Comiflusan 30mg (Oseltamivir Phosphate)
Oseltamivir Phosphate 39.4mg
Prescription medication
Kolon Pharmaceuticals Co., Ltd.
MFDS item code 201908619 · Approved 2019.12.24 · Insurance code 670304391
Treatment and prevention of influenza A·B virus infections
This medication is used for the treatment of influenza A and B virus infections in patients aged 2 weeks and older, including adults. It is particularly effective when administered within 48 hours of the onset of initial symptoms. It may also be used for the prevention of influenza in individuals aged 1 year and older; however, vaccination is the primary method of prevention, and this medication serves as an adjunct in situations where vaccination is difficult or less effective. This medication should not replace vaccination and it is essential to receive immunizations to ensure full protective benefits. It helps in the treatment of influenza infections and limited prevention.
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; tolerability may improve in some patients when it is 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 medicine for dosing. Patients with renal impairment: No dosage adjustment is required for patients with creatinine clearance of 60 mL/min or greater. For patients with creatinine clearance of 30 ~ 60 mL/min, reducing the dose to 30 mg twice daily for 5 days is recommended. For patients with creatinine clearance of 10 ~ 30 mL/min, reducing the dose to 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; 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. Patients with hepatic impairment: No dosage adjustment is required for treatment in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9). 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 influenza outbreaks 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 for patients with creatinine clearance of 60 mL/min or greater. For patients with creatinine clearance of 30 ~ 60 mL/min, reducing the dose to 30 mg once daily is recommended. For patients with creatinine clearance of 10 ~ 30 mL/min, reducing the dose to 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 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 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 dosage adjustment is required for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).
Children aged 1 to 12 years (treatment): 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. ≤ 15 kg: 30 mg (packet) twice daily 15 kg<, ≤ 23 kg: 45 mg (packet) twice daily 23 kg<, ≤ 40 kg: 60 mg (two 30mg packets) twice daily > 40 kg: 75 mg (packet) twice daily Infants aged 2 weeks to under 1 year: The recommended dose for infants 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. Pediatric patients who have difficulty taking the powder of this medicine should use the suspension for dosing. 3 kg: 9 mg twice daily; 1.5mL twice daily 4 kg: 12 mg twice daily; 2.0mL twice daily 5 kg: 15 mg twice daily; 2.5mL twice daily 6 kg: 18 mg twice daily; 3.0mL twice daily 7 kg: 21 mg twice daily; 3.5mL twice daily 8 kg: 24 mg twice daily; 4.0mL twice daily 9 kg: 27 mg twice daily; 4.5mL twice daily 10 kg: 30 mg twice daily; 5.0mL twice daily A dose of 3mg/kg of this medicine is recommended for children under 1 year of age. Children aged 1 to 12 years (prevention): 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. ≤ 15 kg: 30 mg (packet) once daily 15 kg<, ≤ 23 kg: 45 mg (packet) once daily 23 kg<, ≤ 40 kg: 60 mg (two 30mg packets) once daily > 40 kg: 75 mg (packet) once daily The safety and efficacy of preventing 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 in addition to vaccines. Its efficacy has been proven only against influenza A and B viruses, and safety and efficacy have not been established for other infections. Reports of neuropsychiatric adverse reactions, such as seizures or delirium and abnormal behavior, have occurred in children and adolescents, and caution is advised. In pediatric patients older than 10 years, this medication is not generally used unless they are in a high-risk category, and caregivers should closely monitor the patient for abnormal behaviors during treatment. It should not be administered to patients with hypersensitivity to this medication or its components. Patients with renal impairment, particularly those with moderate or severe impairment, require dosage adjustment, and it is not recommended for patients with end-stage renal disease. This medication should be administered cautiously in high-risk patients with asthma, chronic bronchitis, or immunosuppressive conditions. Common side effects include nausea, vomiting, headache, and pain, and they are mostly transient. Rarely, symptoms such as shock, anaphylaxis, liver dysfunction, skin reactions, acute renal failure, and neurological symptoms may occur, and immediate consultation with medical personnel is necessary if any abnormal symptoms arise. If used by pregnant or nursing women, careful consideration of the effects on the fetus or newborn and the therapeutic benefits should be made. The safety and efficacy of this medication in children under 1 year of age has not been established, and its use is not recommended. Elderly patients may experience decreased physical function and comorbidities, requiring careful observation upon administration. In case of overdose, symptoms similar to existing side effects may occur, and timely medical consultation is necessary for any unusual symptoms. This medication should be stored out of reach of children, and transferring to another container should be avoided.
Convulsions, delirium, abnormal behavior, nausea, vomiting, headache, pain, unstable angina, anemia, pseudomembranous colitis, pneumonia, peritonsillar abscess, humeral fracture, hallucinations, dermatitis, rash, urticaria, eczema, shock, anaphylactic reaction, hepatitis, abnormal liver function, jaundice, mucocutaneous syndrome, toxic epidermal necrolysis, acute kidney failure, leukopenia, thrombocytopenia, neuropsychiatric syndrome (altered consciousness, abnormal behavior, delirium, hallucinations, delusions, convulsions), hemorrhagic colitis, erythema, flushing, pruritus, subcutaneous hemorrhage, cheilitis, stomatitis, hematochezia, melena, hematemesis, peptic ulcer, abdominal distension, abnormal stools, oral discomfort, loss of appetite, agitation, tremors, paresthesia, lethargy, drowsiness, ventricular tachycardia, ventricular ectopic beat, abnormal electrocardiogram, 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, sleep disturbances
Not everyone experiences these, and they can vary from person to person.
This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain the storage temperature between 1°C and 30°C. Proper storage helps to maintain the effectiveness and safety of the medication.
White or slightly yellow powder
10 packets/box
Even with the same ingredient, strength, dosage form and how it is taken can differ.
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Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.
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For anything that needs medical judgment, consult a doctor or pharmacist.
This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.