Tamiflu Capsule 75mg (Oseltamivir Phosphate)

Adult dose

1. 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 administered regardless of food intake; tolerability may improve in some patients when taken with food. 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 dose adjustment is necessary for patients with creatinine clearance of 60 mL/min or more. 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 plasma concentrations within the therapeutic range; treatment should not exceed 5 days. If influenza symptoms develop during the 48 hours between dialysis sessions, the dose may also 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 less than 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment: No dose adjustment is necessary for treatment in adults 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 close contacts of an infected person, administer 75 mg of oseltamivir 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 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 this medicine is being taken. Patients with renal impairment: No dose adjustment is necessary for patients with creatinine clearance of 60 mL/min or more. 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 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 also be administered before dialysis begins. For peritoneal dialysis, a 30mg dose 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 dose adjustment is necessary for prevention in adults with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

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

This medication cannot replace influenza vaccination, and it is only used for treatment and prevention during influenza outbreaks. Its safety and effectiveness have not been proven for infections other than influenza A and B. Rarely, neuropsychiatric side effects may occur in children and adolescents, so guardians should observe for abnormal behaviors. In particular, it is recommended not to use this medication in children over 10 years old who are not in a high-risk group. People who are allergic to this drug or its components should not take it. Patients with renal failure require dose adjustments, and it is not recommended for patients with end-stage renal failure. Patients with asthma, chronic bronchitis, or those on immunosuppressive therapy should use it cautiously. Common side effects include nausea, vomiting, headache, etc., but most are mild and temporary. Rarely, symptoms such as shock, anaphylaxis, liver dysfunction, skin rash, acute renal failure, and neurological symptoms may occur, and if any abnormal symptoms appear, patients should consult medical personnel immediately. The use of this drug in pregnant or breastfeeding women should be determined carefully after considering the benefits and risks, as safety data for fetuses or newborns is limited. Safety and effectiveness have not been established for children, particularly those under 1 year old. Elderly patients can use it without special dose adjustments, but caution is needed in the presence of diminished bodily function or other diseases. No serious side effects have been reported in cases of overdose, but if abnormal reactions occur, medical personnel should be informed immediately. The possibility of interactions with other drugs is low with this medication, but caution may be required when used with certain medications. No effects on driving or operating machinery have been observed, but influenza itself may impair such abilities, so caution should be practiced. Keep 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 protect it from air and moisture, preferably at a cool temperature below 25 degrees Celsius. Storing it this way will help maintain the efficacy of the medication for a longer duration.

Appearance

A capsule with a pale yellow upper part and a light gray lower part filled with white or pale yellow powder

Package unit

10 capsules/PTP