Medication info
Hanmi Flu Capsule 75 mg (Oseltamivir)

Hanmi Flu Capsule 75 mg (Oseltamivir)

Prescription medicationHard capsuleOral
Ingredient · strength
Oseltamivir›75mg / 1 capsule
Manufacturer / importer
Hanmi Pharmaceutical Co., Ltd.
Appearance
A hard capsule with a light yellow upper part and white lower part filled with a white to light yellow powder.
Packaging
10 capsules/box [10 capsules/PTP x 1]
Approval status
Active

MFDS item code 201507981 · Approved 2015.11.27 · Insurance code 643507470

Summary

Main use
Treatment and prevention of influenza infections
Who takes it
Adults · Children
Adult dose
1. Influenza A and influenza B virus infections: Treatment should be started on the first or second day after the onset of influenza symptoms. This medicine may be administered regardless of food intake, and tolerability may improve in some patients 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 medicine as a powder for suspension. 4) Patients with renal impairment No dose adjustment is required 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 30mg dose of this medicine after each dialysis session to maintain therapeutic plasma concentrations, and the duration of treatment should not exceed 5 days. If influenza symptoms develop during the 48-hour interval between dialysis sessions, this medicine may also 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 below 10mL/min); therefore, no recommended dose is available for these patients. 5) Patients with hepatic impairment No dose adjustment is required for treatment in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9). 2. 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 medicine have been demonstrated for up to 6 weeks. The preventive effect continues while this medicine is being taken. 3) Patients with renal impairment No dose adjustment is required 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 once daily 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 plasma concentrations. The initial dose may also be administered before the start of dialysis. For peritoneal dialysis, administration of 30mg of this medicine 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 below 10mL/min); therefore, no recommended dose is available for these patients. 4) Patients with hepatic impairment No dose adjustment is required for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).
Child dose
Children aged 1 to 12 years (treatment): Pediatric patients weighing > 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. ≤ 15 kg: 30 mg twice daily; 5.0 mL twice daily 15 kg<, ≤ 23 kg: 45 mg twice daily; 7.5 mL twice daily 23 kg<, ≤ 40 kg: 60 mg twice daily; 10.0 mL twice daily > 40 kg: 75 mg twice daily; 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 medicine 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; 1.5 mL twice daily 4 kg: 12 mg twice daily; 2.0 mL twice daily 5 kg: 15 mg twice daily; 2.5 mL twice daily 6 kg: 18 mg twice daily; 3.0 mL twice daily 7 kg: 21 mg twice daily; 3.5 mL twice daily 8 kg: 24 mg twice daily; 4.0 mL twice daily 9 kg: 27 mg twice daily; 4.5 mL twice daily 10 kg: 30 mg twice daily; 5.0 mL 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 aged 1 to 12 years (prophylaxis): Pediatric patients weighing > 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. ≤ 15 kg: 30 mg once daily; 5.0 mL once daily 15 kg<, ≤ 23 kg: 45 mg once daily; 7.5 mL once daily 23 kg<, ≤ 40 kg: 60 mg once daily; 10.0 mL once daily > 40 kg: 75 mg once daily; 12.5 mL once daily ※ The safety and efficacy of preventing influenza A and B virus infections in children under 1 year of age have not been evaluated.

Ingredients

Manufacturer
Hanmi Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment and prevention of influenza infections

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

This medication is used for the treatment of influenza A and B virus infections from newborns over 2 weeks of age to adults. It is particularly effective when initiated within 48 hours of the onset of infection symptoms. It can also be used for the prevention of influenza in children over 1 year and adults, but only when the influenza vaccine is ineffective or cannot be administered. This medication is not a substitute for vaccination and should be used appropriately alongside vaccination. It is important to start treatment at the suitable time according to the patient's condition or it helps to effectively treat and prevent influenza infections.

How to take

Adult dose

1. Influenza A and influenza B virus infections: Treatment should be started on the first or second day after the onset of influenza symptoms. This medicine may be administered regardless of food intake, and tolerability may improve in some patients 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 medicine as a powder for suspension. 4) Patients with renal impairment No dose adjustment is required 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 30mg dose of this medicine after each dialysis session to maintain therapeutic plasma concentrations, and the duration of treatment should not exceed 5 days. If influenza symptoms develop during the 48-hour interval between dialysis sessions, this medicine may also 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 below 10mL/min); therefore, no recommended dose is available for these patients. 5) Patients with hepatic impairment No dose adjustment is required for treatment in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9). 2. 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 medicine have been demonstrated for up to 6 weeks. The preventive effect continues while this medicine is being taken. 3) Patients with renal impairment No dose adjustment is required 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 once daily 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 plasma concentrations. The initial dose may also be administered before the start of dialysis. For peritoneal dialysis, administration of 30mg of this medicine 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 below 10mL/min); therefore, no recommended dose is available for these patients. 4) Patients with hepatic impairment No dose adjustment is required for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

Children aged 1 to 12 years (treatment): Pediatric patients weighing > 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. ≤ 15 kg: 30 mg twice daily; 5.0 mL twice daily 15 kg<, ≤ 23 kg: 45 mg twice daily; 7.5 mL twice daily 23 kg<, ≤ 40 kg: 60 mg twice daily; 10.0 mL twice daily > 40 kg: 75 mg twice daily; 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 medicine 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; 1.5 mL twice daily 4 kg: 12 mg twice daily; 2.0 mL twice daily 5 kg: 15 mg twice daily; 2.5 mL twice daily 6 kg: 18 mg twice daily; 3.0 mL twice daily 7 kg: 21 mg twice daily; 3.5 mL twice daily 8 kg: 24 mg twice daily; 4.0 mL twice daily 9 kg: 27 mg twice daily; 4.5 mL twice daily 10 kg: 30 mg twice daily; 5.0 mL 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 aged 1 to 12 years (prophylaxis): Pediatric patients weighing > 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. ≤ 15 kg: 30 mg once daily; 5.0 mL once daily 15 kg<, ≤ 23 kg: 45 mg once daily; 7.5 mL once daily 23 kg<, ≤ 40 kg: 60 mg once daily; 10.0 mL once daily > 40 kg: 75 mg once daily; 12.5 mL once daily ※ The safety and efficacy of preventing influenza A and B virus infections in children under 1 year of age have not been evaluated.

Precautions

This medication is an antiviral agent used for the treatment or prevention of influenza virus infections. This medication cannot replace the influenza vaccine, and it is important to use it alongside vaccination. It is effective only against influenza A and B viruses, and its safety and effectiveness against other types of infections have not been established. Particularly in children and adolescents, side effects such as seizures or abnormal behavior have been reported, requiring careful use in this age group with close observation by guardians. Patients with decreased kidney function or those on dialysis require dose adjustment, and it is not recommended for patients with end-stage renal failure. Common side effects include nausea, vomiting, headaches, etc., and most are temporary. Rarely, allergic reactions, liver dysfunction, skin rashes, neuropsychiatric symptoms, etc., may occur; if symptoms appear, consult healthcare professionals immediately. Pregnant or breastfeeding women should use it after consulting their physician, considering the benefits and risks of treatment. This medication does not have significant interactions with other drugs, but caution may be needed when used with specific medications. Children or elderly patients can also take it, but care is required according to the age group, especially the safety and effectiveness in children under 1 year have not been sufficiently established. When taking this medication, adhere to the prescribed method and dosage; if a dose is missed, take it as soon as possible unless it is very close to the next dose time, in which case skip it. Store it out of reach of children, and do not transfer it to other containers for safety.

Side effects

  • Nausea
  • vomiting
  • headache
  • pain
  • unstable angina
  • anemia
  • membranous colitis
  • pneumonia
  • peritonsillar abscess
  • humeral fracture
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  • hallucinations
  • seizures
  • dermatitis
  • rash
  • urticaria
  • eczema
  • dysmenorrhea
  • dizziness
  • fatigue
  • fever
  • influenza-like symptoms
  • limb pain
  • shock
  • anaphylactic reaction
  • hepatitis
  • liver function abnormalities
  • jaundice
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • acute renal failure
  • leukopenia
  • thrombocytopenia
  • neuropsychiatric symptoms
  • hemorrhagic colitis
  • erythema
  • redness
  • itching
  • petechiae
  • cheilitis
  • stomatitis
  • hematochezia
  • melena
  • hematemesis
  • peptic ulcer
  • abdominal distension
  • bowel irregularities
  • oral unpleasantness
  • loss of appetite
  • agitation
  • tremors
  • numbness
  • weakness
  • drowsiness
  • ventricular tachycardia
  • premature ventricular contractions
  • electrocardiogram abnormalities
  • palpitations
  • hematuria
  • positive proteinuria
  • eosinophilia
  • visual disturbances
  • fever
  • hypothermia
  • edema
  • increased blood glucose
  • abdominal pain
  • chest pain
  • pneumonia
  • sinusitis
  • bronchitis
  • otitis media
  • cough
  • nasal congestion
  • asthma
  • epistaxis
  • conjunctivitis
  • ear pain
  • dermatitis
  • sleep disturbances

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is best to maintain the storage temperature between 1°C and 30°C. This way, the drug's effectiveness can be preserved for a longer period.

Appearance and packaging

Appearance

A hard capsule with a light yellow upper part and white lower part filled with a white to light yellow powder.

Package unit

10 capsules/box [10 capsules/PTP x 1]

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.