Viselflu Capsule 75 mg (Oseltamivir Phosphate)

Adult dose

1. Influenza A and influenza B virus infections: Treatment should be initiated on the first or second day after the onset of influenza symptoms. This drug may be administered regardless of food intake, and tolerability may improve in some patients when it is taken with food. 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 drug as powder for suspension. 4) Patients with renal impairment No dose adjustment is required for patients with a creatinine clearance of 60 mL/min or greater. For patients with a creatinine clearance of 30 ~ 60 mL/min, a reduced dose of 30 mg twice daily for 5 days is recommended. For patients with a creatinine clearance of 10 ~ 30 mL/min, a reduced dose of 30 mg once daily for 5 days is recommended. Patients undergoing regular hemodialysis should receive a 30mg dose of this drug after each dialysis session to maintain plasma concentrations within the therapeutic range, and the duration of treatment should not exceed 5 days. If influenza symptoms develop during the 48 hours between dialysis sessions, the drug may also be administered before the start of dialysis. For peritoneal dialysis, a single 30mg dose of this drug 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 less than 10mL/min); therefore, no recommended dose is available for these patients. 5) Patients with hepatic impairment No dose adjustment is required for treatment of adult patients 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 those in close contact with 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 epidemic is 75 mg once daily. The safety and efficacy of this drug have been demonstrated for up to 6 weeks. The preventive effect continues while this drug is being taken. 3) Patients with renal impairment No dose adjustment is required for patients with a creatinine clearance of 60 mL/min or greater. For patients with a creatinine clearance of 30 ～ 60 mL/min, a reduced dose of 30 mg once daily is recommended. For patients with a creatinine clearance of 10 ～ 30 mL/min, a reduced dose of 30 mg once daily every other day is recommended. Patients undergoing regular hemodialysis should receive a 30mg dose of this drug after every 2 dialysis sessions to maintain plasma concentrations within the therapeutic range. The initial dose may also be administered before the start of dialysis. For peritoneal dialysis, administration of 30mg of this drug once weekly 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 less than 10mL/min); therefore, no recommended dose is available for these patients. 4) Patients with hepatic impairment No dose adjustment is required for prevention in adult patients 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 75 mg capsules twice daily or 30 mg and 45 mg capsules twice daily instead of the recommended dose of this drug 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 3) 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 drug 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 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 body weights in this patient group. A dose of 3mg/kg of this drug is recommended for children under 1 year of age. It is recommended that a pharmacist prepare the suspension of this drug before it is administered to the patient. 2) Children aged 1 to 12 years: Pediatric patients weighing more than 40 kg who can swallow capsules may take 75 mg capsules once daily or 30 mg and 45 mg capsules once daily for 10 days instead of the recommended dose of this drug 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 It is recommended that a pharmacist prepare the suspension of this drug before it is administered to the patient. ※ The safety and efficacy of this drug for the prevention of influenza A and B virus infections in children under 1 year of age have not been evaluated.

This medication cannot replace influenza vaccination and should be used separately from vaccination. Its efficacy has been proven only against Influenza A and B viruses, and safety and effectiveness have not been confirmed for other infections. In particular, neuropsychiatric adverse reactions have been reported in children and adolescents, so unusual behavior should be closely monitored. It is generally not recommended for children over the age of 10 except in special circumstances. Patients with a known allergy to this medication should not be administered it. Dose adjustment is needed for patients with poor renal function, and it is not recommended for patients with end-stage renal failure. Although common side effects include nausea, vomiting, headache, etc., most are temporary. Rarely, allergic reactions, liver dysfunction, skin abnormalities, acute renal failure, and neurological symptoms may occur, so if any unusual symptoms arise, consult a doctor immediately. Pregnant or breastfeeding women should carefully consider the benefits and risks of using this medication. Safety and efficacy in children under 1 year of age have not been established, so it is best to avoid its use. Elderly patients typically do not require dose adjustment, but careful monitoring is advised considering physical decline. No specific treatment exists for overdose, but if adverse reactions occur, immediate medical attention is necessary. It is important to store this medication out of reach of children and not to store it in a different container. The potential for drug interactions is low; however, caution is advised when used concurrently with certain medications, so inform healthcare providers of any ongoing medications. No effects on driving or machine operating have been reported, but be aware of possible impairment from influenza itself.

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

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. Additionally, it is recommended to store it at a cool temperature below 25 degrees Celsius. This helps maintain the effectiveness of the medication for an extended period.

Appearance

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

Package unit

10 capsules/PTP×1