects may occur in children and adolescents, such as seizures or delirium. It is recommended that pediatric patients aged over 10 years do not use this medication except in special cases due to the risk of abnormal behavior and thoughts. Since there is a risk of abnormal behavior while using this medication, caregivers should not leave children and adolescents alone for at least 2 days. Patients allergic to this medication or its components should not take it. Patients with reduced kidney function need dosage adjustment, and it is not recommended for patients with severe renal failure. Care should be taken when administering this to patients with asthma, chronic bronchitis, or weakened immune systems. Nausea, vomiting, headache, and other side effects may commonly occur during treatment, most of which are temporary. Rarely, symptoms such as shock, anaphylaxis, liver function abnormalities, skin rash, acute renal failure, and neuropsychiatric symptoms may occur, and medical advice should be sought immediately if abnormal symptoms appear. If pregnant or breastfeeding, the use of this medication should only be considered when the benefits outweigh the risks, as limited data is available on its effects on the fetus or infant. The safety and efficacy of this medication for treating and preventing influenza in children under 1 year of age has not been established. Elderly patients may have decreased physical function and comorbidities, so close monitoring is required during administration, although dosage adjustment is generally not needed. Drug interactions are relatively minimal, but caution may be needed when using certain medications, so it is important to inform your healthcare provider of any other medications being taken. This medication does not replace the influenza vaccine and can be used alongside vaccination, but a certain interval must be maintained with live vaccines. If abnormal behavior or neuropsychiatric symptoms occur during usage, medication should be discontinued immediately, and healthcare professionals should be consulted. Keep out of reach of children and do not transfer to another container for safety.

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

This medication should be stored in a tightly closed container to protect it from air and moisture. Additionally, it is important to store the medication at a cool temperature below 25 degrees Celsius to maintain its effectiveness.

Appearance

Hard capsule with a light gray body and cap filled with white or pale yellow powder.

Package unit

10 capsules (10 capsules/PTP*1)