Iyeon Oseltamivir Phosphate Capsule 75 mg

Adult dosage

Influenza A and influenza B virus infections: Initiate treatment on the first or second day after the onset of influenza symptoms. This medicine may be administered with or without food; in some patients, tolerability may improve when it is taken with food. Adults and adolescents aged 13 years and older: Administer oseltamivir 75 mg orally twice daily for 5 days. Adults and adolescents aged 13 years and older who have difficulty swallowing capsules should use this medicine as powder for suspension. Patients with renal impairment: No dosage adjustment is required in patients with creatinine clearance ≥ 60 mL/min. 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 plasma concentrations within the therapeutic range, and the treatment period 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 aged 13 years and older: For close contacts of an infected person, administer oseltamivir 75 mg orally once daily for 10 days. Initiate 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 taking this medicine. Patients with renal impairment: No dosage adjustment is required in patients with creatinine clearance ≥ 60 mL/min. 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 plasma concentrations within the therapeutic range. The first dose may also be administered before the start of dialysis. For peritoneal dialysis, 30mg of this medicine once weekly 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 prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Children's dosage

Influenza A and influenza B virus infections Pediatric patients aged 1 to 12 years: Pediatric patients weighing more than 40 kg who can swallow capsules may take 75 mg capsules twice daily or 30 mg and 45 mg capsules twice daily instead of the recommended dose of this medicine 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 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. 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 all possible weights in this patient group. A dose of 3mg/kg of this medicine is recommended for pediatric patients younger than 1 year. It is recommended that a pharmacist prepare this medicine suspension before it is administered to the patient. Prevention of influenza A and influenza B virus infections Pediatric patients aged 1 to 12 years: Pediatric patients weighing more than 40 kg who can swallow capsules may take 75 mg capsules once daily or 30 mg and 45 mg capsules once daily for 10 days instead of the recommended dose of this medicine 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 It is recommended that a pharmacist prepare this medicine suspension before it is administered to the patient. ※ The safety and efficacy of preventing influenza A and B virus infections in pediatric patients younger than 1 year have not been evaluated.

This medication cannot replace influenza vaccination and should be used independently of vaccination. This medication is effective only against influenza A and B and its safety and efficacy have not been established for other infections. In pediatric and adolescent patients, rare neuropsychiatric adverse reactions such as seizures or delirium may occur, so careful monitoring for abnormal behaviors should be conducted. Children over 10 years old who are not high-risk patients are generally recommended not to use this medication. Due to the risk of abnormal behavior while taking this medication, caregivers should ensure that children or adolescents are not left alone for at least two days after treatment begins. Patients allergic to this medication or its components should not use it. Patients with renal failure may require dosage adjustments, and it is not recommended for patients with end-stage renal failure. Patients with asthma, chronic bronchitis, or immunosuppressed conditions should be carefully administered this medication. The most common side effects while taking this medication include nausea, vomiting, headache, and are generally transient and mild. Rarely, shock, anaphylaxis, liver dysfunction, skin rash, acute renal failure, blood disorders, and neuropsychiatric symptoms can occur, and immediate consultation with medical personnel is necessary if abnormal symptoms arise. Pregnant or breastfeeding women should only use this medication if the benefits of treatment are assessed to outweigh the risks. Safety and efficacy have not been established in children under 1 year of age, so caution is required. Elderly patients do not require dosage adjustments, but should be monitored closely for potential declines in physical function. No serious side effects have been reported in cases of overdose, but if adverse reactions occur, medical personnel should be notified immediately. This medication has a low potential for interactions with other drugs, but caution is advised when combined with drugs that affect renal excretion. There have been no reports on the effects on driving or machinery operation, but the possibility of reduced capacities due to influenza itself should be considered. It is recommended not to use this medication concurrently with the influenza vaccine, and to space the administration of the vaccine before and after usage.

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

This medication should be stored in a sealed container that can block air and moisture, and should be kept at room temperature between 1 to 30 degrees Celsius. This storage method helps maintain the effectiveness of the medication and prevent degradation.

Appearance

A hard capsule with a gray lower part and a light yellow upper part containing a white or light yellow powder.

Package unit

10 capsules/PTP