Aflu Capsule 45 mg (Oseltamivir Phosphate)

Adult dose

Influenza A and influenza B virus infections: Initiate treatment on the first or second day after the onset of influenza symptoms. This medicine may be administered with or without food; in some patients, taking it with food may improve tolerability. 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: 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: 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 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: 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: No dosage adjustment is required for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

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. Children aged 1 to 12 years, body weight ≤ 15 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily Children aged 1 to 12 years, body weight 15 kg<, ≤ 23 kg: 45 mg twice daily; suspension (6mg/mL) 7.5 mL twice daily Children aged 1 to 12 years, body weight 23 kg<, ≤ 40 kg: 60 mg twice daily; suspension (6mg/mL) 10.0 mL twice daily Children aged 1 to 12 years, body weight > 40 kg: 75 mg twice daily; suspension (6mg/mL) 12.5 mL twice daily 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. Infants aged 2 weeks to less than 1 year, body weight 3 kg: 9 mg twice daily; suspension (6mg/mL) 1.5 mL twice daily Infants aged 2 weeks to less than 1 year, body weight 4 kg: 12 mg twice daily; suspension (6mg/mL) 2.0 mL twice daily Infants aged 2 weeks to less than 1 year, body weight 5 kg: 15 mg twice daily; suspension (6mg/mL) 2.5 mL twice daily Infants aged 2 weeks to less than 1 year, body weight 6 kg: 18 mg twice daily; suspension (6mg/mL) 3.0 mL twice daily Infants aged 2 weeks to less than 1 year, body weight 7 kg: 21 mg twice daily; suspension (6mg/mL) 3.5 mL twice daily Infants aged 2 weeks to less than 1 year, body weight 8 kg: 24 mg twice daily; suspension (6mg/mL) 4.0 mL twice daily Infants aged 2 weeks to less than 1 year, body weight 9 kg: 27 mg twice daily; suspension (6mg/mL) 4.5 mL twice daily Infants aged 2 weeks to less than 1 year, 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 infants under 1 year of age. It is recommended that a pharmacist prepare the suspension of this medicine before it is administered to the patient. 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. Children aged 1 to 12 years, body weight ≤ 15 kg: 30 mg once daily; suspension (6mg/mL) 5.0 mL once daily Children aged 1 to 12 years, body weight 15 kg<, ≤ 23 kg: 45 mg once daily; suspension (6mg/mL) 7.5 mL once daily Children aged 1 to 12 years, body weight 23 kg<, ≤ 40 kg: 60 mg once daily; suspension (6mg/mL) 10.0 mL once daily Children aged 1 to 12 years, 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 preventing influenza A and B virus infections in children under 1 year of age have not been evaluated.

This drug is not a substitute for the influenza vaccine, and it is important to receive the vaccine annually. This drug has been shown to be effective only against influenza A and B viruses, and its safety and efficacy are not verified for other infections. Rarely, neuropsychiatric adverse reactions such as seizures or abnormal behavior may occur in children and adolescents taking this drug, so special care is required for children older than 10. Due to the risk of abnormal behavior during the use of this drug, caregivers should carefully observe children and adolescents to ensure they are not left alone. Patients with hypersensitivity to this drug should not use it, and dosage adjustment or careful administration is necessary for patients with renal failure or specific high-risk groups. Nausea, vomiting, and headaches are common side effects, but they are usually transient and not severe. Rarely, symptoms such as skin rash, liver dysfunction, acute renal failure, and neuropsychiatric symptoms may occur, and if any abnormal symptoms arise, immediate consultation with a physician is required. If pregnant or nursing, the decision to administer this drug should be made with caution considering its effects on the fetus or infant. The safety and efficacy of this drug in children, especially infants under 1 year old, have not been sufficiently confirmed, so caution is needed in its use. While no special dosage adjustments are necessary for the elderly, observation may be required due to possible decline in physical function. This drug has little potential for drug interactions, but caution may be necessary when used with certain medications. Serious side effects from overdose are rarely reported, but if any adverse reactions occur, notify medical personnel immediately. This drug should be kept out of reach of children and should not be transferred to another container. It is important to start treatment quickly when influenza symptoms appear during the use of this drug, and to adhere to the dosage schedule for efficacy. No effects on driving or machinery operation have been reported, but caution should be exercised since influenza itself may affect physical function.

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

This drug is sensitive to air and moisture, so it should be stored in a tightly closed container. It is also recommended to store it at a cool temperature below 25 degrees.

Appearance

A hard capsule with a light gray body and a powder that is white or light yellow

Package unit

10 capsules (10 capsules/PTP × 1)