Oseltamivir Capsule 75mg (Oseltamivir Phosphate)

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; in some patients, tolerability may improve when 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 as powder for oral suspension. Patients with renal impairment (treatment): No dose adjustment is required in patients with creatinine clearance of 60 mL/min or greater. 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 occur during the 48 hours between dialysis sessions, the dose may 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 below 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment (treatment): No dose adjustment is required for treatment in adults 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 close contacts of 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 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 taking this medicine. Patients with renal impairment (prevention): No dose adjustment is required in patients with creatinine clearance of 60 mL/min or greater. 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 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, a 30mg dose 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 below 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment (prevention): No dose adjustment is required for prevention in adults with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

Influenza A and influenza B virus infections, children 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 and 45mg capsules twice daily instead of the recommended dose of this medicine as an oral suspension. ≤ 15 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily. 15 kg<, ≤ 23 kg: 45 mg twice daily; suspension (6mg/mL) 7.5 mL twice daily. 23 kg<, ≤ 40 kg: 60 mg twice daily; suspension (6mg/mL) 10.0 mL twice daily. > 40 kg: 75 mg twice daily; suspension (6mg/mL) 12.5 mL twice daily. 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. Not applicable to infants with a postconceptional age of less than 36 weeks. 3 kg: 9 mg twice daily; suspension (6mg/mL) 1.5 mL twice daily. 4 kg: 12 mg twice daily; suspension (6mg/mL) 2.0 mL twice daily. 5 kg: 15 mg twice daily; suspension (6mg/mL) 2.5 mL twice daily. 6 kg: 18 mg twice daily; suspension (6mg/mL) 3.0 mL twice daily. 7 kg: 21 mg twice daily; suspension (6mg/mL) 3.5 mL twice daily. 8 kg: 24 mg twice daily; suspension (6mg/mL) 4.0 mL twice daily. 9 kg: 27 mg twice daily; suspension (6mg/mL) 4.5 mL twice daily. 10 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily. * This table does not include every possible body weight in this patient group. A dose of 3mg/kg of this medicine is recommended for children under 1 year of age. Prevention of influenza A and influenza B virus infections, children 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 and 45mg capsules once daily for 10 days instead of the recommended dose of this medicine as an oral suspension. ≤ 15 kg: 30 mg once daily; suspension (6mg/mL) 5.0 mL once daily. 15 kg<, ≤ 23 kg: 45 mg once daily; suspension (6mg/mL) 7.5 mL once daily. 23 kg<, ≤ 40 kg: 60 mg once daily; suspension (6mg/mL) 10.0 mL once daily. > 40 kg: 75 mg once daily; suspension (6mg/mL) 12.5 mL 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 is used for the treatment and prevention of influenza virus infections. However, it cannot replace the influenza vaccination; therefore, annual vaccination is essential. This medication has been proven effective only against influenza A and B viruses, and its safety and efficacy have not been confirmed for other infections. It is generally recommended not to use this medication in children and adolescents over 10 years old unless in special cases, as abnormal behavior may occur. Since there is a risk of abnormal behavior while taking this medication, especially for children and adolescents, they should not be left alone, and a guardian should be present. Patients with allergies to this medication or its components should not take it. Patients with impaired renal function may require dose adjustments, and it is not recommended for patients with end-stage renal failure. Caution should be exercised when administering this medication to high-risk patients with asthma, chronic bronchitis, or immunosuppressed conditions. The most common side effects of this medication include nausea, vomiting, and headache; these are generally temporary and mild. Rarely, severe side effects such as skin rash, liver function abnormalities, and neuropsychiatric symptoms may occur, so if symptoms appear, immediate consultation with medical personnel is required. When administering this medication to pregnant or nursing mothers, the benefits and risks of treatment must be carefully considered, and it is advisable to avoid breastfeeding if nursing. Its safety and efficacy have not been established in children, especially in those under 1 year of age, so caution is advised. It can be used in the elderly without special dosage adjustments, but careful observation is necessary due to potential physical decline and underlying diseases. This medication has a low potential for drug interactions, but caution is required when used with certain medications, so it is essential to inform about any medications being taken. When taking this medication, it should be consistently taken at the prescribed times, and if a dose is missed, take it as soon as possible but skip it if the next dose is too close. This medication should be kept out of reach of children, and transferring it to other containers should be avoided. Finally, although this medication is used for the treatment of influenza, there is a possibility of resistance developing against the influenza virus, so it should be used according to a doctor’s instructions.

• Nausea
• vomiting
• headache
• pain
• unstable angina
• anemia
• pseudomembranous colitis
• pneumonia
• peritonsillar abscess
• humeral fracture

This medication should be stored in a tightly closed container to protect it from air and moisture, preferably at a cool temperature below 25 degrees Celsius. This storage helps maintain its effectiveness and prevents deterioration.

Appearance

A hard capsule with an upper yellowish and lower gray color containing a white or slightly yellow powder.

Package unit

10 capsules/PTP - 10 capsules/PTP