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 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). 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 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

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 and 45mg capsules twice daily instead of the recommended dose of this medicine as an oral suspension. ≤ 15 kg: 30 mg twice daily; oral suspension (6mg/mL) 5.0 mL twice daily (for 5 days) 15 kg<, ≤ 23 kg: 45 mg twice daily; oral suspension (6mg/mL) 7.5 mL twice daily (for 5 days) 23 kg<, ≤ 40 kg: 60 mg twice daily; oral suspension (6mg/mL) 10.0 mL twice daily (for 5 days) > 40 kg: 75 mg twice daily; oral suspension (6mg/mL) 12.5 mL twice daily (for 5 days) 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. 3 kg: 9 mg twice daily; oral suspension (6mg/mL) 1.5 mL twice daily (for 5 days) 4 kg: 12 mg twice daily; oral suspension (6mg/mL) 2.0 mL twice daily (for 5 days) 5 kg: 15 mg twice daily; oral suspension (6mg/mL) 2.5 mL twice daily (for 5 days) 6 kg: 18 mg twice daily; oral suspension (6mg/mL) 3.0 mL twice daily (for 5 days) 7 kg: 21 mg twice daily; oral suspension (6mg/mL) 3.5 mL twice daily (for 5 days) 8 kg: 24 mg twice daily; oral suspension (6mg/mL) 4.0 mL twice daily (for 5 days) 9 kg: 27 mg twice daily; oral suspension (6mg/mL) 4.5 mL twice daily (for 5 days) 10 kg: 30 mg twice daily; oral suspension (6mg/mL) 5.0 mL twice daily (for 5 days) * 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. 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 and 45mg capsules once daily for 10 days instead of the recommended dose of this medicine as an oral suspension. ≤ 15 kg: 30 mg once daily; oral suspension (6mg/mL) 5.0 mL once daily (for 10 days) 15 kg<, ≤ 23 kg: 45 mg once daily; oral suspension (6mg/mL) 7.5 mL once daily (for 10 days) 23 kg<, ≤ 40 kg: 60 mg once daily; oral suspension (6mg/mL) 10.0 mL once daily (for 10 days) > 40 kg: 75 mg once daily; oral suspension (6mg/mL) 12.5 mL once daily (for 10 days) 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 drug cannot substitute for influenza vaccination and is only used for treatment and prevention when the influenza virus is circulating. The safety and efficacy of this drug for infections other than influenza A and B have not been established. Rarely, neuropsychiatric adverse reactions such as seizures and delirium have been reported in children and adolescents, and caregivers should closely monitor for abnormal behaviors. This drug is not recommended for non-high-risk patients, especially those over 10 years old, due to the risk of accidents related to abnormal behavior. Patients who are allergic to this drug or any of its components should not take it. Patients with impaired renal function or those undergoing dialysis require dosage adjustments, and it is not recommended for patients with end-stage renal failure. Cautious administration is required for high-risk patients such as those with asthma, chronic bronchitis, or immunosuppressive conditions. Common side effects during administration include nausea, vomiting, headache, and most are temporary and mild symptoms. Rarely, shock, anaphylaxis, liver dysfunction, skin rash, acute renal failure, and neuropsychiatric symptoms may occur, so if any abnormal symptoms occur, immediate consultation with healthcare professionals is necessary. Pregnant or breastfeeding women should carefully consider the risks and benefits of administering this drug, as there is limited information on its effects on fetuses or infants. The safety and efficacy of this drug in children, especially those under 1 year of age, have not been fully established, so caution is needed. Elderly patients may have decreased physical function and other conditions, so careful observation is required during use, although dosage adjustments are generally not needed. When taking the medication, follow the prescribed dosage and administration. If a dose is missed, take it as soon as possible, but if it is very close to the next dose, skip it. This drug has a low likelihood of interaction with other medications; however, if other medications are being taken, this must be reported to healthcare professionals. The impact on driving or operating machinery is unknown, but attention should be paid as influenza itself may decrease concentration. This drug should be stored out of reach of children and not transferred to other containers.

Cramps, delirium, abnormal behavior, nausea, vomiting, headache, pain, unstable angina, anemia, pseudomembranous colitis, pneumonia, peritonsillar abscess, humeral fracture, hallucinations, cramps, dermatitis, rash, urticaria, eczema, headache, insomnia, cough, runny nose, nasal congestion, sore throat, nausea, vomiting, abdominal pain, epigastric pain, diarrhea, dyspepsia, back pain, joint pain, myalgia, menstrual pain, dizziness, fatigue, fever, pain, influenza-like symptoms, limb pain, shock, anaphylactic reaction, hepatitis, liver dysfunction, jaundice, skin-mucous membrane syndrome, toxic epidermal necrolysis, acute renal failure, leukopenia, thrombocytopenia, neuropsychiatric syndrome (consciousness disturbance, abnormal behavior, delirium, hallucinations, delusions, cramps), hemorrhagic colitis, erythema, urticaria, flushing, itching, subcutaneous hemorrhage, cheilitis, stomatitis, hematochezia, melena, hematemesis, peptic ulcer, abdominal distension, abnormal stools, oral discomfort, loss of appetite, agitation, tremor, paresthesia, lethargy, drowsiness, ventricular tachycardia, premature ventricular contractions, ECG abnormalities, palpitations, increased AST, increased ALT, increased γ-GTP, increased ALP, hematuria, positive proteinuria, eosinophilia, visual disturbances, fever, hypothermia, edema, increased blood glucose, abdominal pain, chest pain, pneumonia, sinusitis, bronchitis, otitis media, asthma, epistaxis, conjunctivitis, ear pain, dermatitis, sleep disturbance

This medicine should be stored in a tightly closed container to protect it from air and moisture, and it is important to store it at room temperature between 1°C and 30°C. Storing it this way will help maintain the drug's effectiveness and ensure safe use.

Appearance

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

Package unit

10 capsules/PTP