Oseltamivir Phosphate 45 mg

Adult dose

Influenza A and influenza B virus infections: Begin treatment on the first or second day after the onset of influenza symptoms. This medicine may be taken with or without food; tolerability may improve in some patients when it is taken with food. 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. 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. 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 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. 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. 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

Pediatric patients 1 to 12 years of age: Pediatric patients weighing more than 40 kg who can swallow capsules may take 75mg capsules twice daily or 30mg capsules and 45mg capsules twice daily instead of the recommended dose of this medicine. Recommended dose for 5-day treatment: ≤ 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 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. Pediatric patients who have difficulty taking this medicine as a powder should use the suspension. A dose of 3mg/kg of this medicine is recommended for pediatric patients under 1 year of age. 3 kg: 9 mg twice daily; 1.5mL twice daily 4 kg: 12 mg twice daily; 2.0mL twice daily 5 kg: 15 mg twice daily; 2.5mL twice daily 6 kg: 18 mg twice daily; 3.0mL twice daily 7 kg: 21 mg twice daily; 3.5mL twice daily 8 kg: 24 mg twice daily; 4.0mL twice daily 9 kg: 27 mg twice daily; 4.5mL twice daily 10 kg: 30 mg twice daily; 5.0mL twice daily Prevention of influenza A and influenza B virus infections Pediatric patients 1 to 12 years of age: Pediatric patients weighing more than 40 kg who can swallow capsules may take 75mg capsules once daily or 30mg capsules and 45mg capsules once daily for 10 days instead of the recommended dose of this medicine. Recommended dose for 10-day prevention: ≤ 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 pediatric patients under 1 year of age have not been evaluated.

This drug cannot replace influenza vaccination and should only be used for treatment and prevention of influenza. The safety and efficacy of this drug against infections other than influenza A and B have not been confirmed. Particularly in children and adolescents, neuropsychiatric adverse reactions have been reported, and if abnormal behavior occurs, caregivers should observe carefully. It is generally recommended not to use this medication in children over 10 years of age unless in special cases. Patients with hypersensitivity to this drug or its components should not use it. Dosage adjustments are necessary for patients with renal impairment or those receiving hemodialysis, and it is not recommended for patients with end-stage renal failure. Caution should be exercised when administering to high-risk patients (asthma, chronic bronchitis, immunosuppressed patients). While taking this medication, side effects such as nausea, vomiting, headaches may occur, but most are temporary. Serious adverse reactions may include shock, anaphylaxis, pneumonia, hepatitis, skin-mucous membrane syndrome, acute renal failure, leukopenia, neuropsychiatric symptoms, etc. If any of these abnormal symptoms occur, medical personnel should be notified immediately. This drug is not a substitute for influenza vaccines, and vaccinations should continue. The risks and benefits of use in pregnant or nursing women should be carefully considered. Safety and efficacy in children under 1 year of age have not been adequately studied; caution is advised for their use. Elderly patients may have diminished physical function and pre-existing conditions, thus careful observation is required. In case of overdose, contact a medical institution immediately for appropriate action, and keep it out of reach of children. The drug should not be transferred to other containers, and care should be taken to maintain its quality.

• Cramps
• delirium
• abnormal behavior
• nausea
• vomiting
• headache
• pain
• unstable angina
• anemia
• pseudomembranous colitis

This medication should be stored in a tightly closed container to prevent air or moisture ingress, at room temperature between 1 and 30 degrees Celsius. Storing it this way can help maintain the drug's effectiveness.

Appearance

White or yellowish powder

Package unit

10 sachets/box