Antiflu Capsule 75 mg (Oseltamivir Phosphate)

Adult dose

1. Influenza A and influenza B virus infections: Start 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 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 an oral suspension. Patients with renal impairment: No dosage adjustment is necessary 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 receiving intermittent hemodialysis should receive a 30mg dose of this medicine after each dialysis session to maintain therapeutic plasma concentrations; treatment should not exceed 5 days. If influenza symptoms develop during the 48 hours between dialysis sessions, the dose may be administered before the start of dialysis. 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 dosage adjustment is necessary for treatment in adults with mild to moderate hepatic impairment (Child-Pugh score ≤ 9). 2. Prevention of influenza A and influenza B virus infections Adults and adolescents 13 years of age and older: For individuals in close contact with 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 protective effect continues while taking this medicine. Patients with renal impairment: No dosage adjustment is necessary 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 every other day is recommended. Patients receiving intermittent hemodialysis should receive a 30mg dose of this medicine after every 2 dialysis sessions to maintain therapeutic plasma concentrations. The initial dose may also be administered before the start of dialysis. For peritoneal dialysis, 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 receiving 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 necessary for prevention in adults with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

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. ≤ 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 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 post-conceptional 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 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. 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. ≤ 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 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 have not been evaluated in children under 1 year of age.

This medication is used to treat or prevent influenza virus infections. However, it cannot replace the influenza vaccine and should be used separately from vaccination. This medication is effective only against Influenza A and B viruses, and its safety and efficacy have not been confirmed for other types of infections. Especially in children and adolescents, abnormal behaviors or neuropsychiatric reactions have been reported after taking this medication, so careful observation for unusual behaviors is necessary during treatment. This medication is generally not used in children over 10 years old except in special circumstances. While taking this medication, it is essential to have supervision to avoid being alone. Patients with hypersensitivity or allergies to any component of this medication should not take it. Patients with impaired renal function may need dose adjustments, and it is not recommended for those with end-stage renal failure. High-risk groups such as asthmatics, chronic bronchitis patients, and immunocompromised individuals should be administered with caution. Common side effects include nausea, vomiting, and headaches, which are mostly temporary and mild. Rarely, symptoms such as shock, anaphylaxis, liver function abnormalities, skin reactions, acute renal failure, and neuropsychiatric symptoms may occur, requiring immediate consultation with healthcare professionals if any unusual symptoms appear. Pregnant or nursing women should carefully consider the risks and benefits of using this medication, as it may be excreted in breast milk and thus need caution for nursing mothers. Safety and efficacy in infants under 1 year are not established, and its use should be avoided. Elderly patients do not require special dose adjustments, but those with reduced bodily functions should be carefully monitored. Drug interactions are not widely known, but caution is advised when taking certain medications concurrently, and it is crucial to inform healthcare professionals about any current medications. If any unusual behaviors, neurological changes, skin rashes, or breathing difficulties occur while taking this medication, it should be stopped immediately, and healthcare professionals should be consulted. This medication should be kept out of the reach of children and should not be stored in a different container.

• Seizures
• delirium
• abnormal behavior
• nausea
• vomiting
• headache
• pain
• unstable angina
• anemia
• membranous colitis

This medication should be stored in a tightly closed container to prevent exposure to air or moisture, and it is important to maintain a temperature below 25 degrees. By keeping the proper temperature and storage conditions, the effectiveness and safety of the medication can be preserved.

Appearance

A hard capsule with a pale yellow upper part and light grey lower part containing white or light yellow powder.

Package unit

10 capsules/PTP [(10 capsules/PTP x 1)]