Tamiflu Capsule 75mg (Oseltamivir Phosphate)

Adult dose

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 with or without food; in some patients, tolerability may improve 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 this drug as a powder for suspension. Patients with renal impairment: No dosage adjustment is required for patients with creatinine clearance ≥ 60 mL/min. For patients with creatinine clearance of 30 ~ 60 mL/min, reducing the dose to 30 mg twice daily for 5 days is recommended. For patients with creatinine clearance of 10 ~ 30 mL/min, reducing the dose to 30 mg once daily for 5 days is recommended. Patients receiving periodic hemodialysis should receive a 30 mg dose of this drug after each dialysis session to maintain plasma concentrations within the therapeutic range; the treatment period 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 30 mg 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 < 10 mL/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). Prevention of influenza A and influenza B virus infections Adults and adolescents aged 13 years and older: For those in close contact with 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 drug have been demonstrated for up to 6 weeks. The preventive effect persists while taking this drug. Patients with renal impairment: No dosage adjustment is required for patients with creatinine clearance ≥ 60 mL/min. For patients with creatinine clearance of 30 ～ 60 mL/min, reducing the dose to 30 mg once daily is recommended. For patients with creatinine clearance of 10 ～ 30 mL/min, reducing the dose to 30 mg once daily and administering it every other day is recommended. Patients receiving periodic hemodialysis should receive a 30 mg dose of this drug after every 2 dialysis sessions to maintain plasma concentrations within the therapeutic range. The first dose may also be administered before the start of dialysis. For peritoneal dialysis, administration of 30 mg of this drug 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 < 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

Treatment of influenza A and influenza B virus infections — children aged 1 to 12 years: ≤ 15 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily for 5 days 15 kg<, ≤ 23 kg: 45 mg twice daily; suspension (6mg/mL) 7.5 mL twice daily for 5 days 23 kg<, ≤ 40 kg: 60 mg twice daily; suspension (6mg/mL) 10.0 mL twice daily for 5 days > 40 kg: 75 mg twice daily; suspension (6mg/mL) 12.5 mL twice daily for 5 days 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 drug suspension. 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 postconceptional age of less than 36 weeks. 3 kg: 9 mg twice daily; suspension (6mg/mL) 1.5 mL twice daily for 5 days 4 kg: 12 mg twice daily; suspension (6mg/mL) 2.0 mL twice daily for 5 days 5 kg: 15 mg twice daily; suspension (6mg/mL) 2.5 mL twice daily for 5 days 6 kg: 18 mg twice daily; suspension (6mg/mL) 3.0 mL twice daily for 5 days 7 kg: 21 mg twice daily; suspension (6mg/mL) 3.5 mL twice daily for 5 days 8 kg: 24 mg twice daily; suspension (6mg/mL) 4.0 mL twice daily for 5 days 9 kg: 27 mg twice daily; suspension (6mg/mL) 4.5 mL twice daily for 5 days 10 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily for 5 days * This table does not include all possible weights in this patient group. For children under 1 year of age, a dose of 3mg/kg of this drug is recommended. Prevention of influenza A and influenza B virus infections — children aged 1 to 12 years: ≤ 15 kg: 30 mg once daily; suspension (6mg/mL) 5.0 mL once daily for 10 days 15 kg<, ≤ 23 kg: 45 mg once daily; suspension (6mg/mL) 7.5 mL once daily for 10 days 23 kg<, ≤ 40 kg: 60 mg once daily; suspension (6mg/mL) 10.0 mL once daily for 10 days > 40 kg: 75 mg once daily; suspension (6mg/mL) 12.5 mL once daily for 10 days 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 drug suspension. ※ 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 vaccinations and should be used separately from inoculations. It is effective only against influenza A and B viruses, and safety and efficacy have not been established for other infections. Neurological and psychiatric adverse reactions such as seizures or delirium have been reported in pediatric and adolescent patients, so patients in this age group should be monitored closely for unusual behaviors. Particularly, children over 10 years old may be at risk of accidents due to abnormal behaviors; therefore, ideally, it should not be used unless in a non-high-risk population. Due to the risk of unusual behaviors during treatment, children and adolescents should be observed carefully for at least 2 days without leaving them unattended. Patients with hypersensitivity to this medication should not receive it, and patients with renal insufficiency or certain high-risk groups require dosage adjustment or careful administering. Common side effects include nausea, vomiting, and headache, which are mostly temporary and mild. Rarely, shock, anaphylaxis, hepatitis, skin abnormalities, acute renal failure, and neuropsychiatric symptoms may occur, so if any unusual symptoms develop, treatment should be immediately discontinued and medical advice sought. Pregnant or nursing women should use this medication only when the therapeutic benefits outweigh the risks due to incomplete safety establishment. The safety and efficacy for infants under 1 year old have not been established, so its use in this age group is inadvisable. Elderly patients do not require dosage adjustments, but careful monitoring considering physical decline and underlying diseases is recommended. In the case of overdose, there is no specific treatment; however, if adverse reactions occur, immediate medical consultation and appropriate measures should be taken. This medication should be stored out of reach of children and should not be transferred to another container for safety. There is a low possibility of interaction with other medications, but caution may be needed when combined with certain drugs, so inform healthcare providers of any concurrent medications. There is no effect on driving or machinery operation; however, influenza itself can affect physical function, so caution is warranted.

• Cramps
• delirium
• abnormal behavior
• nausea
• vomiting
• headache
• pain
• unstable angina
• anemia
• membranous colitis

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture and should be kept in a cool place below 25 degrees Celsius. This will help maintain the medication's effectiveness for a longer period.

Appearance

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

Package unit

10 capsules ((10 capsules/PTP)x1)