Yuhan Enflu Capsule 30 mg (Oseltamivir Phosphate)

Adult dose

Influenza A and influenza B virus infections: Begin treatment on the first or second day after the onset of influenza symptoms. This medicine may be administered regardless of food intake; in some patients, taking it with food may improve tolerability. Adults and adolescents aged 13 years and older: Administer 75 mg of oseltamivir orally 2 times daily for 5 days. Adults and adolescents aged 13 years and older who have difficulty swallowing capsules should use this medicine as suspension powder. Patients with renal impairment: No dose adjustment is required for patients with creatinine clearance of 60 mL/min or more. For patients with creatinine clearance of 30 ~ 60 mL/min, a reduced dose of 30 mg 2 times 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 medicine after each dialysis session to maintain plasma concentrations within the therapeutic range, and the treatment period should not exceed 5 days. If influenza symptoms occur during the 48 hours between dialysis sessions, the dose may be administered before dialysis begins. 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 required for treatment in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9). Immunocompromised patients: No dose adjustment is required for treatment in immunocompromised patients; administration for 10 days is recommended. 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. Begin 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 required for patients with creatinine clearance of 60 mL/min or more. 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 medicine after every 2 dialysis sessions to maintain plasma concentrations within the therapeutic range. The initial dose may also be administered before dialysis begins. 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 below 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment: No dose adjustment is required for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

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 2 times daily or a 30mg capsule and a 45mg capsule 2 times daily instead of the recommended dose of this medicine as a suspension. ≤ 15 kg: 30 mg per dose 2 times daily; suspension (6mg/mL) 5.0 mL per dose 2 times daily 15 kg<, ≤ 23 kg: 45 mg per dose 2 times daily; suspension (6mg/mL) 7.5 mL per dose 2 times daily 23 kg<, ≤ 40 kg: 60 mg per dose 2 times daily; suspension (6mg/mL) 10.0 mL per dose 2 times daily > 40 kg: 75 mg per dose 2 times daily; suspension (6mg/mL) 12.5 mL per dose 2 times 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 medicine, administered orally 2 times daily for 5 days. This does not apply to children with a postconceptional age of less than 36 weeks. 3 kg: 9 mg per dose 2 times daily; suspension (6mg/mL) 1.5 mL per dose 2 times daily 4 kg: 12 mg per dose 2 times daily; suspension (6mg/mL) 2.0 mL per dose 2 times daily 5 kg: 15 mg per dose 2 times daily; suspension (6mg/mL) 2.5 mL per dose 2 times daily 6 kg: 18 mg per dose 2 times daily; suspension (6mg/mL) 3.0 mL per dose 2 times daily 7 kg: 21 mg per dose 2 times daily; suspension (6mg/mL) 3.5 mL per dose 2 times daily 8 kg: 24 mg per dose 2 times daily; suspension (6mg/mL) 4.0 mL per dose 2 times daily 9 kg: 27 mg per dose 2 times daily; suspension (6mg/mL) 4.5 mL per dose 2 times daily 10 kg: 30 mg per dose 2 times daily; suspension (6mg/mL) 5.0 mL per dose 2 times daily * This table does not include all possible weights in this patient group. A dose of 3mg/kg of this medicine is recommended for children under 1 year of age. 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. ≤ 15 kg: 30 mg per dose once daily; suspension (6mg/mL) 5.0 mL per dose once daily 15 kg<, ≤ 23 kg: 45 mg per dose once daily; suspension (6mg/mL) 7.5 mL per dose once daily 23 kg<, ≤ 40 kg: 60 mg per dose once daily; suspension (6mg/mL) 10.0 mL per dose once daily > 40 kg: 75 mg per dose once daily; suspension (6mg/mL) 12.5 mL per dose once daily ※ The safety and efficacy of prevention of influenza A and B virus infections in children under 1 year of age have not been evaluated. No dose adjustment is required for seasonal prevention in immunocompromised patients aged 1 year and older; administration for 12 weeks is recommended.

This medication is used for treating or preventing influenza virus infections and cannot replace influenza vaccination. It has been proven effective only against influenza A and B viruses, and its safety and efficacy have not been confirmed for other viral infections. Notably, neuropsychiatric adverse reactions have been reported in children and adolescents taking this medication, therefore, guardians should carefully monitor for unusual behaviors. This medication is generally not used for pediatric patients over 10 years old, except in special cases. Patients with hypersensitivity or allergies to the components of this medication should not be administered. Patients with renal failure or those undergoing dialysis require dosage adjustments and are not recommended for patients with end-stage renal disease. Caution should be exercised when administering to high-risk patients, such as those with asthma or chronic bronchitis or immune-suppressed patients. Common side effects include nausea, vomiting, and headaches, which are usually transient and mild. Rarely, serious adverse effects such as shock, anaphylaxis, hepatitis, Stevens-Johnson syndrome, acute renal failure, and neurological symptoms may occur, and if any unusual symptoms appear, consultation with healthcare professionals should be sought immediately. Pregnant or breastfeeding women should use this medication only when the benefits outweigh the risks due to limited data about its effects on the fetus or infant. The safety and efficacy in children, especially infants under 1 year old, have not been established, so caution is required in their use. Generally, elderly patients do not require dosage adjustments, but careful observation is needed due to decreased bodily functions. There is a low likelihood of drug interactions with this medication; however, caution should be exercised when used in conjunction with drugs that may affect renal excretion. If unusual behaviors or neuropsychiatric symptoms occur during use, the medication should be stopped immediately, and healthcare professionals should be notified. Store in a place out of reach of children and do not transfer to a different container for safety. This medication is effective when taken early in the onset of influenza symptoms, and if a dose is missed, it should be taken as soon as possible without approaching the time of the next dose too closely.

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, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute renal failure, leukopenia, thrombocytopenia, neuropsychiatric syndrome (altered consciousness, abnormal behavior, delirium, hallucinations, delusions, convulsions), hemorrhagic colitis, redness, erythema, itching, subcutaneous hemorrhage, cheilitis, stomatitis, melena, hematochezia, hematemesis, peptic ulcer, abdominal distension, abnormal stools, oral unpleasantness, loss of appetite, excitation, tremor, tingling, lethargy, drowsiness, ventricular tachycardia, ventricular extrasystole, 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

This medication must 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 its effectiveness.

Appearance

A hard capsule with a pale yellow color containing a white or pale yellow powder

Package unit

10 capsules (10 capsules/PTP x 1)