Tamiflu Capsule 75 mg (Oseltamivir Phosphate)

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 aged 13 years and older: Administer 75 mg of oseltamivir 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 oral suspension. Patients with renal impairment: No dosage adjustment is required for 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 regular hemodialysis should receive a 30mg dose of this medicine after each dialysis session to maintain therapeutic plasma concentrations, and the treatment duration 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 less than 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 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 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 for 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 once daily 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 plasma concentrations. The initial dose may 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 receiving dialysis (e.g., creatinine clearance less than 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

1. 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 an oral suspension. ≤ 15 kg : 30 mg twice daily; oral suspension (6mg/mL) 5.0 mL twice daily; for 5 days. 15 kg<, ≤ 23 kg : 45 mg twice daily; oral suspension (6mg/mL) 7.5 mL twice daily; for 5 days. 23 kg<, ≤ 40 kg : 60 mg twice daily; oral suspension (6mg/mL) 10.0 mL twice daily; for 5 days. > 40 kg : 75 mg twice daily; oral suspension (6mg/mL) 12.5 mL twice daily; for 5 days. Children 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 post-conceptional age of less than 36 weeks. 3 kg : 9 mg twice daily; oral suspension (6mg/mL) 1.5 mL twice daily; for 5 days. 4 kg : 12 mg twice daily; oral suspension (6mg/mL) 2.0 mL twice daily; for 5 days. 5 kg : 15 mg twice daily; oral suspension (6mg/mL) 2.5 mL twice daily; for 5 days. 6 kg : 18 mg twice daily; oral suspension (6mg/mL) 3.0 mL twice daily; for 5 days. 7 kg : 21 mg twice daily; oral suspension (6mg/mL) 3.5 mL twice daily; for 5 days. 8 kg : 24 mg twice daily; oral suspension (6mg/mL) 4.0 mL twice daily; for 5 days. 9 kg : 27 mg twice daily; oral suspension (6mg/mL) 4.5 mL twice daily; for 5 days. 10 kg : 30 mg twice daily; oral suspension (6mg/mL) 5.0 mL twice daily; for 5 days. * This table does not include all possible body 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 oral suspension of this medicine before it is administered to the patient. 2. 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 an oral suspension. ≤ 15 kg : 30 mg once daily; oral suspension (6mg/mL) 5.0 mL once daily; for 10 days. 15 kg<, ≤ 23 kg : 45 mg once daily; oral suspension (6mg/mL) 7.5 mL once daily; for 10 days. 23 kg<, ≤ 40 kg : 60 mg once daily; oral suspension (6mg/mL) 10.0 mL once daily; for 10 days. > 40 kg : 75 mg once daily; oral suspension (6mg/mL) 12.5 mL once daily; for 10 days. It is recommended that a pharmacist prepare the oral suspension of this medicine before it is administered to the patient. ※ The safety and efficacy of this medicine for prevention of influenza A and B virus infections in children under 1 year of age have not been evaluated.

This medication should not replace the influenza vaccine, and it should be used separately from influenza vaccination. This drug has only been proven effective for influenza A and B, and its safety or efficacy regarding other infections has not been confirmed. Neurological and psychiatric side effects may occur in children and adolescents taking this medication, so caregivers should closely monitor for abnormal behaviors. Children over 10 years of age should generally avoid using this medication unless in specific circumstances, and must not be left alone for at least two days after starting treatment. Patients with allergies to this medication or its components should not use it. Dose adjustment is necessary for patients with renal failure or those undergoing dialysis, and it is not recommended for patients with end-stage renal failure. High-risk patients with asthma, chronic bronchitis, or immunocompromised states should use this medication cautiously. Common side effects include nausea, vomiting, and headache, but most are temporary. Rarely, symptoms such as shock, anaphylaxis, liver dysfunction, skin abnormalities, acute renal failure, blood disorders, and neuropsychiatric symptoms may occur, so inform healthcare professionals immediately if unusual symptoms arise. Pregnant or nursing mothers should carefully weigh the effects on the fetus or infant before using this medication and should only use it if the therapeutic benefits outweigh the risks. Safety and efficacy for children under 1 year of age have not been established, so use is not advised. Elderly patients may have decreased bodily functions, so careful monitoring during administration is required. This drug has a low likelihood of interactions with other medications, but caution may be needed when combined with certain drugs. This drug is effective when taken early during the onset of influenza symptoms, and if a dose is missed, take it as soon as possible. If the next dose is within 2 hours, the missed dose should be skipped. There is no significant effect on driving or operating machinery, but the potential for decreased abilities due to influenza itself should be considered. Store out of reach of children and do not transfer 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 exposure to air or moisture. The recommended storage temperature is room temperature between 1 and 30 degrees Celsius.

Appearance

A hard capsule with a light yellow upper part and a gray lower part containing white or pale yellow powder.

Package unit

10 capsules/PTP