Oseltamivir Capsule 75mg (Oseltamivir Phosphate)

Adult dosage

Influenza A and influenza B virus infections: Initiate treatment on the first or second day after the onset of influenza symptoms. This drug may be administered regardless of food intake, although some patients may tolerate it better when taken with food. Adults and adolescents 13 years of age and older: Administer oseltamivir 75 mg orally twice daily for 5 days. Adults and adolescents 13 years of age and older who have difficulty swallowing capsules should use this drug as an oral suspension prepared from the powder. Patients with renal impairment: No dose adjustment is necessary in patients with a creatinine clearance of 60 mL/min or greater. 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 hemodialysis on a regular schedule should receive a 30mg dose of this drug after each dialysis session to maintain blood concentrations within the therapeutic range; the treatment duration should not exceed 5 days. If influenza symptoms develop 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 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 below 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment: No dose adjustment is necessary for treatment in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9). Prevention of influenza A and influenza B virus infections Adults and adolescents 13 years of age and older: For close contacts of an infected person, administer oseltamivir 75 mg orally once daily for 10 days. Initiate 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 drug have been demonstrated for up to 6 weeks. Protection continues while this drug is being taken. Patients with renal impairment: No dose adjustment is necessary in patients with a creatinine clearance of 60 mL/min or greater. 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 hemodialysis on a regular schedule 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 also be administered before the start of dialysis. For peritoneal dialysis, administration of 30mg of this drug once weekly 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 dose adjustment is necessary for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Children's dosage

Children 1 to 12 years of age: Pediatric patients weighing more than 40 kg who can swallow capsules may take 75mg capsules twice daily, or 30mg capsules and 45mg capsules twice daily, instead of the recommended dose of this drug suspension. Weight ≤ 15 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily Weight 15 kg<, ≤ 23 kg: 45 mg twice daily; suspension (6mg/mL) 7.5 mL twice daily Weight 23 kg<, ≤ 40 kg: 60 mg twice daily; suspension (6mg/mL) 10.0 mL twice daily Weight > 40 kg: 75 mg twice daily; suspension (6mg/mL) 12.5 mL twice daily Children 2 weeks to under 1 year of age: The recommended dose for pediatric patients 2 weeks to 12 months of age is 3mg/kg of this drug orally twice daily for 5 days. This does not apply to infants with a post-conceptional age of less than 36 weeks. Weight 3 kg: 9 mg twice daily; suspension (6mg/mL) 1.5 mL twice daily Weight 4 kg: 12 mg twice daily; suspension (6mg/mL) 2.0 mL twice daily Weight 5 kg: 15 mg twice daily; suspension (6mg/mL) 2.5 mL twice daily Weight 6 kg: 18 mg twice daily; suspension (6mg/mL) 3.0 mL twice daily Weight 7 kg: 21 mg twice daily; suspension (6mg/mL) 3.5 mL twice daily Weight 8 kg: 24 mg twice daily; suspension (6mg/mL) 4.0 mL twice daily Weight 9 kg: 27 mg twice daily; suspension (6mg/mL) 4.5 mL twice daily Weight 10 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily * This table does not include all possible weights in this patient group. A dose of 3mg/kg of this drug is recommended for children under 1 year of age. It is recommended that a pharmacist prepare the suspension of this drug before it is administered to the patient. Prevention of influenza A and influenza B virus infections Children 1 to 12 years of age: Pediatric patients weighing more than 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. Weight ≤ 15 kg: 30 mg once daily; suspension (6mg/mL) 5.0 mL once daily Weight 15 kg<, ≤ 23 kg: 45 mg once daily; suspension (6mg/mL) 7.5 mL once daily Weight 23 kg<, ≤ 40 kg: 60 mg once daily; suspension (6mg/mL) 10.0 mL once daily Weight > 40 kg: 75 mg once daily; suspension (6mg/mL) 12.5 mL once daily It is recommended that a pharmacist prepare the suspension of this drug before it is administered 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 it. This medication has been confirmed to be effective only against influenza A and B viruses, and safety and efficacy have not been demonstrated for other infections. Particularly in pediatric and adolescent patients, neuropsychiatric adverse reactions may occur rarely; caretakers should observe carefully if any abnormal behaviors appear during treatment. It should not be used in case of allergic reactions to this medication or its components. Dosing adjustments may be required for patients with renal impairment or those on dialysis, and it is not recommended for patients with end-stage renal disease. Use with caution in high-risk patients with asthma, chronic bronchitis, or immunosuppressive conditions. Common side effects include nausea, vomiting, headache, etc., but these are usually temporary and mild. Rarely, anaphylaxis, liver function abnormalities, skin reactions, acute renal failure, and neuropsychiatric symptoms may occur; consult a doctor immediately if unusual symptoms arise. When used in pregnant or breastfeeding individuals, benefits and risks should be carefully considered, as safety for the fetus has not been adequately established. Safety and efficacy for children under 1 year have not been established and should therefore be avoided. Elderly patients, who often have decreased bodily function, should be cautious during treatment; however, specific dosage adjustments are generally not necessary. Serious side effects are rarely reported even in cases of overdose, but adherence to prescribed dosing and administration is critical. This medication has a low potential for interactions with other drugs, but caution may be required with certain drugs; inform healthcare professionals of any concurrent medications. While it has minimal impact on driving or machine operation, influenza itself may affect neurological function, so caution is advised. Store this medication out of reach of children and do not transfer it to other containers for safety.

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

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. Moreover, it is crucial to keep the medication in a cool place, specifically below 25 degrees Celsius, to maintain its efficacy.

Appearance

Hard capsule with upper light yellow and lower gray, containing white or pale yellow powder

Package unit

10 capsules/PTP