Fluta Capsule 45 mg (Oseltamivir Phosphate)

Adult dose

Influenza A and influenza B virus infections: Start treatment on the first or second day after influenza symptoms appear. This medicine may be taken with or without food; in some patients, taking it with food may improve tolerability. Treatment—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 as powder for suspension. Treatment—Patients with renal impairment: No dosage adjustment is required in patients with creatinine clearance of 60 mL/min or higher. 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; treatment should not exceed 5 days. If influenza symptoms develop during the 48-hour interval between dialysis sessions, the dose may 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 below 10mL/min); therefore, no recommended dose is available for these patients. Treatment—Patients with hepatic impairment: No dosage 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 oseltamivir 75 mg orally once daily for 10 days. Start administration within 2 days after 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 this medicine is being taken. Prevention—Patients with renal impairment: No dosage adjustment is required in patients with creatinine clearance of 60 mL/min or higher. 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 regular hemodialysis should receive a 30mg dose of this medicine after every 2 dialysis sessions to maintain therapeutic blood concentrations. The first dose may also be administered before dialysis begins. For peritoneal dialysis, administration of 30mg 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 below 10mL/min); therefore, no recommended dose is available for these patients. Prevention—Patients with hepatic impairment: No dosage adjustment is required for prevention in adults with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

Treatment—Children aged 1 to 12 years, weighing more than 40 kg: If able to swallow capsules, pediatric patients 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 as a suspension. Treatment—Children aged 1 to 12 years, ≤ 15 kg: 30 mg per dose twice daily; suspension (6mg/mL) 5.0 mL per dose twice daily Treatment—Children aged 1 to 12 years, 15 kg<, ≤ 23 kg: 45 mg per dose twice daily; suspension (6mg/mL) 7.5 mL per dose twice daily Treatment—Children aged 1 to 12 years, 23 kg<, ≤ 40 kg: 60 mg per dose twice daily; suspension (6mg/mL) 10.0 mL per dose twice daily Treatment—Children aged 1 to 12 years, > 40 kg: 75 mg per dose twice daily; suspension (6mg/mL) 12.5 mL per dose twice daily Treatment—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 orally twice daily for 5 days. This does not apply to infants with a postconceptional age of less than 36 weeks. Treatment—Children aged 2 weeks to under 1 year, 3 kg: 9 mg per dose twice daily; suspension (6mg/mL) 1.5 mL per dose twice daily Treatment—Children aged 2 weeks to under 1 year, 4 kg: 12 mg per dose twice daily; suspension (6mg/mL) 2.0 mL per dose twice daily Treatment—Children aged 2 weeks to under 1 year, 5 kg: 15 mg per dose twice daily; suspension (6mg/mL) 2.5 mL per dose twice daily Treatment—Children aged 2 weeks to under 1 year, 6 kg: 18 mg per dose twice daily; suspension (6mg/mL) 3.0 mL per dose twice daily Treatment—Children aged 2 weeks to under 1 year, 7 kg: 21 mg per dose twice daily; suspension (6mg/mL) 3.5 mL per dose twice daily Treatment—Children aged 2 weeks to under 1 year, 8 kg: 24 mg per dose twice daily; suspension (6mg/mL) 4.0 mL per dose twice daily Treatment—Children aged 2 weeks to under 1 year, 9 kg: 27 mg per dose twice daily; suspension (6mg/mL) 4.5 mL per dose twice daily Treatment—Children aged 2 weeks to under 1 year, 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 group. For children under 1 year, a dose of 3mg/kg of this medicine is recommended. It is recommended that a pharmacist prepare the suspension before administration to the patient. Prevention—Children aged 1 to 12 years, weighing more than 40 kg: If able to swallow capsules, pediatric patients 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 as a suspension. Prevention—Children aged 1 to 12 years, ≤ 15 kg: 30 mg per dose once daily; suspension (6mg/mL) 5.0 mL per dose once daily Prevention—Children aged 1 to 12 years, 15 kg<, ≤ 23 kg: 45 mg per dose once daily; suspension (6mg/mL) 7.5 mL per dose once daily Prevention—Children aged 1 to 12 years, 23 kg<, ≤ 40 kg: 60 mg per dose once daily; suspension (6mg/mL) 10.0 mL per dose once daily Prevention—Children aged 1 to 12 years, > 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 before administration to the patient. ※ The safety and efficacy of this medicine for prevention of influenza A and B virus infections in children under 1 year have not been evaluated.

This medication cannot replace influenza vaccination, and it is important to get the influenza vaccine annually. This medication is used for treatment or prevention in areas where the influenza virus is prevalent. Its safety and efficacy have not been established for infections other than influenza A and B. Reports of seizures or neuropsychiatric symptoms have been documented in children and adolescents taking this medication, particularly those over 10 years old, necessitating caution. Caregivers should closely monitor patients for unusual behavior while taking this medication and should not leave them alone. Individuals with allergies to this medication or its components should not use it. Dosage adjustments are required for patients with impaired kidney function, and it is not recommended for patients with end-stage renal failure. Patients with asthma, chronic bronchitis, or immunocompromised states should also use this medication with caution. Common side effects include nausea, vomiting, and headache, but they are mostly temporary. Rarely, serious reactions such as shock, anaphylaxis, liver dysfunction, skin rash, acute renal failure, and neuropsychiatric symptoms may occur, requiring immediate consultation with a healthcare provider if any adverse symptoms appear. Safety during pregnancy or breastfeeding has not been sufficiently established, and it should be used only when necessary and under a physician's guidance. It is advised not to use this medication in children under 1 year of age since its efficacy and safety have not been established. Elderly patients can use it without special dosage adjustments, but they should be closely monitored if they have reduced physical functions or underlying conditions. This medication has a low potential for drug interactions, but caution is required when used with drugs affecting renal excretion. If a dose is missed, it should be taken as soon as possible, but if it is within 2 hours of the next scheduled dose, it should be skipped and the next dose taken. Care should be taken when driving or operating machinery due to potential impairment from influenza symptoms. Keep out of reach of children and do not transfer to a different container.

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

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain storage temperatures between 1 to 30 degrees Celsius.

Appearance

A gray hard capsule containing a white or pale yellow powder

Package unit

10 capsules/PTP