Medication info

Yuyu Tamiflu Powder for Suspension 6 mg/mL (Oseltamivir Phosphate)

Prescription medicationSuspensionOralExpired
Ingredient · strength
Oseltamivir Phosphate›3.94g / 100g
Manufacturer / importer
Yuyu Pharmaceutical Co., Ltd.
Appearance
A suspension that appears as white or pale yellow granules contained in a brown glass bottle
Packaging
10 grams/bottle [50 mL], 13 grams/bottle [65 mL]
Approval status
Expired

MFDS item code 201904553 · Approved 2019.07.04

This product's status changed to Expired on 2024.07.04. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment and prevention of influenza A and B infections
Who takes it
Adults · Children
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 with or without food; tolerability may improve in some patients when taken with food. Treatment - Adults and adolescents 13 years of age and older: Administer 75 mg of oseltamivir orally twice daily for 5 days. Adults and adolescents 13 years of age and older who have difficulty swallowing capsules should take this drug. Prophylaxis - Adults and adolescents 13 years of age 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 prophylaxis 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 protective effect persists while the drug is being taken. Treatment - Patients with renal impairment: No dose adjustment is required in patients with a creatinine clearance of 60 mL/min or more. 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 30mg dose of this drug after each dialysis session to maintain blood concentrations within the therapeutic range; treatment should not exceed 5 days. If influenza symptoms develop 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 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. Treatment - Patients with hepatic impairment: No dose adjustment is required for treatment in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9). Prophylaxis - Patients with renal impairment: No dose adjustment is required in patients with a creatinine clearance of 60 mL/min or more. 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 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 also be administered before the start of dialysis. For peritoneal dialysis, administration of 30mg of this drug once weekly 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. Prophylaxis - Patients with hepatic impairment: No dose adjustment is required for prophylaxis in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).
Child dose
Treatment - Children 1 to 12 years of age: Pediatric patients weighing more than 40 kg who can swallow capsules may take a 75mg capsule twice daily or a 30mg capsule and a 45mg capsule twice daily instead of the recommended dose of this drug. Treatment - Weight ≤ 15 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily Treatment - Weight 15 kg<, ≤ 23 kg: 45 mg twice daily; suspension (6mg/mL) 7.5 mL twice daily Treatment - Weight 23 kg<, ≤ 40 kg: 60 mg twice daily; suspension (6mg/mL) 10.0 mL twice daily Treatment - Weight > 40 kg: 75 mg twice daily; suspension (6mg/mL) 12.5 mL twice daily Treatment - Infants 2 weeks to under 1 year of age: The recommended dose for pediatric patients 2 weeks to 12 months of age 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. Treatment - Weight 3 kg: 9 mg twice daily; suspension (6mg/mL) 1.5 mL twice daily Treatment - Weight 4 kg: 12 mg twice daily; suspension (6mg/mL) 2.0 mL twice daily Treatment - Weight 5 kg: 15 mg twice daily; suspension (6mg/mL) 2.5 mL twice daily Treatment - Weight 6 kg: 18 mg twice daily; suspension (6mg/mL) 3.0 mL twice daily Treatment - Weight 7 kg: 21 mg twice daily; suspension (6mg/mL) 3.5 mL twice daily Treatment - Weight 8 kg: 24 mg twice daily; suspension (6mg/mL) 4.0 mL twice daily Treatment - Weight 9 kg: 27 mg twice daily; suspension (6mg/mL) 4.5 mL twice daily Treatment - Weight 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 the suspension of this drug before it is administered to the patient. Prophylaxis - Children 1 to 12 years of age: 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 drug. Prophylaxis - Weight ≤ 15 kg: 30 mg once daily; suspension (6mg/mL) 5.0 mL once daily Prophylaxis - Weight 15 kg<, ≤ 23 kg: 45 mg once daily; suspension (6mg/mL) 7.5 mL once daily Prophylaxis - Weight 23 kg<, ≤ 40 kg: 60 mg once daily; suspension (6mg/mL) 10.0 mL once daily Prophylaxis - Weight > 40 kg: 75 mg once daily; suspension (6mg/mL) 12.5 mL once daily It is recommended that a pharmacist prepare the suspension of this drug before it is administered to the patient. ※ The safety and efficacy of prophylaxis against 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 A and B infections

  • Influenza A and B virus infections
View approved original text

This medication is used to treat influenza A and B virus infections in patients from newborns aged 2 weeks and older to adults. However, it is not applicable for children under 36 weeks of gestational age. It is important to start treatment within 48 hours of presenting initial symptoms of influenza infection. Additionally, it is used off-label for the prevention of influenza virus infections in children aged 1 year and older and adults. This medication is used as an adjunct when vaccination is not possible or when the circulating strain is not covered by the vaccine, and it cannot replace vaccination. Therefore, it is effectively used for the treatment and prevention of influenza infection.

How to take

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 with or without food; tolerability may improve in some patients when taken with food. Treatment - Adults and adolescents 13 years of age and older: Administer 75 mg of oseltamivir orally twice daily for 5 days. Adults and adolescents 13 years of age and older who have difficulty swallowing capsules should take this drug. Prophylaxis - Adults and adolescents 13 years of age 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 prophylaxis 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 protective effect persists while the drug is being taken. Treatment - Patients with renal impairment: No dose adjustment is required in patients with a creatinine clearance of 60 mL/min or more. 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 30mg dose of this drug after each dialysis session to maintain blood concentrations within the therapeutic range; treatment should not exceed 5 days. If influenza symptoms develop 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 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. Treatment - Patients with hepatic impairment: No dose adjustment is required for treatment in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9). Prophylaxis - Patients with renal impairment: No dose adjustment is required in patients with a creatinine clearance of 60 mL/min or more. 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 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 also be administered before the start of dialysis. For peritoneal dialysis, administration of 30mg of this drug once weekly 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. Prophylaxis - Patients with hepatic impairment: No dose adjustment is required for prophylaxis in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

Treatment - Children 1 to 12 years of age: Pediatric patients weighing more than 40 kg who can swallow capsules may take a 75mg capsule twice daily or a 30mg capsule and a 45mg capsule twice daily instead of the recommended dose of this drug. Treatment - Weight ≤ 15 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily Treatment - Weight 15 kg<, ≤ 23 kg: 45 mg twice daily; suspension (6mg/mL) 7.5 mL twice daily Treatment - Weight 23 kg<, ≤ 40 kg: 60 mg twice daily; suspension (6mg/mL) 10.0 mL twice daily Treatment - Weight > 40 kg: 75 mg twice daily; suspension (6mg/mL) 12.5 mL twice daily Treatment - Infants 2 weeks to under 1 year of age: The recommended dose for pediatric patients 2 weeks to 12 months of age 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. Treatment - Weight 3 kg: 9 mg twice daily; suspension (6mg/mL) 1.5 mL twice daily Treatment - Weight 4 kg: 12 mg twice daily; suspension (6mg/mL) 2.0 mL twice daily Treatment - Weight 5 kg: 15 mg twice daily; suspension (6mg/mL) 2.5 mL twice daily Treatment - Weight 6 kg: 18 mg twice daily; suspension (6mg/mL) 3.0 mL twice daily Treatment - Weight 7 kg: 21 mg twice daily; suspension (6mg/mL) 3.5 mL twice daily Treatment - Weight 8 kg: 24 mg twice daily; suspension (6mg/mL) 4.0 mL twice daily Treatment - Weight 9 kg: 27 mg twice daily; suspension (6mg/mL) 4.5 mL twice daily Treatment - Weight 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 the suspension of this drug before it is administered to the patient. Prophylaxis - Children 1 to 12 years of age: 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 drug. Prophylaxis - Weight ≤ 15 kg: 30 mg once daily; suspension (6mg/mL) 5.0 mL once daily Prophylaxis - Weight 15 kg<, ≤ 23 kg: 45 mg once daily; suspension (6mg/mL) 7.5 mL once daily Prophylaxis - Weight 23 kg<, ≤ 40 kg: 60 mg once daily; suspension (6mg/mL) 10.0 mL once daily Prophylaxis - Weight > 40 kg: 75 mg once daily; suspension (6mg/mL) 12.5 mL once daily It is recommended that a pharmacist prepare the suspension of this drug before it is administered to the patient. ※ The safety and efficacy of prophylaxis against influenza A and B virus infections in children under 1 year of age have not been evaluated.

Precautions

This medication cannot replace influenza vaccination and should be used separately from it. This drug specifically targets influenza A and B viruses, and safety and efficacy have not been established for other infections. Rare neurological or psychiatric side effects, such as seizures or delirium, may occur in children and adolescents, so caregivers should closely monitor for unusual behavior. Patients with an allergy to this medication should not use it. Patients with reduced kidney function may require dosage adjustments, and it is not recommended for patients with severe renal failure. Patients at high risk, such as those with asthma or chronic bronchitis or those who are immunocompromised, should use it with caution. During treatment, side effects like nausea, vomiting, headache, and others may occur, but most are temporary. If severe allergic reactions, liver function abnormalities, rashes, or neuropsychiatric symptoms occur, discontinue use immediately and consult a healthcare professional. This medication should be used cautiously in pregnant or breastfeeding women, and it should only be used when the therapeutic benefits outweigh the risks. Children aged 1 year and older can use this medication, and safety and efficacy in children under 1 year have not been established. No special dosage adjustment is needed for the elderly; however, they should be monitored closely due to decreased physical function. This drug has a low likelihood of interacting with other medications, but caution may be advised when used with certain drugs. Any unusual behavior or neurological symptoms during treatment should be reported immediately to a healthcare provider, and caregivers should pay close attention. This medication contains sorbitol, and patients with hereditary fructose intolerance should avoid it. When preparing the medication, it should be diluted precisely according to the instructions, and storage conditions should be followed after preparation. Generally, there have been no severe side effects reported from overdosing, but if unusual symptoms occur, consult a healthcare professional immediately.

Side effects

  • convulsion
  • delirium
  • abnormal behavior
  • nausea
  • vomiting
  • headache
  • pain
  • unstable angina
  • anemia
  • pseudomembranous colitis
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  • pneumonia
  • peritonsillar abscess
  • humeral fracture
  • hallucination
  • dermatitis
  • rash
  • urticaria
  • eczema
  • insomnia
  • cough
  • runny nose
  • congestion
  • sore throat
  • abdominal pain
  • upper abdominal pain
  • diarrhea
  • dyspepsia
  • back pain
  • arthralgia
  • myalgia
  • dysmenorrhea
  • dizziness
  • fatigue
  • fever
  • influenza-like symptoms
  • limb pain
  • shock
  • anaphylactic reaction
  • hepatitis
  • abnormal liver function
  • jaundice
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • acute kidney failure
  • leukopenia
  • thrombocytopenia
  • altered consciousness
  • hallucination
  • delusion
  • hemorrhagic colitis
  • erythema
  • flushing
  • itching
  • petechiae
  • cheilitis
  • stomatitis
  • bloody stool
  • melena
  • hematemesis
  • peptic ulcer
  • abdominal distension
  • abnormal stool
  • oral discomfort
  • loss of appetite
  • agitation
  • tremor
  • paresthesia
  • lethargy
  • drowsiness
  • ventricular tachycardia
  • premature ventricular contractions
  • abnormal ECG
  • 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 disorders

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture, and it is safe to store at room temperature between 1 to 30 degrees Celsius. Therefore, avoid extremely hot or cold places, and it is best to store it in an area that maintains a proper indoor temperature.

Appearance and packaging

Appearance

A suspension that appears as white or pale yellow granules contained in a brown glass bottle

Package unit

10 grams/bottle [50 mL], 13 grams/bottle [65 mL]

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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.