Tamiflu Capsule 45 mg (Oseltamivir Phosphate)

Adult dose

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. [Treatment of influenza A and influenza B virus infections] 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 a powder for suspension. Patients with renal impairment: No dosage adjustment is required in patients with a creatinine clearance of 60 mL/min or more. A reduced dose of 30 mg twice daily for 5 days is recommended for patients with a creatinine clearance of 30 ~ 60 mL/min. A reduced dose of 30 mg once daily for 5 days is recommended for patients with a creatinine clearance of 10 ~ 30 mL/min. Patients receiving regular hemodialysis should receive a 30mg dose of this medicine after each dialysis session to maintain therapeutic blood concentrations, and the treatment period should not exceed 5 days. If influenza symptoms develop during the 48 hours between dialysis sessions, this medicine may also be administered 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 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 this medicine is being taken. Patients with renal impairment: No dosage adjustment is required in patients with a creatinine clearance of 60 mL/min or more. A reduced dose of 30 mg once daily is recommended for patients with a creatinine clearance of 30 ～ 60 mL/min. A reduced dose of 30 mg once daily every other day is recommended for patients with a creatinine clearance of 10 ～ 30 mL/min. Patients receiving regular hemodialysis should receive a 30mg dose of this medicine after every 2 dialysis sessions to maintain therapeutic blood concentrations. The initial dose may also be administered before dialysis begins. 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

[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 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 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 Infants aged 2 weeks to under 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 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. It is recommended that a pharmacist prepare this medicine as a suspension before administration 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 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 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 It is recommended that a pharmacist prepare this medicine as a suspension before administration to the patient. ※ The safety and efficacy of 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-infected patients and cannot replace the influenza vaccine. This medication has been proven effective only against influenza A and B viruses, and its safety and efficacy have not been confirmed for other infections. Especially in children and adolescents, abnormal behavior or neuropsychiatric reactions may occur after taking this medication; therefore, caregivers must closely monitor the patient during treatment. Patients allergic to this medication or its components should not take it. Patients with impaired renal function or those undergoing dialysis need dosage adjustments, and it is not recommended for patients with end-stage renal failure. Side effects such as nausea, vomiting, headache, and others may occur; and rarely, adverse effects such as skin rash, liver function abnormalities, and neuropsychiatric symptoms may arise, so immediate consultation with a physician is required if unusual symptoms appear. Women who are pregnant or breastfeeding should carefully consider the risks and benefits of using this medication. In cases of children, it is not used for those under 1 year old, as safety and efficacy have not been established, and it is administered in appropriate doses starting from the age of 1. Elderly patients may have decreased body function and various diseases, thus caution is necessary when taking this medication. The risk of interaction with other drugs is low, but caution may be needed when combined with certain medications, so it is important to inform about any concurrent medications. Serious side effects due to overdose are rare, but the prescribed dosage and administration should be followed strictly. This medication should be kept out of reach of children and should not be transferred to other containers. If unusual behavior, rash, difficulty breathing, severe vomiting, or other unusual symptoms occur, discontinue use immediately and consult medical personnel.

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

This medication is sensitive to air and moisture; therefore, it should be stored in a tightly sealed container. Additionally, it should be kept in a cool place below 25 degrees Celsius to maintain its efficacy.

Appearance

A hard capsule with a bright gray upper and lower part containing a white or light yellow powder

Package unit

10 capsules (10 capsules/PTP X 1)