Utaplu Capsule 75mg (Oseltamivir Phosphate)

Adult dose

Treatment of influenza A and influenza B virus infections: Begin treatment on the first or second day after the onset of influenza symptoms. This medicine may be taken with or without food; tolerability may improve in some patients 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 as a powder for suspension. Patients with renal impairment (treatment): No dosage adjustment is needed for 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 undergoing periodic hemodialysis should receive a 30mg dose of this medicine after each dialysis session to maintain plasma concentrations within the therapeutic range; treatment should not exceed 5 days. If influenza symptoms occur during the 48 hours between dialysis sessions, the dose may also be administered before the start of dialysis. 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 undergoing dialysis (e.g., creatinine clearance below 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment (treatment): No dosage adjustment is needed 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 persons in close contact with an infected individual, administer oseltamivir 75 mg orally once daily for 10 days. Begin 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 dosage adjustment is needed for 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 daily every other day is recommended. Patients undergoing periodic hemodialysis should receive a 30mg dose of this medicine after every 2 dialysis sessions to maintain plasma concentrations within the therapeutic range. The first dose may also be administered before the start of dialysis. 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 undergoing dialysis (e.g., creatinine clearance below 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment (prevention): No dosage adjustment is needed 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 aged 1 to 12 years: Pediatric patients weighing more than 40 kg who can swallow capsules may take 75mg capsules twice daily or 30mg and 45mg capsules twice daily instead of the recommended dose of this medicine as a suspension. ≤ 15 kg: 30 mg per dose twice daily; suspension (6mg/mL) 5.0 mL per dose twice daily. 15 kg<, ≤ 23 kg: 45 mg per dose twice daily; suspension (6mg/mL) 7.5 mL per dose twice daily. 23 kg<, ≤ 40 kg: 60 mg per dose twice daily; suspension (6mg/mL) 10.0 mL per dose twice daily. > 40 kg: 75 mg per dose twice daily; suspension (6mg/mL) 12.5 mL per dose twice daily. Infants aged 2 weeks to less than 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. 3 kg: 9 mg per dose twice daily; suspension (6mg/mL) 1.5 mL per dose twice daily. 4 kg: 12 mg per dose twice daily; suspension (6mg/mL) 2.0 mL per dose twice daily. 5 kg: 15 mg per dose twice daily; suspension (6mg/mL) 2.5 mL per dose twice daily. 6 kg: 18 mg per dose twice daily; suspension (6mg/mL) 3.0 mL per dose twice daily. 7 kg: 21 mg per dose twice daily; suspension (6mg/mL) 3.5 mL per dose twice daily. 8 kg: 24 mg per dose twice daily; suspension (6mg/mL) 4.0 mL per dose twice daily. 9 kg: 27 mg per dose twice daily; suspension (6mg/mL) 4.5 mL per dose twice daily. 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. 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 administration to the patient. Prevention of influenza A and influenza B virus infections — Children aged 1 to 12 years: Pediatric patients weighing more than 40 kg who can swallow capsules may take 75mg capsules once daily or 30mg and 45mg capsules once daily for 10 days instead of the recommended dose of this medicine as a suspension. ≤ 15 kg: 30 mg per dose once daily; suspension (6mg/mL) 5.0 mL per dose once daily. 15 kg<, ≤ 23 kg: 45 mg per dose once daily; suspension (6mg/mL) 7.5 mL per dose once daily. 23 kg<, ≤ 40 kg: 60 mg per dose once daily; suspension (6mg/mL) 10.0 mL per dose once daily. > 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 of this medicine before administration to the patient. ※ The safety and efficacy of prevention of influenza A and B virus infections in children under 1 year of age have not been evaluated.

This medication cannot replace influenza vaccination and should be used separately from vaccination. This drug is recommended only for influenza A and B viruses, and its safety and efficacy for other infections have not been established. Particularly in children and adolescents, neuropsychiatric adverse reactions have been reported, and behaviors should be carefully monitored in this age group. It is not recommended to use this medication in pediatric patients aged 10 years or older unless in special circumstances, and a guardian should be present during treatment if abnormal behavior occurs. This drug should not be administered to patients with an allergic reaction to it, and dosage adjustment or careful administration is required for patients with renal failure or certain high-risk groups. Nausea, vomiting, headache, and other symptoms may occur, but they are mostly temporary and often mild. Serious side effects such as skin rash, liver function abnormalities, neurological symptoms, and blood abnormalities can occur rarely, and if any unusual symptoms arise, consultation with healthcare professionals should occur immediately. Women who are pregnant or breastfeeding should use this drug only when the therapeutic benefit outweighs the risk to the fetus or infant, as the effects on them are not fully established. The safety and efficacy in children, particularly those under 1 year of age, have not been well-established, so caution is needed when using it. Older adults do not need dose adjustments, but careful monitoring is required during administration due to possible declined physical function and underlying diseases. Serious side effects have rarely been reported from overdose, but it is important to adhere to the recommended dosage. This medication has a low likelihood of interactions with other drugs, but caution is needed when used in combination with certain drugs, and patients should inform healthcare professionals of all medications they are taking. The impact on driving or operating machinery is minimal, but caution is advised due to symptoms caused by influenza itself. This medication should be kept out of the reach of children and not transferred to other containers.

• convulsions
• delirium
• unusual behaviors
• nausea
• vomiting
• headache
• pain
• unstable angina
• anemia
• pseudomembranous colitis

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. Additionally, it is important to store the medication at a cool temperature below 25 degrees Celsius to maintain its efficacy.

Appearance

A hard capsule with upper green opaque and lower gray opaque containing white or slightly yellow powder

Package unit

10 capsules (10 capsules/PTP×1)