Easy Flu Capsule 75 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. This medicine may be taken with or without food; tolerability may improve in some patients when taken with food. Adults and adolescents aged 13 years and older: Administer oseltamivir 75 mg 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 dose adjustment is necessary for patients with creatinine clearance ≥ 60 mL/min. For patients with creatinine clearance of 30 ~ 60 mL/min, reduction to 30 mg twice daily for 5 days is recommended. For patients with creatinine clearance of 10 ~ 30 mL/min, reduction to 30 mg once daily for 5 days is recommended. Patients receiving periodic hemodialysis should receive a 30mg dose of this medicine after each dialysis session to maintain blood concentrations within the therapeutic range; treatment should not exceed 5 days. If influenza symptoms develop 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 receiving dialysis (e.g., creatinine clearance below 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment: No dose adjustment is necessary for treatment in 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 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 taking this medicine. Patients with renal impairment: No dose adjustment is necessary for patients with creatinine clearance ≥ 60 mL/min. For patients with creatinine clearance of 30 ～ 60 mL/min, reduction to 30 mg once daily is recommended. For patients with creatinine clearance of 10 ～ 30 mL/min, reduction to 30 mg once daily every other day is recommended. Patients receiving periodic hemodialysis should receive a 30mg dose of this medicine after every 2 dialysis sessions to maintain blood concentrations within the therapeutic range. The initial dose may also be given before dialysis begins. For peritoneal dialysis, administration of 30mg 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 below 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment: No dose adjustment is necessary for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

1. 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 a 75mg capsule twice daily or a 30mg capsule and a 45mg capsule twice daily instead of the recommended dose of this medicine as a suspension. Weight ≤ 15 kg: 30 mg per dose twice daily; suspension (6mg/mL) 5.0 mL per dose twice daily Weight 15 kg<, ≤ 23 kg: 45 mg per dose twice daily; suspension (6mg/mL) 7.5 mL per dose twice daily Weight 23 kg<, ≤ 40 kg: 60 mg per dose twice daily; suspension (6mg/mL) 10.0 mL per dose twice daily Weight > 40 kg: 75 mg per dose twice daily; suspension (6mg/mL) 12.5 mL per dose twice daily Infants aged 2 weeks to under 1 year: The recommended dose for 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 post-conceptional age under 36 weeks. Weight 3 kg: 9 mg per dose twice daily; suspension (6mg/mL) 1.5 mL per dose twice daily Weight 4 kg: 12 mg per dose twice daily; suspension (6mg/mL) 2.0 mL per dose twice daily Weight 5 kg: 15 mg per dose twice daily; suspension (6mg/mL) 2.5 mL per dose twice daily Weight 6 kg: 18 mg per dose twice daily; suspension (6mg/mL) 3.0 mL per dose twice daily Weight 7 kg: 21 mg per dose twice daily; suspension (6mg/mL) 3.5 mL per dose twice daily Weight 8 kg: 24 mg per dose twice daily; suspension (6mg/mL) 4.0 mL per dose twice daily Weight 9 kg: 27 mg per dose twice daily; suspension (6mg/mL) 4.5 mL per dose twice daily Weight 10 kg: 30 mg per dose twice daily; suspension (6mg/mL) 5.0 mL per dose twice daily * This table does not include every possible body weight 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. 2. 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 a 75mg capsule once daily or a 30mg capsule and a 45mg capsule once daily for 10 days instead of the recommended dose of this medicine as a suspension. Weight ≤ 15 kg: 30 mg per dose once daily; suspension (6mg/mL) 5.0 mL per dose once daily Weight 15 kg<, ≤ 23 kg: 45 mg per dose once daily; suspension (6mg/mL) 7.5 mL per dose once daily Weight 23 kg<, ≤ 40 kg: 60 mg per dose once daily; suspension (6mg/mL) 10.0 mL per dose once daily Weight > 40 kg: 75 mg per dose once daily; suspension (6mg/mL) 12.5 mL per dose 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 medication cannot replace influenza vaccination, and the preventive effect lasts only during the medication period. It should only be used for treatment and prevention of influenza in areas where the influenza virus is prevalent. The safety and efficacy of this medication for infections other than influenza A and B have not been established. Particularly in children and adolescents, neurological and psychiatric adverse reactions such as seizures and delirium have been reported, so caregivers should observe carefully for abnormal behaviors. In general, it is not used for children over 10 years old except in special cases. Individuals with allergies to this medication or its components should not take it. Patients with impaired renal function require dosage adjustments, and it is not recommended for patients with end-stage renal failure. Care should be taken when administering to high-risk patients with asthma, chronic bronchitis, or immunosuppressed states. Common side effects during use include nausea, vomiting, and headache, which are mostly transient. Rarely, symptoms such as shock, anaphylaxis, liver function abnormalities, skin rashes, and neuropsychiatric symptoms may occur, so if any abnormal symptoms arise, consult a healthcare provider immediately. Pregnant or nursing women should only take this medication if the therapeutic benefits outweigh the risks and should consult a physician. This medication has not been established for safety and efficacy in children under 1 year of age, so it should be avoided. Elderly patients can take it without special dosage adjustments, but should be carefully monitored considering physical function decline and underlying diseases. If abnormal behaviors or consciousness changes occur during use, the administration should be stopped immediately and informed to a healthcare provider. Drug interactions are relatively few, but caution is needed when used with some drugs that affect renal excretion. This medication may interfere with live vaccines if used concurrently with influenza vaccines, so it should be administered with an interval. Store it out of children's reach, and it is advisable not to change the container. The time of administration should be kept as consistent as possible, and if a dose is missed, take it as soon as possible but skip it if it is within 2 hours of the next dose. No effect on driving or operating machinery has been reported, but caution should be exercised as influenza symptoms themselves may have an effect.

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

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. It is also advisable to store it at room temperature between 1 to 30 degrees Celsius, avoiding extreme heat or cold.

Appearance

A hard capsule with lower gray and upper light yellow parts filled with white or light yellow powder.

Package unit

10 capsules/PTP