Daewoong Bio Flu Capsule 45mg (Oseltamivir Phosphate)

Adult dose

Influenza A and influenza B virus infections Start treatment on the first or second day after influenza symptoms appear. This medicine may be taken with or without food; 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 as an oral suspension powder. Patients with renal impairment: No dosage adjustment is needed in 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 30mg dose of this medicine after each dialysis session to maintain blood concentrations within the therapeutic range; treatment should not exceed 5 days. If influenza symptoms develop during the 48 hours between dialysis sessions, the dose may also 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 dosage adjustment is needed 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: 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 outbreak 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 this medicine is being taken. Patients with renal impairment: No dosage adjustment is needed in 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 every other day is recommended. Patients receiving regular hemodialysis should receive a 30mg dose of this medicine after every two dialysis sessions to maintain blood concentrations within the therapeutic range. The first dose may also be administered before dialysis begins. For peritoneal dialysis, administration of 30mg 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 less than 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment: No dosage adjustment is needed 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 75mg capsules twice daily or 30mg and 45mg capsules twice daily instead of the recommended dose of this medicine as an oral suspension. Body weight ≤ 15 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily Body weight 15 kg<, ≤ 23 kg: 45 mg twice daily; suspension (6mg/mL) 7.5 mL twice daily Body weight 23 kg<, ≤ 40 kg: 60 mg twice daily; suspension (6mg/mL) 10.0 mL twice daily Body weight > 40 kg: 75 mg twice daily; suspension (6mg/mL) 12.5 mL twice daily Children aged 2 weeks to less than 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 children with a post-conceptional age of less than 36 weeks. Body weight 3 kg: 9 mg twice daily; suspension (6mg/mL) 1.5 mL twice daily Body weight 4 kg: 12 mg twice daily; suspension (6mg/mL) 2.0 mL twice daily Body weight 5 kg: 15 mg twice daily; suspension (6mg/mL) 2.5 mL twice daily Body weight 6 kg: 18 mg twice daily; suspension (6mg/mL) 3.0 mL twice daily Body weight 7 kg: 21 mg twice daily; suspension (6mg/mL) 3.5 mL twice daily Body weight 8 kg: 24 mg twice daily; suspension (6mg/mL) 4.0 mL twice daily Body weight 9 kg: 27 mg twice daily; suspension (6mg/mL) 4.5 mL twice daily Body weight 10 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily * 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 younger than 1 year. 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 as an oral suspension. Body weight ≤ 15 kg: 30 mg once daily; suspension (6mg/mL) 5.0 mL once daily Body weight 15 kg<, ≤ 23 kg: 45 mg once daily; suspension (6mg/mL) 7.5 mL once daily Body weight 23 kg<, ≤ 40 kg: 60 mg once daily; suspension (6mg/mL) 10.0 mL once daily Body weight > 40 kg: 75 mg once daily; suspension (6mg/mL) 12.5 mL once daily ※ The safety and efficacy of preventing influenza A and B virus infections in children younger than 1 year have not been evaluated.

This medication cannot replace influenza vaccination and should only be used for treatment and prevention during influenza outbreaks. Safety and effectiveness have not been established for infections other than influenza A and B. Particularly in children and adolescents, neuropsychiatric adverse reactions have been reported, and caregivers should closely monitor if unusual behaviors occur. Generally, it is not used in pediatric patients aged 10 years or older. Patients with allergies to this medication or its components should not use it. Patients with impaired renal function or those undergoing dialysis may require dosage adjustments, and it is not recommended for patients with end-stage renal failure. Nausea, vomiting, headache, and dizziness may occur after taking this medication, though they are usually temporary. Serious side effects such as allergic reactions, liver dysfunction, skin rashes, neuropsychiatric symptoms, and bleeding colitis may occur rarely, and if any abnormal symptoms occur, immediate consultation with healthcare professionals is required. Pregnant or breastfeeding women should use this medication only if the benefits outweigh the risks and after consulting with a doctor. In children, it is not used for those under 1 year old as safety and effectiveness have not been established. Elderly individuals may experience reduced bodily functions and therefore should be closely observed during treatment. Drug interactions are minimal, but caution may be required when combined with specific medications. This medication is most effective when taken at the onset of influenza symptoms, and if a dose is missed, it should be taken as soon as possible, but if close to the next dose, it should be skipped. There is little impact on driving or operating machinery, but influenza itself may impair abilities, so caution is advised. Severe adverse reactions are rare in cases of overdose, but if abnormal symptoms appear, immediate medical attention should be sought. This medication should be stored out of reach of children, and it should be kept in its original container.

Convulsions, delirium, abnormal behavior, nausea, vomiting, headache, pain, unstable angina, anemia, pseudomembranous colitis, pneumonia, peritonsillar abscess, humeral fracture, hallucinations, convulsions, dermatitis, rash, urticaria, eczema, insomnia, cough, runny nose, nasal congestion, sore throat, abdominal pain, epigastric pain, diarrhea, dyspepsia, back pain, arthralgia, myalgia, menstrual pain, dizziness, fatigue, fever, influenza-like symptoms, limb pain, shock, anaphylactic reaction, hepatitis, abnormal liver function, jaundice, epidermal mucous membrane syndrome, toxic epidermal necrolysis, acute renal failure, leukopenia, thrombocytopenia, neuropsychiatric syndrome (altered consciousness, abnormal behavior, delirium, hallucinations, delusions, convulsions), hemorrhagic colitis, erythema, redness, itching, petechiae, cheilitis, stomatitis, hematochezia, melena, hematemesis, peptic ulcer, abdominal distension, bowel irregularities, oral discomfort, loss of appetite, agitation, tremors, numbness, lethargy, drowsiness, ventricular tachycardia, ventricular ectopic beats, ECG 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 disturbances

This medication may be sensitive to air or moisture; therefore, it should be stored in a tightly closed container. It is advisable to store it in a cool place below 25 degrees Celsius.

Appearance

A hard capsule with light gray upper and lower parts containing a white or pale yellow powder

Package unit

10 capsules (10 capsules/PTP X 1)