Phail Tamiflu Capsules 30 mg (Oseltamivir Phosphate)

Adult dose

1. Influenza A and influenza B virus infections: Initiate treatment on the first or second day after the onset of influenza symptoms. This medicine may be administered with or without food; taking it with food may improve tolerability in some patients. 1) 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 oral suspension. 4) Patients with renal impairment No dose adjustment is necessary for patients with creatinine clearance of 60 mL/min or greater. 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 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. 5) Patients with hepatic impairment No dose adjustment is necessary for the treatment of adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9). 2. Prevention of influenza A and influenza B virus infections 1) 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. 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 medicine have been demonstrated for up to 6 weeks. The preventive effect continues while taking this medicine. 3) Patients with renal impairment No dose adjustment is necessary for patients with creatinine clearance of 60 mL/min or greater. 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 also be administered before the start of dialysis. 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. 4) Patients with hepatic impairment No dose adjustment is necessary for the prevention of influenza in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

1) 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 a suspension. ≤ 15 kg — 30 mg per dose twice daily; 5.0 mL per dose twice daily 15 kg<, ≤ 23 kg — 45 mg per dose twice daily; 7.5 mL per dose twice daily 23 kg<, ≤ 40 kg — 60 mg per dose twice daily; 10.0 mL per dose twice daily > 40 kg — 75 mg per dose twice daily; 12.5 mL per dose twice daily 3) Infants aged 2 weeks to under 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 per dose twice daily; 1.5 mL per dose twice daily 4 kg — 12 mg per dose twice daily; 2.0 mL per dose twice daily 5 kg — 15 mg per dose twice daily; 2.5 mL per dose twice daily 6 kg — 18 mg per dose twice daily; 3.0 mL per dose twice daily 7 kg — 21 mg per dose twice daily; 3.5 mL per dose twice daily 8 kg — 24 mg per dose twice daily; 4.0 mL per dose twice daily 9 kg — 27 mg per dose twice daily; 4.5 mL per dose twice daily 10 kg — 30 mg per dose twice daily; 5.0 mL per dose twice daily * This table does not include all possible body weights in this patient group. For children under 1 year of age, a dose of 3mg/kg of this medicine is recommended. 2) 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 a suspension. ≤ 15 kg — 30 mg per dose once daily; 5.0 mL per dose once daily 15 kg<, ≤ 23 kg — 45 mg per dose once daily; 7.5 mL per dose once daily 23 kg<, ≤ 40 kg — 60 mg per dose once daily; 10.0 mL per dose once daily > 40 kg — 75 mg per dose once daily; 12.5 mL per dose once daily ※ The safety and efficacy of this medicine for the prevention of influenza A and B virus infections in children under 1 year of age have not been evaluated.

This medication cannot replace the influenza vaccine and must be used together with vaccination. Its efficacy has only been proven against influenza A and B viruses, and safety and efficacy against other infections have not been confirmed. In particular, rare neuropsychiatric adverse reactions may occur in children and adolescents, so caregivers should monitor for unusual behavior immediately. Patients with allergies to this medication or its components should not use it. Dose adjustment is required for patients with impaired kidney function, and it is not recommended for patients with end-stage renal failure. It should be used with caution in high-risk patients with asthma, chronic respiratory diseases, or immunosuppression. Common side effects upon administration include nausea, vomiting, and headache, most of which are transient. Rarely, severe side effects may occur, including allergic reactions, liver function abnormalities, neuropsychiatric symptoms, and acute renal failure; thus, if unusual symptoms arise, advice from medical personnel should be sought immediately. This medication's safety and efficacy have not been established for children under 1 year of age, and elderly patients should be carefully monitored. There is no specific antidote in cases of overdose, so it is essential to visit a medical facility immediately. The potential for interactions with other medications is low, but caution is needed when used with specific drugs. Women who are pregnant or breastfeeding should consult their doctor due to insufficient information regarding the impact of this medication on the fetus or infant. If unusual behavior or neurological symptoms occur after taking this medication, immediate discontinuation is necessary, and medical personnel should be informed. It is most effective when taken early in the onset of influenza symptoms; if a dose is missed, it should be taken as soon as possible but skipped if too close to the next scheduled dose. No specific effects have been reported when operating vehicles or machinery; however, caution is advised as influenza itself can impact physical functioning. Store this medication out of the reach of children, and it is advisable not to 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 sealed container to prevent exposure to air or moisture and should be kept at a cool temperature below 25 degrees Celsius. Proper storage will maintain the medication's effectiveness for a long time.

Appearance

A hard capsule with a light yellow color containing white or slightly yellow powder

Package unit

10 capsules/PTP