Tamiflu Capsule 45 mg (Oseltamivir Phosphate)

Adult dose

Treatment of influenza A and influenza B virus infections: Treatment should be initiated on the first or second day after the onset of influenza symptoms. This medicine may be administered with or without food; in some patients, taking it with food may improve tolerability. Adults and adolescents aged 13 years and older: Administer oseltamivir 75 mg orally twice daily for 5 days. Adults and adolescents aged 13 years and older who have difficulty swallowing capsules should be treated using this medicine as powder for suspension. Patients with renal impairment (treatment): No dose adjustment is required for 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 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 also 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 undergoing dialysis (e.g., creatinine clearance below 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment (treatment): No dose adjustment is required for treatment in adults with mild to moderate hepatic impairment (Child-Pugh score ≤ 9). Prevention of influenza A and influenza B virus infections: For close contacts of an infected person, administer oseltamivir 75 mg 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 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 (prevention): No dose adjustment is required for 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 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 first dose may also 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 undergoing dialysis (e.g., creatinine clearance below 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment (prevention): No dose adjustment is required for prevention in adults with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

Treatment 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 twice daily or a 30mg capsule and a 45mg capsule twice daily instead of the recommended dose of this medicine suspension. Weight ≤ 15 kg: 30 mg twice daily for 5 days; suspension (6mg/mL) 5.0 mL twice daily Weight 15 kg<, ≤ 23 kg: 45 mg twice daily for 5 days; suspension (6mg/mL) 7.5 mL twice daily Weight 23 kg<, ≤ 40 kg: 60 mg twice daily for 5 days; suspension (6mg/mL) 10.0 mL twice daily Weight > 40 kg: 75 mg twice daily for 5 days; suspension (6mg/mL) 12.5 mL twice daily Treatment of influenza A and influenza B virus infections, 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 administered orally twice daily for 5 days. This does not apply to children with a postconceptional age of less than 36 weeks. Weight 3 kg: 9 mg twice daily for 5 days; suspension (6mg/mL) 1.5 mL twice daily Weight 4 kg: 12 mg twice daily for 5 days; suspension (6mg/mL) 2.0 mL twice daily Weight 5 kg: 15 mg twice daily for 5 days; suspension (6mg/mL) 2.5 mL twice daily Weight 6 kg: 18 mg twice daily for 5 days; suspension (6mg/mL) 3.0 mL twice daily Weight 7 kg: 21 mg twice daily for 5 days; suspension (6mg/mL) 3.5 mL twice daily Weight 8 kg: 24 mg twice daily for 5 days; suspension (6mg/mL) 4.0 mL twice daily Weight 9 kg: 27 mg twice daily for 5 days; suspension (6mg/mL) 4.5 mL twice daily Weight 10 kg: 30 mg twice daily for 5 days; 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. 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 a 30mg capsule and a 45mg capsule once daily for 10 days instead of the recommended dose of this medicine suspension. Weight ≤ 15 kg: 30 mg once daily for 10 days; suspension (6mg/mL) 5.0 mL once daily Weight 15 kg<, ≤ 23 kg: 45 mg once daily for 10 days; suspension (6mg/mL) 7.5 mL once daily Weight 23 kg<, ≤ 40 kg: 60 mg once daily for 10 days; suspension (6mg/mL) 10.0 mL once daily Weight > 40 kg: 75 mg once daily for 10 days; 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 cannot replace the influenza vaccine and should be used separately from the annual influenza vaccination. This medication is effective only against Influenza A and B viruses, and safety and efficacy against other infections have not been confirmed. When children and adolescents take this medication, unusual behavior or neuropsychiatric reactions may occur, so caregivers should observe them closely. In particular, it is generally recommended not to use this medication for pediatric patients over 10 years old due to the risk of accidents caused by unusual behavior, except in special cases. Individuals allergic to this drug should not take it, and those with impaired kidney function may require dose adjustment or are advised not to use it. Patients with asthma or chronic bronchitis, and those in immunocompromised states should use this medication with caution. Common side effects after taking it include nausea, vomiting, headache, pain, etc., most of which are temporary. Rarely, skin rash, liver dysfunction, renal failure, leukopenia, and neuropsychiatric symptoms may occur, so immediate consultation with a doctor is required if any unusual symptoms appear. The use of this medication in pregnant or breastfeeding women should carefully consider the therapeutic effects and risks, as clinical data are limited. The safety and efficacy for children under 1 year of age have not been sufficiently established, so its use is not recommended. For the elderly, no special dose adjustments are needed, but careful observation is required considering overall health status. This medication has a low potential for drug interactions, but caution may be needed when used with certain medications, so patients must inform their doctor of all medications being taken. Patients should adhere to the prescribed usage and dosage; if a dose is missed, it should be taken as soon as possible, but if it is too close to the next dose, do not double the dose. No special effects are reported while driving or operating machinery, but caution is needed due to symptoms caused by the influenza itself. Keep out of reach of children and do not transfer to other containers for safety.

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

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. Moreover, it is important to store it at a cool temperature below 25 degrees to maintain the drug's efficacy.

Appearance

Gray hard capsule containing white or pale yellow powder

Package unit

10 capsules (10 capsules/PTP)