Medication info
Hana Flu Capsule 30 mg (Oseltamivir Phosphate)

Hana Flu Capsule 30 mg (Oseltamivir Phosphate)

Prescription medicationHard capsuleOral
Ingredient · strength
Oseltamivir Phosphate›39.4mg / 1 capsule
Manufacturer / importer
Hana Pharmaceutical Co., Ltd.
Appearance
A hard capsule containing white or pale yellow powder with pale yellow upper and lower parts.
Packaging
10 capsules/PTP
Approval status
Active

MFDS item code 201903321 · Approved 2019.05.22 · Insurance code 657806550

Summary

Main use
Treatment of influenza A and B infections; 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 taken with or without food; 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 in powder form for suspension. Patients with renal impairment: No dose adjustment is necessary 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 intermittent hemodialysis should receive a 30mg dose of this medicine after each dialysis session to maintain therapeutic plasma concentrations; the treatment period 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 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. No dose adjustment is necessary for treatment in adults 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 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 taking this medicine. Patients with renal impairment: No dose adjustment is necessary 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 intermittent 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 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 below 10mL/min); therefore, no recommended dose is available for these patients. No dose adjustment is necessary for prevention in adults with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).
Child dose
Influenza A and influenza B virus infections Children aged 1 to 12 years: 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. Body weight ≤ 15 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily Body weight 15 kg<, ≤ 23 kg: 45 mg twice daily; suspension (6mg/mL) 7.5 mL twice daily Body weight 23 kg<, ≤ 40 kg: 60 mg twice daily; suspension (6mg/mL) 10.0 mL twice daily Body weight > 40 kg: 75 mg twice daily; suspension (6mg/mL) 12.5 mL twice daily Infants aged 2 weeks to under 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. Body weight 3 kg: 9 mg twice daily; suspension (6mg/mL) 1.5 mL twice daily Body weight 4 kg: 12 mg twice daily; suspension (6mg/mL) 2.0 mL twice daily Body weight 5 kg: 15 mg twice daily; suspension (6mg/mL) 2.5 mL twice daily Body weight 6 kg: 18 mg twice daily; suspension (6mg/mL) 3.0 mL twice daily Body weight 7 kg: 21 mg twice daily; suspension (6mg/mL) 3.5 mL twice daily Body weight 8 kg: 24 mg twice daily; suspension (6mg/mL) 4.0 mL twice daily Body weight 9 kg: 27 mg twice daily; suspension (6mg/mL) 4.5 mL twice daily Body weight 10 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily This table does not include all possible body weights in this patient group. The recommended dose for children under 1 year of age is 3mg/kg of this medicine. Prevention of influenza A and influenza B virus infections Children aged 1 to 12 years: 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. Body weight ≤ 15 kg: 30 mg once daily; suspension (6mg/mL) 5.0 mL once daily Body weight 15 kg<, ≤ 23 kg: 45 mg once daily; suspension (6mg/mL) 7.5 mL once daily Body weight 23 kg<, ≤ 40 kg: 60 mg once daily; suspension (6mg/mL) 10.0 mL once daily 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
Hana Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of influenza A and B infections; prevention of influenza

  • 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 in newborns from 2 weeks of age, as well as in children and adults. It is especially important to begin treatment within 48 hours of the onset of initial flu symptoms. It is also used for the prevention of influenza in children aged 1 year and older and adults, but only in cases where vaccination is not possible, and it cannot replace vaccination. Therefore, patients should take this medication as soon as symptoms appear and remember that vaccination is a priority for prevention. This medication provides effective assistance for the treatment and prevention of influenza.

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 taken with or without food; 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 in powder form for suspension. Patients with renal impairment: No dose adjustment is necessary 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 intermittent hemodialysis should receive a 30mg dose of this medicine after each dialysis session to maintain therapeutic plasma concentrations; the treatment period 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 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. No dose adjustment is necessary for treatment in adults 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 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 taking this medicine. Patients with renal impairment: No dose adjustment is necessary 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 intermittent 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 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 below 10mL/min); therefore, no recommended dose is available for these patients. No dose adjustment is necessary for prevention in adults with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

Influenza A and influenza B virus infections Children aged 1 to 12 years: 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. Body weight ≤ 15 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily Body weight 15 kg<, ≤ 23 kg: 45 mg twice daily; suspension (6mg/mL) 7.5 mL twice daily Body weight 23 kg<, ≤ 40 kg: 60 mg twice daily; suspension (6mg/mL) 10.0 mL twice daily Body weight > 40 kg: 75 mg twice daily; suspension (6mg/mL) 12.5 mL twice daily Infants aged 2 weeks to under 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. Body weight 3 kg: 9 mg twice daily; suspension (6mg/mL) 1.5 mL twice daily Body weight 4 kg: 12 mg twice daily; suspension (6mg/mL) 2.0 mL twice daily Body weight 5 kg: 15 mg twice daily; suspension (6mg/mL) 2.5 mL twice daily Body weight 6 kg: 18 mg twice daily; suspension (6mg/mL) 3.0 mL twice daily Body weight 7 kg: 21 mg twice daily; suspension (6mg/mL) 3.5 mL twice daily Body weight 8 kg: 24 mg twice daily; suspension (6mg/mL) 4.0 mL twice daily Body weight 9 kg: 27 mg twice daily; suspension (6mg/mL) 4.5 mL twice daily Body weight 10 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily This table does not include all possible body weights in this patient group. The recommended dose for children under 1 year of age is 3mg/kg of this medicine. Prevention of influenza A and influenza B virus infections Children aged 1 to 12 years: 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. Body weight ≤ 15 kg: 30 mg once daily; suspension (6mg/mL) 5.0 mL once daily Body weight 15 kg<, ≤ 23 kg: 45 mg once daily; suspension (6mg/mL) 7.5 mL once daily Body weight 23 kg<, ≤ 40 kg: 60 mg once daily; suspension (6mg/mL) 10.0 mL once daily 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 medication is used to treat or prevent influenza virus infections. However, it cannot replace influenza vaccination, which must be received. This medication is effective only against influenza A and B, and safety and efficacy have not been confirmed for other infections. Rarely, neuropsychiatric side effects such as seizures, delirium, and abnormal behavior have been reported in children and adolescents, and caution is needed in patients of this age group. If abnormal behavior occurs during treatment with this medication, immediate observation by a guardian is necessary, and they should not be left alone. Patients with allergies to this medication or its components should not take it. Patients with reduced kidney function or those undergoing dialysis may need dosage adjustments, and it is not recommended for patients with end-stage renal failure. Caution should also be exercised in high-risk patients with asthma, chronic bronchitis, or immunosuppression. Common side effects after taking this medication may include nausea, vomiting, headache, and pain, and most are temporary. Rarely, skin rashes, liver function abnormalities, neuropsychiatric symptoms, acute renal failure, and blood disorders may occur, so if any unusual symptoms arise, consult a doctor immediately. Women who are pregnant or breastfeeding should carefully consider the benefits and risks of this medication if treatment is necessary. Safety and efficacy in children under 1 year of age have not been sufficiently confirmed, so it is not recommended for use. The elderly can use this medication without special dosage adjustments, but careful observation should be maintained considering the decline in physical function. This medication has a low likelihood of drug interactions, but caution may be needed when used with specific medications, so inform the healthcare provider of any concomitant medications. Follow the prescribed usage and dosage, and take any missed doses as soon as possible, while being careful not to take it alone. Store this medication out of reach of children and do not transfer it to other containers.

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
  • nasal 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
  • liver dysfunction
  • jaundice
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • acute renal failure
  • leukopenia
  • thrombocytopenia
  • neuropsychiatric symptoms
  • altered consciousness
  • hallucinations
  • delusions
  • hemorrhagic colitis
  • erythema
  • redness
  • itching
  • petechiae
  • cheilitis
  • stomatitis
  • hematochezia
  • melena
  • hematemesis
  • peptic ulcer
  • abdominal distension
  • abnormal stools
  • oral unpleasantness
  • loss of appetite
  • agitation
  • tremors
  • numbness
  • weakness
  • drowsiness
  • ventricular tachycardia
  • ventricular ectopy
  • 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 disorder
  • lymphadenitis
  • tympanic membrane abnormalities
  • seizures
  • confusion
  • gastrointestinal hemorrhage
  • worsening of diabetes
  • eosinophilia
  • leukopenia
  • pancreatitis
  • angioedema
  • laryngeal edema
  • tongue edema
  • bronchospasm
  • facial edema
  • hematuria
  • nightmares
  • dizziness
  • dermatitis

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 contact with air and moisture. The appropriate storage temperature is in a cool place below 25 degrees Celsius.

Appearance and packaging

Appearance

A hard capsule containing white or pale yellow powder with pale yellow upper and lower parts.

Package unit

10 capsules/PTP

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.

Questions about this medicine

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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.