Seltaplu Capsule 45 mg (Oseltamivir Phosphate)

Adult dose

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: 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: 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: 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: 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. Body weight ≤ 15 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily Body weight 15 kg<, ≤ 23 kg: 45 mg twice daily; suspension (6mg/mL) 7.5 mL twice daily Body weight 23 kg<, ≤ 40 kg: 60 mg twice daily; suspension (6mg/mL) 10.0 mL twice daily 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. Body weight 3 kg: 9 mg twice daily; suspension (6mg/mL) 1.5 mL twice daily Body weight 4 kg: 12 mg twice daily; suspension (6mg/mL) 2.0 mL twice daily Body weight 5 kg: 15 mg twice daily; suspension (6mg/mL) 2.5 mL twice daily Body weight 6 kg: 18 mg twice daily; suspension (6mg/mL) 3.0 mL twice daily Body weight 7 kg: 21 mg twice daily; suspension (6mg/mL) 3.5 mL twice daily Body weight 8 kg: 24 mg twice daily; suspension (6mg/mL) 4.0 mL twice daily Body weight 9 kg: 27 mg twice daily; suspension (6mg/mL) 4.5 mL twice daily Body weight 10 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily 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 a suspension. Body weight ≤ 15 kg: 30 mg once daily; suspension (6mg/mL) 5.0 mL once daily Body weight 15 kg<, ≤ 23 kg: 45 mg once daily; suspension (6mg/mL) 7.5 mL once daily Body weight 23 kg<, ≤ 40 kg: 60 mg once daily; suspension (6mg/mL) 10.0 mL once daily Body weight > 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 cannot replace influenza vaccination and should only be used for treatment and preventive purposes in areas where influenza virus is prevalent. Safety and efficacy have not been established for infections other than influenza A and B. In pediatric and adolescent patients, neurological and psychiatric adverse reactions such as seizures and delirium have been reported; particular caution is needed for patients over the age of 10, and caregivers should be present if abnormal behaviors appear. This medication should not be administered to patients with known allergic reactions to it or its components. Dose adjustment is necessary for patients with impaired renal function or those on dialysis, and it is not recommended for patients with end-stage renal failure. Caution should be exercised in high-risk groups such as those with asthma, chronic bronchitis, or immunosuppressed conditions. The most common side effects are nausea, vomiting, and headaches, which are mostly transient and mild. Rarely, shock, anaphylaxis, liver function abnormalities, skin rashes, acute renal failure, and neurological symptoms may occur; any unusual symptoms should be discussed with a healthcare provider immediately. Pregnant or nursing women should only use this medication if the benefits outweigh the risks. Safety and efficacy in children under 1 year of age have not been established, so use should be cautious. Elderly patients may have decreased physiological function and multiple diseases, requiring careful monitoring when administering this medication. When taking this medication, it is recommended to start as early as possible after the onset of symptoms; if a dose is missed, take it as soon as possible, but if the next scheduled dose is within 2 hours, skip the missed dose. This medication has minimal interactions with other drugs; however, caution may be necessary when administered with certain medications. It is advisable not to use this medication concurrently with the influenza vaccine, especially live vaccines, and a specific interval should be maintained.

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

This medication should be stored in a tightly sealed container to prevent air or moisture from entering. It is recommended to store it in a cool place below 25 degrees Celsius.

Appearance

Gray hard capsules filled with white or yellowish powder

Package unit

10 capsules/PTP