Tamiflu Capsule 45 mg (Oseltamivir Phosphate)

Adult dose

Influenza A and influenza B virus infections: Start treatment on the first or second day after the onset of influenza symptoms. This medicine may be taken with or without food; in some patients, taking it with food may improve tolerability. 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 medicine as powder for oral suspension. Patients with renal impairment: No dosage adjustment is required for patients with a creatinine clearance of 60 mL/min or greater. 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 duration should not exceed 5 days. If influenza symptoms develop during the 48 hours between dialysis sessions, the dose 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 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 close contacts of an infected person, administer 75 mg of oseltamivir 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 taking this medicine. Patients with renal impairment: No dosage adjustment is required for patients with a creatinine clearance of 60 mL/min or greater. 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 once daily 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 be administered before the start of dialysis. For peritoneal dialysis, administration of 30mg 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 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 required 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 75mg capsules twice daily or 30mg and 45mg capsules twice daily instead of the recommended dose of this medicine as an oral suspension. Body weight ≤ 15 kg: 30 mg twice daily; oral suspension (6mg/mL) 5.0 mL twice daily Body weight 15 kg<, ≤ 23 kg: 45 mg twice daily; oral suspension (6mg/mL) 7.5 mL twice daily Body weight 23 kg<, ≤ 40 kg: 60 mg twice daily; oral suspension (6mg/mL) 10.0 mL twice daily Body weight > 40 kg: 75 mg twice daily; oral 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 medicine orally twice daily for 5 days. This does not apply to infants with a post-conceptional age of less than 36 weeks. Body weight 3 kg: 9 mg twice daily; oral suspension (6mg/mL) 1.5 mL twice daily Body weight 4 kg: 12 mg twice daily; oral suspension (6mg/mL) 2.0 mL twice daily Body weight 5 kg: 15 mg twice daily; oral suspension (6mg/mL) 2.5 mL twice daily Body weight 6 kg: 18 mg twice daily; oral suspension (6mg/mL) 3.0 mL twice daily Body weight 7 kg: 21 mg twice daily; oral suspension (6mg/mL) 3.5 mL twice daily Body weight 8 kg: 24 mg twice daily; oral suspension (6mg/mL) 4.0 mL twice daily Body weight 9 kg: 27 mg twice daily; oral suspension (6mg/mL) 4.5 mL twice daily Body weight 10 kg: 30 mg twice daily; oral 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 medicine is recommended for children under 1 year of age. It is recommended that a pharmacist prepare the oral suspension of this medicine before it is administered to the patient. 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 75mg capsules once daily or 30mg and 45mg capsules once daily for 10 days instead of the recommended dose of this medicine as an oral suspension. Body weight ≤ 15 kg: 30 mg once daily; oral suspension (6mg/mL) 5.0 mL once daily Body weight 15 kg<, ≤ 23 kg: 45 mg once daily; oral suspension (6mg/mL) 7.5 mL once daily Body weight 23 kg<, ≤ 40 kg: 60 mg once daily; oral suspension (6mg/mL) 10.0 mL once daily Body weight > 40 kg: 75 mg once daily; oral suspension (6mg/mL) 12.5 mL once daily It is recommended that a pharmacist prepare the oral suspension of this medicine 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, but it cannot replace the influenza vaccine. This medication is only effective against influenza A and B viruses, and its safety and efficacy have not been established for other infections. Rarely, neuropsychiatric side effects may occur in children and adolescents, thus careful observation should be carried out in case of unusual behavior. It is generally not recommended for children over 10 years old, and caregivers should not leave children alone for at least 2 days after treatment has started. Patients with hypersensitivity to this medication should not take it, and dosage adjustments or careful administration is needed for patients with renal failure or in high-risk groups. Common side effects may include nausea, vomiting, headache, but these are usually temporary. Rarely, serious adverse reactions such as skin rashes, liver function abnormalities, neuropsychiatric symptoms, and acute renal failure may occur, and immediate medical consultation is necessary if symptoms arise. Women who are pregnant or breastfeeding should carefully consider the risks and benefits of taking this medication. The safety and efficacy for children, especially infants under 1 year of age, have not been fully established, thus caution is needed for use. Elderly patients may have different sensitivities to the medication due to decreased bodily functions, hence administration should be under medical supervision. This medication is unlikely to interact with other medications, but caution may be necessary when combined with specific drugs. If unusual behavior, skin abnormalities, breathing difficulties occur while taking this medication, stop taking it immediately and inform a healthcare professional. This medication should be stored out of reach of children and it is advisable not to change the storage container. It should be started as early as possible during the initial symptoms, and if a dose is missed, take it as soon as possible but skip if it is within 2 hours of the next dose time.

• Nausea
• vomiting
• headache
• pain
• unstable angina
• anemia
• membranous colitis
• pneumonia
• peritonsillar abscess
• humeral fracture

This medication may be sensitive to air or moisture; therefore, it must be stored in a sealed container. Additionally, it is best stored at room temperature between 1°C and 30°C. Storing it this way will help maintain its effectiveness.

Appearance

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

Package unit

10 capsules/PTP