Genuone Oseltamivir Capsule 30 mg (Oseltamivir Phosphate)

Adult dose

1. Treatment of 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 taken with or without food; tolerability may improve in some patients when taken with food. Adults and adolescents aged 13 years and older: Administer oseltamivir 75 mg orally twice daily for 5 days. Adults and adolescents aged 13 years and older who have difficulty swallowing capsules should use this medicine as a powder for suspension. Patients with renal impairment: No dosage adjustment is needed for patients with creatinine clearance of 60 mL/min or higher. For patients with creatinine clearance of 30 ~ 60 mL/min, a reduced dose of 30 mg twice 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 undergoing periodic 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 occur during the 48 hours between dialysis sessions, the dose may also 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 undergoing 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 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 persons in close contact with an infected individual, administer oseltamivir 75 mg 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 dosage adjustment is needed for patients with creatinine clearance of 60 mL/min or higher. 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 once daily every other day is recommended. Patients undergoing periodic hemodialysis should receive a 30mg dose of this medicine after every 2 dialysis sessions to maintain plasma concentrations within the therapeutic range. The first dose may also 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 undergoing 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 needed for prevention in adults with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

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 75mg capsules twice daily or 30mg and 45mg capsules twice daily instead of the recommended dose of this medicine as a suspension. ≤ 15 kg: 30 mg per dose twice daily; suspension (6mg/mL) 5.0 mL per dose twice daily 15 kg<, ≤ 23 kg: 45 mg per dose twice daily; suspension (6mg/mL) 7.5 mL per dose twice daily 23 kg<, ≤ 40 kg: 60 mg per dose twice daily; suspension (6mg/mL) 10.0 mL per dose twice daily > 40 kg: 75 mg per dose twice daily; suspension (6mg/mL) 12.5 mL per dose twice daily Infants 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 postconceptional age of less than 36 weeks. 3 kg: 9 mg per dose twice daily; suspension (6mg/mL) 1.5 mL per dose twice daily 4 kg: 12 mg per dose twice daily; suspension (6mg/mL) 2.0 mL per dose twice daily 5 kg: 15 mg per dose twice daily; suspension (6mg/mL) 2.5 mL per dose twice daily 6 kg: 18 mg per dose twice daily; suspension (6mg/mL) 3.0 mL per dose twice daily 7 kg: 21 mg per dose twice daily; suspension (6mg/mL) 3.5 mL per dose twice daily 8 kg: 24 mg per dose twice daily; suspension (6mg/mL) 4.0 mL per dose twice daily 9 kg: 27 mg per dose twice daily; suspension (6mg/mL) 4.5 mL per dose twice daily 10 kg: 30 mg per dose twice daily; suspension (6mg/mL) 5.0 mL per dose twice 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. It is recommended that a pharmacist prepare the suspension of this medicine before administration to the patient. 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 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 It is recommended that a pharmacist prepare the suspension of this medicine before administration to the patient. ※ The safety and efficacy of 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, so it is important to receive the influenza vaccine annually. This medication is effective only against influenza A and B viruses, and its safety or efficacy for other infections has not been confirmed. In pediatric and adolescent patients, neurological and psychiatric adverse reactions such as seizures or delirium have been rarely reported, so caregivers should closely monitor for unusual behavior. Particularly in children over 10 years old, there is a risk of unusual behavior and accidents when using this medication, so it is generally not used unless in special cases. While taking this medication, caregivers should ensure that the child is not left alone for at least two days to reduce the risk of unusual behavior. Patients with allergies to this medication or its components should not use it. Patients with decreased kidney function may require dose adjustments, and it is not recommended for those with severe renal failure. This medication should be administered with caution to high-risk patients with asthma, chronic bronchitis, or immunosuppressive conditions. Common side effects may include nausea, vomiting, headache, pain, etc., but most are transient and mild. Rarely, symptoms such as shock, anaphylaxis, liver function abnormalities, skin rash, acute renal failure, and neurological adverse reactions may occur, so any symptoms should be immediately reported to medical personnel. Women who are pregnant or breastfeeding should consider the therapeutic effects and risks of this medication carefully before use. The safety and efficacy for children under 1 year of age have not been sufficiently studied, so its use is not recommended. Elderly patients do not require dose adjustments, but they should be carefully monitored due to potential declines in physical function and other pre-existing conditions. This medication has a low potential for drug interactions with other medications, but caution is necessary when used in combination with some drugs that may affect renal excretion. This medication can be used together with influenza vaccines, but it should be administered at certain intervals from live vaccines. It is important to adhere to the dosing schedule, and if a dose is missed, it should be taken as soon as possible unless it is too close to the next dose, in which case it should be skipped. Store this medication out of reach of children, and it is advisable not to transfer it to another container.

Convulsions, delirium, abnormal behavior, nausea, vomiting, headache, pain, unstable angina, anemia, pseudomembranous colitis, pneumonia, peritonsillar abscess, humeral fracture, hallucinations, convulsions, dermatitis, rash, urticaria, eczema, 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, liver dysfunction, jaundice, skin and mucous membrane adverse reaction syndrome, toxic epidermal necrolysis, acute renal failure, leukopenia, thrombocytopenia, neuropsychiatric symptoms, altered consciousness, abnormal behavior, hallucinations, delusions, hemorrhagic colitis, erythema, hyperemia, pruritus, petechiae, cheilitis, stomatitis, hematochezia, melena, hematemesis, peptic ulcer, abdominal distension, abnormal stool, oral discomfort, loss of appetite, agitation, tremors, paresthesia, 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, pneumonia, sinusitis, bronchitis, otitis media, asthma, epistaxis, conjunctivitis, ear pain, dermatitis, sleep disorders, seizures, confusion, gastrointestinal hemorrhage, worsening diabetes, eosinophilia, leukopenia, pancreatitis, angioedema, laryngeal edema, tongue edema, bronchospasm, facial edema, hematuria, nightmares, dizziness, dermatitis

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius. Proper storage will help preserve the medication's efficacy and safety.

Appearance

Yellow hard capsule containing white or light yellow powder

Package unit

10 capsules/PTP