Medication info

Fluphid Powder 45 mg (Oseltamivir Phosphate)

Prescription medicationOral
Ingredient · strength
Oseltamivir Phosphate›59.1mg / 1 packet
Manufacturer / importer
Gunil Pharmaceutical Co., Ltd.
Appearance
White or pale yellow powder
Packaging
10 packets/box
Approval status
Active

MFDS item code 202004119 · Approved 2020.05.29

Summary

Main use
Treatment and prevention of influenza A and B infections
Who takes it
Adults · Children
Adult dose
Initiate treatment on the first or second day after the onset of influenza symptoms. This medicine may be taken with or without food; tolerability may be improved in some patients when taken with food. Treatment - 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 for dosing. Treatment - No dose adjustment is required for 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 periodic hemodialysis should receive a 30mg dose of this medicine after each dialysis session to maintain plasma concentrations within the therapeutic range, and the treatment period should not exceed 5 days. If influenza symptoms occur during the 48 hours between dialysis sessions, the dose may 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. Treatment - No dose adjustment is required for treatment in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9). Prevention - Adults and adolescents aged 13 years and older: For those in close contact with an infected person, administer oseltamivir 75 mg orally once daily for 10 days. Initiate treatment within 2 days of contact with the infected person. The recommended dose for prevention during an influenza epidemic 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. Prevention - No dose adjustment is required for 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 every other day is recommended. Patients receiving periodic hemodialysis should receive a 30mg dose of this medicine after every 2 dialysis sessions to maintain plasma 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 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. Prevention - No dose adjustment is required for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).
Child dose
Treatment - Children aged 1 year 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. Treatment - Body weight ≤ 15 kg: 30 mg (sachet) per dose twice daily Treatment - Body weight 15 kg<, ≤ 23 kg: 45 mg (sachet) per dose twice daily Treatment - Body weight 23 kg<, ≤ 40 kg: 60 mg (two 30mg sachets) per dose twice daily Treatment - Body weight > 40 kg: 75 mg (sachet) per dose twice daily Treatment - 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. Pediatric patients who have difficulty taking this medicine as a powder should use the suspension for dosing. Treatment - Body weight 3 kg: 9 mg per dose twice daily; 1.5mL twice daily Treatment - Body weight 4 kg: 12 mg per dose twice daily; 2.0mL twice daily Treatment - Body weight 5 kg: 15 mg per dose twice daily; 2.5mL twice daily Treatment - Body weight 6 kg: 18 mg per dose twice daily; 3.0mL twice daily Treatment - Body weight 7 kg: 21 mg per dose twice daily; 3.5mL twice daily Treatment - Body weight 8 kg: 24 mg per dose twice daily; 4.0mL twice daily Treatment - Body weight 9 kg: 27 mg per dose twice daily; 4.5mL twice daily Treatment - Body weight 10 kg: 30 mg per dose twice daily; 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 infants under 1 year of age. Prevention - Children aged 1 year 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 this medicine. Prevention - Body weight ≤ 15 kg: 30 mg (sachet) per dose once daily Prevention - Body weight 15 kg<, ≤ 23 kg: 45 mg (sachet) per dose once daily Prevention - Body weight 23 kg<, ≤ 40 kg: 60 mg (two 30mg sachets) per dose once daily Prevention - Body weight > 40 kg: 75 mg (sachet) per dose 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
Gunil Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment and prevention of influenza A and B infections

  • Influenza A virus infection
  • influenza B virus infection
  • initial symptoms of influenza infection
View approved original text

This medication is used for the treatment of influenza A and influenza B virus infections in pediatric patients aged 2 weeks and older, as well as adults. It is particularly effective when taken within 48 hours of the onset of initial influenza symptoms. Additionally, it is used to prevent influenza in children aged 1 year or older and adults, but this use is strictly limited to situations where the vaccine is ineffective or cannot be administered. This medication cannot replace vaccination; therefore, vaccination should be prioritized whenever possible. Thus, it is used for the treatment of influenza infection and limited prevention.

How to take

Adult dose

Initiate treatment on the first or second day after the onset of influenza symptoms. This medicine may be taken with or without food; tolerability may be improved in some patients when taken with food. Treatment - 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 for dosing. Treatment - No dose adjustment is required for 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 periodic hemodialysis should receive a 30mg dose of this medicine after each dialysis session to maintain plasma concentrations within the therapeutic range, and the treatment period should not exceed 5 days. If influenza symptoms occur during the 48 hours between dialysis sessions, the dose may 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. Treatment - No dose adjustment is required for treatment in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9). Prevention - Adults and adolescents aged 13 years and older: For those in close contact with an infected person, administer oseltamivir 75 mg orally once daily for 10 days. Initiate treatment within 2 days of contact with the infected person. The recommended dose for prevention during an influenza epidemic 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. Prevention - No dose adjustment is required for 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 every other day is recommended. Patients receiving periodic hemodialysis should receive a 30mg dose of this medicine after every 2 dialysis sessions to maintain plasma 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 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. Prevention - No dose adjustment is required for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

Treatment - Children aged 1 year 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. Treatment - Body weight ≤ 15 kg: 30 mg (sachet) per dose twice daily Treatment - Body weight 15 kg<, ≤ 23 kg: 45 mg (sachet) per dose twice daily Treatment - Body weight 23 kg<, ≤ 40 kg: 60 mg (two 30mg sachets) per dose twice daily Treatment - Body weight > 40 kg: 75 mg (sachet) per dose twice daily Treatment - 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. Pediatric patients who have difficulty taking this medicine as a powder should use the suspension for dosing. Treatment - Body weight 3 kg: 9 mg per dose twice daily; 1.5mL twice daily Treatment - Body weight 4 kg: 12 mg per dose twice daily; 2.0mL twice daily Treatment - Body weight 5 kg: 15 mg per dose twice daily; 2.5mL twice daily Treatment - Body weight 6 kg: 18 mg per dose twice daily; 3.0mL twice daily Treatment - Body weight 7 kg: 21 mg per dose twice daily; 3.5mL twice daily Treatment - Body weight 8 kg: 24 mg per dose twice daily; 4.0mL twice daily Treatment - Body weight 9 kg: 27 mg per dose twice daily; 4.5mL twice daily Treatment - Body weight 10 kg: 30 mg per dose twice daily; 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 infants under 1 year of age. Prevention - Children aged 1 year 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 this medicine. Prevention - Body weight ≤ 15 kg: 30 mg (sachet) per dose once daily Prevention - Body weight 15 kg<, ≤ 23 kg: 45 mg (sachet) per dose once daily Prevention - Body weight 23 kg<, ≤ 40 kg: 60 mg (two 30mg sachets) per dose once daily Prevention - Body weight > 40 kg: 75 mg (sachet) per dose 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 used to treat or prevent influenza viruses and cannot replace the influenza vaccination. This medication is only effective against influenza viruses A and B, and its safety and efficacy have not been confirmed for other infections. Particularly in children and adolescents, abnormal behavior, convulsions, and delirium have been reported. Caregivers should closely monitor for any unusual behavior during treatment. Patients with hypersensitivity to this medication should not take it, and dosage adjustment is necessary for patients with impaired renal function or dialysis patients. Common side effects during administration may include nausea, vomiting, headache, and pain; however, most are temporary. Severe allergic reactions, liver function abnormalities, skin diseases, acute renal failure, blood disorders, and neuropsychiatric symptoms should prompt immediate consultation with healthcare professionals. Pregnant or nursing women should discuss the benefits and risks of treatment with their physician. Safety and efficacy in children, especially those under 1 year of age, have not been sufficiently proven, so caution is advised. Elderly patients may have reduced physiological function, necessitating careful administration. This medication has a low likelihood of drug interactions, but caution should be exercised when used with specific drugs, so patients should inform healthcare providers of any medications they are currently taking. Adhere strictly to the prescribed dosages and administration methods; if a dose is missed, take it as soon as possible but avoid taking it too close to the next dose. This medication contains sorbitol, so patients with fructose intolerance should avoid it. Store out of reach of children and avoid transferring 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
  • shock
  • anaphylactic reaction
  • hepatitis
  • liver function abnormalities
  • jaundice
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • acute kidney failure
  • leukopenia
  • thrombocytopenia
  • neurological symptoms
  • bleeding colitis
  • flushing
  • erythema
  • itching
  • petechiae
  • cheilitis
  • stomatitis
  • melena
  • hematemesis
  • peptic ulcer
  • abdominal distension
  • abnormal stool
  • oral discomfort
  • loss of appetite
  • agitation
  • tremors
  • paresthesia
  • lethargy
  • drowsiness
  • ventricular tachycardia
  • premature ventricular contractions
  • electrocardiogram abnormalities
  • palpitations
  • increased AST
  • increased ALT
  • increased γ-GTP
  • increased ALP
  • hematuria
  • positive proteinuria
  • eosinophilia
  • visual disturbances
  • fever
  • hypothermia
  • edema
  • increased blood glucose
  • abdominal pain
  • chest pain
  • sleep disorders

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air and moisture. It is recommended to maintain storage temperatures between 1 and 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

White or pale yellow powder

Package unit

10 packets/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.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.