Medication info

Tamiflu 30 mg (Oseltamivir Phosphate)

Prescription medicationApproval withdrawn
Ingredient · strength
Oseltamivir Phosphate›Strength being verified
Manufacturer / importer
Korea United Pharmaceutical Co., Ltd.
Appearance
White or pale yellow powder
Packaging
10 sachets/box
Approval status
Approval withdrawn

MFDS item code 201907524 · Approved 2019.10.28

This product's status changed to Approval withdrawn on 2023.05.22. 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 uses it
Adults · Children
Adult dosage
Influenza A and influenza B virus infections: Start treatment on the first or second day after influenza symptoms appear. This medicine may be taken with or without food; in some patients, taking it with food may improve tolerability. Adults and adolescents 13 years of age and older: The recommended dose is 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 use this medicine for dosing. Patients with renal impairment: No dosage adjustment is required for patients with a creatinine clearance of 60 mL/min or higher. 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 medicine after each dialysis session to maintain therapeutic blood concentrations, and treatment should not exceed 5 days. If influenza symptoms develop during the 48-hour interval between dialysis sessions, the dose may be given before dialysis begins. 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: No dosage adjustment is necessary for the treatment of 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 contact with 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 influenza outbreaks 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: No dosage adjustment is required for patients with a creatinine clearance of 60 mL/min or higher. 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 30mg dose of this medicine after every 2 dialysis sessions to maintain therapeutic blood concentrations. The initial dose may also be administered before dialysis begins. 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: No dosage adjustment is necessary for the prevention of influenza in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).
Children's dosage
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 medicine. ≤ 15 kg: 30 mg (sachet) twice daily 15 kg<, ≤ 23 kg: 45 mg (sachet) twice daily 23 kg<, ≤ 40 kg: 60 mg (two 30mg sachets) twice daily > 40 kg: 75 mg (sachet) twice daily Children 2 weeks to less than 1 year of age: The recommended dose for pediatric patients 2 weeks to 12 months of age 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. Pediatric patients who have difficulty taking this medicine as powder should use the suspension. 3 kg: 9 mg twice daily; suspension (6mg/mL), 1.5mL twice daily 4 kg: 12 mg twice daily; suspension (6mg/mL), 2.0mL twice daily 5 kg: 15 mg twice daily; suspension (6mg/mL), 2.5mL twice daily 6 kg: 18 mg twice daily; suspension (6mg/mL), 3.0mL twice daily 7 kg: 21 mg twice daily; suspension (6mg/mL), 3.5mL twice daily 8 kg: 24 mg twice daily; suspension (6mg/mL), 4.0mL twice daily 9 kg: 27 mg twice daily; suspension (6mg/mL), 4.5mL twice daily 10 kg: 30 mg twice daily; suspension (6mg/mL), 5.0mL twice daily * This table does not include all possible body weights in this patient group. A dose of 3mg/kg of this medicine is recommended for children under 1 year of age. 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 medicine. ≤ 15 kg: 30 mg (sachet) once daily 15 kg<, ≤ 23 kg: 45 mg (sachet) once daily 23 kg<, ≤ 40 kg: 60 mg (two 30mg sachets) once daily > 40 kg: 75 mg (sachet) 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
Korea United Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment and prevention of influenza A and B infections

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

This medication is used to treat infections caused by influenza A and B viruses in children aged 2 weeks and older up to adults. It is effective when administered within 48 hours of the onset of initial infection symptoms. It is also used to prevent influenza virus infection in individuals 1 year and older, but vaccination is the priority. This medication is used as an adjunct if the vaccine does not contain the circulating strain of the virus, if the vaccine effect is not expected, or if vaccination is not possible. This medication does not replace vaccination but helps treat and prevent influenza infections.

Dosage and Administration

Adult dosage

Influenza A and influenza B virus infections: Start treatment on the first or second day after influenza symptoms appear. This medicine may be taken with or without food; in some patients, taking it with food may improve tolerability. Adults and adolescents 13 years of age and older: The recommended dose is 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 use this medicine for dosing. Patients with renal impairment: No dosage adjustment is required for patients with a creatinine clearance of 60 mL/min or higher. 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 medicine after each dialysis session to maintain therapeutic blood concentrations, and treatment should not exceed 5 days. If influenza symptoms develop during the 48-hour interval between dialysis sessions, the dose may be given before dialysis begins. 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: No dosage adjustment is necessary for the treatment of 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 contact with 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 influenza outbreaks 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: No dosage adjustment is required for patients with a creatinine clearance of 60 mL/min or higher. 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 30mg dose of this medicine after every 2 dialysis sessions to maintain therapeutic blood concentrations. The initial dose may also be administered before dialysis begins. 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: No dosage adjustment is necessary for the prevention of influenza in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Children's dosage

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 medicine. ≤ 15 kg: 30 mg (sachet) twice daily 15 kg<, ≤ 23 kg: 45 mg (sachet) twice daily 23 kg<, ≤ 40 kg: 60 mg (two 30mg sachets) twice daily > 40 kg: 75 mg (sachet) twice daily Children 2 weeks to less than 1 year of age: The recommended dose for pediatric patients 2 weeks to 12 months of age 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. Pediatric patients who have difficulty taking this medicine as powder should use the suspension. 3 kg: 9 mg twice daily; suspension (6mg/mL), 1.5mL twice daily 4 kg: 12 mg twice daily; suspension (6mg/mL), 2.0mL twice daily 5 kg: 15 mg twice daily; suspension (6mg/mL), 2.5mL twice daily 6 kg: 18 mg twice daily; suspension (6mg/mL), 3.0mL twice daily 7 kg: 21 mg twice daily; suspension (6mg/mL), 3.5mL twice daily 8 kg: 24 mg twice daily; suspension (6mg/mL), 4.0mL twice daily 9 kg: 27 mg twice daily; suspension (6mg/mL), 4.5mL twice daily 10 kg: 30 mg twice daily; suspension (6mg/mL), 5.0mL twice daily * This table does not include all possible body weights in this patient group. A dose of 3mg/kg of this medicine is recommended for children under 1 year of age. 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 medicine. ≤ 15 kg: 30 mg (sachet) once daily 15 kg<, ≤ 23 kg: 45 mg (sachet) once daily 23 kg<, ≤ 40 kg: 60 mg (two 30mg sachets) once daily > 40 kg: 75 mg (sachet) 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 medication is used to treat or prevent infections caused by influenza viruses. However, this medication cannot replace influenza vaccinations and should be used separately from vaccinations. This medication has only been confirmed to be effective against influenza A and B viruses and its safety and efficacy have not been proven for other infections. Particularly in pediatric and adolescent patients, neurological and psychiatric side effects such as seizures or abnormal behavior may occur rarely during treatment with this medication, so careful monitoring is required during use. In children aged over 10 years, the risk of accidents due to abnormal behavior is present, thus use is not recommended except in special cases. The risk of abnormal behavior during treatment should be recognized and caregivers should ensure that children and adolescents are not left alone. Patients with a history of allergic reactions to this medication or its components should not use it. Patients with impaired kidney function may require dose adjustments, and it is not recommended for patients with end-stage renal failure. Use caution in high-risk patients with asthma, chronic bronchitis, or immunosuppressed conditions. While side effects such as nausea, vomiting, headache, and pain may commonly occur, they are usually temporary and mild. Serious side effects such as shock, anaphylaxis, liver function abnormalities, skin rash, neurological complications, and acute renal failure can occur rarely, so any abnormal symptoms should be consulted with medical personnel immediately. Pregnant or breastfeeding women should carefully consider the potential impacts on the fetus or infant, and it should only be used when the benefits of treatment outweigh the risks. The safety and efficacy of this medication have not been established in children under 1 year, so use should be avoided. Elderly patients do not typically require special dose adjustments, but should be monitored closely if they have impaired physical function or multiple health conditions. During treatment, the medication should be taken regularly, and if a dose is missed, it should be taken as soon as possible but skipped if it is close to the next scheduled dose. Additionally, this medication contains sorbitol, so patients with fructose intolerance should not take it. Interactions with other medications are rare, but caution may be needed when used in combination with certain drugs, so if taking other medications, it should be reported to medical personnel. Finally, it should be stored out of reach of children, and it is safer not to transfer it to another container.

Side effects

  • Convulsions
  • delirium
  • abnormal behavior
  • nausea
  • vomiting
  • headache
  • pain
  • unstable angina
  • anemia
  • pseudomembranous colitis
Show 58 more
  • pneumonia
  • peritonsillar abscess
  • humeral fracture
  • hallucinations
  • dermatitis
  • rash
  • urticaria
  • eczema
  • shock
  • anaphylactic reaction
  • hepatitis
  • abnormal liver function
  • jaundice
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • acute kidney failure
  • leukopenia
  • thrombocytopenia
  • neuropsychiatric syndrome
  • hemorrhagic colitis
  • erythema
  • redness
  • itching
  • petechiae
  • cheilitis
  • stomatitis
  • hematochezia
  • melena
  • hematemesis
  • peptic ulcer
  • abdominal distension
  • abnormal stool
  • oral discomfort
  • anorexia
  • agitation
  • tremors
  • paresthesia
  • lethargy
  • drowsiness
  • ventricular tachycardia
  • ventricular ectopic beats
  • electrocardiogram abnormalities
  • 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
  • sleep disturbance

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

Storage

This medication is sensitive to air and moisture, so it should be stored in a tightly sealed container. The storage temperature should be kept between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

White or pale yellow powder

Package unit

10 sachets/box

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

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.