Shinpoong Flu Capsule 45 mg (Oseltamivir Phosphate)

Adult dose

Treatment: 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. Treatment, 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. Treatment, patients with hepatic impairment: No dose adjustment is necessary for treatment of adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9). Prevention, 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. Prevention, 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. Prevention, 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, 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. Treatment, weight ≤ 15 kg: 30 mg per dose twice daily; suspension (6mg/mL) 5.0 mL per dose twice daily, for 5 days Treatment, weight 15 kg<, ≤ 23 kg: 45 mg per dose twice daily; suspension (6mg/mL) 7.5 mL per dose twice daily, for 5 days Treatment, weight 23 kg<, ≤ 40 kg: 60 mg per dose twice daily; suspension (6mg/mL) 10.0 mL per dose twice daily, for 5 days Treatment, weight > 40 kg: 75 mg per dose twice daily; suspension (6mg/mL) 12.5 mL per dose twice daily, for 5 days Treatment, 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. Treatment, weight 3 kg: 9 mg per dose twice daily; suspension (6mg/mL) 1.5 mL per dose twice daily, for 5 days Treatment, weight 4 kg: 12 mg per dose twice daily; suspension (6mg/mL) 2.0 mL per dose twice daily, for 5 days Treatment, weight 5 kg: 15 mg per dose twice daily; suspension (6mg/mL) 2.5 mL per dose twice daily, for 5 days Treatment, weight 6 kg: 18 mg per dose twice daily; suspension (6mg/mL) 3.0 mL per dose twice daily, for 5 days Treatment, weight 7 kg: 21 mg per dose twice daily; suspension (6mg/mL) 3.5 mL per dose twice daily, for 5 days Treatment, weight 8 kg: 24 mg per dose twice daily; suspension (6mg/mL) 4.0 mL per dose twice daily, for 5 days Treatment, weight 9 kg: 27 mg per dose twice daily; suspension (6mg/mL) 4.5 mL per dose twice daily, for 5 days Treatment, weight 10 kg: 30 mg per dose twice daily; suspension (6mg/mL) 5.0 mL per dose twice daily, for 5 days 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. Prevention, 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. Prevention, weight ≤ 15 kg: 30 mg per dose once daily; suspension (6mg/mL) 5.0 mL per dose once daily, for 10 days Prevention, weight 15 kg<, ≤ 23 kg: 45 mg per dose once daily; suspension (6mg/mL) 7.5 mL per dose once daily, for 10 days Prevention, weight 23 kg<, ≤ 40 kg: 60 mg per dose once daily; suspension (6mg/mL) 10.0 mL per dose once daily, for 10 days Prevention, weight > 40 kg: 75 mg per dose once daily; suspension (6mg/mL) 12.5 mL per dose once daily, for 10 days It is recommended that a pharmacist prepare the suspension of this medication before it is administered to the patient. The safety and efficacy of this medication for prevention of influenza A and B virus infections in children under 1 year of age have not been evaluated.

This medicine cannot replace influenza vaccination and should only be used for treatment and prevention in areas where influenza virus is prevalent. The safety and efficacy of this medicine have not been established for infections outside of influenza A and B viruses. Close monitoring is required when children and adolescents take this medicine, as neuropsychiatric adverse reactions, such as seizures or abnormal behaviors, may occur. In particular, children or adolescents over 10 years of age have a risk of accidents due to abnormal behaviors; therefore, it is generally not used except in special cases. Patients with renal failure should have their doses adjusted, 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, and immunosuppressed states. During treatment with this medicine, side effects such as nausea, vomiting, and headache are common but mostly temporary. However, severe side effects such as shock, anaphylaxis, hepatitis, skin mucosal syndrome, acute renal failure, and neuropsychiatric abnormalities may rarely occur, so patients should inform their doctor immediately if symptoms arise. Use of this medicine should only occur when the benefits to the fetus or infant exceed the potential risks, as its effects during pregnancy or breastfeeding are not clearly established. The safety and efficacy of this medicine for children under 1 year have not been established, and its use in this age group is not recommended. Elderly patients generally do not need dose adjustments, but careful monitoring is required due to potential declines in physical function and underlying diseases. While taking this medicine, consider the possibility of impaired ability to operate vehicles or machinery due to influenza symptoms. Drug interactions are rare, but caution is advised when used with certain drugs that share renal excretion pathways. This medicine can be administered concurrently with influenza vaccines, but there should be an interval before live vaccines. If abnormal behaviors or neurological symptoms occur during treatment with this medicine, inform healthcare professionals immediately and discontinue treatment. Store out of reach of children and avoid transferring to other containers.

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

This medicine should be stored in a tightly sealed container to prevent air and moisture from entering, and it should be kept in a cool place below 25 degrees Celsius to maintain its efficacy and safety.

Appearance

Gray hard capsules containing white or light yellow powder

Package unit

10 capsules (10 capsules/PTP x 1)