Tamiflu Capsule 30 mg (Oseltamivir Phosphate)

Adult dose

Influenza A and influenza B virus infections: Begin treatment on the first or second day after the onset of influenza symptoms. This drug may be administered regardless of food intake; in some patients, tolerability may improve when it is 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 powder for suspension. Patients with renal impairment: No dosage 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 drug 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 also be administered before the start of dialysis. For peritoneal dialysis, a single 30mg 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 less than 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment: No dosage adjustment is necessary 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 outbreak is 75 mg once daily. The safety and efficacy of this drug have been demonstrated for up to 6 weeks. The preventive effect continues while taking this drug. Patients with renal impairment: No dosage 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 daily every other day is recommended. Patients receiving regular hemodialysis should receive a 30mg dose of this drug after every 2 dialysis sessions to maintain therapeutic plasma concentrations. The initial dose may be administered before the start of dialysis. For peritoneal dialysis, 30mg of this drug 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 dosage adjustment is necessary for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

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. Body weight ≤ 15 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily Body weight 15 kg<, ≤ 23 kg: 45 mg twice daily; suspension (6mg/mL) 7.5 mL twice daily Body weight 23 kg<, ≤ 40 kg: 60 mg twice daily; suspension (6mg/mL) 10.0 mL twice daily Body weight > 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. Body weight 3 kg: 9 mg twice daily; suspension (6mg/mL) 1.5 mL twice daily Body weight 4 kg: 12 mg twice daily; suspension (6mg/mL) 2.0 mL twice daily Body weight 5 kg: 15 mg twice daily; suspension (6mg/mL) 2.5 mL twice daily Body weight 6 kg: 18 mg twice daily; suspension (6mg/mL) 3.0 mL twice daily Body weight 7 kg: 21 mg twice daily; suspension (6mg/mL) 3.5 mL twice daily Body weight 8 kg: 24 mg twice daily; suspension (6mg/mL) 4.0 mL twice daily Body weight 9 kg: 27 mg twice daily; suspension (6mg/mL) 4.5 mL twice daily Body weight 10 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily A dose of 3mg/kg of this drug is recommended for children under 1 year of age. 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. Body weight ≤ 15 kg: 30 mg once daily; suspension (6mg/mL) 5.0 mL once daily Body weight 15 kg<, ≤ 23 kg: 45 mg once daily; suspension (6mg/mL) 7.5 mL once daily Body weight 23 kg<, ≤ 40 kg: 60 mg once daily; suspension (6mg/mL) 10.0 mL once daily Body weight > 40 kg: 75 mg once daily; suspension (6mg/mL) 12.5 mL once daily 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 is used for the treatment or prevention of influenza virus infections and cannot replace the influenza vaccine. It has been proven effective only against influenza A and B viruses, and safety and efficacy have not been established for other infections. Abnormal behavior or neuropsychiatric reactions have been reported, especially in children and adolescents; therefore, caregivers should carefully observe these patients for at least 2 days after administration. Patients with any allergic reactions to this medication or its ingredients should not take it. Patients with impaired kidney function may require dose adjustment, and it is not recommended for patients with end-stage renal failure. It should be administered with caution to patients with asthma, chronic bronchitis, or immunocompromised states. Nausea, vomiting, headache, and other side effects may occur when taking this medication, but these are usually temporary. Serious adverse reactions may include shock, liver dysfunction, mucocutaneous syndrome, acute renal failure, and neuropsychiatric symptoms, and if they occur, immediate consultation with a physician is needed. Pregnant or breastfeeding women should only take it when the therapeutic benefits outweigh the risks, as safety for the fetus or infant has not been sufficiently established. In children, it is advisable not to use this medication for those under 1 year old, as safety and efficacy have not been established. Older adults may have decreased physical function, so caution is required during administration, but dose adjustment is usually not necessary. Take the medication at the scheduled time and if a dose is missed, take it as soon as possible, but do not take it too close to the next dose. This medication has a low potential for interactions with other drugs, but caution may be required when taken with some medications. No special effects have been reported while driving or operating machinery, but influenza symptoms themselves can reduce attentiveness, so caution is advised. Keep this medication out of reach of children and do not transfer it to another container.

• Convulsions
• delirium
• abnormal behavior
• nausea
• vomiting
• headache
• pain
• unstable angina
• anemia
• membrane colitis

This medication should be stored in a tightly closed container to prevent exposure to air or moisture and kept in a cool place below 25 degrees Celsius to maintain effectiveness.

Appearance

A yellowish hard capsule containing white or slightly yellow powder.

Package unit

10 capsules/PTP