Medication info
Yuyu Tamiflu Capsule 75 mg (Oseltamivir Phosphate)

Yuyu Tamiflu Capsule 75 mg (Oseltamivir Phosphate)

Prescription medicationHard capsuleOral
Ingredient · strength
Oseltamivir Phosphate›98.5mg / 1 capsule
Manufacturer / importer
Yuyu Pharmaceutical Co., Ltd.
Appearance
A hard capsule with a powder that is white or light yellow in color, with a light yellow upper part and a light gray bottom part.
Packaging
10 capsules/PTP
Approval status
Active

MFDS item code 201603119 · Approved 2016.05.31

Summary

Main use
Treatment and prevention of influenza
Who takes it
Adults · Children
Adult dose
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 administered with or without food; tolerability may improve in some patients when taken with food. Adults and adolescents 13 years of age and older: Administer oseltamivir 75 mg orally twice daily for 5 days. Adults and adolescents 13 years of age and older who have difficulty swallowing capsules should use this medicine as a powder for suspension. Patients with renal impairment: No dose adjustment is necessary for patients with a creatinine clearance of 60 mL/min or greater. For patients with a creatinine clearance of 30 ~ 60 mL/min, a reduced dose of 30 mg twice daily for 5 days is recommended. For patients with a 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 30 mg dose of this medicine after each dialysis session to maintain therapeutic plasma concentrations, 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 the start of dialysis. For peritoneal dialysis, a single 30 mg 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 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 13 years of age and older: For close contacts of an infected person, administer oseltamivir 75 mg 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 epidemic 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 necessary for patients with a creatinine clearance of 60 mL/min or greater. For patients with a creatinine clearance of 30 ~ 60 mL/min, a reduced dose of 30 mg once daily is recommended. For patients with a 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 30 mg dose of this medicine after every 2 dialysis sessions to maintain therapeutic plasma concentrations. The initial dose may also be administered before the start of dialysis. For peritoneal dialysis, administration of 30 mg 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 dose adjustment is necessary for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).
Child dose
Children 1 to 12 years of age, treatment: 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. Children 1 to 12 years of age, body weight ≤ 15 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily Children 1 to 12 years of age, body weight 15 kg<, ≤ 23 kg: 45 mg twice daily; suspension (6mg/mL) 7.5 mL twice daily Children 1 to 12 years of age, body weight 23 kg<, ≤ 40 kg: 60 mg twice daily; suspension (6mg/mL) 10.0 mL twice daily Children 1 to 12 years of age, body weight > 40 kg: 75 mg twice daily; suspension (6mg/mL) 12.5 mL twice daily Infants 2 weeks to under 1 year of age: 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. Infants 2 weeks to under 1 year of age, body weight 3 kg: 9 mg twice daily; suspension (6mg/mL) 1.5 mL twice daily Infants 2 weeks to under 1 year of age, body weight 4 kg: 12 mg twice daily; suspension (6mg/mL) 2.0 mL twice daily Infants 2 weeks to under 1 year of age, body weight 5 kg: 15 mg twice daily; suspension (6mg/mL) 2.5 mL twice daily Infants 2 weeks to under 1 year of age, body weight 6 kg: 18 mg twice daily; suspension (6mg/mL) 3.0 mL twice daily Infants 2 weeks to under 1 year of age, body weight 7 kg: 21 mg twice daily; suspension (6mg/mL) 3.5 mL twice daily Infants 2 weeks to under 1 year of age, body weight 8 kg: 24 mg twice daily; suspension (6mg/mL) 4.0 mL twice daily Infants 2 weeks to under 1 year of age, body weight 9 kg: 27 mg twice daily; suspension (6mg/mL) 4.5 mL twice daily Infants 2 weeks to under 1 year of age, body weight 10 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily A dose of 3mg/kg of this medicine is recommended for children under 1 year of age. Children 1 to 12 years of age, prevention: 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. Children 1 to 12 years of age, body weight ≤ 15 kg: 30 mg once daily; suspension (6mg/mL) 5.0 mL once daily Children 1 to 12 years of age, body weight 15 kg<, ≤ 23 kg: 45 mg once daily; suspension (6mg/mL) 7.5 mL once daily Children 1 to 12 years of age, body weight 23 kg<, ≤ 40 kg: 60 mg once daily; suspension (6mg/mL) 10.0 mL once daily Children 1 to 12 years of age, body weight > 40 kg: 75 mg once daily; suspension (6mg/mL) 12.5 mL 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.

Ingredients

Manufacturer
Yuyu Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment and prevention of influenza

  • Influenza A virus infection
  • influenza B virus infection
View approved original text

This medication is used to treat influenza A and B virus infections in neonates over 2 weeks of age to adults. Treatment should start within 48 hours of the onset of influenza symptoms to be effective. Additionally, it can be used for influenza prevention in individuals aged 1 year and older, but it does not replace vaccination. It is used restrictively when circulating viruses not included in the vaccine are present or when vaccination is not possible. Therefore, this drug can contribute to both the treatment and prevention of influenza infections.

How to take

Adult dose

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 administered with or without food; tolerability may improve in some patients when taken with food. Adults and adolescents 13 years of age and older: Administer oseltamivir 75 mg orally twice daily for 5 days. Adults and adolescents 13 years of age and older who have difficulty swallowing capsules should use this medicine as a powder for suspension. Patients with renal impairment: No dose adjustment is necessary for patients with a creatinine clearance of 60 mL/min or greater. For patients with a creatinine clearance of 30 ~ 60 mL/min, a reduced dose of 30 mg twice daily for 5 days is recommended. For patients with a 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 30 mg dose of this medicine after each dialysis session to maintain therapeutic plasma concentrations, 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 the start of dialysis. For peritoneal dialysis, a single 30 mg 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 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 13 years of age and older: For close contacts of an infected person, administer oseltamivir 75 mg 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 epidemic 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 necessary for patients with a creatinine clearance of 60 mL/min or greater. For patients with a creatinine clearance of 30 ~ 60 mL/min, a reduced dose of 30 mg once daily is recommended. For patients with a 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 30 mg dose of this medicine after every 2 dialysis sessions to maintain therapeutic plasma concentrations. The initial dose may also be administered before the start of dialysis. For peritoneal dialysis, administration of 30 mg 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 dose adjustment is necessary for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

Children 1 to 12 years of age, treatment: 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. Children 1 to 12 years of age, body weight ≤ 15 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily Children 1 to 12 years of age, body weight 15 kg<, ≤ 23 kg: 45 mg twice daily; suspension (6mg/mL) 7.5 mL twice daily Children 1 to 12 years of age, body weight 23 kg<, ≤ 40 kg: 60 mg twice daily; suspension (6mg/mL) 10.0 mL twice daily Children 1 to 12 years of age, body weight > 40 kg: 75 mg twice daily; suspension (6mg/mL) 12.5 mL twice daily Infants 2 weeks to under 1 year of age: 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. Infants 2 weeks to under 1 year of age, body weight 3 kg: 9 mg twice daily; suspension (6mg/mL) 1.5 mL twice daily Infants 2 weeks to under 1 year of age, body weight 4 kg: 12 mg twice daily; suspension (6mg/mL) 2.0 mL twice daily Infants 2 weeks to under 1 year of age, body weight 5 kg: 15 mg twice daily; suspension (6mg/mL) 2.5 mL twice daily Infants 2 weeks to under 1 year of age, body weight 6 kg: 18 mg twice daily; suspension (6mg/mL) 3.0 mL twice daily Infants 2 weeks to under 1 year of age, body weight 7 kg: 21 mg twice daily; suspension (6mg/mL) 3.5 mL twice daily Infants 2 weeks to under 1 year of age, body weight 8 kg: 24 mg twice daily; suspension (6mg/mL) 4.0 mL twice daily Infants 2 weeks to under 1 year of age, body weight 9 kg: 27 mg twice daily; suspension (6mg/mL) 4.5 mL twice daily Infants 2 weeks to under 1 year of age, body weight 10 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily A dose of 3mg/kg of this medicine is recommended for children under 1 year of age. Children 1 to 12 years of age, prevention: 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. Children 1 to 12 years of age, body weight ≤ 15 kg: 30 mg once daily; suspension (6mg/mL) 5.0 mL once daily Children 1 to 12 years of age, body weight 15 kg<, ≤ 23 kg: 45 mg once daily; suspension (6mg/mL) 7.5 mL once daily Children 1 to 12 years of age, body weight 23 kg<, ≤ 40 kg: 60 mg once daily; suspension (6mg/mL) 10.0 mL once daily Children 1 to 12 years of age, body weight > 40 kg: 75 mg once daily; suspension (6mg/mL) 12.5 mL 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.

Precautions

This drug cannot replace influenza vaccination, and there is no association between vaccination and the use of this drug. The preventive effect of this drug lasts only during the period of administration. Effectiveness has only been proven for influenza A and B, and safety and efficacy have not been confirmed for other infections. Especially in children and adolescents, neuropsychiatric adverse reactions such as seizures and delirium have been rarely reported, so they must be carefully monitored for unusual behaviors. Children over 10 years old are generally not recommended to use this drug unless they are in special high-risk groups. There is a risk of unusual behaviors occurring during the use of this drug, so caregivers should ensure that children and adolescents are not left alone for at least two days. Patients with allergic reactions to this drug or any of its components should not be given it. Patients with impaired kidney function or dialysis patients need dose adjustments, and it is not recommended for patients with end-stage renal failure. Caution should be used in patients with asthma, chronic bronchitis, and immunosuppressed high-risk groups. Commonly reported side effects during the use of this drug include nausea, vomiting, and headache, and most of these are temporary. Rarely, skin rash, liver function abnormalities, psychiatric symptoms, and acute renal failure may occur; if these symptoms appear, seek medical advice immediately. Pregnant or nursing women should only use this drug if the therapeutic benefits outweigh the risks, as its effects on the fetus or infant have not been sufficiently studied. Safety and effectiveness for children younger than 1 year have not been established, so use should be approached with caution. Elderly patients generally do not require dose adjustments, but they should be monitored closely considering reduced physical function and pre-existing conditions. Reported adverse reactions in case of overdose are similar to common side effects, and while there is no specific treatment, immediate consultation with a medical professional is recommended. This medication should be kept out of reach of children, and it is advisable not to transfer it to other containers. The potential for interactions with other drugs is low, but caution may be needed when taken with certain medications, so any medications being taken should be disclosed to healthcare providers. It is effective to start taking it as soon as possible after the onset of influenza symptoms, and if a dose is missed, it should be taken as soon as remembered; if it is less than two hours until the next dose, the next dose should not be taken. There is no impact on driving or operating machinery, but caution should be exercised as influenza itself may affect these capabilities.

Side effects

  • Cramps
  • delirium
  • abnormal behavior
  • nausea
  • vomiting
  • headache
  • pain
  • unstable angina
  • anemia
  • pseudomembranous colitis
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  • pneumonia
  • peritonsillar abscess
  • humeral fracture
  • hallucinations
  • dermatitis
  • rash
  • urticaria
  • eczema
  • insomnia
  • cough
  • runny nose
  • 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
  • abnormal liver function
  • jaundice
  • skin and mucous membrane syndrome
  • toxic epidermal necrolysis
  • acute renal failure
  • leukopenia
  • thrombocytopenia
  • neuropsychiatric syndrome
  • hemorrhagic colitis
  • erythema
  • flushing
  • itching
  • petechiae
  • cheilitis
  • stomatitis
  • melena
  • hematemesis
  • peptic ulcer
  • abdominal distension
  • abnormal stool
  • oral unpleasantness
  • anorexia
  • agitation
  • tremors
  • paresthesia
  • lethargy
  • drowsiness
  • ventricular tachycardia
  • ventricular extrasystole
  • electrocardiogram abnormality
  • palpitations
  • increased AST
  • increased ALT
  • increased γ-GTP
  • increased ALP
  • 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

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture, and it is important to store it in a cool place below 25 degrees Celsius. This will help maintain the efficacy of the medicine and prevent degradation.

Appearance and packaging

Appearance

A hard capsule with a powder that is white or light yellow in color, with a light yellow upper part and a light gray bottom part.

Package unit

10 capsules/PTP

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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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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.