Tamiflu Capsule 75 mg (Oseltamivir Phosphate)

Adult dose

Influenza A and influenza B virus infections: Initiate treatment on the first or second day 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. 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 undergoing regular hemodialysis should receive a 30mg dose of this medicine after each dialysis session to maintain blood concentrations within the therapeutic range; treatment should not exceed 5 days. If influenza symptoms develop during the 48 hours between dialysis sessions, the dose may be given 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 undergoing 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). 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. 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 medicine have been demonstrated for up to 6 weeks. The preventive effect continues while this medicine is being taken. 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 daily every other day is recommended. Patients undergoing regular hemodialysis should receive a 30mg dose of this medicine after every 2 dialysis sessions to maintain blood concentrations within the therapeutic range. The initial dose may also be given before dialysis begins. 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 undergoing 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

Children aged 1 to 12 years: Pediatric patients weighing more than 40 kg who are able to swallow capsules may take 75mg capsules twice daily or 30mg and 45mg capsules twice daily instead of the recommended dose of this medicine suspension. ≤ 15 kg: 30 mg per dose twice daily; suspension(6mg/mL) 5.0 mL per dose twice daily 15 kg<, ≤ 23 kg: 45 mg per dose twice daily; suspension(6mg/mL) 7.5 mL per dose twice daily 23 kg<, ≤ 40 kg: 60 mg per dose twice daily; suspension(6mg/mL) 10.0 mL per dose twice daily > 40 kg: 75 mg per dose twice daily; suspension(6mg/mL) 12.5 mL per dose twice daily Infants aged 2 weeks to less than 1 year: The recommended dose for 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 postconceptional age of less than 36 weeks. 3 kg: 9 mg per dose twice daily; suspension(6mg/mL) 1.5 mL per dose twice daily 4 kg: 12 mg per dose twice daily; suspension(6mg/mL) 2.0 mL per dose twice daily 5 kg: 15 mg per dose twice daily; suspension(6mg/mL) 2.5 mL per dose twice daily 6 kg: 18 mg per dose twice daily; suspension(6mg/mL) 3.0 mL per dose twice daily 7 kg: 21 mg per dose twice daily; suspension(6mg/mL) 3.5 mL per dose twice daily 8 kg: 24 mg per dose twice daily; suspension(6mg/mL) 4.0 mL per dose twice daily 9 kg: 27 mg per dose twice daily; suspension(6mg/mL) 4.5 mL per dose twice daily 10 kg: 30 mg per dose twice daily; suspension(6mg/mL) 5.0 mL per dose twice daily * This table does not include all possible body weights in this patient group. A dose of 3mg/kg of this medicine is recommended for children under 1 year of age. It is recommended that a pharmacist prepare the suspension before it is administered to the patient. Children aged 1 to 12 years: Pediatric patients weighing more than 40 kg who are able to 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 suspension. ≤ 15 kg: 30 mg per dose once daily; suspension(6mg/mL) 5.0 mL per dose once daily 15 kg<, ≤ 23 kg: 45 mg per dose once daily; suspension(6mg/mL) 7.5 mL per dose once daily 23 kg<, ≤ 40 kg: 60 mg per dose once daily; suspension(6mg/mL) 10.0 mL per dose once daily > 40 kg: 75 mg per dose once daily; suspension(6mg/mL) 12.5 mL per dose once daily It is recommended that a pharmacist prepare the suspension before it is administered to the patient. ※ The safety and efficacy of this medicine for prevention of influenza A and B virus infections in children under 1 year of age have not been evaluated.

This medication is used for the treatment and prevention of influenza virus infections. This drug cannot replace the influenza vaccine and must be used separately from vaccinations. Safety and efficacy have not been confirmed for infections other than influenza A and B viruses. Rarely in children and adolescents, neuropsychiatric reactions such as seizures, delirium, and abnormal behavior have been reported, necessitating caution in patients of this age group. Due to the risk of abnormal behavior during treatment, children and adolescents should not be left alone for at least 2 days and should be under the supervision of a guardian. Individuals who are allergic to this medicine or its components should not use it. Dose adjustment is needed for patients with impaired kidney function, and it is not recommended for patients with end-stage renal failure. Patients at high risk, such as those with asthma, chronic bronchitis, or immunocompromised states, should use it cautiously. The most common side effects of this medication are nausea, vomiting, and headache, which are mostly temporary and mild symptoms. Rarely, shock, anaphylaxis, liver dysfunction, severe skin reactions, acute renal failure, hematological abnormalities, and neuropsychiatric symptoms may occur, hence consultation with healthcare professionals should be sought immediately if any unusual symptoms arise. This medication is relatively safe for use across a range of ages and conditions, including children, the elderly, and immunocompromised patients, but caution is needed according to each patient's condition. Women who are pregnant or breastfeeding should only use this drug when the therapeutic benefits outweigh the risks, as its effects on the fetus or infant have not been adequately studied. There is little potential for drug interactions with other medications, but caution is advised when co-administered with drugs that affect renal excretion pathways. When using this medication, it is effective to start as soon as influenza symptoms begin, and if a dose is missed, it should be taken as soon as possible, but if too close to the next dose, it should be skipped. This medication should be stored out of the reach of children and should not be transferred to other containers. In case of overdose, contact a medical institution immediately, as there is no specific antidote.

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

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance

Hard capsule containing white or pale yellow powder with a gray bottom and pale yellow top

Package unit

10 capsules [(10 capsules/PTP) × 1]