Aflusan 75 mg (Oseltamivir Phosphate)

Adult dose

Influenza A and influenza B virus infections: Begin treatment on the first or second day after the onset of influenza symptoms. This medicine may be administered regardless of food intake, although taking it with food may improve tolerability in some patients. 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 this medicine for dosing. Patients with renal impairment (treatment): No dosage adjustment is necessary for patients with creatinine clearance ≥ 60 mL/min. 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 30 mg dose of this medicine after each dialysis session to maintain therapeutic plasma concentrations, and treatment should not exceed 5 days. If influenza symptoms develop during the 48 hours between dialysis sessions, the dose may be administered before dialysis begins. For peritoneal dialysis, a single 30 mg 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 < 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment (treatment): No dosage adjustment is necessary for treatment in adult patients 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: If in close contact with an infected person, administer 75 mg of oseltamivir orally once daily for 10 days. Start 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 (prevention): No dosage adjustment is necessary for patients with creatinine clearance ≥ 60 mL/min. 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 regular hemodialysis should receive a 30 mg dose of this medicine after every 2 dialysis sessions to maintain therapeutic plasma concentrations. The first dose may also be administered before dialysis begins. For peritoneal dialysis, administration of 30 mg 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 10mL/min or less); therefore, no recommended dose is available for these patients. Patients with hepatic impairment (prevention): No dosage adjustment is necessary for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

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 a 75mg capsule twice daily or a 30mg capsule and a 45mg capsule twice daily instead of the recommended dose of this medicine. ≤ 15 kg: 30 mg (sachet) twice daily for 5 days 15 kg<, ≤ 23 kg: 45 mg (sachet) twice daily for 5 days 23 kg<, ≤ 40 kg: 60 mg (two 30mg sachets) twice daily for 5 days > 40 kg: 75 mg (sachet) twice daily for 5 days 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. Pediatric patients who have difficulty taking the powder form of this medicine should use the suspension. 3 kg: 9 mg twice daily, suspension (6mg/mL) 1.5mL twice daily, for 5 days 4 kg: 12 mg twice daily, suspension (6mg/mL) 2.0mL twice daily, for 5 days 5 kg: 15 mg twice daily, suspension (6mg/mL) 2.5mL twice daily, for 5 days 6 kg: 18 mg twice daily, suspension (6mg/mL) 3.0mL twice daily, for 5 days 7 kg: 21 mg twice daily, suspension (6mg/mL) 3.5mL twice daily, for 5 days 8 kg: 24 mg twice daily, suspension (6mg/mL) 4.0mL twice daily, for 5 days 9 kg: 27 mg twice daily, suspension (6mg/mL) 4.5mL twice daily, for 5 days 10 kg: 30 mg twice daily, suspension (6mg/mL) 5.0mL twice daily, for 5 days * This table does not include all possible body 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 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. ≤ 15 kg: 30 mg (sachet) once daily for 10 days 15 kg<, ≤ 23 kg: 45 mg (sachet) once daily for 10 days 23 kg<, ≤ 40 kg: 60 mg (two 30mg sachets) once daily for 10 days > 40 kg: 75 mg (sachet) once daily for 10 days ※ 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 vaccination and should be used separately from vaccination. It is only to be used for influenza treatment and prevention where influenza virus is currently circulating. Safety and efficacy have not been established for infections other than influenza A and B. Neuropsychiatric adverse reactions, especially symptoms such as seizures and delirium, have been rarely reported in children and adolescents, requiring caution. Particularly, it is not recommended for children over the age of 10 who are not at high risk due to the risk of abnormal behavior and thought. Guardians should ensure that children or adolescents are not left alone for at least 2 days after treatment begins. Patients with allergies to this medication or its components should not be administered this drug. Patients with impaired renal function or those on dialysis require dosage adjustment, and it is not recommended for patients with end-stage renal failure. It should be used cautiously in high-risk patients with asthma, chronic bronchitis, or immunosuppressed conditions. The most common side effects include nausea, vomiting, headache, and pain, and most are temporary. Serious allergic reactions, liver function abnormalities, skin abnormalities, acute renal failure, blood abnormalities, and neuropsychiatric symptoms may occur rarely, so any unusual symptoms should be reported to healthcare professionals immediately. This medication contains sorbitol, making it unsuitable for patients with fructose intolerance. Drug interactions are limited, but caution is required when combined with certain medications that affect renal excretion. Pregnant or breastfeeding women should only use this medication when the therapeutic benefits outweigh the risks, as safety for the fetus or neonate has not been adequately established. Efficacy for children under 1 year of age has not been established, and safety and efficacy have not been studied in neonates under 2 weeks old. Elderly patients do not require dosage adjustment but should be observed closely considering physical function decline and pre-existing medical conditions. In the case of overdose, since there is no specific antidote, immediate medical attention should be sought for appropriate treatment. Store out of reach of children, and it is safer not to transfer to another container.

Convulsions, delirium, abnormal behavior, nausea, vomiting, headache, pain, unstable angina, anemia, pseudomembranous colitis, pneumonia, peritonsillar abscess, humeral fracture, hallucinations, dermatitis, rash, urticaria, eczema, shock, anaphylaxis, hepatitis, abnormal liver function, jaundice, mucocutaneous syndrome, toxic epidermal necrolysis, acute renal failure, leukopenia, thrombocytopenia, neuropsychiatric syndrome (altered consciousness, abnormal behavior, delirium, hallucinations, delusions, convulsions), hemorrhagic colitis, erythema, flush, itching, purpura, cheilitis, stomatitis, hematochezia, melena, hematemesis, peptic ulcer, abdominal distension, abnormal stools, oral discomfort, loss of appetite, excitement, tremors, paresthesia, lethargy, drowsiness, ventricular tachycardia, premature ventricular contractions, electrocardiogram abnormalities, palpitations, increased AST, increased ALT, increased γ-GTP, increased ALP, hematuria, positive proteinuria, eosinophilia, visual disturbances, fever, hypothermia, edema, hyperglycemia, abdominal pain, chest pain, sleep disturbances

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. It is recommended to keep the storage temperature between 1 and 30 degrees Celsius. This will safely maintain the effectiveness of the medication.

Appearance

White or pale yellow powder

Package unit

10 sachets/box