Tamiflu Powder 75 mg (Oseltamivir Phosphate)

Adult dosage

1. 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. 1) Adults and adolescents 13 years of age and older: Administer 75 mg of oseltamivir orally twice daily for 5 days. Adults and adolescents 13 years of age and older who have difficulty swallowing capsules should use this medicine for dosing. 4) Patients with renal impairment No dosage adjustment is required for patients with a creatinine clearance of 60 mL/min or greater. For patients with a creatinine clearance of 30 ~ 60 mL/min, a reduced dose of 30 mg twice 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 intermittent hemodialysis should receive a 30mg dose of this medicine after each dialysis session to maintain blood concentrations within the therapeutic range, and treatment should not exceed 5 days. If influenza symptoms develop during the 48 hours between dialysis sessions, the dose may be given 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. 5) Patients with hepatic impairment No dosage adjustment is required for treatment of adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9). 2. Prevention of influenza A and influenza B virus infections 1) Adults and adolescents 13 years of age 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 the medicine is being taken. 3) Patients with renal impairment No dosage adjustment is required for patients with a creatinine clearance of 60 mL/min or greater. 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 intermittent hemodialysis should receive a 30mg dose of this medicine after every 2 dialysis sessions to maintain blood concentrations within the therapeutic range. The first dose may also be given 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. 4) Patients with hepatic impairment No dosage adjustment is required for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Children's dosage

1. Influenza A and influenza B virus infections 2) Children 1 to 12 years of age: 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 (packet) twice daily 15 kg<, ≤ 23 kg — 45 mg (packet) twice daily 23 kg<, ≤ 40 kg — 60 mg (two 30mg packets) twice daily > 40 kg — 75 mg (packet) twice daily 3) Infants 2 weeks to less than 1 year of age: The recommended dose for pediatric patients 2 weeks to 12 months of age 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. 3 kg — 9 mg twice daily; suspension (6mg/mL) dose 1.5mL twice daily 4 kg — 12 mg twice daily; suspension (6mg/mL) dose 2.0mL twice daily 5 kg — 15 mg twice daily; suspension (6mg/mL) dose 2.5mL twice daily 6 kg — 18 mg twice daily; suspension (6mg/mL) dose 3.0mL twice daily 7 kg — 21 mg twice daily; suspension (6mg/mL) dose 3.5mL twice daily 8 kg — 24 mg twice daily; suspension (6mg/mL) dose 4.0mL twice daily 9 kg — 27 mg twice daily; suspension (6mg/mL) dose 4.5mL twice daily 10 kg — 30 mg twice daily; suspension (6mg/mL) dose 5.0mL twice daily * This table does not include all possible weights for this patient group. A dose of 3mg/kg of this medicine is recommended for children younger than 1 year. 2. Prevention of influenza A and influenza B virus infections 2) Children 1 to 12 years of age: 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 (packet) once daily 15 kg<, ≤ 23 kg — 45 mg (packet) once daily 23 kg<, ≤ 40 kg — 60 mg (two 30mg packets) once daily > 40 kg — 75 mg (packet) once daily ※ The safety and efficacy of prevention of influenza A and B virus infections in children younger than 1 year have not been evaluated.

This medication cannot replace the influenza vaccine and should be used separately from vaccination. This medication is only effective against influenza A and B viruses, and safety and efficacy in other infections have not been established. Rarely, psychiatric side effects may occur in children and adolescents, and if unusual behavior is observed, caregivers should monitor closely. In children over 10 years of age, this medication is not used except in special cases. Patients with an allergy to this medication or its components should not take it. Dose adjustment is necessary for patients with impaired kidney function, and it is not recommended for patients with severe renal impairment. Patients in high-risk groups, such as those with asthma or chronic bronchitis, should use this medication with caution. Common side effects during use may include nausea, vomiting, headache, and pain, but most are temporary. Rarely, shock, anaphylaxis, liver dysfunction, skin anomalies, acute renal failure, blood disorders, and neuropsychiatric symptoms may occur, so immediate consultation with medical personnel is advised if any abnormal symptoms appear. Pregnant or breastfeeding women should carefully weigh the benefits and risks of treatment, as sufficient safety data is lacking. Efficacy and safety in children under 1 year have not been established, so caution is necessary when using this medication. Elderly individuals should be carefully monitored after administration considering reduced physical function and underlying diseases. This medication contains sorbitol and is not suitable for patients with hereditary fructose intolerance. If unusual behavior or neurological symptoms emerge during use, immediately discontinue the medication and consult a healthcare provider. No significant interactions are reported with other medications; however, caution is necessary when used in combination with specific medications. Store out of reach of children and do not transfer to another container.

Seizures, vomiting, headache, pain, unstable angina, anemia, pseudomembranous colitis, pneumonia, peritonsillar abscess, humeral fracture, hallucinations, convulsions, dermatitis, rash, urticaria, eczema, shock, anaphylactic reactions, hepatitis, abnormal liver function, jaundice, skin and mucous membrane syndrome, toxic epidermal necrolysis, acute renal failure, leukopenia, thrombocytopenia, neuropsychiatric symptoms (consciousness disturbance, abnormal behavior, delirium, hallucinations, delusions, convulsions), hemorrhagic colitis, erythema, flushing, itching, petechiae, cheilitis, stomatitis, hematochezia, melena, hematemesis, peptic ulcer, abdominal distension, abnormal stool, oral unpleasantness, loss of appetite, excitement, tremors, numbness, 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, increased blood sugar, abdominal pain, chest pain, sleep disturbances

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. A storage temperature of 1 to 30 degrees Celsius is recommended.

Appearance

White or yellowish powder

Package unit

10 packets/box