Tamiflu Capsule 75 mg (Oseltamivir Phosphate)

Adult dose

1. Treatment of influenza A and influenza B virus infections Begin treatment on the first or second day after influenza symptoms appear. This medicine may be taken with or without food; taking it with food may improve tolerability in some patients. 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 suspension. Patients with renal impairment: No dose adjustment is needed for patients with creatinine clearance of 60 mL/min or greater. For patients with creatinine clearance of 30 ~ 60 mL/min, reduction to 30 mg twice daily for 5 days is recommended. For patients with creatinine clearance of 10 ~ 30 mL/min, reduction to 30 mg once daily for 5 days is recommended. Patients receiving intermittent hemodialysis should receive a 30mg dose of this medicine after each dialysis session to maintain therapeutic plasma concentrations; treatment must 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 below 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment: No dose adjustment is needed for treatment in adults 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 outbreak 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 dose adjustment is needed for patients with creatinine clearance of 60 mL/min or greater. For patients with creatinine clearance of 30 ～ 60 mL/min, reduction to 30 mg once daily is recommended. For patients with creatinine clearance of 10 ～ 30 mL/min, reduction to 30 mg once every other day is recommended. Patients receiving intermittent hemodialysis should receive a 30mg dose of this medicine after every 2 dialysis sessions to maintain therapeutic plasma concentrations. The first dose may be administered before the start of dialysis. For peritoneal dialysis, administration of 30mg of this medicine once weekly 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 below 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment: No dose adjustment is needed for prevention in adults with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

1. 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 as a 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 (pediatric patients aged 2 weeks to 12 months): Administer 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 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. For children under 1 year, 3mg/kg of this medicine is recommended. It is recommended that a pharmacist prepare this medicine as a suspension before administration 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 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 as a 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 It is recommended that a pharmacist prepare this medicine as a suspension before administration to the patient. The safety and efficacy of this medicine for prevention of influenza A and B virus infections in children under 1 year have not been evaluated.

This medicine cannot substitute for influenza vaccination and should be used annually along with vaccination. This medicine is effective only against influenza A and B, so it should not be used for other infections. Particularly, in children and adolescents, abnormal behavior or neuropsychiatric adverse reactions may occur, so caregivers should carefully observe the patient for at least 2 days after administration. Patients with hypersensitivity to this medicine or its components should not use it. Patients with impaired renal function require dose adjustment, and it is not recommended for patients with end-stage renal failure. Patients in high-risk groups (such as those with asthma, chronic bronchitis, or immunocompromised conditions) should use this medicine with caution. Side effects such as nausea, vomiting, headache, and dizziness may occur during use, but most are temporary. Rarely, symptoms such as shock, anaphylaxis, liver function abnormalities, skin adverse reactions, acute renal failure, blood abnormalities, and neuropsychiatric symptoms may occur; any unusual symptoms should be immediately discussed with a healthcare professional. Pregnant or nursing women should use this medication only when the therapeutic benefits outweigh the risks, and consultation with a specialist is necessary. The safety and efficacy for children under 1 year of age have not been established, so it is preferable not to use it. Elderly patients should be closely monitored and dosed considering decreased physical function and comorbidities. Drug interactions are rare, but caution is needed when combined with drugs affecting renal excretion. If abnormal behaviors or neurological symptoms appear during use, drug intake should be immediately stopped and healthcare professionals notified. Store out of reach of children and do not transfer to other containers.

cramps, delirium, abnormal behavior, nausea, vomiting, headache, pain, unstable angina, anemia, colitis associated with Clostridium difficile, pneumonia, peritonsillar abscess, humeral fracture, hallucinations, dermatitis, rash, hives, eczema, insomnia, dizziness, fatigue, fever, influenza-like symptoms, limb pain, back pain, arthralgia, myalgia, menstrual pain, cough, runny nose, congestion, sore throat, abdominal pain, upper abdominal pain, diarrhea, dyspepsia, hemorrhagic colitis, shock, anaphylactic reaction, hepatitis, abnormal liver function, jaundice, mucocutaneous syndrome, toxic epidermal necrolysis, acute renal failure, leukopenia, thrombocytopenia, psychiatric symptoms, consciousness disturbances, hallucinations, delusions, hemorrhagic colitis, erythema, redness, itching, petechiae, cheilitis, stomatitis, hematochezia, melena, hematemesis, peptic ulcer, abdominal distension, abnormal stool, oral unpleasantness, loss of appetite, agitation, tremor, numbness, lethargy, drowsiness, ventricular tachycardia, ventricular ectopic beats, abnormal ECG, palpitations, increased AST, increased ALT, increased γ-GTP, increased ALP, hematuria, positive proteinuria, eosinophilia, visual disturbances, fever, hypothermia, edema, increased blood sugar, abdominal pain, chest pain, pneumonia, sinusitis, bronchitis, otitis media, asthma, epistaxis, conjunctivitis, ear pain, dermatitis, sleep disturbances

This medicine should be stored in a tightly closed container to protect from air and moisture, and it is important to maintain a temperature below 25 degrees Celsius. Proper storage helps to keep the medication effective for a longer time.

Appearance

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

Package unit

10 capsules (10 capsules/PTP)