Tamiflu Capsule 45 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; tolerability may improve in some patients when taken with food. 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 the powder for suspension of this medicine. Patients with renal impairment: No dose adjustment is necessary in 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 receiving regular hemodialysis should receive a 30mg dose of this medicine after each dialysis session to maintain therapeutic plasma concentrations, and 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 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 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 dose adjustment is necessary in 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 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 dialysis begins. For peritoneal dialysis, administration of 30mg of this medicine 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 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

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 a 75mg capsule twice daily or one 30mg capsule and one 45mg capsule twice daily instead of the recommended dose of this drug suspension. ≤ 15 kg — 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily 15 kg<, ≤ 23 kg — 45 mg twice daily; suspension (6mg/mL) 7.5 mL twice daily 23 kg<, ≤ 40 kg — 60 mg twice daily; suspension (6mg/mL) 10.0 mL twice daily > 40 kg — 75 mg twice daily; suspension (6mg/mL) 12.5 mL twice daily 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 drug orally twice daily for 5 days. This does not apply to infants with a postmenstrual age of less than 36 weeks. 3 kg — 9 mg twice daily; suspension (6mg/mL) 1.5 mL twice daily 4 kg — 12 mg twice daily; suspension (6mg/mL) 2.0 mL twice daily 5 kg — 15 mg twice daily; suspension (6mg/mL) 2.5 mL twice daily 6 kg — 18 mg twice daily; suspension (6mg/mL) 3.0 mL twice daily 7 kg — 21 mg twice daily; suspension (6mg/mL) 3.5 mL twice daily 8 kg — 24 mg twice daily; suspension (6mg/mL) 4.0 mL twice daily 9 kg — 27 mg twice daily; suspension (6mg/mL) 4.5 mL twice daily 10 kg — 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily * This table does not include all possible body 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 reconstitute this drug suspension before it is administered 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 a 75mg capsule once daily or one 30mg capsule and one 45mg capsule once daily for 10 days instead of the recommended dose of this drug suspension. ≤ 15 kg — 30 mg once daily; suspension (6mg/mL) 5.0 mL once daily 15 kg<, ≤ 23 kg — 45 mg once daily; suspension (6mg/mL) 7.5 mL once daily 23 kg<, ≤ 40 kg — 60 mg once daily; suspension (6mg/mL) 10.0 mL once daily > 40 kg — 75 mg once daily; suspension (6mg/mL) 12.5 mL once daily It is recommended that a pharmacist reconstitute this drug 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 must be used separately from it. This medication is effective only against influenza A and B viruses and its safety and efficacy have not been established for other infections. Neuropsychiatric effects may occur rarely in pediatric and adolescent patients, and caregivers should closely monitor for abnormal behaviors. Individuals with allergies to this medication or its components should not use it. Patients with renal impairment require dosage adjustment; in severe cases, use is not recommended. Patients in high-risk groups such as those with asthma or chronic bronchitis should use it cautiously. Common side effects such as nausea, vomiting, headache may occur, but they are mostly temporary. Rarely, serious allergic reactions, liver function abnormalities, skin symptoms, acute renal failure, blood abnormalities, psychiatric symptoms may occur, necessitating immediate consultation with a healthcare professional if symptoms appear. This medication is effective when taken at the onset of influenza symptoms, and if a dose is missed, it should be taken as soon as possible but not too close to the next scheduled dose. It has no impact on driving or operating machinery, but caution is advised due to impairment from influenza itself. The likelihood of drug interactions is low; however, caution is warranted when taken with specific medications. Pregnant or nursing individuals should use it only after consulting a doctor when the therapeutic benefit outweighs the risks. Safety and efficacy in children under 1 year of age have not been established, so its use in this age group is not recommended. The elderly can use it without special dosage adjustment, but caution due to decreased bodily function is necessary. Severe side effects from overdose are rare, but any adverse reactions should be reported to a healthcare professional immediately. Keep this medication out of the reach of children, and do not transfer it to other containers.

• 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 and moisture, preferably in a cool place below 25 degrees Celsius. Storing in this manner will help maintain the medication's effectiveness and prevent deterioration.

Appearance

A hard capsule with a gray body and grey cap containing white or pale yellow powder.

Package unit

10 capsules/PTP