Fluviem Capsule 75 mg (Oseltamivir Phosphate)

Adult dose

Influenza A and influenza B virus infections: Start treatment on the first or second day after the onset of influenza symptoms. This drug may be administered with or without food; tolerability may improve in some patients when taken with food. Adults and adolescents aged 13 years and older: Administer 75 mg of oseltamivir orally 2 times daily for 5 days. Adults and adolescents aged 13 years and older who have difficulty swallowing capsules should use the powder for suspension of this drug. Patients with renal impairment: No dose adjustment is required in patients with a creatinine clearance of 60 mL/min or more. For patients with a creatinine clearance of 30 ~ 60 mL/min, a reduced dose of 30 mg 2 times daily for 5 days is recommended. For patients with a 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 drug after each dialysis session to maintain blood concentrations within the therapeutic range; the treatment period should not exceed 5 days. If influenza symptoms occur 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 drug 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 required 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 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 drug have been demonstrated for up to 6 weeks. The preventive effect continues while taking this drug. Patients with renal impairment: No dose adjustment is required in patients with a creatinine clearance of 60 mL/min or more. For patients with a creatinine clearance of 30 ～ 60 mL/min, a reduced dose of 30 mg once daily is recommended. For patients with a 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 30mg dose of this drug after every 2 dialysis sessions to maintain blood concentrations within the therapeutic range. The initial dose may be administered before the start of dialysis. For peritoneal dialysis, administration of 30mg of this drug 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 less than 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment: No dose adjustment is required for prevention in adults with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

Treatment — Children 1 year to 12 years of age, body weight ≤ 15 kg: 30 mg per dose 2 times daily for 5 days; suspension (6mg/mL) 5.0 mL per dose 2 times daily Treatment — Children 1 year to 12 years of age, body weight 15 kg<, ≤ 23 kg: 45 mg per dose 2 times daily for 5 days; suspension (6mg/mL) 7.5 mL per dose 2 times daily Treatment — Children 1 year to 12 years of age, body weight 23 kg<, ≤ 40 kg: 60 mg per dose 2 times daily for 5 days; suspension (6mg/mL) 10.0 mL per dose 2 times daily Treatment — Children 1 year to 12 years of age, body weight > 40 kg: 75 mg per dose 2 times daily for 5 days; suspension (6mg/mL) 12.5 mL per dose 2 times daily Treatment — Children 2 weeks to less than 1 year of age: Administer 3mg/kg orally 2 times daily for 5 days Treatment — Children 2 weeks to 12 months of age, body weight 3 kg: 9 mg per dose 2 times daily; suspension (6mg/mL) 1.5 mL per dose 2 times daily Treatment — Children 2 weeks to 12 months of age, body weight 4 kg: 12 mg per dose 2 times daily; suspension (6mg/mL) 2.0 mL per dose 2 times daily Treatment — Children 2 weeks to 12 months of age, body weight 5 kg: 15 mg per dose 2 times daily; suspension (6mg/mL) 2.5 mL per dose 2 times daily Treatment — Children 2 weeks to 12 months of age, body weight 6 kg: 18 mg per dose 2 times daily; suspension (6mg/mL) 3.0 mL per dose 2 times daily Treatment — Children 2 weeks to 12 months of age, body weight 7 kg: 21 mg per dose 2 times daily; suspension (6mg/mL) 3.5 mL per dose 2 times daily Treatment — Children 2 weeks to 12 months of age, body weight 8 kg: 24 mg per dose 2 times daily; suspension (6mg/mL) 4.0 mL per dose 2 times daily Treatment — Children 2 weeks to 12 months of age, body weight 9 kg: 27 mg per dose 2 times daily; suspension (6mg/mL) 4.5 mL per dose 2 times daily Treatment — Children 2 weeks to 12 months of age, body weight 10 kg: 30 mg per dose 2 times daily; suspension (6mg/mL) 5.0 mL per dose 2 times daily Prevention — Children 1 year to 12 years of age, body weight ≤ 15 kg: 30 mg per dose once daily for 10 days; suspension (6mg/mL) 5.0 mL per dose once daily Prevention — Children 1 year to 12 years of age, body weight 15 kg<, ≤ 23 kg: 45 mg per dose once daily for 10 days; suspension (6mg/mL) 7.5 mL per dose once daily Prevention — Children 1 year to 12 years of age, body weight 23 kg<, ≤ 40 kg: 60 mg per dose once daily for 10 days; suspension (6mg/mL) 10.0 mL per dose once daily Prevention — Children 1 year to 12 years of age, body weight > 40 kg: 75 mg per dose once daily for 10 days; suspension (6mg/mL) 12.5 mL per dose once daily

This medication is used to treat or prevent influenza viruses; however, it cannot replace influenza vaccination. This medication is effective only against influenza A and B viruses, and its safety and efficacy have not been confirmed for other infections. Particularly in children and adolescents, abnormal behavior or neuropsychiatric side effects may occur after taking this medication, so it is important for guardians to carefully observe and not leave them alone. This medication should not be used by individuals who are allergic to it or its components. Patients with reduced kidney function require dosage adjustments, and it is not recommended for patients with end-stage renal failure. It should be administered cautiously to high-risk patients with asthma, chronic bronchitis, or immunosuppressive conditions. The most common side effects during use include nausea, vomiting, headache, all of which are usually temporary and mild. Rarely, anaphylaxis, hepatic dysfunction, skin rash, neuropsychiatric abnormalities, and acute renal failure may occur; therefore, if any abnormal symptoms appear, medical consultation should be sought immediately. This medication can be used cautiously in pregnant or breastfeeding women under medical judgement, but the safety for fetuses or infants has not been sufficiently established. For children, especially those under 1 year of age, its safety and efficacy have not been established, so use is not recommended. Older patients generally do not require dosage adjustments, but caution is necessary if physical function is impaired. When taking this medication, follow the prescribed usage and dosage; if a dose is missed, take it as soon as possible, but if it's close to the next scheduled dose, skip the missed dose. This medication has a low potential for interactions with other drugs; however, caution may be needed when combined with certain medications, so patients should inform healthcare providers about any other medications they are taking. There are no reported effects on driving or machine operation; however, influenza itself can cause decreased concentration, so caution should be exercised. This medication should be kept out of reach of children and should not be transferred to other containers.

Convulsions, delirium, abnormal behavior, nausea, vomiting, headache, pain, unstable angina, anemia, pseudomembranous colitis, pneumonia, peritonsillar abscess, humeral fracture, hallucination, convulsions, dermatitis, rash, urticaria, eczema, insomnia, dizziness, fatigue, fever, influenza-like symptoms, limb pain, back pain, arthralgia, myalgia, dysmenorrhea, cough, runny nose, congestion, sore throat, abdominal pain, upper abdominal pain, diarrhea, dyspepsia, hemorrhagic colitis, shock, anaphylactic reaction, hepatitis, liver function abnormalities, jaundice, skin and mucous membrane syndrome, toxic epidermal necrolysis, acute renal failure, leukopenia, thrombocytopenia, neuropsychiatric symptoms (altered consciousness, abnormal behavior, delirium, hallucination, delusions, convulsions), erythema, flushing, itching, petechiae, cheilitis, stomatitis, melena, black stool, hematemesis, peptic ulcer, abdominal distension, abnormal stool, oral discomfort, loss of appetite, agitation, tremor, paresthesia, lethargy, drowsiness, ventricular tachycardia, ventricular extrasystole, electrocardiogram abnormalities, palpitations, increased AST, increased ALT, increased γ-GTP, increased ALP, hematuria, positive proteinuria, eosinophilia, visual disturbances, fever, hypothermia, edema, increased blood sugar, abdominal pain, chest pain, pneumonia, sinusitis, bronchitis, otitis media, asthma, epistaxis, conjunctivitis, ear pain, dermatitis, sleep disorders, arrhythmia, seizures, confusion, gastrointestinal bleeding, worsening diabetes, eosinophilia, leukopenia, pancreatitis, angioedema, laryngeal edema, tongue edema, bronchospasm, facial edema, hematuria, nightmares, dizziness, dermatitis

This medication is sensitive to air and humidity, so it must be stored in a tightly sealed container. It is best to keep it at room temperature between 1 and 30 degrees Celsius. Doing so will help maintain the medication's effectiveness for a longer period.

Appearance

Hard capsules with a grey lower part and a light yellow upper part filled with white or light yellow powder

Package unit

10 capsules/PTP