Shinpoong Flu Capsule 30 mg (Oseltamivir Phosphate)

Adult dose

1. 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 taken with or without food; taking it with food may improve tolerability in some patients. 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 take this medication using the powder for oral suspension. Patients with renal impairment: No dose 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 dose of 30mg of this medication after each dialysis session to maintain plasma concentrations within the therapeutic range; treatment 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 dose of 30mg 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 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 close contacts of 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 medication have been demonstrated for up to 6 weeks. The preventive effect continues while taking this medication. Patients with renal impairment: No dose 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 once every other day is recommended. Patients receiving intermittent hemodialysis should receive a dose of 30mg 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 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 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

1. 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 twice daily or 30mg capsules and 45mg capsules twice daily instead of the recommended dose of this medication as a suspension. Children 1 to 12 years of age, weight ≤ 15 kg: 30 mg per dose twice daily; suspension (6mg/mL) 5.0 mL per dose twice daily Children 1 to 12 years of age, weight 15 kg<, ≤ 23 kg: 45 mg per dose twice daily; suspension (6mg/mL) 7.5 mL per dose twice daily Children 1 to 12 years of age, weight 23 kg<, ≤ 40 kg: 60 mg per dose twice daily; suspension (6mg/mL) 10.0 mL per dose twice daily Children 1 to 12 years of age, weight > 40 kg: 75 mg per dose twice daily; suspension (6mg/mL) 12.5 mL per dose twice daily Children 2 weeks to less than 1 year of age: The recommended dose for pediatric patients aged 2 weeks to 12 months is 3mg/kg of this medication orally twice daily for 5 days. This does not apply to infants with a postconceptional age of less than 36 weeks. Children 2 weeks to less than 1 year of age, weight 3 kg: 9 mg per dose twice daily; suspension (6mg/mL) 1.5 mL per dose twice daily Children 2 weeks to less than 1 year of age, weight 4 kg: 12 mg per dose twice daily; suspension (6mg/mL) 2.0 mL per dose twice daily Children 2 weeks to less than 1 year of age, weight 5 kg: 15 mg per dose twice daily; suspension (6mg/mL) 2.5 mL per dose twice daily Children 2 weeks to less than 1 year of age, weight 6 kg: 18 mg per dose twice daily; suspension (6mg/mL) 3.0 mL per dose twice daily Children 2 weeks to less than 1 year of age, weight 7 kg: 21 mg per dose twice daily; suspension (6mg/mL) 3.5 mL per dose twice daily Children 2 weeks to less than 1 year of age, weight 8 kg: 24 mg per dose twice daily; suspension (6mg/mL) 4.0 mL per dose twice daily Children 2 weeks to less than 1 year of age, weight 9 kg: 27 mg per dose twice daily; suspension (6mg/mL) 4.5 mL per dose twice daily Children 2 weeks to less than 1 year of age, weight 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 population. A dose of 3mg/kg of this medication is recommended for children under 1 year of age. It is recommended that a pharmacist prepare the suspension of this medication before it is administered to the patient. 2. 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 capsules and 45mg capsules once daily for 10 days instead of the recommended dose of this medication as a suspension. Children 1 to 12 years of age, weight ≤ 15 kg: 30 mg per dose once daily; suspension (6mg/mL) 5.0 mL per dose once daily Children 1 to 12 years of age, weight 15 kg<, ≤ 23 kg: 45 mg per dose once daily; suspension (6mg/mL) 7.5 mL per dose once daily Children 1 to 12 years of age, weight 23 kg<, ≤ 40 kg: 60 mg per dose once daily; suspension (6mg/mL) 10.0 mL per dose once daily Children 1 to 12 years of age, weight > 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 medication before it is administered 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 drug cannot replace influenza vaccination and should be used separately from vaccination. It is effective only against influenza A and B, and its safety and efficacy against other infections have not been confirmed. Particularly in children and adolescents, neuropsychiatric adverse reactions, such as seizures or abnormal behavior, may occur, so careful monitoring is necessary during use. It is generally advisable not to use this drug in children over 10 years old unless there is no specific risk. Due to the risk of abnormal behavior during treatment, caregivers should ensure that pediatric and adolescent patients are not left alone. Patients with hypersensitivity to this drug should not use it, and those with renal impairment may require dosage adjustment or should not be administered the drug. It should be used cautiously in high-risk patients with asthma, chronic bronchitis, or immunosuppression. The most common side effects during use include nausea, vomiting, and headaches, most of which are transient and mild symptoms. Rarely, serious side effects such as skin rashes, liver dysfunction, psychiatric symptoms, and acute renal failure may occur, so if any abnormal symptoms arise, consult a healthcare professional immediately. Women who are pregnant or may become pregnant should carefully consider the therapeutic effects and risks of this drug; breastfeeding women should also consult a physician. The safety and efficacy of this drug in children under 1 year of age have not been established, so its use should be avoided. For the elderly, dosage adjustment is not necessary, but careful monitoring is required due to possible declining physical function and underlying diseases. Reports of serious adverse reactions from overdose are rare, but if suspected, immediate medical attention should be sought. This drug should be kept out of reach of children and should not be transferred to other containers for safety purposes. Drug interactions are not a major concern, but caution may be needed when used with certain drugs, so inform healthcare personnel of any other medications being taken. There have been no reports of effects on driving or operating machinery, but influenza itself may impair these abilities, so caution is advised.

• Cramp
• delirium
• abnormal behavior
• nausea
• vomiting
• headache
• pain
• unstable angina
• anemia
• membranous colitis

This drug should be stored in an airtight container to avoid contact with air or moisture. Additionally, it is important to store it in a cool place below 25 degrees to maintain its effectiveness.

Appearance

Hard capsules in light yellow, containing a white or light yellow powder.

Package unit

10 capsules (10 capsules/PTP x 1)