Eziphrusan 45 mg (Oseltamivir Phosphate)

Adult dose

Treatment of influenza A and influenza B virus infections Initiate treatment on the first or second day after the onset of influenza symptoms. This medication 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 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 medication. Patients with renal impairment: No dose adjustment is necessary for patients with creatinine clearance of 60 mL/min or higher. 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 regular hemodialysis should receive a 30mg dose of this medication after each dialysis session to maintain plasma concentrations within the therapeutic range; the duration of administration should not exceed 5 days. If influenza symptoms develop during the 48 hours between dialysis sessions, the dose may also be administered before dialysis begins. For peritoneal dialysis, a single 30mg dose of this medication 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 less than 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). 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. Initiate 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 medication have been demonstrated for up to 6 weeks. The preventive effect continues while this medication is being taken. Patients with renal impairment: No dose adjustment is necessary for patients with creatinine clearance of 60 mL/min or higher. 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 once daily every other day is recommended. Patients receiving regular hemodialysis should receive a 30mg dose of this medication 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, administration of 30mg of this medication after dialysis once a week 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 less than 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

Treatment of influenza A and influenza B virus infections Children aged 1 to 12 years: Pediatric patients weighing more than 40 kg who are able to 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. ≤ 15 kg: 30 mg (sachet) twice daily 15 kg<, ≤ 23 kg: 45 mg (sachet) twice daily 23 kg<, ≤ 40 kg: 60 mg (2 sachets of 30mg) twice daily > 40 kg: 75 mg (sachet) twice daily Children aged 2 weeks to under 1 year: The recommended dose for pediatric patients aged 2 weeks to 12 months is 3mg/kg of this medicine, administered orally twice daily for 5 days. This does not apply to children with a postconceptional age of less than 36 weeks. However, pediatric patients who have difficulty taking this medicine as a powder should be given the suspension. 3 kg: 9 mg twice daily; suspension (6mg/mL) dose of 1.5mL twice daily 4 kg: 12 mg twice daily; suspension (6mg/mL) dose of 2.0mL twice daily 5 kg: 15 mg twice daily; suspension (6mg/mL) dose of 2.5mL twice daily 6 kg: 18 mg twice daily; suspension (6mg/mL) dose of 3.0mL twice daily 7 kg: 21 mg twice daily; suspension (6mg/mL) dose of 3.5mL twice daily 8 kg: 24 mg twice daily; suspension (6mg/mL) dose of 4.0mL twice daily 9 kg: 27 mg twice daily; suspension (6mg/mL) dose of 4.5mL twice daily 10 kg: 30 mg twice daily; suspension (6mg/mL) dose of 5.0mL 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 aged 1 to 12 years: Pediatric patients weighing more than 40 kg who are able to swallow capsules may take a 75mg capsule once daily or a 30mg capsule and a 45mg capsule once daily for 10 days instead of this medicine. ≤ 15 kg: 30 mg (sachet) once daily 15 kg<, ≤ 23 kg: 45 mg (sachet) once daily 23 kg<, ≤ 40 kg: 60 mg (2 sachets of 30mg) once daily > 40 kg: 75 mg (sachet) once daily ※ The safety and efficacy of this medicine for preventing influenza A and B virus infections in children under 1 year of age have not been evaluated.

This medication cannot replace influenza vaccination and is to be used for treatment and prevention only during the period when the influenza virus is circulating. This medication has only been proven effective for influenza A and B, and its safety and efficacy have not been confirmed for other infections. Particularly in children and adolescents, neuropsychiatric adverse reactions, such as seizures, delirium, and abnormal behavior, have been reported rarely, so patients in this age group should be closely monitored for abnormal behavior after taking this medication. Children over 10 years of age are generally not recommended to use this medication unless they are in a high-risk group. During treatment with this medication, both patients and guardians should be aware of the risk of abnormal behavior, and care should be taken not to leave the patient alone for at least two days. Patients with hypersensitivity to this medication or its components should not take it. Patients with renal impairment or dialysis patients require dosage adjustment, and it is not recommended for patients with end-stage renal failure. Caution should be exercised when administering to high-risk patients with asthma, chronic bronchitis, or immune suppression. Common side effects during treatment include nausea, vomiting, headache, and pain, which usually appear temporarily and resolve quickly. Rarely, serious side effects such as shock, anaphylaxis, liver dysfunction, skin rashes, acute kidney failure, blood abnormalities, and neuropsychiatric symptoms may occur; therefore, if any unusual symptoms appear, immediate consultation with a healthcare provider is required. This medication does not replace the influenza vaccine, and it is important to use it in conjunction with vaccination. Women who are pregnant or breastfeeding should carefully consider the risks and benefits of using this medication and consult with healthcare providers if necessary. The safety and efficacy of this medication in children under 1 year of age have not been established, so its use should be avoided. Elderly patients do not require dosage adjustments but should be closely monitored considering the potential decline in physical function. In cases of overdose, immediate medical attention should be sought for appropriate measures. This medication contains sorbitol, so it is not suitable for patients with hereditary fructose intolerance. Drug interactions are relatively few, but caution may be needed when combined with certain medications, so if patients are taking other medications, they should inform healthcare providers. The effect of this medication on driving or operating machinery has not been reported; however, the influence of influenza itself should be taken into consideration.

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

This medication may be sensitive to air and moisture, so it must be stored in a tightly closed container. The storage temperature should be maintained at room temperature between 1 degree and 30 degrees Celsius. This will help preserve the drug's effectiveness and safety for a long time.

Appearance

White or yellowish powder

Package unit

10 packets per box