Phail Tamiflu Capsule 45 Milligrams (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. 1) Adults and adolescents 13 years of age and older: Administer 75 mg of oseltamivir orally twice daily for 5 days. Adults and adolescents 13 years of age and older who have difficulty swallowing capsules should use this medicine as powder for oral suspension. 4) Patients with renal impairment No dosage adjustment is required in patients with a creatinine clearance of 60 mL/min or higher. 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 plasma concentrations within the therapeutic range, and treatment 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 below 10mL/min); therefore, no recommended dose is available for these patients. 5) 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 1) Adults and adolescents 13 years of age and older: For individuals in close contact with 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. 3) Patients with renal impairment No dosage adjustment is required in patients with a creatinine clearance of 60 mL/min or higher. 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 every other day is recommended. Patients receiving regular hemodialysis should receive a 30mg dose of this medicine after every 2 dialysis sessions to maintain plasma concentrations within the therapeutic range. The initial dose may be administered before the start of dialysis. For peritoneal dialysis, administration of 30mg of this medicine after dialysis once a week 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. 4) 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

2) Children 1 to 12 years of age: Pediatric patients weighing more than 40 kg who are able to 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 an oral suspension. ≤ 15 kg: 30 mg twice daily; 5.0 mL twice daily 15 kg<, ≤ 23 kg: 45 mg twice daily; 7.5 mL twice daily 23 kg<, ≤ 40 kg: 60 mg twice daily; 10.0 mL twice daily > 40 kg: 75 mg twice daily; 12.5 mL twice daily 3) Infants 2 weeks to less than 1 year of age: The recommended dose for pediatric patients 2 weeks to 12 months of age 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. 3 kg: 9 mg twice daily; 1.5 mL twice daily 4 kg: 12 mg twice daily; 2.0 mL twice daily 5 kg: 15 mg twice daily; 2.5 mL twice daily 6 kg: 18 mg twice daily; 3.0 mL twice daily 7 kg: 21 mg twice daily; 3.5 mL twice daily 8 kg: 24 mg twice daily; 4.0 mL twice daily 9 kg: 27 mg twice daily; 4.5 mL twice daily 10 kg: 30 mg twice daily; 5.0 mL twice daily * This table does not include all possible body weights in this patient group. For children under 1 year of age, a dose of 3mg/kg of this medicine is recommended. It is recommended that a pharmacist prepare this medicine as an oral suspension before administration to the patient. 2) Children 1 to 12 years of age: Pediatric patients weighing more than 40 kg who are able to 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 an oral suspension. ≤ 15 kg: 30 mg once daily; 5.0 mL once daily 15 kg<, ≤ 23 kg: 45 mg once daily; 7.5 mL once daily 23 kg<, ≤ 40 kg: 60 mg once daily; 10.0 mL once daily > 40 kg: 75 mg once daily; 12.5 mL once daily It is recommended that a pharmacist prepare this medicine as an oral suspension before administration to the patient. ※ The safety and efficacy of this medicine for the prevention of influenza A and B virus infections in children under 1 year of age have not been evaluated.

This medication cannot replace influenza vaccination and should be used separately from vaccination. This medication is effective only for influenza A and B viruses, and safety and efficacy for other infections have not been established. Neurological and psychiatric adverse reactions, including abnormal behavior, have been reported, especially in children and adolescents, so caregivers should closely monitor during the 2 days following administration. Patients with allergies to this medication or its components should not take it. Patients with impaired renal function require dose adjustment, and it is not recommended for patients with end-stage renal failure. Use with caution in high-risk groups such as those with asthma, chronic bronchitis, or immunosuppression. Commonly, symptoms such as nausea, vomiting, and headache may occur but are usually temporary and not serious. Rarely, manifestations such as shock, anaphylaxis, hepatitis, skin reactions, acute renal failure, and neuropsychiatric symptoms may occur, and in case of unusual symptoms, consultation with healthcare providers should be sought immediately. This medication can be used for children, but safety and efficacy have not been established for children under 1 year of age. Pregnant or breastfeeding women should only use this after consulting a physician, and only when the therapeutic benefits outweigh the risks. The potential for drug interactions is low, but caution is advised when used with certain medications. When taking the medication, it is most effective to start as early as possible when influenza symptoms begin, and if a dose is missed, take it as soon as possible, skipping the dose if it's too close to the next scheduled time. Consider the potential reduced ability to drive or operate machinery due to the influenza itself. Store this medication out of reach of children and do not transfer it to other containers.

Convulsions, delirium, abnormal behavior, nausea, vomiting, headache, pain, unstable angina, anemia, pseudomembranous colitis, pneumonia, peritonsillar abscess, humeral fracture, hallucinations, convulsions, dermatitis, rash, urticaria, eczema, headache, insomnia, cough, runny nose, congestion, sore throat, abdominal pain, upper abdominal pain, diarrhea, dyspepsia, back pain, arthralgia, myalgia, menstrual pain, dizziness, fatigue, fever, influenza-like symptoms, limb pain, shock, anaphylaxis, hepatitis, abnormal liver function, jaundice, syndrome of inappropriate secretion of antidiuretic hormone, toxic epidermal necrolysis, acute renal failure, leukopenia, thrombocytopenia, altered consciousness, hallucinations, delusions, hemorrhagic colitis, erythema, erythema, itching, subcutaneous hemorrhage, cheilitis, stomatitis, bloody stools, black stools, hematemesis, peptic ulcer, abdominal distension, abnormal stools, oral discomfort, loss of appetite, agitation, tremors, paresthesia, lethargy, drowsiness, ventricular tachycardia, ventricular ectopy, electrocardiogram 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 disturbances

This medication should be stored in a tightly sealed container to prevent air or moisture from entering, and it should be kept in a cool place, below 25 degrees Celsius, to maintain effectiveness.

Appearance

A gray hard capsule containing white or off-white powder.

Package unit

10 capsules/PTP