Entiflu Capsule 45mg (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. Patients with hepatic impairment: 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. 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; 5.0 mL twice daily 15 kg<, ≤ 23 kg: 45 mg twice daily; 7.5 mL twice daily 23 kg<, ≤ 40 kg: 60 mg twice daily; 10.0 mL twice daily > 40 kg: 75 mg twice daily; 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; 1.5 mL twice daily 4 kg: 12 mg twice daily; 2.0 mL twice daily 5 kg: 15 mg twice daily; 2.5 mL twice daily 6 kg: 18 mg twice daily; 3.0 mL twice daily 7 kg: 21 mg twice daily; 3.5 mL twice daily 8 kg: 24 mg twice daily; 4.0 mL twice daily 9 kg: 27 mg twice daily; 4.5 mL twice daily 10 kg: 30 mg twice daily; 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. Prevention of influenza A and influenza B virus infections 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; 5.0 mL once daily 15 kg<, ≤ 23 kg: 45 mg once daily; 7.5 mL once daily 23 kg<, ≤ 40 kg: 60 mg once daily; 10.0 mL once daily > 40 kg: 75 mg once daily; 12.5 mL once daily ※ 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 vaccinations and should be used separately from vaccination. This medication is effective only against influenza A and B and its safety or efficacy has not been confirmed for other infections. Neuropsychiatric side effects such as seizures or delirium have been rarely reported in children and adolescents, and caution should be exercised particularly in children over 10 years old. Behavioral abnormalities may occur during the course of treatment, so caregivers should monitor the patient for at least 2 days and should not leave them alone. Patients with an allergy to this medication or any of its components should not take it. Patients with impaired kidney function may require dose adjustment, and its use is not recommended for patients with end-stage renal failure. Caution should be taken when administering to high-risk patients such as those with asthma, chronic bronchitis, or immune suppression. Common side effects include nausea, vomiting, headache, etc., and are usually temporary. Rarer side effects such as shock, liver function abnormalities, skin rashes, acute kidney failure, and neuropsychiatric disturbances may occur, so if such symptoms develop, medical advice should be sought immediately. Pregnant or breastfeeding women should carefully consider the benefits and risks of treatment, as there is limited data regarding its impact on the fetus or newborn. The safety and efficacy in infants under 1 year have not been sufficiently validated. Elderly patients generally do not require dosage adjustment; however, caution is warranted if there is physical impairment or existing health conditions. In cases of overdose, no specific antidote is available, and management should be based on symptoms. The potential for interactions with other drugs is low, but caution may be needed when used with certain medications. Although there are no reported effects on driving or operating machinery, caution is advised due to the effects of influenza itself. This medication should be stored out of reach of children and should not be transferred to another container.

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

This medication should be stored in a tightly closed container to prevent air or moisture exposure, and it is best stored in a cool place below 25 degrees Celsius. Storing it this way helps maintain the medication's effectiveness for a longer period.

Appearance

Hard capsules with a pale gray upper and lower body containing a white or pale yellow powder

Package unit

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