Unitamivir Capsule 75mg (Oseltamivir Phosphate)

Adult dose

Initiate treatment on the first or second day after the onset of influenza symptoms. This medicine may be administered with or without food; tolerability may improve in some patients when taken with food. Treatment of influenza A and influenza B virus infections — Adults and adolescents aged 13 years or older: Administer oseltamivir 75 mg orally twice daily for 5 days. Adults and adolescents aged 13 years or older who have difficulty swallowing capsules should use this medicine as a powder for suspension. Patients with renal impairment (treatment): No dose adjustment is required in 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 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 periodic hemodialysis should receive a 30mg dose of this medicine after each dialysis session to maintain blood concentrations within the therapeutic range, and the duration of 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 less than 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment (treatment): No dose adjustment is necessary 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 or older: For those in close contact with an infected person, administer oseltamivir 75 mg orally once daily for 10 days. Initiate 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 the medicine is being taken. Patients with renal impairment (prevention): No dose adjustment is required in 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 once daily every other day is recommended. Patients receiving periodic hemodialysis should receive a 30mg dose of this medicine after every 2 dialysis sessions to maintain blood 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 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 (prevention): No dose adjustment is necessary for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

Treatment of influenza A and influenza B virus infections — Children aged 1 year to 12 years, weighing ≤ 15 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily. Treatment of influenza A and influenza B virus infections — Children aged 1 year to 12 years, weighing 15 kg<, ≤ 23 kg: 45 mg twice daily; suspension (6mg/mL) 7.5 mL twice daily. Treatment of influenza A and influenza B virus infections — Children aged 1 year to 12 years, weighing 23 kg<, ≤ 40 kg: 60 mg twice daily; suspension (6mg/mL) 10.0 mL twice daily. Treatment of influenza A and influenza B virus infections — Children aged 1 year to 12 years, weighing > 40 kg: 75 mg twice daily; suspension (6mg/mL) 12.5 mL twice daily. 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 drug suspension. Treatment of influenza A and influenza B virus infections — Children aged 2 weeks to less than 1 year (2 weeks to 12 months): Administer this drug orally at 3mg/kg twice daily for 5 days. This does not apply to children with a postconceptional age of less than 36 weeks. Treatment of influenza A and influenza B virus infections — Children aged 2 weeks to less than 1 year, weighing 3 kg: 9 mg twice daily; suspension (6mg/mL) 1.5 mL twice daily. Treatment of influenza A and influenza B virus infections — Children aged 2 weeks to less than 1 year, weighing 4 kg: 12 mg twice daily; suspension (6mg/mL) 2.0 mL twice daily. Treatment of influenza A and influenza B virus infections — Children aged 2 weeks to less than 1 year, weighing 5 kg: 15 mg twice daily; suspension (6mg/mL) 2.5 mL twice daily. Treatment of influenza A and influenza B virus infections — Children aged 2 weeks to less than 1 year, weighing 6 kg: 18 mg twice daily; suspension (6mg/mL) 3.0 mL twice daily. Treatment of influenza A and influenza B virus infections — Children aged 2 weeks to less than 1 year, weighing 7 kg: 21 mg twice daily; suspension (6mg/mL) 3.5 mL twice daily. Treatment of influenza A and influenza B virus infections — Children aged 2 weeks to less than 1 year, weighing 8 kg: 24 mg twice daily; suspension (6mg/mL) 4.0 mL twice daily. Treatment of influenza A and influenza B virus infections — Children aged 2 weeks to less than 1 year, weighing 9 kg: 27 mg twice daily; suspension (6mg/mL) 4.5 mL twice daily. Treatment of influenza A and influenza B virus infections — Children aged 2 weeks to less than 1 year, weighing 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. For children younger than 1 year, a dose of 3mg/kg of this drug is recommended. Prevention of influenza A and influenza B virus infections — Children aged 1 year to 12 years, weighing ≤ 15 kg: 30 mg once daily; suspension (6mg/mL) 5.0 mL once daily. Prevention of influenza A and influenza B virus infections — Children aged 1 year to 12 years, weighing 15 kg<, ≤ 23 kg: 45 mg once daily; suspension (6mg/mL) 7.5 mL once daily. Prevention of influenza A and influenza B virus infections — Children aged 1 year to 12 years, weighing 23 kg<, ≤ 40 kg: 60 mg once daily; suspension (6mg/mL) 10.0 mL once daily. Prevention of influenza A and influenza B virus infections — Children aged 1 year to 12 years, weighing > 40 kg: 75 mg once daily; suspension (6mg/mL) 12.5 mL once daily. 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 drug suspension. ※ The safety and efficacy of preventing influenza A and B virus infections in children younger than 1 year have not been evaluated.

This medication cannot replace influenza vaccination and should be used separately from influenza vaccinations. Its effectiveness has only been proven against influenza A and B, and its safety and efficacy against other infections have not been established. In pediatric and adolescent patients, rare neuropsychiatric adverse reactions may occur, so caregivers should closely monitor for unusual behavior. In principle, this medication is not used in children over 10 years of age, and should be used cautiously only in high-risk populations. Patients with allergies to this medication or its components should not use it. Patients with renal insufficiency or undergoing dialysis may need dose adjustment, and it is not recommended for end-stage renal failure patients. Careful monitoring is necessary when administering to high-risk patients. Side effects such as nausea, vomiting, headache, and others may occur with the use of this medication; however, most are temporary. Rarely, shock, anaphylaxis, hepatitis, Stevens-Johnson syndrome, acute kidney failure, and neuropsychiatric adverse reactions may occur, and if unusual symptoms appear, immediate consultation with a healthcare professional is required. Pregnant women or those who may become pregnant should consider the therapeutic effects and risks of this medication thoroughly, and nursing mothers should also be administered cautiously. In children, safety and efficacy of this medication in those under 1 year of age have not been established, hence caution is needed. Elderly patients should be closely monitored when administered due to the possibility of decreased physiological functions. In case of overdose, adverse reactions may be similar to those seen during regular administration, but patients should inform healthcare professionals immediately to receive appropriate measures. The potential for interaction with other drugs is low, but caution may be required when combined with specific medications. No special effects have been reported when driving or operating machinery, but care should be taken as influenza itself may affect physical functions. Keep out of reach of children, and do not transfer to another container for safety.

Nausea, vomiting, headache, pain, unstable angina, anemia, pseudomembranous colitis, pneumonia, peritonsillar abscess, humeral fracture, hallucinations, seizures, dermatitis, rash, urticaria, eczema, insomnia, cough, runny nose, nasal congestion, sore throat, abdominal pain, epigastric pain, diarrhea, dyspepsia, back pain, arthralgia, myalgia, dysmenorrhea, dizziness, fatigue, fever, influenza-like symptoms, limb pain, shock, anaphylactic reaction, hepatitis, liver dysfunction, jaundice, mucocutaneous syndrome, toxic epidermal necrolysis, acute renal failure, leukopenia, thrombocytopenia, neurological syndrome (altered consciousness, abnormal behavior, delirium, hallucinations, delusions, seizures), hemorrhagic colitis, erythema, redness, itching, subcutaneous bleeding, cheilitis, stomatitis, hematochezia, melena, hematemesis, peptic ulcer, abdominal distension, abnormal stool, oral discomfort, loss of appetite, agitation, tremor, paresthesia, lethargy, drowsiness, ventricular tachycardia, ventricular ectopic contraction, electrocardiogram abnormality, palpitations, increased AST, increased ALT, increased γ-GPT, increased ALP, hematuria, positive proteinuria, eosinophilia, visual disturbances, fever, hypothermia, edema, hyperglycemia, abdominal pain, chest pain, pneumonia, sinusitis, bronchitis, otitis media, asthma, epistaxis, conjunctivitis, ear pain, dermatitis, lymphadenitis, tympanic membrane abnormality, nightmare, dermatitis

This medication should be stored in a tightly closed container to prevent exposure to air and moisture, preferably in a cool place at temperatures below 25 degrees Celsius. Storing this way will help to maintain the effectiveness of the medication over time.

Appearance

A light yellow hard capsule with a white or pale yellow powder inside

Package unit

10 capsules (10 capsules/PTP x 1)