Lite Oseltamivir Capsule 45mg (Oseltamivir Phosphate)

Adult dose

Influenza A and influenza B virus infections: Initiate treatment on the first or second day after the onset of influenza symptoms. This drug may be administered without regard to food; in some patients, tolerability may be improved when 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 drug powder for suspension. Patients with renal impairment: No dosage adjustment is required in patients with creatinine clearance of 60 mL/min or greater. 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 receiving regular hemodialysis should receive a 30mg dose of this drug after each dialysis session to maintain blood concentrations within the therapeutic range; the duration of administration should not exceed 5 days. If influenza symptoms occur 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 drug 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 less than 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 an influenza outbreak is 75 mg once daily. The safety and efficacy of this drug have been demonstrated for up to 6 weeks. The preventive effect continues while taking this drug. Patients with renal impairment: No dosage adjustment is required in patients with creatinine clearance of 60 mL/min or greater. 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 receiving regular hemodialysis should receive a 30mg dose of this drug after every 2 dialysis sessions to maintain blood concentrations within the therapeutic range. The initial dose may be administered before the start of dialysis. For peritoneal dialysis, administration of 30mg of this drug 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 less than 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).

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 75mg capsules twice daily or 30mg and 45mg capsules twice daily instead of the recommended dose of this drug suspension. ≤ 15 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily 15 kg<, ≤ 23 kg: 45 mg twice daily; suspension (6mg/mL) 7.5 mL twice daily 23 kg<, ≤ 40 kg: 60 mg twice daily; suspension (6mg/mL) 10.0 mL twice daily > 40 kg: 75 mg twice daily; suspension (6mg/mL) 12.5 mL twice daily Children 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 drug 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; suspension (6mg/mL) 1.5 mL twice daily 4 kg: 12 mg twice daily; suspension (6mg/mL) 2.0 mL twice daily 5 kg: 15 mg twice daily; suspension (6mg/mL) 2.5 mL twice daily 6 kg: 18 mg twice daily; suspension (6mg/mL) 3.0 mL twice daily 7 kg: 21 mg twice daily; suspension (6mg/mL) 3.5 mL twice daily 8 kg: 24 mg twice daily; suspension (6mg/mL) 4.0 mL twice daily 9 kg: 27 mg twice daily; suspension (6mg/mL) 4.5 mL twice daily 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. A dose of 3mg/kg of this drug is recommended for children under 1 year of age. It is recommended that a pharmacist prepare this drug suspension before it is administered 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 drug suspension. ≤ 15 kg: 30 mg once daily; suspension (6mg/mL) 5.0 mL once daily 15 kg<, ≤ 23 kg: 45 mg once daily; suspension (6mg/mL) 7.5 mL once daily 23 kg<, ≤ 40 kg: 60 mg once daily; suspension (6mg/mL) 10.0 mL once daily > 40 kg: 75 mg once daily; suspension (6mg/mL) 12.5 mL once daily It is recommended that a pharmacist prepare this drug suspension before it is administered to the patient. ※ The safety and efficacy of this drug for the prevention of influenza A and B virus infections in children under 1 year of age have not been evaluated.

This medication is used for the treatment and prevention of influenza virus infections but cannot replace the influenza vaccine. Preventive effects are maintained only during the use of this medication, so annual influenza vaccination must be received. It has been proven effective only against influenza A and B viruses, and safety and effectiveness have not been confirmed for other infections. Especially in children and adolescents, rare neuropsychiatric adverse reactions, such as seizures or delirium, may occur, so guardians should observe carefully to prevent abnormal behaviors. In children over 10 years of age, the risk of accidents due to abnormal behaviors has been reported, so it is generally not used unless there are special risks. Patients with hypersensitivity to this medication should not take it. Patients with reduced kidney function need dose adjustments, and it is not recommended for patients with end-stage renal failure. Patients at high risk with asthma, chronic bronchitis, or immunosuppression should be treated with caution. The most common side effects upon taking this medication include nausea, vomiting, headache, etc., which are mostly temporary and mild symptoms. Severe allergic reactions, hepatic dysfunction, Stevens-Johnson syndrome, acute renal failure, and neuropsychiatric symptoms can occur, so if symptoms appear, immediate consultation with healthcare professionals is required. There is insufficient data on the effects of this medication on fetuses or newborns in pregnant or breastfeeding women, so it should be used cautiously only when the therapeutic benefits outweigh the risks. The safety and efficacy of this medication in children under 1 year old have not been established, so its use is not recommended. No dose adjustments are needed for the elderly, but careful observation is required as they may have reduced physical functions or underlying diseases. During the administration of this drug, careful observation for abnormal behaviors, neurological symptoms, allergic reactions, and liver or kidney dysfunction symptoms is necessary, and if any abnormal symptoms occur, administration should be stopped immediately and healthcare professionals notified. Additionally, this medication has a low potential for significant interactions with other drugs, but caution may be required when combined with specific drugs, so if any other medications are being taken, it is essential to inform healthcare professionals.

Cramps, delirium, abnormal behavior, nausea, vomiting, headache, pain, unstable angina, anemia, pseudomembranous colitis, pneumonia, peritonsillar abscess, humeral fracture, hallucinations, dermatitis, rash, urticaria, eczema, dysmenorrhea, dizziness, fatigue, fever, influenza-like symptoms, limb pain, 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, seizures), hemorrhagic colitis, redness, erythema, itching, petechiae, cheilitis, stomatitis, hematochezia, melena, hematemesis, peptic ulcer, abdominal distension, abnormal stools, oral discomfort, loss of appetite, agitation, tremor, numbness, weakness, drowsiness, ventricular tachycardia, premature ventricular contractions, electrocardiogram abnormalities, palpitations, 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, nightmares

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is recommended to maintain a storage temperature between 1 to 30 degrees Celsius at room temperature. This helps to preserve the drug's effectiveness for a long time.

Appearance

A hard capsule with gray upper and lower parts containing white or pale yellow powder

Package unit

10 capsules/PTP