Genuone Oseltamivir Capsule 45mg (Oseltamivir Phosphate)

Adult dose

1. Treatment of influenza A and influenza B virus infections: Begin 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. 1) 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. 4) Patients with renal impairment: No dosage adjustment is needed 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 undergoing periodic hemodialysis should receive a 30mg dose of this medicine after each dialysis session to maintain plasma concentrations within the therapeutic range; treatment should not exceed 5 days. If influenza symptoms occur during the 48 hours between dialysis sessions, the dose may also 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 undergoing dialysis (e.g., creatinine clearance below 10mL/min); therefore, no recommended dose is available for these patients. 5) Patients with hepatic impairment: No dosage adjustment is needed for treatment in adults with mild to moderate hepatic impairment (Child-Pugh score ≤ 9). 2. Prevention of influenza A and influenza B virus infections 1) Adults and adolescents aged 13 years and older: For persons in close contact with an infected individual, administer oseltamivir 75 mg orally once daily for 10 days. Begin 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. 3) Patients with renal impairment: No dosage adjustment is needed 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 undergoing periodic hemodialysis should receive a 30mg dose of this medicine after every 2 dialysis sessions to maintain plasma concentrations within the therapeutic range. The first dose may also be administered before the start of dialysis. For peritoneal dialysis, administration of 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 undergoing dialysis (e.g., creatinine clearance below 10mL/min); therefore, no recommended dose is available for these patients. 4) Patients with hepatic impairment: No dosage adjustment is needed for prevention in adults with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

1) Children aged 1 to 12 years: 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 per dose twice daily; suspension (6mg/mL) 5.0 mL per dose twice daily 15 kg<, ≤ 23 kg — 45 mg per dose twice daily; suspension (6mg/mL) 7.5 mL per dose twice daily 23 kg<, ≤ 40 kg — 60 mg per dose twice daily; suspension (6mg/mL) 10.0 mL per dose twice daily > 40 kg — 75 mg per dose twice daily; suspension (6mg/mL) 12.5 mL per dose twice daily 3) Infants aged 2 weeks to less than 1 year: The recommended dose for pediatric 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 postconceptional age of less than 36 weeks. 3 kg — 9 mg per dose twice daily; suspension (6mg/mL) 1.5 mL per dose twice daily 4 kg — 12 mg per dose twice daily; suspension (6mg/mL) 2.0 mL per dose twice daily 5 kg — 15 mg per dose twice daily; suspension (6mg/mL) 2.5 mL per dose twice daily 6 kg — 18 mg per dose twice daily; suspension (6mg/mL) 3.0 mL per dose twice daily 7 kg — 21 mg per dose twice daily; suspension (6mg/mL) 3.5 mL per dose twice daily 8 kg — 24 mg per dose twice daily; suspension (6mg/mL) 4.0 mL per dose twice daily 9 kg — 27 mg per dose twice daily; suspension (6mg/mL) 4.5 mL per dose twice daily 10 kg — 30 mg per dose twice daily; suspension (6mg/mL) 5.0 mL per dose 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 administration to the patient. 2) Children aged 1 to 12 years: 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 per dose once daily; suspension (6mg/mL) 5.0 mL per dose once daily 15 kg<, ≤ 23 kg — 45 mg per dose once daily; suspension (6mg/mL) 7.5 mL per dose once daily 23 kg<, ≤ 40 kg — 60 mg per dose once daily; suspension (6mg/mL) 10.0 mL per dose once daily > 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 administration 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 is used for the treatment and prevention of influenza virus infections, but cannot replace influenza vaccination and should be administered separately from vaccinations. This drug has been proven effective only against influenza A and B viruses, and its safety and efficacy for other types of infections have not been confirmed. Particularly in children and adolescents, neuropsychiatric adverse reactions such as seizures or delirium have been reported during the use of this medication, therefore caution should be exercised in this age group, and caregivers should closely monitor for abnormal behavior. Individuals who are allergic to this medication or any of its components should not take it. Patients with reduced kidney function or those undergoing dialysis require dosage adjustment, and it is not recommended for patients with end-stage renal failure. Care should be taken when administering this medication to patients with chronic respiratory diseases such as asthma or chronic bronchitis or those in an immunosuppressed state. Common side effects may include nausea, vomiting, and headache, which are mostly transient and mild. Serious side effects may rarely occur, including shock, anaphylaxis, liver dysfunction, skin rashes, and neuropsychiatric symptoms, so if any abnormal symptoms occur, it is essential to consult with healthcare professionals immediately. Due to limited data on the effects of this medication on the fetus or infant, its use in pregnant or breastfeeding women should only be considered when the therapeutic benefits outweigh the risks. The safety and efficacy for children under 1 year of age have not been sufficiently studied, so caution is advised when using this drug in this age group. The elderly often have reduced physical functions and multiple comorbid conditions; therefore, careful observation is needed, but special dosage adjustments are generally not necessary. There is no specific treatment for overdose, but if adverse reactions occur, immediate medical assistance should be sought. This medication has a low potential for interaction with other drugs, but caution is advised when used in combination with certain medications that affect renal excretion. During treatment, caution should be exercised while driving or operating machinery due to potential symptoms caused by the influenza itself. Keep out of reach of children and do not transfer to other containers.

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

This medication should be stored in a tightly sealed container to prevent air or moisture from entering. Additionally, it is safest to store it at room temperature between 1°C and 30°C.

Appearance

A hard capsule with a gray upper and lower part containing a white or pale yellow powder

Package unit

10 capsules/PTP