Oseltamivir Phosphate Powder 30 mg

Adult dose

Treatment of influenza A and influenza B virus infections — 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. Prevention of influenza A and influenza B virus infections — Adults and adolescents 13 years of age and older: For those in close contact with an infected person, administer 75 mg of oseltamivir orally once daily for 10 days. Begin 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 medicine have been demonstrated for up to 6 weeks. The preventive effect continues while this medicine is being taken. Treatment — Patients with renal impairment: No dosage adjustment is required for patients with creatinine clearance of 60 mL/min or more. 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 therapeutic plasma concentrations; treatment should not exceed 5 days. If influenza symptoms develop during the 48 hours between dialysis sessions, the dose may also be administered before the start of dialysis. 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 required for treatment in 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 creatinine clearance of 60 mL/min or more. 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 once daily 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 plasma concentrations. The initial dose may be administered before the start of dialysis. For peritoneal dialysis, 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 required for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

Treatment of influenza A and influenza B virus infections — Pediatric patients 1 to 12 years of age: ≤ 15 kg — 30 mg (sachet) twice daily Treatment of influenza A and influenza B virus infections — Pediatric patients 1 to 12 years of age: 15 kg<, ≤ 23 kg — 45 mg (sachet) twice daily Treatment of influenza A and influenza B virus infections — Pediatric patients 1 to 12 years of age: 23 kg<, ≤ 40 kg — 60 mg (two 30mg sachets) twice daily Treatment of influenza A and influenza B virus infections — Pediatric patients 1 to 12 years of age: > 40 kg — 75 mg (sachet) twice daily Treatment of influenza A and influenza B virus infections — Pediatric patients 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 pediatric patients with a postconceptional age of less than 36 weeks. Treatment of influenza A and influenza B virus infections — Pediatric patients aged 2 weeks to less than 1 year, body weight 3 kg: 9 mg twice daily; suspension (6mg/mL) dose 1.5mL twice daily Treatment of influenza A and influenza B virus infections — Pediatric patients aged 2 weeks to less than 1 year, body weight 4 kg: 12 mg twice daily; suspension (6mg/mL) dose 2.0mL twice daily Treatment of influenza A and influenza B virus infections — Pediatric patients aged 2 weeks to less than 1 year, body weight 5 kg: 15 mg twice daily; suspension (6mg/mL) dose 2.5mL twice daily Treatment of influenza A and influenza B virus infections — Pediatric patients aged 2 weeks to less than 1 year, body weight 6 kg: 18 mg twice daily; suspension (6mg/mL) dose 3.0mL twice daily Treatment of influenza A and influenza B virus infections — Pediatric patients aged 2 weeks to less than 1 year, body weight 7 kg: 21 mg twice daily; suspension (6mg/mL) dose 3.5mL twice daily Treatment of influenza A and influenza B virus infections — Pediatric patients aged 2 weeks to less than 1 year, body weight 8 kg: 24 mg twice daily; suspension (6mg/mL) dose 4.0mL twice daily Treatment of influenza A and influenza B virus infections — Pediatric patients aged 2 weeks to less than 1 year, body weight 9 kg: 27 mg twice daily; suspension (6mg/mL) dose 4.5mL twice daily Treatment of influenza A and influenza B virus infections — Pediatric patients aged 2 weeks to less than 1 year, body weight 10 kg: 30 mg twice daily; suspension (6mg/mL) dose 5.0mL twice daily A dose of 3mg/kg of this medicine is recommended for pediatric patients under 1 year of age. Prevention of influenza A and influenza B virus infections — Pediatric patients 1 to 12 years of age: ≤ 15 kg — 30 mg (sachet) once daily Prevention of influenza A and influenza B virus infections — Pediatric patients 1 to 12 years of age: 15 kg<, ≤ 23 kg — 45 mg (sachet) once daily Prevention of influenza A and influenza B virus infections — Pediatric patients 1 to 12 years of age: 23 kg<, ≤ 40 kg — 60 mg (two 30mg sachets) once daily Prevention of influenza A and influenza B virus infections — Pediatric patients 1 to 12 years of age: > 40 kg — 75 mg (sachet) once daily

This drug cannot replace influenza vaccination and should only be used for treatment and prevention during periods when the influenza virus is circulating. The safety and efficacy of this drug for infections other than influenza A and B have not been established. Especially for children and adolescents, rare reports of neuropsychiatric adverse reactions, such as seizures or delirium, have been noted, and careful observation for abnormal behavior should be maintained. Children aged 10 years and older are at risk of accidents due to abnormal behavior, so it is generally advised not to use this drug except in special cases. To reduce the risk of abnormal behavior after taking this drug, children and adolescents should not be left alone for at least 2 days after the start of treatment. Patients who are allergic to this drug or its ingredients should not use it. Dosing adjustments are necessary in patients with impaired renal function, and it is not recommended for patients with end-stage renal failure. Caution should be exercised when administering to high-risk patients with asthma, chronic bronchitis, or immunosuppressed conditions. While taking this drug, side effects such as nausea, vomiting, headache, and pain may occur, which are mostly transient and mild. Rarely, shock, anaphylaxis, pneumonia, liver function abnormalities, skin symptoms, acute renal failure, blood abnormalities, and neuropsychiatric symptoms may occur, so immediate consultation with medical personnel should be sought in the presence of any adverse symptoms. Pregnant women or those who may become pregnant should carefully consider the treatment benefits and risks of this drug, and nursing mothers should consult experts before use. The safety and efficacy in children under 1 year have not been established, so caution in use is required. Generally, elderly patients do not require dosing adjustments, but should be carefully monitored considering physical decline and underlying diseases. This drug contains sorbitol, making it unsuitable for patients with hereditary fructose intolerance. Interactions with other drugs are rare, but caution is required when used concurrently with medications that affect renal excretion. This drug should be kept out of the reach of children and not transferred to other containers.

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 (altered consciousness, abnormal behavior, delirium, hallucinations, delusions, convulsions), hemorrhagic colitis, redness, erythema, itching, petechiae, cheilitis, stomatitis, hematochezia, melena, hematemesis, peptic ulcer, abdominal distension, abnormal stool, oral discomfort, loss of appetite, agitation, tremors, 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 glucose, abdominal pain, chest pain, sleep disturbances

This drug may be sensitive to air or moisture, so it should be stored in a tightly sealed container. Additionally, it is advisable to store the medication at room temperature between 1 degree and 30 degrees Celsius. Do not place it in extremely hot or cold places, and store safely avoiding direct sunlight.

Appearance

White or pale yellow powder

Package unit

10 packets/box