Tamiflu Capsule 30 mg (Oseltamivir Phosphate)

Adult dose

1. 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 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). 2. 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

1. 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; suspension (6mg/mL) 5.0 mL twice daily for 5 days. Weight 15 kg<, ≤ 23 kg: 45 mg twice daily; suspension (6mg/mL) 7.5 mL twice daily for 5 days. Weight 23 kg<, ≤ 40 kg: 60 mg twice daily; suspension (6mg/mL) 10.0 mL twice daily for 5 days. Weight > 40 kg: 75 mg twice daily; suspension (6mg/mL) 12.5 mL twice daily for 5 days. 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; suspension (6mg/mL) 1.5 mL twice daily for 5 days. Weight 4 kg: 12 mg twice daily; suspension (6mg/mL) 2.0 mL twice daily for 5 days. Weight 5 kg: 15 mg twice daily; suspension (6mg/mL) 2.5 mL twice daily for 5 days. Weight 6 kg: 18 mg twice daily; suspension (6mg/mL) 3.0 mL twice daily for 5 days. Weight 7 kg: 21 mg twice daily; suspension (6mg/mL) 3.5 mL twice daily for 5 days. Weight 8 kg: 24 mg twice daily; suspension (6mg/mL) 4.0 mL twice daily for 5 days. Weight 9 kg: 27 mg twice daily; suspension (6mg/mL) 4.5 mL twice daily for 5 days. Weight 10 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily for 5 days. * 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 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; suspension (6mg/mL) 5.0 mL once daily for 10 days. Weight 15 kg<, ≤ 23 kg: 45 mg once daily; suspension (6mg/mL) 7.5 mL once daily for 10 days. Weight 23 kg<, ≤ 40 kg: 60 mg once daily; suspension (6mg/mL) 10.0 mL once daily for 10 days. Weight > 40 kg: 75 mg once daily; suspension (6mg/mL) 12.5 mL once daily for 10 days. ※ 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 infection and cannot replace the influenza vaccine. It has been proven effective only against influenza A and B viruses, and its safety and efficacy have not been confirmed for other infections. Particularly in children and adolescents, neuropsychiatric adverse reactions such as seizures or delirium have been reported rarely, requiring careful monitoring for abnormal behavior in this age group. For children over 10 years, it is generally recommended not to use unless there are specific risk factors. As abnormal behavior or neuropsychiatric symptoms may occur during treatment, caregivers should ensure that children or adolescents do not remain alone for at least 2 days. Patients with hypersensitivity to this drug should not use it, and those with renal impairment or certain high-risk factors may need dose adjustments or careful administration. The most common side effects include nausea, vomiting, and headache, which are mostly temporary and mild. Rarely, serious adverse reactions such as shock, anaphylaxis, hepatitis, Stevens-Johnson syndrome, acute renal failure, and neuropsychiatric abnormalities can occur; if any adverse symptoms arise, the drug should be discontinued immediately and medical consultation should be obtained. The use of this drug during pregnancy or breastfeeding should be carefully considered only if the therapeutic benefits outweigh the risks. Safety and efficacy have not been established for children under the age of 1, so its use is not recommended. Elderly patients generally do not require dose adjustments; however, careful monitoring is necessary for those with impaired bodily functions or underlying conditions. There have been no reported special harms from overdose; however, it is important to alert medical personnel if adverse reactions occur. This medication should be stored out of reach of children and it is advisable to avoid transferring it to other containers. While clinically significant interactions with other medications are rare, caution may be necessary when combined with certain drugs; it is important to inform healthcare professionals of any other medications being taken. No effects on driving or operating machinery have been reported, but since influenza itself may impair ability, caution is advised.

• 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 and moisture, and kept in a cool place below 25 degrees Celsius. This will help maintain the medication's effectiveness for a longer period.

Appearance

Hard capsules with a light yellow color containing a white or pale yellow powder.

Package unit

10 capsules (10 capsules/PTP X 1)