Tamiflu Capsule 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 product may be administered with or without food; tolerability may be improved 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 this product as suspension powder. 4) Patients with renal impairment No dosage adjustment is required for patients with a creatinine clearance of 60 mL/min or more. For patients with a creatinine clearance of 30 ~ 60 mL/min, a reduced dose of 30 mg twice daily for 5 days is recommended. For patients with a 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 product 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 product 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 dosage adjustment is required for treatment in adult patients 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. 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 product have been demonstrated for up to 6 weeks. The protective effect continues while this medication is being taken. 3) Patients with renal impairment No dosage adjustment is required for patients with a creatinine clearance of 60 mL/min or more. For patients with a creatinine clearance of 30 ～ 60 mL/min, a reduced dose of 30 mg once daily is recommended. For patients with a 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 product after every 2 dialysis sessions to maintain therapeutic plasma concentrations. The initial dose may also be administered before dialysis begins. For peritoneal dialysis, administration of 30mg of this product 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. 4) 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

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 product as a 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 product orally twice daily for 5 days. This does not apply to infants with a postconceptional 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 * This table does not include all possible body weights in this patient group. A dose of 3mg/kg of this product is recommended for children under 1 year of age. It is recommended that a pharmacist prepare this product as a suspension before administration to the patient. 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 product as a 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 It is recommended that a pharmacist prepare this product as a suspension before administration to the patient. ※ The safety and efficacy of this product 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 influenza vaccination, and the use of this medication and vaccination are separate matters. This medication has demonstrated efficacy only against influenza A and B viruses and is not used for other infections. Reports of unusual behavior or neuropsychiatric adverse reactions have been noted in children and adolescents taking this medication, so special caution is required in this age group. During treatment with this medication, there is a risk of unusual behavior, and caregivers should ensure that the patient is not left alone for at least 2 days. Patients with allergies to this medication or its components should not use it. Patients with impaired renal function or undergoing dialysis may require dose adjustments, and it is not recommended for patients with end-stage renal failure. High-risk patients, such as those with asthma, chronic bronchitis, or immunocompromised states should use this medication cautiously. Common side effects of this medication include nausea, vomiting, headache, etc., which mostly occur at the beginning of treatment and improve rapidly. Rarely, serious allergic reactions, liver dysfunction, skin abnormalities, acute renal failure, blood disorders, and neuropsychiatric symptoms may occur, so if any abnormal symptoms appear, immediate consultation with a healthcare professional is necessary. The safety and efficacy of this medication have not been established in children under 1 year of age. Pregnant or breastfeeding women should carefully consider the benefits and risks of using this medication. This medication has a low possibility of drug interactions, but caution may be required when used in combination with certain drugs. When taking this medication, it is best to start as early as possible when symptoms begin, and if a dose is missed, take it as soon as possible but not too close to the next dose. No effects on driving or operating machinery have been reported; however, influenza itself may affect these activities, so caution should be exercised. This medication should be kept out of the reach of children and it is advisable not to transfer it to another container.

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

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. Additionally, it is important to store it at a cool temperature below 25 degrees to maintain its effectiveness.

Appearance

A hard capsule with a light yellow upper and lower shell containing white or light yellow powder.

Package unit

10 capsules/PTP