Boryeong Tamiflu Powder 30 mg (Oseltamivir Phosphate)

Adult dose

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; in some patients, taking it with food may improve tolerability. 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. 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. 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). 2. Prevention of influenza A and influenza B virus infections 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. 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. 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

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 (sachet) twice daily 15 kg<, ≤ 23 kg — 45 mg (sachet) twice daily 23 kg<, ≤ 40 kg — 60 mg (two 30mg sachets) twice daily > 40 kg — 75 mg (sachet) twice daily 3) 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. Administer according to the following dosage table*. Pediatric patients who have difficulty taking this medicine as powder should use the suspension. 3 kg — 9 mg twice daily; suspension (6mg/mL), 1.5mL twice daily 4 kg — 12 mg twice daily; suspension (6mg/mL), 2.0mL twice daily 5 kg — 15 mg twice daily; suspension (6mg/mL), 2.5mL twice daily 6 kg — 18 mg twice daily; suspension (6mg/mL), 3.0mL twice daily 7 kg — 21 mg twice daily; suspension (6mg/mL), 3.5mL twice daily 8 kg — 24 mg twice daily; suspension (6mg/mL), 4.0mL twice daily 9 kg — 27 mg twice daily; suspension (6mg/mL), 4.5mL twice daily 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. 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 (sachet) once daily 15 kg<, ≤ 23 kg — 45 mg (sachet) once daily 23 kg<, ≤ 40 kg — 60 mg (two 30mg sachets) once daily > 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 medication cannot replace influenza vaccinations and should only be used for treatment and prevention during influenza virus epidemics. Safety and efficacy have not been confirmed for infections other than influenza A and B. Abnormal behaviors or neuropsychiatric adverse reactions have been reported in pediatric and adolescent patients, especially in those over 10 years old, requiring caution, and guardians should closely monitor patients for abnormal behaviors. Individuals allergic to this medication or its components should not take it. Patients with impaired renal function or those on dialysis require dose adjustments, and it is not recommended for patients with end-stage renal disease. Caution should be exercised in patients at high risk, such as those with asthma or chronic bronchitis. Common side effects may include nausea, vomiting, headache, and pain, which are mostly temporary and mild. Serious side effects can occur rarely, including shock, anaphylaxis, liver dysfunction, skin rash, neuropsychiatric disorders, acute renal failure, so immediate consultation with a healthcare professional is advised when unusual symptoms appear. Women who are pregnant or breastfeeding should consult a doctor before decision-making regarding the use of this medication, as the effects on the fetus or infant are not fully known. The safety and efficacy in infants under 1 year old have not been established, while children over 1 year old and adults can generally use it safely. Elderly individuals may have reduced physical functions, so careful monitoring is needed upon administration; however, generally, dose adjustments are not necessary. This medication contains sorbitol, so patients with fructose intolerance should avoid its use. Interactions with other medications are minimal, but caution may be necessary when used concurrently with specific medications, so inform healthcare professionals of any medications being taken. Patients should take care when driving or operating machinery during treatment, considering the potential impairment due to influenza itself. Keep this medication out of reach of children and do not transfer it 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, anaphylactic reaction, hepatitis, abnormal liver function, jaundice, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute renal failure, leukopenia, thrombocytopenia, neuropsychiatric syndrome (consciousness disturbance, abnormal behavior, delirium, hallucinations, delusions, convulsions), hemorrhagic colitis, erythema, redness, itching, petechiae, cheilitis, stomatitis, bloody stools, black stools, hematemesis, peptic ulcer, abdominal distension, abnormal stools, oral discomfort, loss of appetite, agitation, tremor, 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, increased blood sugar, abdominal pain, chest pain, sleep disturbances

This medication should be stored in a tightly sealed container to protect it from air and moisture, at room temperature between 1 to 30 degrees Celsius. Storing it this way will help maintain its effectiveness for a long time.

Appearance

White or light yellow powder

Package unit

10 packets/box