Aplu Capsule 30 mg (Oseltamivir Phosphate)

Adult dose

1. Influenza A and influenza B virus infections: Initiate treatment on the first or second day after the onset of influenza symptoms. 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 suspension. Patients with renal impairment (treatment): No dosage adjustment is required for 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 undergoing periodic hemodialysis should receive a 30 mg 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 develop during the 48 hours between dialysis sessions, the dose may also be given before dialysis begins. 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 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). 2. 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 75 mg of oseltamivir 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 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 this medicine is being taken. Patients with renal impairment (prevention): No dosage adjustment is required for 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 undergoing periodic hemodialysis should receive a 30 mg dose of this medicine after every 2 dialysis sessions to maintain plasma concentrations within the therapeutic range. The initial dose may also be administered before dialysis begins. For peritoneal dialysis, 30 mg 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 — children aged 1 to 12 years: ≤ 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 weighing more than 40kg 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 as a suspension. Treatment — infants 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 body weights in this patient group. A dose of 3mg/kg of this medicine is recommended for infants under 1 year of age. Prevention — children aged 1 to 12 years: ≤ 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. Pediatric patients weighing more than 40 kg who can swallow capsules may take 75 mg capsules once daily or 30 mg capsules and 45 mg capsules once daily for 10 days instead of the recommended dose of this medicine as a suspension. * The safety and efficacy of preventing influenza A and B virus infections in children under 1 year of age have not been evaluated.

This medication is used to treat or prevent influenza virus infections. This medication cannot replace influenza vaccination, so vaccination must be received. It is only effective against the influenza A and B viruses, and its safety and effectiveness have not been verified for other infections. The safety and efficacy of this medication have not been sufficiently studied in children under 1 year old, so its use is not recommended. In children and adolescents, abnormal neuropsychiatric reactions such as seizures or delirium have been reported after taking this medication, so caregivers should closely monitor for unusual behavior. Particularly in pediatric patients over 10 years old, the use of this medication should be avoided except in special cases due to the risk of abnormal behavior and thoughts. Patients who have an allergic reaction to this medication or are hypersensitive to any components of it should not take this medication. Patients with decreased renal function require dose 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 immunosuppressive states. Generally, side effects such as nausea, vomiting, and headaches may occur but are mostly temporary and are not severe enough to require discontinuation of the medication. Rarely, there may be allergic reactions, hepatic dysfunction, skin disorders, renal failure, blood abnormalities, or psychiatric symptoms, so if abnormal symptoms occur, immediate consultation with medical personnel is necessary. This medication has relatively few drug interactions when used with multiple drugs, but caution may be needed in combination with certain medications. Pregnant or breastfeeding women should carefully consider the benefits and risks of using this medication and consult a doctor if necessary. Elderly patients may have decreased physical function, so careful observation during administration is necessary. This medication should be kept out of the reach of children and the prescribed dosage and administration should be strictly followed. If abnormal behavior or severe side effects occur during treatment, stop taking the medication immediately and inform a healthcare professional.

• Area
• vomiting
• headache
• pain
• unstable angina
• anemia
• pseudomembranous colitis
• pneumonia
• peritonsillar abscess
• humeral fracture

This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. Additionally, it is best to store it in a cool place below 25 degrees Celsius.

Appearance

Light yellow hard capsules containing a white or light yellow powder

Package unit

10 capsules (10 capsules/PTP × 1)