Seltaplu Capsule 75 mg (Oseltamivir Phosphate)

Adult dose

Treatment of influenza A and influenza B virus infections — Initiate treatment on the first or second day of 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 13 years of age and older: Administer oseltamivir 75 mg 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 suspension. Patients with renal impairment (treatment): No dosage adjustment is required for 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 undergoing periodic hemodialysis should receive a 30mg dose of this medicine after each dialysis session to maintain plasma concentrations within the therapeutic range, and treatment should not exceed 5 days. If influenza symptoms occur during the 48 hours between dialysis sessions, the dose may 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 undergoing dialysis (e.g., creatinine clearance below 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment (treatment): No dosage adjustment is required for treatment of 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 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 (prevention): No dosage adjustment is required for 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 once daily every other day is recommended. Patients undergoing periodic 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 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 undergoing dialysis (e.g., creatinine clearance below 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment (prevention): No dosage 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 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 a suspension. Children 1 to 12 years of age, body weight ≤ 15 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily Children 1 to 12 years of age, body weight 15 kg<, ≤ 23 kg: 45 mg twice daily; suspension (6mg/mL) 7.5 mL twice daily Children 1 to 12 years of age, body weight 23 kg<, ≤ 40 kg: 60 mg twice daily; suspension (6mg/mL) 10.0 mL twice daily Children 1 to 12 years of age, body weight > 40 kg: 75 mg twice daily; suspension (6mg/mL) 12.5 mL twice daily Infants 2 weeks to under 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. This does not apply to infants with a postconceptional age of less than 36 weeks. Infants 2 weeks to under 1 year of age, body weight 3 kg: 9 mg twice daily; suspension (6mg/mL) 1.5 mL twice daily Infants 2 weeks to under 1 year of age, body weight 4 kg: 12 mg twice daily; suspension (6mg/mL) 2.0 mL twice daily Infants 2 weeks to under 1 year of age, body weight 5 kg: 15 mg twice daily; suspension (6mg/mL) 2.5 mL twice daily Infants 2 weeks to under 1 year of age, body weight 6 kg: 18 mg twice daily; suspension (6mg/mL) 3.0 mL twice daily Infants 2 weeks to under 1 year of age, body weight 7 kg: 21 mg twice daily; suspension (6mg/mL) 3.5 mL twice daily Infants 2 weeks to under 1 year of age, body weight 8 kg: 24 mg twice daily; suspension (6mg/mL) 4.0 mL twice daily Infants 2 weeks to under 1 year of age, body weight 9 kg: 27 mg twice daily; suspension (6mg/mL) 4.5 mL twice daily Infants 2 weeks to under 1 year of age, body weight 10 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily This table does not include all possible body weights in this patient group. A dose of 3mg/kg of this medicine is recommended for children under 1 year of age. It is recommended that a pharmacist prepare the suspension of this medicine before it is administered to the patient. 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 a suspension. Children 1 to 12 years of age, body weight ≤ 15 kg: 30 mg once daily; suspension (6mg/mL) 5.0 mL once daily Children 1 to 12 years of age, body weight 15 kg<, ≤ 23 kg: 45 mg once daily; suspension (6mg/mL) 7.5 mL once daily Children 1 to 12 years of age, body weight 23 kg<, ≤ 40 kg: 60 mg once daily; suspension (6mg/mL) 10.0 mL once daily Children 1 to 12 years of age, body weight > 40 kg: 75 mg once daily; suspension (6mg/mL) 12.5 mL once daily It is recommended that a pharmacist prepare the suspension of this medicine before it is administered to the patient. 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 drug cannot replace influenza vaccinations, and its use alongside vaccinations will not provide overlapping preventive effects. Treatment and preventive effects have only been proven for influenza A and B viruses, and safety and effectiveness have not been established for other infections. This medication may cause neuropsychiatric side effects, particularly in children and adolescents, so careful observation is necessary; parents should be present if abnormal behavior occurs. Individuals allergic to this drug or its ingredients should not take it. Patients with impaired kidney function may need dosage adjustments, and it is not recommended for patients with end-stage renal failure. Asthmatic patients, patients with chronic bronchitis, and immunocompromised individuals should be administered this drug with caution. Common side effects during use include nausea, vomiting, headache, pain, but most are temporary. Rarely, shock, anaphylaxis, liver function abnormalities, skin reactions, acute renal failure, neurological symptoms may occur; if any abnormal symptoms arise, discontinue use immediately and consult medical staff. Pregnant or breastfeeding women should use this drug only if the benefit of treatment is believed to outweigh the risks, as its effects on the fetus or newborn are not fully understood. There is insufficient evidence of safety and effectiveness in children under 1 year of age, thus use should be avoided. The elderly may have reduced bodily function and pre-existing diseases, so careful monitoring during administration is essential. In case of overdose, severe side effects have generally not been reported, but if adverse reactions occur, inform medical staff immediately. This drug has low potential for interactions with other medications, but caution is advised when used with certain drugs that share renal excretion pathways. There is no effect on driving or operating machinery, but influenza symptoms themselves may reduce attentiveness, so caution is advised. Store out of the reach of children and do not transfer to other containers for safety.

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

This medication should be stored in a tightly sealed container to protect it from air and moisture, and should be kept in a cool place at a temperature below 25 degrees. Proper storage will help maintain the medication's effectiveness and prevent degradation.

Appearance

Light yellow or white powder filled in a hard capsule with a light yellow upper part and gray lower part

Package unit

10 capsules/PTP