Tamiflu 30mg Capsule (Oseltamivir Phosphate)

Adult dose

1. Influenza A and influenza B virus infections: Initiate treatment on the first or second day after the onset of influenza symptoms. This drug may be administered with or without food; in some patients, tolerability may be improved when taken with food. 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 drug as a powder for suspension. Patients with renal impairment: No dosage adjustment is required in patients with creatinine clearance of 60 mL/min or greater. 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 drug after each dialysis session to maintain plasma concentrations within the therapeutic range; treatment 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 drug 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. Initiate administration within 2 days of contact with the infected person. During an influenza epidemic, the recommended dose for prevention is 75 mg once daily. The safety and efficacy of this drug have been demonstrated for up to 6 weeks. The protective effect continues while this drug is being taken. Patients with renal impairment: No dosage adjustment is required in patients with creatinine clearance of 60 mL/min or greater. 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 every other day is recommended. Patients receiving regular hemodialysis should receive a 30mg dose of this drug after every 2 dialysis sessions to maintain plasma concentrations within the therapeutic range. The initial dose may also be administered before the start of dialysis. For peritoneal dialysis, administration of 30mg of this drug 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 year to 12 years: Pediatric patients weighing more than 40kg who are able to swallow capsules may take 75 mg capsules twice daily or 30 mg capsules and 45 mg capsules twice daily instead of the recommended dose of this drug 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 Children aged 2 weeks to under 1 year: The recommended dose for pediatric patients aged 2 weeks to 12 months is 3mg/kg of this drug, administered orally twice daily for 5 days. This does not apply to infants with a post-conceptional 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 drug is recommended for children under 1 year of age. 2. Prevention of influenza A and influenza B virus infections Children aged 1 year to 12 years: Pediatric patients weighing more than 40 kg who are able to swallow capsules may take 75 mg capsules once daily or 30 mg capsules and 45 mg capsules once daily for 10 days instead of the recommended dose of this drug 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 drug for the prevention of influenza A and B virus infections in children under 1 year of age have not been evaluated.

This medicine is used to treat or prevent influenza virus infections but cannot replace influenza vaccinations. It is essential to receive the annual influenza vaccine even if this medicine is used, as its preventive effect lasts only during the treatment period. Safety and efficacy have only been proven for influenza A and B viruses, and it is not used for other types of infections. Use is not recommended in children under 1 year of age due to inadequate studies on its safety and efficacy. Special care should be taken when administering this medicine to children and adolescents, as rare neurological symptoms, such as seizures or unusual behavior, may occur. Generally, this medicine is not used in children over 10 years old unless special circumstances arise. Since there is a risk of unusual behavior after taking this medicine, caregivers should ensure that children and adolescents are not left alone for at least 2 days after treatment initiation. Patients with allergies to this medicine or hypersensitivity to its components should not take it. Dose adjustments are needed for patients with renal impairment or on dialysis, and it is not recommended for those with end-stage renal failure. Care should be taken when using this medicine in high-risk patients, such as those with asthma or chronic bronchitis. Common side effects may include nausea, vomiting, headache, and most are temporary and mild. Rarely, skin rashes, liver function abnormalities, renal failure, or neuropsychiatric symptoms may occur, so any unusual symptoms should be reported to a healthcare professional immediately. Pregnant or breastfeeding women should carefully consider the risks and benefits of this medicine and consult with a doctor if necessary. It can also be used in children or the elderly, but safety and efficacy should be closely monitored in these respective age groups. This medicine has a low potential for drug interactions, but caution is needed with specific medications. When taking this medicine, it is important to adhere to the prescribed dosage and administration. If a dose is missed, it should be taken as soon as possible, but not too close to the next scheduled dose. There have been no reports of effects on driving or operating machinery, but the potential for decreased physical function due to influenza itself should be considered. This medicine should be stored out of reach of children and not transferred to other containers.

• spasms
• delirium
• abnormal behavior
• nausea
• vomiting
• headache
• pain
• unstable angina
• anemia
• pseudomembranous colitis

This medicine should be stored in a tightly closed container to protect it from air and moisture, preferably at a cool temperature below 25 degrees Celsius. This helps maintain the efficacy of the medicine for a longer duration.

Appearance

Hard yellowish capsules containing gray or pale yellow powder

Package unit

10 capsules (10 capsules/PTP×1)