Medication info

Flutacapsule 30mg (Oseltamivir Phosphate)

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

MFDS item code 201902966 · Approved 2019.05.08

This product's status changed to Expired on 2024.05.08. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of influenza A and B infections and prevention of influenza
Who takes it
Adults · Children
Adult dose
Treatment of 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 aged 13 years and older: Administer oseltamivir 75 mg orally twice daily for 5 days. Adults and adolescents aged 13 years and older who have difficulty swallowing capsules should use this medicine as powder for suspension. Patients with renal impairment (treatment): No dosage adjustment is required in patients with creatinine clearance of 60 mL/min or higher. 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 regular hemodialysis should receive a 30mg dose of this medicine after each dialysis session to maintain therapeutic blood concentrations; treatment should not exceed 5 days. If influenza symptoms develop during the 48-hour interval between dialysis sessions, the dose may be administered 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 below 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment (treatment): No dosage adjustment is required 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 who are close contacts of an infected person should receive oseltamivir 75 mg orally once daily for 10 days. Start administration within 2 days after 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. Patients with renal impairment (prevention): No dosage adjustment is required in patients with creatinine clearance of 60 mL/min or higher. 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 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 first 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 below 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment (prevention): No dosage adjustment is required for prevention in adults with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).
Child dose
Treatment 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 a 75mg capsule twice daily or a 30mg capsule and a 45mg capsule twice daily instead of the recommended dose of this medicine as a suspension. Treatment, body weight ≤ 15 kg: 30 mg per dose twice daily; suspension (6mg/mL) 5.0 mL per dose twice daily, for 5 days. Treatment, body weight 15 kg<, ≤ 23 kg: 45 mg per dose twice daily; suspension (6mg/mL) 7.5 mL per dose twice daily, for 5 days. Treatment, body weight 23 kg<, ≤ 40 kg: 60 mg per dose twice daily; suspension (6mg/mL) 10.0 mL per dose twice daily, for 5 days. Treatment, body weight > 40 kg: 75 mg per dose twice daily; suspension (6mg/mL) 12.5 mL per dose twice daily, for 5 days. Treatment, children 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. Treatment, body weight 3 kg: 9 mg per dose twice daily; suspension (6mg/mL) 1.5 mL per dose twice daily, for 5 days. Treatment, body weight 4 kg: 12 mg per dose twice daily; suspension (6mg/mL) 2.0 mL per dose twice daily, for 5 days. Treatment, body weight 5 kg: 15 mg per dose twice daily; suspension (6mg/mL) 2.5 mL per dose twice daily, for 5 days. Treatment, body weight 6 kg: 18 mg per dose twice daily; suspension (6mg/mL) 3.0 mL per dose twice daily, for 5 days. Treatment, body weight 7 kg: 21 mg per dose twice daily; suspension (6mg/mL) 3.5 mL per dose twice daily, for 5 days. Treatment, body weight 8 kg: 24 mg per dose twice daily; suspension (6mg/mL) 4.0 mL per dose twice daily, for 5 days. Treatment, body weight 9 kg: 27 mg per dose twice daily; suspension (6mg/mL) 4.5 mL per dose twice daily, for 5 days. Treatment, body weight 10 kg: 30 mg per dose twice daily; suspension (6mg/mL) 5.0 mL per dose twice daily, for 5 days. Treatment, children under 1 year: This table does not include all possible weights in this patient group. For children under 1 year, a dose of 3mg/kg of this medicine is recommended. 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 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 as a suspension. Prevention, body weight ≤ 15 kg: 30 mg per dose once daily; suspension (6mg/mL) 5.0 mL per dose once daily, for 10 days. Prevention, body weight 15 kg<, ≤ 23 kg: 45 mg per dose once daily; suspension (6mg/mL) 7.5 mL per dose once daily, for 10 days. Prevention, body weight 23 kg<, ≤ 40 kg: 60 mg per dose once daily; suspension (6mg/mL) 10.0 mL per dose once daily, for 10 days. Prevention, body weight > 40 kg: 75 mg per dose once daily; suspension (6mg/mL) 12.5 mL per dose once daily, for 10 days. The safety and efficacy of this medicine for prevention of influenza A and B virus infections in children under 1 year have not been evaluated.

Ingredients

Manufacturer
KMS Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of influenza A and B infections and 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 patients aged 2 weeks and older, up to adults. It is critical to begin treatment within 48 hours of the onset of infection. It is also used for influenza prevention in individuals over 1 year old; however, vaccination is the priority, and it is only utilized for prevention if the circulating strain is not included in the vaccine or if vaccination is not feasible. This drug does not substitute for vaccination. Thus, it helps prevent and treat influenza, improving health.

How to take

Adult dose

Treatment of 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 aged 13 years and older: Administer oseltamivir 75 mg orally twice daily for 5 days. Adults and adolescents aged 13 years and older who have difficulty swallowing capsules should use this medicine as powder for suspension. Patients with renal impairment (treatment): No dosage adjustment is required in patients with creatinine clearance of 60 mL/min or higher. 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 regular hemodialysis should receive a 30mg dose of this medicine after each dialysis session to maintain therapeutic blood concentrations; treatment should not exceed 5 days. If influenza symptoms develop during the 48-hour interval between dialysis sessions, the dose may be administered 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 below 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment (treatment): No dosage adjustment is required 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 who are close contacts of an infected person should receive oseltamivir 75 mg orally once daily for 10 days. Start administration within 2 days after 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. Patients with renal impairment (prevention): No dosage adjustment is required in patients with creatinine clearance of 60 mL/min or higher. 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 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 first 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 below 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment (prevention): No dosage adjustment is required for prevention in adults with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

Treatment 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 a 75mg capsule twice daily or a 30mg capsule and a 45mg capsule twice daily instead of the recommended dose of this medicine as a suspension. Treatment, body weight ≤ 15 kg: 30 mg per dose twice daily; suspension (6mg/mL) 5.0 mL per dose twice daily, for 5 days. Treatment, body weight 15 kg<, ≤ 23 kg: 45 mg per dose twice daily; suspension (6mg/mL) 7.5 mL per dose twice daily, for 5 days. Treatment, body weight 23 kg<, ≤ 40 kg: 60 mg per dose twice daily; suspension (6mg/mL) 10.0 mL per dose twice daily, for 5 days. Treatment, body weight > 40 kg: 75 mg per dose twice daily; suspension (6mg/mL) 12.5 mL per dose twice daily, for 5 days. Treatment, children 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. Treatment, body weight 3 kg: 9 mg per dose twice daily; suspension (6mg/mL) 1.5 mL per dose twice daily, for 5 days. Treatment, body weight 4 kg: 12 mg per dose twice daily; suspension (6mg/mL) 2.0 mL per dose twice daily, for 5 days. Treatment, body weight 5 kg: 15 mg per dose twice daily; suspension (6mg/mL) 2.5 mL per dose twice daily, for 5 days. Treatment, body weight 6 kg: 18 mg per dose twice daily; suspension (6mg/mL) 3.0 mL per dose twice daily, for 5 days. Treatment, body weight 7 kg: 21 mg per dose twice daily; suspension (6mg/mL) 3.5 mL per dose twice daily, for 5 days. Treatment, body weight 8 kg: 24 mg per dose twice daily; suspension (6mg/mL) 4.0 mL per dose twice daily, for 5 days. Treatment, body weight 9 kg: 27 mg per dose twice daily; suspension (6mg/mL) 4.5 mL per dose twice daily, for 5 days. Treatment, body weight 10 kg: 30 mg per dose twice daily; suspension (6mg/mL) 5.0 mL per dose twice daily, for 5 days. Treatment, children under 1 year: This table does not include all possible weights in this patient group. For children under 1 year, a dose of 3mg/kg of this medicine is recommended. 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 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 as a suspension. Prevention, body weight ≤ 15 kg: 30 mg per dose once daily; suspension (6mg/mL) 5.0 mL per dose once daily, for 10 days. Prevention, body weight 15 kg<, ≤ 23 kg: 45 mg per dose once daily; suspension (6mg/mL) 7.5 mL per dose once daily, for 10 days. Prevention, body weight 23 kg<, ≤ 40 kg: 60 mg per dose once daily; suspension (6mg/mL) 10.0 mL per dose once daily, for 10 days. Prevention, body weight > 40 kg: 75 mg per dose once daily; suspension (6mg/mL) 12.5 mL per dose once daily, for 10 days. The safety and efficacy of this medicine for prevention of influenza A and B virus infections in children under 1 year have not been evaluated.

Precautions

This medication cannot replace the influenza vaccine and should be used separately from vaccination. It is effective only against influenza A and B, and its safety or effectiveness has not been established for other infections. Special care must be taken to monitor for unusual behavior or neuropsychiatric symptoms in children and adolescents. Generally, children over 10 years old should not use this medication except in special cases. If abnormal behavior occurs during treatment, caregivers should be vigilant and ensure that the child is not left alone. Patients with allergies to this medication or its components should not use it. Patients with impaired renal function require dose adjustment, and it is not recommended for those with end-stage renal failure. High-risk patients with asthma, chronic bronchitis, or immunocompromised states should use this medication cautiously. Nausea, vomiting, headache, and other side effects may commonly occur but are usually temporary. Rarely, rashes, liver function abnormalities, renal failure, and neuropsychiatric symptoms may occur; if any abnormal symptoms arise, consult medical personnel immediately. Women who are pregnant or breastfeeding should only use this medication if the therapeutic benefits outweigh the risks. Safety and effectiveness in children under 1 year have not been established, so caution is warranted. Elderly patients require careful observation during administration due to declining physical function, although separate dose adjustments are usually not necessary. Serious adverse reactions are rare, but if symptoms appear after overdose, medical attention should be sought immediately. This medication has a low likelihood of interaction with other drugs; however, caution may be needed when combined with specific medications. Consider the potential impairment of ability caused by influenza symptoms when driving or operating machinery. During treatment, keep this medication out of the reach of children and do not transfer it to other containers for safety.

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
  • seizures
  • 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
  • skin and mucous membrane syndrome
  • toxic epidermal necrolysis
  • acute renal failure
  • leukopenia
  • thrombocytopenia
  • neurological symptoms
  • hemorrhagic colitis
  • erythema
  • rash
  • pruritus
  • petechiae
  • cheilitis
  • stomatitis
  • hematochezia
  • melena
  • hematemesis
  • peptic ulcer
  • abdominal distension
  • abnormal stool
  • oral discomfort
  • appetite loss
  • agitation
  • tremors
  • numbness
  • lethargy
  • drowsiness
  • ventricular tachycardia
  • premature ventricular contractions
  • abnormal electrocardiogram
  • palpitations
  • increased AST
  • increased ALT
  • increased γ-GPT
  • increased ALP
  • hematuria
  • positive proteinuria
  • eosinophilia
  • visual disturbances
  • fever
  • hypothermia
  • edema
  • increased blood glucose
  • abdominal pain
  • chest pain
  • pneumonia
  • sinusitis
  • bronchitis
  • otitis media
  • asthma
  • epistaxis
  • conjunctivitis
  • ear pain
  • dermatitis
  • sleep disturbances
  • lymphadenitis
  • tympanic membrane abnormalities
  • pancreatitis
  • angioedema
  • laryngeal edema
  • lingual edema
  • bronchospasm
  • facial edema

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 air or moisture from entering, and it is best kept at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the medication's efficacy over time.

Appearance and packaging

Appearance

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

Package unit

10 capsules/PTP

Same-ingredient medicines

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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.