Fluviem Capsule 30mg (Oseltamivir Phosphate)

Adult dose

Treatment of 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 (treatment): 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. Patients with hepatic impairment (treatment): 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 (prevention): 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. Patients with hepatic impairment (prevention): 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. Body weight ≤ 15 kg: 30 mg per dose 2 times daily; suspension (6mg/mL) 5.0 mL per dose 2 times daily (recommended dose for 5 days) Body weight 15 kg<, ≤ 23 kg: 45 mg per dose 2 times daily; suspension (6mg/mL) 7.5 mL per dose 2 times daily (recommended dose for 5 days) Body weight 23 kg<, ≤ 40 kg: 60 mg per dose 2 times daily; suspension (6mg/mL) 10.0 mL per dose 2 times daily (recommended dose for 5 days) Body weight > 40 kg: 75 mg per dose 2 times daily; suspension (6mg/mL) 12.5 mL per dose 2 times daily (recommended dose for 5 days) 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. Body weight 3 kg: 9 mg per dose 2 times daily; suspension (6mg/mL) 1.5 mL per dose 2 times daily (recommended dose for 5 days) Body weight 4 kg: 12 mg per dose 2 times daily; suspension (6mg/mL) 2.0 mL per dose 2 times daily (recommended dose for 5 days) Body weight 5 kg: 15 mg per dose 2 times daily; suspension (6mg/mL) 2.5 mL per dose 2 times daily (recommended dose for 5 days) Body weight 6 kg: 18 mg per dose 2 times daily; suspension (6mg/mL) 3.0 mL per dose 2 times daily (recommended dose for 5 days) Body weight 7 kg: 21 mg per dose 2 times daily; suspension (6mg/mL) 3.5 mL per dose 2 times daily (recommended dose for 5 days) Body weight 8 kg: 24 mg per dose 2 times daily; suspension (6mg/mL) 4.0 mL per dose 2 times daily (recommended dose for 5 days) Body weight 9 kg: 27 mg per dose 2 times daily; suspension (6mg/mL) 4.5 mL per dose 2 times daily (recommended dose for 5 days) Body weight 10 kg: 30 mg per dose 2 times daily; suspension (6mg/mL) 5.0 mL per dose 2 times daily (recommended dose for 5 days) * This table does not include all possible body weights in this patient group. Children under 1 year of age are recommended to take 3mg/kg of this drug. It is recommended that a pharmacist prepare the suspension of this drug before administration to the patient. 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. Body weight ≤ 15 kg: 30 mg per dose once daily; suspension (6mg/mL) 5.0 mL per dose once daily (recommended dose for 10 days) Body weight 15 kg<, ≤ 23 kg: 45 mg per dose once daily; suspension (6mg/mL) 7.5 mL per dose once daily (recommended dose for 10 days) Body weight 23 kg<, ≤ 40 kg: 60 mg per dose once daily; suspension (6mg/mL) 10.0 mL per dose once daily (recommended dose for 10 days) Body weight > 40 kg: 75 mg per dose once daily; suspension (6mg/mL) 12.5 mL per dose once daily (recommended dose for 10 days) It is recommended that a pharmacist prepare the suspension of this drug before administration to the patient. ※ 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 to treat or prevent influenza virus infections. It cannot replace influenza vaccinations, and there is no interaction when used together with vaccinations. Effectiveness has been established only for influenza A and B viruses; safety and efficacy have not been confirmed for other infections. During treatment with this medication, special attention should be given to watch for neuropsychiatric adverse reactions such as seizures, delirium, and unusual behavior, especially in children and adolescents. In principle, this medication should not be used in children over 10 years old except in special cases, and a caregiver should be present for at least 2 days after administering the medication to reduce the risk of abnormal behavior. Patients with an allergic reaction or hypersensitivity to this medication's components should not be administered. Patients with impaired kidney function or those undergoing hemodialysis require dose adjustment, 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, or immunocompromised states. Commonly, this medication may cause side effects such as nausea, vomiting, headache, and pain, most of which are temporary and mild. Rarely, it may lead to shock, anaphylaxis, liver function abnormalities, skin reactions, acute renal failure, and neuropsychiatric symptoms; should adverse symptoms arise, immediate consultation with medical personnel is necessary. Women who are pregnant or breastfeeding should use this medication only when the therapeutic benefits outweigh the risks, as literature regarding its effects on fetuses or infants is limited. Safety and efficacy in infants under the age of 1 year have not been established, thus it is advisable not to use it in this age group. Elderly patients may have diminished bodily functions and multiple diseases, so care is necessary during administration, but dose adjustment is typically not required. This medication has low potential for drug interactions, but caution is warranted when used in combination with specific medications. When taking, symptoms should ideally be initiated as early as possible, and if a dose is missed, it should be taken as soon as possible, provided it is not too close to the next scheduled dose. This medication must be stored out of reach of children, and transferring it to another container is to be avoided.

• 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, preferably at room temperature between 1°C and 30°C. Proper storage helps maintain the effectiveness of the medication for a longer duration.

Appearance

A hard capsule with yellow upper and lower parts containing a white or pale yellow powder

Package unit

10 capsules/PTP