Entiflu Capsule 30 mg (Oseltamivir Phosphate)

Adult dose

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. No dosage adjustment is necessary for treatment in adults 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 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. 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 cannot replace influenza vaccination and should be used separately from vaccination. This drug has only been proven effective against influenza A and B, and its safety and efficacy against other infections have not been confirmed. Rarely, neuropsychiatric side effects such as seizures or abnormal behavior may occur in children and adolescents; therefore, caregivers should monitor for such behaviors. This medication is generally not recommended for children over the age of 10, and if used, they should not be left alone by caregivers for 2 days. Individuals with allergies to this medication or its components should not take it. Patients with impaired renal function may require dose adjustments, and it is not recommended for patients with end-stage renal failure. Caution should be exercised in high-risk patients with asthma, chronic bronchitis, or immunocompromised states. Common side effects include nausea, vomiting, and headache, which are usually mild and transient. Rarely, allergic reactions, abnormal liver function, skin rashes, and neuropsychiatric symptoms may occur; any unusual symptoms should be reported to a doctor immediately. The safety of this medication in pregnant or breastfeeding women has not been well established, and it should only be used if the benefits outweigh the risks. This medication has not been established as safe and effective for children under 1 year, and its use in this age group is not recommended. Older adults can use this product without special dosage adjustments, but careful observation is needed if there is any decline in bodily function or multiple health issues. The possibility of interactions with other medications is low; however, caution may be warranted when used in combination with certain medications. When taking the medication, adhere to the prescribed dosage and schedule, and if a dose is missed, take it as soon as possible, but skip if the next dose time is very close. There have been no reports of special effects when driving or operating machinery, but caution is advised due to symptoms caused by influenza itself. When storing, keep out of reach of children and do not transfer to another container.

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

This medication should be stored in a sealed container to protect it from air and moisture and kept at a cool temperature below 25 degrees Celsius. This will help maintain the medication's effectiveness for an extended period.

Appearance

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

Package unit

10 capsules/PTP [(10 capsules/PTPx1)]