Samjin Flu Suspension Powder 6 mg/mL (Oseltamivir Phosphate)

Adult dose

Influenza A and influenza B virus infections: Initiate treatment on the first or second day after influenza symptoms appear. This medicine may be administered with or without food; some patients may tolerate it better when taken with food. 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. Patients with renal impairment (treatment): No dose adjustment is necessary for patients with creatinine clearance of 60 mL/min or more. 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 medicine after each dialysis session to maintain therapeutic blood concentrations, and the treatment period 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 medicine 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 (treatment): 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 medicine have been demonstrated for up to 6 weeks. The preventive effect continues while taking this medicine. Patients with renal impairment (prevention): No dose adjustment is necessary for patients with creatinine clearance of 60 mL/min or more. 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 every other day is recommended. Patients receiving regular hemodialysis should receive a 30mg dose of this medicine after every 2 dialysis sessions to maintain therapeutic blood concentrations. The initial dose may also be administered before dialysis begins. For peritoneal dialysis, a 30mg dose 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 receiving dialysis (e.g., creatinine clearance less than 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment (prevention): No dose adjustment is necessary for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

Children aged 1 year to 12 years: Pediatric patients weighing more than 40 kg who can 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. Treatment, weight ≤ 15 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily Treatment, weight 15 kg<, ≤ 23 kg: 45 mg twice daily; suspension (6mg/mL) 7.5 mL twice daily Treatment, weight 23 kg<, ≤ 40 kg: 60 mg twice daily; suspension (6mg/mL) 10.0 mL twice daily Treatment, weight > 40 kg: 75 mg twice daily; suspension (6mg/mL) 12.5 mL 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 infants with a postconceptional age of less than 36 weeks. Treatment, weight 3 kg: 9 mg twice daily; suspension (6mg/mL) 1.5 mL twice daily Treatment, weight 4 kg: 12 mg twice daily; suspension (6mg/mL) 2.0 mL twice daily Treatment, weight 5 kg: 15 mg twice daily; suspension (6mg/mL) 2.5 mL twice daily Treatment, weight 6 kg: 18 mg twice daily; suspension (6mg/mL) 3.0 mL twice daily Treatment, weight 7 kg: 21 mg twice daily; suspension (6mg/mL) 3.5 mL twice daily Treatment, weight 8 kg: 24 mg twice daily; suspension (6mg/mL) 4.0 mL twice daily Treatment, weight 9 kg: 27 mg twice daily; suspension (6mg/mL) 4.5 mL twice daily Treatment, weight 10 kg: 30 mg twice daily; suspension (6mg/mL) 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 medicine is recommended for children under 1 year of age. It is recommended that a pharmacist prepare the suspension of this medicine before it is administered to the patient. Prophylaxis, children aged 1 year to 12 years: Pediatric patients weighing more than 40 kg who can swallow capsules may take a 75mg capsule once daily or a 30mg capsule and a 45mg capsule once daily for 10 days instead of the recommended dose of this medicine. Prophylaxis, weight ≤ 15 kg: 30 mg once daily; suspension (6mg/mL) 5.0 mL once daily Prophylaxis, weight 15 kg<, ≤ 23 kg: 45 mg once daily; suspension (6mg/mL) 7.5 mL once daily Prophylaxis, weight 23 kg<, ≤ 40 kg: 60 mg once daily; suspension (6mg/mL) 10.0 mL once daily Prophylaxis, weight > 40 kg: 75 mg once daily; suspension (6mg/mL) 12.5 mL once daily It is recommended that a pharmacist prepare the suspension of this medicine before it is administered to the patient. ※ The safety and efficacy of this medicine for the prevention of influenza A and B virus infections in children under 1 year of age have not been evaluated.

This medication should not be used as a substitute for the influenza vaccine and should be used separately from vaccinations. It has been confirmed effective only for influenza A and B, and its safety or effectiveness has not been verified for other infections. Caution is warranted when administering to children and adolescents, as neuropsychiatric symptoms can occur, especially in children over 10 years old, and guardians should monitor for unusual behaviors immediately. Patients with known hypersensitivity to this medication or its components should not use it. Dose adjustment is necessary for patients with reduced renal function or those undergoing dialysis, and it is not recommended for patients with end-stage renal failure. Careful administration is advised for high-risk patients with asthma, chronic bronchitis, or immunosuppressive conditions. Common side effects include nausea, vomiting, and headaches, while rare side effects can include skin rashes, hepatic dysfunction, and neuropsychiatric symptoms; any abnormal symptoms should prompt immediate consultation with a physician. Extremely rare occurrences of shock or anaphylactic reactions may require immediate discontinuation and emergency care if allergy symptoms arise. In pregnant or nursing women, due to insufficient data on potential effects on the fetus or infant, this medication should only be used if the therapeutic benefits outweigh the risks after consultation with healthcare providers. For pediatrics, it is not recommended for those under 1 year of age due to lack of established safety and efficacy, and those over this age should be administered per physician's instructions. Elderly patients should be monitored carefully due to diminished bodily functions, though separate dose adjustments are not required. This medication contains sorbitol, so it is advisable for patients with hereditary fructose intolerance to refrain from taking it. Drug interactions are limited, but caution is necessary when taking medications that may affect renal excretion concurrently. During treatment, patients should be careful while driving or operating machinery, as attention may be diminished due to influenza itself. This medication should be prepared as a suspension correctly and stored in accordance with refrigeration requirements or consumed within the specified time after preparation. Any unusual behaviors, skin rashes, shortness of breath, severe vomiting, or other symptoms while taking this medication should be reported immediately to healthcare professionals.

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

This medication should be stored in a tightly sealed container to protect it from air and moisture. The recommended storage temperature is between 1 to 30 degrees Celsius.

Appearance

A suspension formulation in brown glass bottles, containing white or light yellow granules to be dissolved before use

Package unit

10 grams/bottle [50 mL]