Boryeong Tamiflu 75 mg (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; in some patients, taking it with food may improve tolerability. Treatment — Adults and adolescents 13 years of age and older: The recommended dose is 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. Prevention — Adults and adolescents 13 years of age and older: For 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 influenza outbreaks 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. Treatment — Patients with renal impairment: No dosage adjustment is required for patients with a creatinine clearance of 60 mL/min or higher. 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 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 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. Treatment — Patients with hepatic impairment: No dosage adjustment is necessary for the treatment of adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9). Prevention — Patients with renal impairment: No dosage adjustment is required for patients with a creatinine clearance of 60 mL/min or higher. 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 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 initial 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. Prevention — Patients with hepatic impairment: No dosage adjustment is necessary for the prevention of influenza in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

Treatment — 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. Body weight ≤ 15 kg: 30 mg (sachet) twice daily Body weight 15 kg<, ≤ 23 kg: 45 mg (sachet) twice daily Body weight 23 kg<, ≤ 40 kg: 60 mg (two 30mg sachets) twice daily Body weight > 40 kg: 75 mg (sachet) twice daily Treatment — Children 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. Pediatric patients who have difficulty taking this medicine as powder should use the suspension. Body weight 3 kg: 9 mg twice daily; suspension (6mg/mL), 1.5mL twice daily Body weight 4 kg: 12 mg twice daily; suspension (6mg/mL), 2.0mL twice daily Body weight 5 kg: 15 mg twice daily; suspension (6mg/mL), 2.5mL twice daily Body weight 6 kg: 18 mg twice daily; suspension (6mg/mL), 3.0mL twice daily Body weight 7 kg: 21 mg twice daily; suspension (6mg/mL), 3.5mL twice daily Body weight 8 kg: 24 mg twice daily; suspension (6mg/mL), 4.0mL twice daily Body weight 9 kg: 27 mg twice daily; suspension (6mg/mL), 4.5mL twice daily Body weight 10 kg: 30 mg twice daily; suspension (6mg/mL), 5.0mL 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 under 1 year of age. Prevention — 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. Body weight ≤ 15 kg: 30 mg (sachet) once daily Body weight 15 kg<, ≤ 23 kg: 45 mg (sachet) once daily Body weight 23 kg<, ≤ 40 kg: 60 mg (two 30mg sachets) once daily Body weight > 40 kg: 75 mg (sachet) once daily 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 drug cannot replace influenza vaccination and must be used separately from the influenza vaccine. This drug is only effective against influenza A and B viruses, and safety and efficacy have not been established for other infections. In particular, neuropsychiatric adverse effects have been reported in children and adolescents; therefore, patients in this age group must be closely monitored for abnormal behavior. Children over 10 years of age are advised not to use this drug unless they are in a special high-risk group. As there is a risk of abnormal behavior while taking this medication, caregivers should ensure that the patient is not alone for at least 2 days. Patients with hypersensitivity to this drug or its components should not take it. Dose adjustment is needed for patients with renal insufficiency, and it is not recommended for patients with end-stage renal failure. Caution is required for patients in high-risk groups (e.g., asthma, chronic bronchitis, immunosuppressed patients). Common side effects include nausea, vomiting, headache, and pain, which are mostly temporary. Rarely, symptoms such as shock, anaphylaxis, pneumonia, liver dysfunction, Stevens-Johnson syndrome, acute renal failure, leukopenia, and neuropsychiatric symptoms may occur, and immediate consultation with medical staff is necessary if any abnormal symptoms appear. This drug contains sorbitol and is not suitable for patients with hereditary fructose intolerance. For pregnant or nursing women, careful consideration must be given to whether the therapeutic benefits outweigh the risks. Safety and efficacy for children under 1 year have not been established, so caution is needed for their use. For the elderly, dose adjustment is not necessary, but careful monitoring should be conducted considering decline in physical function and underlying conditions. While special adverse reactions to overdose are rare, if any abnormal symptoms occur, an immediate visit to a medical institution is required. This drug should be kept out of reach of children and it is advisable not to transfer it to another container.

Nausea, vomiting, headache, pain, unstable angina, anemia, membranous colitis, pneumonia, peritonsillar abscess, humerus fracture, hallucination, seizure, dermatitis, rash, hives, eczema, shock, anaphylactic reaction, hepatitis, abnormal liver function, jaundice, Steven-Johnson syndrome, toxic epidermal necrolysis, acute renal failure, leukopenia, thrombocytopenia, neuropsychiatric syndrome (disorder of consciousness, abnormal behavior, delirium, hallucination, delusion, seizure), hemorrhagic colitis, erythema, flushing, pruritus, petechiae, cheilitis, stomatitis, bloody stool, melena, hematemesis, peptic ulcer, abdominal distension, abnormal stool, oral unpleasantness, loss of appetite, excitement, tremor, paresthesia, lethargy, drowsiness, ventricular tachycardia, premature ventricular contractions, abnormal electrocardiogram, 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, dermatitis, rash, eczema, hives, erythema multiforme, allergy, anaphylaxis, facial edema, psychiatric sleep disorders, seizure, confusion, gastrointestinal hemorrhage, hemorrhagic colitis, worsening of diabetes, leukopenia, pancreatitis, vascular edema, laryngeal edema, tongue edema, bronchospasm, facial edema, hematuria, nightmares, dizziness

This drug should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius to safely preserve the drug's efficacy.

Appearance

White or pale yellow powder

Package unit

10 sachets/box