Iyeon Oseltamivir Phosphate Capsules 30 mg

Adult dosage

1. Influenza A and influenza B virus infections: Start 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, taking it with food may improve tolerability. Adults and adolescents aged 13 years or older: Administer oseltamivir 75 mg orally twice daily for 5 days. Adults and adolescents aged 13 years or older who have difficulty swallowing capsules should use the powder for oral suspension. Patients with renal impairment: No dose adjustment is necessary for patients with creatinine clearance of 60 mL/min or more. For patients with creatinine clearance of 30 ~ 60 mL/min, reduction to 30 mg twice daily for 5 days is recommended. For patients with creatinine clearance of 10 ~ 30 mL/min, reduction to 30 mg once daily for 5 days is recommended. Patients receiving intermittent hemodialysis should receive a 30mg dose of this medicine after each dialysis session to maintain therapeutic plasma concentrations, and treatment should not exceed 5 days. If influenza symptoms develop during the 48 hours between dialysis sessions, the dose may also be administered 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 below 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment: No dose adjustment is necessary for treatment in 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 aged 13 years or older: For close contacts of an infected person, administer oseltamivir 75 mg orally once daily for 10 days. Start 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 this medicine is being taken. Patients with renal impairment: No dose adjustment is necessary for patients with creatinine clearance of 60 mL/min or more. For patients with creatinine clearance of 30 ～ 60 mL/min, reduction to 30 mg once daily is recommended. For patients with creatinine clearance of 10 ～ 30 mL/min, reduction to 30 mg once every other day is recommended. Patients receiving intermittent hemodialysis should receive a 30mg dose of this medicine after every 2 dialysis sessions to maintain therapeutic plasma 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 below 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment: No dose adjustment is necessary for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Children's dosage

Treatment of influenza A and influenza B virus infections, children aged 1 to 12 years: 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 as an oral suspension. ≤ 15 kg: 30 mg per dose twice daily; oral suspension (6mg/mL) 5.0 mL per dose twice daily. 15 kg<, ≤ 23 kg: 45 mg per dose twice daily; oral suspension (6mg/mL) 7.5 mL per dose twice daily. 23 kg<, ≤ 40 kg: 60 mg per dose twice daily; oral suspension (6mg/mL) 10.0 mL per dose twice daily. > 40 kg: 75 mg per dose twice daily; oral suspension (6mg/mL) 12.5 mL per dose twice daily. Children aged 2 weeks to under 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 infants with a postconceptional age of less than 36 weeks. 3 kg: 9 mg per dose twice daily; oral suspension (6mg/mL) 1.5 mL per dose twice daily. 4 kg: 12 mg per dose twice daily; oral suspension (6mg/mL) 2.0 mL per dose twice daily. 5 kg: 15 mg per dose twice daily; oral suspension (6mg/mL) 2.5 mL per dose twice daily. 6 kg: 18 mg per dose twice daily; oral suspension (6mg/mL) 3.0 mL per dose twice daily. 7 kg: 21 mg per dose twice daily; oral suspension (6mg/mL) 3.5 mL per dose twice daily. 8 kg: 24 mg per dose twice daily; oral suspension (6mg/mL) 4.0 mL per dose twice daily. 9 kg: 27 mg per dose twice daily; oral suspension (6mg/mL) 4.5 mL per dose twice daily. 10 kg: 30 mg per dose twice daily; oral suspension (6mg/mL) 5.0 mL per dose twice daily. Prevention of influenza A and influenza B virus infections, children aged 1 to 12 years: 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 as an oral suspension. ≤ 15 kg: 30 mg per dose once daily; oral suspension (6mg/mL) 5.0 mL per dose once daily. 15 kg<, ≤ 23 kg: 45 mg per dose once daily; oral suspension (6mg/mL) 7.5 mL per dose once daily. 23 kg<, ≤ 40 kg: 60 mg per dose once daily; oral suspension (6mg/mL) 10.0 mL per dose once daily. > 40 kg: 75 mg per dose once daily; oral suspension (6mg/mL) 12.5 mL per dose once daily.

This drug cannot replace influenza vaccination and should be used separately from vaccination. This drug has only been proven effective against influenza A and B, and its safety and efficacy against other infections have not been confirmed. Particularly in children and adolescents, neuropsychiatric adverse reactions, such as seizures or delirium, have been reported, indicating a risk of abnormal behavior, so caregivers should observe closely. Children over 10 years old should not typically use this drug unless they are part of a special high-risk group. Patients with allergic reactions to this drug or hypersensitivity to its components should not be administered this drug. Patients with decreased kidney function need dose adjustment, 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, and immunosuppressive states. Common side effects include nausea, vomiting, headache, and these are mostly transient and mild symptoms. Rarely, allergic reactions, liver function abnormalities, skin rashes, and neuropsychiatric symptoms may occur, so any abnormal symptoms should immediately be reported to healthcare professionals. Women who are pregnant or breastfeeding should only use this drug when the benefits exceed the risks, as the effects on the fetus or newborn are not fully understood. This drug's safety and efficacy have not been adequately studied in infants under 1 year old, so caution is advised. Elderly patients may have declining bodily functions and a higher likelihood of chronic diseases, so monitoring is essential during administration. This drug has a relatively low risk of drug interactions, but caution is needed when used in combination with certain medications, so inform healthcare professionals of any other medications being taken. During administration, caution should be exercised regarding the potential impairment of driving ability or operating machinery due to influenza itself. Serious side effects due to overdose are rare, but if any abnormal symptoms occur, seek medical attention immediately. Keep this medication out of reach of children and do not transfer it to other containers.

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

Store this medication in a tightly sealed container to prevent air or moisture from entering. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius. Storing it this way will help safely preserve its effectiveness.

Appearance

Hard capsules with a yellow upper and lower part containing a white or light yellow powder

Package unit

10 capsules/PTP