Seltaplu Capsule 30mg (Oseltamivir Phosphate)

Adult dose

Initiate treatment on the first or second day after the onset of influenza symptoms. This medicine may be administered regardless of food intake, and tolerability may improve in some patients when taken with food. Treatment of influenza A and influenza B virus infections—Adults and adolescents aged 13 years and older: Administer 75 mg of oseltamivir orally twice daily for 5 days. Adults and adolescents aged 13 years and older who have difficulty swallowing capsules should use this medicine as a powder for oral suspension. Patients with renal impairment (treatment): No dose adjustment is required for patients with a creatinine clearance of 60 mL/min or greater. For patients with a creatinine clearance of 30 ~ 60 mL/min, a reduced dose of 30 mg twice daily for 5 days is recommended. For patients with a 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 30 mg dose of this medicine after each dialysis session to maintain plasma concentrations within the therapeutic range; the treatment duration should not exceed 5 days. If influenza symptoms develop during the 48 hours between dialysis sessions, this medicine may be administered before the start of dialysis. For peritoneal dialysis, a single 30 mg 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 (treatment): No dose 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 individuals in close contact with an infected person, administer 75 mg of oseltamivir 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 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 for patients with a creatinine clearance of 60 mL/min or greater. For patients with a creatinine clearance of 30 ～ 60 mL/min, a reduced dose of 30 mg once daily is recommended. For patients with a 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 30 mg 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, administration of 30 mg 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 (prevention): No dose 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—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 and 45mg capsules twice daily instead of the recommended dose of this medicine as a 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 Treatment of influenza A and influenza B virus infections—Children 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 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 all possible weights in this patient group. For children younger than 1 year, a dose of 3mg/kg of this medicine is recommended. 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 and 45mg capsules once daily for 10 days instead of the recommended dose of this medicine as a 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 this medicine for the prevention of influenza A and B virus infections in children younger than 1 year have not been evaluated.

This drug cannot replace influenza vaccination and may be used alongside vaccination, but the preventive effect of this drug lasts only during the period of use. Safety and efficacy have not been established for other infections beyond influenza A and B. Adverse neuropsychiatric reactions such as seizures or abnormal behavior have been reported during the use of this drug, particularly in children and teenagers, so caution is required. It is generally advised not to use this drug for children over 10 years unless in specific cases, and caregivers should closely monitor the patient for at least 2 days after administration due to the risk of abnormal behavior. Patients with an allergy to this drug or hypersensitivity to any of its components should not take it. Patients with impaired kidney function require dosage adjustment, and it is not recommended for patients with end-stage renal failure. It should be administered with caution in high-risk patients with asthma, chronic bronchitis, or immune suppression. Common side effects include nausea, vomiting, and headache, most of which are temporary and mild. Rarely, shock, anaphylaxis, liver function abnormalities, skin reactions, acute renal failure, blood disorders, and neuropsychiatric symptoms may occur, so any abnormal symptoms should prompt immediate consultation with a physician. Pregnant or breastfeeding women should use this drug only when the therapeutic benefits outweigh the risks, as its effects on fetuses or infants are not fully understood. The safety and efficacy of this drug in children under 1 year old have not been sufficiently verified. Elderly patients should be carefully observed while being treated, considering any decline in physical function and multiple diseases. Severe side effects are rare even in overdose situations, but adhering to the dosage is important. This drug does not have significant interactions with other common medications, though caution may be needed when combined with certain drugs. The impact on driving or operating machinery is not significant, but caution is warranted due to symptoms caused by influenza itself. If abnormal behavior or neurological symptoms occur during treatment with this drug, immediate notification of medical personnel and appropriate measures are necessary.

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

This drug should be stored in a sealed container to protect it from air and moisture. Additionally, it is important to store it at a cool temperature below 25 degrees to maintain its effectiveness.

Appearance

Hard capsules with a yellowish powder inside, colored yellowish on top and bottom

Package unit

10 capsules/PTP