Oseltamivir Phosphate 75 mg Capsule

Adult dose

1. Influenza A and influenza B virus infections: Start treatment on the first or second day after the onset of influenza symptoms. This medicine may be taken with or without food. In some patients, taking it with food may improve tolerability. Adults and adolescents 13 years of age and older: Administer 75 mg of oseltamivir orally twice daily for 5 days. Adults and adolescents 13 years of age and older who have difficulty swallowing capsules should use this medicine as powder for oral suspension. Patients with renal impairment: No dosage adjustment is required in patients with a creatinine clearance of 60 mL/min or higher. For patients with a creatinine clearance of 30 ~ 60 mL/min, a reduced dose of 30 mg twice 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 medicine after each dialysis session to maintain plasma concentrations within the therapeutic range, and treatment should not exceed 5 days. If influenza symptoms develop 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 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. Patients with hepatic impairment: No dosage adjustment is required for treatment in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9). 2. Prevention of influenza A and influenza B virus infections Adults and adolescents 13 years of age and older: For individuals in close contact with 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 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: No dosage adjustment is required in patients with a creatinine clearance of 60 mL/min or higher. 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 every other day is recommended. Patients receiving regular hemodialysis should receive a 30mg dose of this medicine after every 2 dialysis sessions to maintain plasma concentrations within the therapeutic range. The initial dose may be administered before the start of dialysis. For peritoneal dialysis, administration of 30mg of this medicine after dialysis once a week 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. Patients with hepatic impairment: No dosage adjustment is required for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

Children 1 to 12 years of age: Pediatric patients weighing more than 40 kg who are able to swallow capsules may take 75mg capsules twice daily or 30mg capsules and 45mg capsules twice daily instead of the recommended dose of this medicine as an oral suspension. ≤ 15 kg: 30 mg twice daily; oral suspension (6mg/mL) 5.0 mL twice daily 15 kg<, ≤ 23 kg: 45 mg twice daily; oral suspension (6mg/mL) 7.5 mL twice daily 23 kg<, ≤ 40 kg: 60 mg twice daily; oral suspension (6mg/mL) 10.0 mL twice daily > 40 kg: 75 mg twice daily; oral suspension (6mg/mL) 12.5 mL twice daily Infants 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 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 twice daily; oral suspension (6mg/mL) 1.5 mL twice daily 4 kg: 12 mg twice daily; oral suspension (6mg/mL) 2.0 mL twice daily 5 kg: 15 mg twice daily; oral suspension (6mg/mL) 2.5 mL twice daily 6 kg: 18 mg twice daily; oral suspension (6mg/mL) 3.0 mL twice daily 7 kg: 21 mg twice daily; oral suspension (6mg/mL) 3.5 mL twice daily 8 kg: 24 mg twice daily; oral suspension (6mg/mL) 4.0 mL twice daily 9 kg: 27 mg twice daily; oral suspension (6mg/mL) 4.5 mL twice daily 10 kg: 30 mg twice daily; oral suspension (6mg/mL) 5.0 mL twice daily Children 1 to 12 years of age: Pediatric patients weighing more than 40 kg who are able to 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 medicine as an oral suspension. ≤ 15 kg: 30 mg once daily; oral suspension (6mg/mL) 5.0 mL once daily 15 kg<, ≤ 23 kg: 45 mg once daily; oral suspension (6mg/mL) 7.5 mL once daily 23 kg<, ≤ 40 kg: 60 mg once daily; oral suspension (6mg/mL) 10.0 mL once daily > 40 kg: 75 mg once daily; oral suspension (6mg/mL) 12.5 mL once daily

This medication is used for the treatment and prevention of influenza virus infections. It cannot replace influenza vaccinations and should be used alongside them. Its efficacy has only been established for influenza A and B viruses, and safety and efficacy for other infections have not been proven. Particularly in children and adolescents, neurological and psychiatric adverse effects, such as seizures or confusion, have been reported rarely, requiring caution. Unusual behaviors may occur during medication use, so children and adolescents should not be left alone for 2 days and need to be observed by guardians. Patients with allergies to this medication or its ingredients should not use it. Patients with reduced kidney function require dosage adjustments, and it is not recommended for patients with end-stage renal failure. Use should be cautiously assessed in high-risk groups such as those with asthma, chronic bronchitis, or immune suppression. The most common side effects include nausea, vomiting, and headaches, which are mostly transient. Rarely, shock, anaphylaxis, liver function abnormalities, skin rashes, and neuropsychiatric symptoms may occur, and treatment should be discontinued immediately if symptoms arise and a physician should be consulted. Pregnant or nursing patients should only use this medication after discussion with a doctor when the benefits outweigh the risks, and safety and efficacy in children under 1 year old have not been adequately studied, requiring caution. Elderly patients do not require dosage adjustments but should be closely monitored considering decreased bodily functions. This medication has a low potential for drug interactions, but caution may be necessary when used concomitantly with certain medications, so consultation with a doctor or pharmacist is necessary. When taking the medication, the dosage and administration timing must be adhered to accurately, and if a dose is missed, it should be taken as soon as possible, but if it is too close to the next scheduled dose, it should be skipped. This medication should be stored out of reach of children, and it is advisable not to transfer it to another container.

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

This medication should be stored in a tightly sealed container to prevent air and moisture from entering, and it is recommended to keep it in a cool place below 25 degrees Celsius. This way, the effectiveness of the medication can be maintained for a longer period.

Appearance

A hard capsule with an upper yellowish and lower gray part filled with white or light yellow powder

Package unit

10 capsules/PTP