Tamiflu Capsule 75 mg (Oseltamivir Phosphate)

Adult dose

1. Influenza A and influenza B virus infections Treatment should be started on the first or second day after the onset of influenza symptoms. This medicine may be administered with or without food; tolerability may improve in some patients when it is taken with food. Adults and adolescents 13 years of age and older: Administer oseltamivir 75 mg orally twice daily for 5 days. Adults and adolescents 13 years of age and older who have difficulty swallowing capsules should use this medicine as an oral suspension prepared from powder. Patients with renal impairment: No dosage adjustment is necessary 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 medicine after each dialysis session to maintain therapeutic plasma concentrations, and the treatment period should not exceed 5 days. If influenza symptoms develop during the 48 hours between dialysis sessions, this medicine 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. Patients with hepatic impairment: No dosage adjustment is necessary for treatment of adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9). Immunocompromised patients: No dosage adjustment is necessary for treatment of immunocompromised patients, and administration for 10 days is recommended. 2. Prevention of influenza A and influenza B virus infections Adults and adolescents 13 years of age and older: For close contacts of an infected person, administer oseltamivir 75 mg orally once daily for 10 days. Start 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 medicine have been demonstrated for up to 6 weeks. The preventive effect continues while this medicine is being taken. Patients with renal impairment: No dosage adjustment is necessary 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 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, administration of 30mg of this medicine 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

1. Influenza A and influenza B virus infections Children 1 to 12 years of age: Pediatric patients weighing more than 40 kg who can swallow capsules may take 75mg capsules twice daily or 30mg capsules and 45mg capsules twice daily instead of the recommended dose of this medicine as a suspension. Weight ≤ 15 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily Weight 15 kg<, ≤ 23 kg: 45 mg twice daily; suspension (6mg/mL) 7.5 mL twice daily Weight 23 kg<, ≤ 40 kg: 60 mg twice daily; suspension (6mg/mL) 10.0 mL twice daily Weight > 40 kg: 75 mg twice daily; suspension (6mg/mL) 12.5 mL twice daily Infants 2 weeks to under 1 year of age: The recommended dose for pediatric patients 2 weeks to 12 months of age 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. Weight 3 kg: 9 mg twice daily; suspension (6mg/mL) 1.5 mL twice daily Weight 4 kg: 12 mg twice daily; suspension (6mg/mL) 2.0 mL twice daily Weight 5 kg: 15 mg twice daily; suspension (6mg/mL) 2.5 mL twice daily Weight 6 kg: 18 mg twice daily; suspension (6mg/mL) 3.0 mL twice daily Weight 7 kg: 21 mg twice daily; suspension (6mg/mL) 3.5 mL twice daily Weight 8 kg: 24 mg twice daily; suspension (6mg/mL) 4.0 mL twice daily Weight 9 kg: 27 mg twice daily; suspension (6mg/mL) 4.5 mL twice daily Weight 10 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily * This table does not include all possible weights in this patient group. A dose of 3mg/kg of this medicine is recommended for children under 1 year of age. 2. Prevention of influenza A and influenza B virus infections Children 1 to 12 years of age: Pediatric patients weighing more than 40 kg who can swallow capsules may take 75mg capsules once daily or 30mg capsules and 45mg capsules once daily for 10 days instead of the recommended dose of this medicine as a suspension. Weight ≤ 15 kg: 30 mg once daily; suspension (6mg/mL) 5.0 mL once daily Weight 15 kg<, ≤ 23 kg: 45 mg once daily; suspension (6mg/mL) 7.5 mL once daily Weight 23 kg<, ≤ 40 kg: 60 mg once daily; suspension (6mg/mL) 10.0 mL once daily Weight > 40 kg: 75 mg once daily; suspension (6mg/mL) 12.5 mL once daily 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. No dosage adjustment is necessary for seasonal prophylaxis in immunocompromised patients 1 year of age and older, and administration for 12 weeks is recommended.

This medication is used to treat or prevent influenza viruses but cannot replace annual influenza vaccinations. Therefore, it is important to receive the influenza vaccination every year. This medication is effective only against influenza A and B viruses, and its safety and efficacy have not been confirmed for the treatment of other infections. During the use of this medication, there have been rare cases of neuropsychiatric symptoms, such as seizures or abnormal behavior, particularly in children and adolescents; careful observation is required. If abnormal behavior occurs, the caregiver should immediately attend to the patient and ensure they are not left alone. Patients who are allergic to this medication or any of its components should not use it. Patients with poor kidney function may need dose adjustments, and it is not recommended for patients with severe renal impairment. Caution is required when administering this medication to patients with respiratory conditions such as asthma or chronic bronchitis, or to those with impaired immune function. The most common side effects when taking this medication include nausea, vomiting, headache, and pain, and most are temporary and mild. Serious allergic reactions, liver dysfunction, skin rashes, acute renal failure, and blood disorders are rarely reported, so immediate consultation with a physician is required if such symptoms appear. Pregnant or nursing women should only use this medication after consulting with a doctor, as there is insufficient data on its effects on the fetus or infant, only when the benefits outweigh the risks. Safety and efficacy have not been established for children under 1 year old, so use is not recommended. Elderly patients generally do not require dose adjustments, but careful observation is necessary in cases of deteriorating physical function or underlying conditions. This medication has a low potential for drug interactions, but caution is needed when co-administered with certain drugs that affect renal excretion. When taking this medication, adhere to the prescribed dosage and frequencies, and if a dose is missed, it should be taken as soon as possible but not too close to the next dose time. This medication should be stored out of reach of children and should not be transferred to other containers.

• Cramps
• 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 humidity. Additionally, it is advisable to store the medication at a cool temperature, below 25 degrees Celsius.

Appearance

A hard capsule where the lower part is gray and the upper part is a yellowish color, containing white or yellowish powder.

Package unit

10 capsules (10 capsules/PTP packaging x 1)