Flubem Capsule 45 mg (Oseltamivir Phosphate)

Adult dose

Influenza A and influenza B virus infections: Start treatment on the first or second day after the onset of influenza symptoms. This drug may be administered with or without food; tolerability may improve in some patients when taken with food. Adults and adolescents aged 13 years and older: Administer 75 mg of oseltamivir orally 2 times daily for 5 days. Adults and adolescents aged 13 years and older who have difficulty swallowing capsules should use the powder for suspension of this drug. Patients with renal impairment: No dose adjustment is required in patients with a creatinine clearance of 60 mL/min or more. For patients with a creatinine clearance of 30 ~ 60 mL/min, a reduced dose of 30 mg 2 times 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 receiving regular hemodialysis should receive a 30mg dose of this drug after each dialysis session to maintain blood concentrations within the therapeutic range; the treatment period should not exceed 5 days. If influenza symptoms occur during the 48 hours between dialysis sessions, the dose may 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 receiving dialysis (e.g., creatinine clearance less than 10mL/min); therefore, no recommended dose is available for these patients. No dose adjustment is required for treatment in adults 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 75 mg of oseltamivir 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 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 taking this drug. Patients with renal impairment: No dose adjustment is required in patients with a creatinine clearance of 60 mL/min or more. 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 receiving regular hemodialysis should receive a 30mg dose of this drug after every 2 dialysis sessions to maintain blood concentrations within the therapeutic range. The initial dose may be administered before the start of dialysis. For peritoneal dialysis, administration of 30mg of this drug 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. No dose adjustment is required for prevention in adults with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

Treatment of influenza A and influenza B virus infections — Children 1 year to 12 years of age: Pediatric patients weighing > 40 kg who can swallow capsules may take 75mg capsules 2 times daily or 30mg capsules and 45mg capsules 2 times daily instead of the recommended dose of this drug suspension. Treatment — ≤ 15 kg: 30 mg per dose 2 times daily; suspension (6mg/mL) 5.0 mL per dose 2 times daily Treatment — 15 kg<, ≤ 23 kg: 45 mg per dose 2 times daily; suspension (6mg/mL) 7.5 mL per dose 2 times daily Treatment — 23 kg<, ≤ 40 kg: 60 mg per dose 2 times daily; suspension (6mg/mL) 10.0 mL per dose 2 times daily Treatment — > 40 kg: 75 mg per dose 2 times daily; suspension (6mg/mL) 12.5 mL per dose 2 times daily Children 2 weeks to less than 1 year of age: The recommended dose for pediatric patients 2 weeks to 12 months of age is 3mg/kg of this drug orally 2 times daily for 5 days. This does not apply to children with a post-conceptional age of less than 36 weeks. Treatment — 3 kg: 9 mg per dose 2 times daily; suspension (6mg/mL) 1.5 mL per dose 2 times daily Treatment — 4 kg: 12 mg per dose 2 times daily; suspension (6mg/mL) 2.0 mL per dose 2 times daily Treatment — 5 kg: 15 mg per dose 2 times daily; suspension (6mg/mL) 2.5 mL per dose 2 times daily Treatment — 6 kg: 18 mg per dose 2 times daily; suspension (6mg/mL) 3.0 mL per dose 2 times daily Treatment — 7 kg: 21 mg per dose 2 times daily; suspension (6mg/mL) 3.5 mL per dose 2 times daily Treatment — 8 kg: 24 mg per dose 2 times daily; suspension (6mg/mL) 4.0 mL per dose 2 times daily Treatment — 9 kg: 27 mg per dose 2 times daily; suspension (6mg/mL) 4.5 mL per dose 2 times daily Treatment — 10 kg: 30 mg per dose 2 times daily; suspension (6mg/mL) 5.0 mL per dose 2 times daily Children under 1 year of age are recommended to take 3mg/kg of this drug. Prevention of influenza A and influenza B virus infections — Children 1 year to 12 years of age: Pediatric patients weighing > 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 drug suspension. Prevention — ≤ 15 kg: 30 mg per dose once daily; suspension (6mg/mL) 5.0 mL per dose once daily Prevention — 15 kg<, ≤ 23 kg: 45 mg per dose once daily; suspension (6mg/mL) 7.5 mL per dose once daily Prevention — 23 kg<, ≤ 40 kg: 60 mg per dose once daily; suspension (6mg/mL) 10.0 mL per dose once daily Prevention — > 40 kg: 75 mg per dose once daily; suspension (6mg/mL) 12.5 mL per dose once daily The safety and efficacy of preventing influenza A and B virus infections in children under 1 year of age have not been evaluated.

This medication is used for treating or preventing influenza but cannot replace influenza vaccination. It is advisable to use this medication only during periods when influenza viruses are prevalent. Its safety and efficacy have not been confirmed for infections other than influenza A and B. Close observation is required when administering this medication to children and adolescents as neuropsychiatric side effects, such as seizures or abnormal behavior, may occur. Especially in children over the age of 10, there is a reported risk of accidents due to abnormal behavior, and it should not be used except in special cases. Since there is a risk of abnormal behavior while taking this medication, caregivers should closely monitor children and adolescents for a minimum of 2 days for safety. Patients with hypersensitivity to this medication or its components should not take it. Patients with impaired kidney function require dosage adjustments, and this medication is not recommended for patients with end-stage renal failure. Caution should be exercised in high-risk patients with asthma, chronic bronchitis, or immunosuppressed states. The most common side effects include nausea, vomiting, and headache, which are mostly temporary. Rarely, symptoms such as shock, anaphylaxis, liver function abnormalities, skin rash, and neuropsychiatric phenomena may occur, and if these symptoms arise, consult a physician immediately. Pregnant or breastfeeding women should only use this medication when the benefits of treatment outweigh the risks, as its safety is not fully established. Safety and efficacy for children under 1 year of age have not been confirmed, so its use is not recommended. Elderly patients can use it without special dosage adjustments, but careful monitoring is required due to physical functioning decline. This medication has a low potential for interaction with other drugs, but caution may be needed when used in combination with specific medications. It is essential to start treatment as early as possible and adhere to the dosing schedule when taking the medication. Caution is advised while driving or operating machinery due to potential impairment caused by influenza itself. This medication should be stored out of reach of children, and it is advisable not to transfer it to other containers.

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

This medication may be sensitive to air and moisture, so it should be stored in a tightly closed container. The storage temperature should be maintained at room temperature between 1 and 30 degrees Celsius. This way, the efficacy and safety of the medication can be well maintained.

Appearance

A hard capsule with gray upper and lower parts containing white or light yellow powder

Package unit

10 capsules/PTP