Medication info

Aniflu Powder 45 mg (Oseltamivir Phosphate)

Prescription medicationOralExpired
Ingredient · strength
Oseltamivir Phosphate›59.1mg / 1 packet
Manufacturer / importer
Ankuk Pharmaceutical Co., Ltd.
Appearance
white or pale yellow powder
Packaging
10 packets per box
Approval status
Expired

MFDS item code 201907520 · Approved 2019.10.28

This product's status changed to Expired on 2024.10.28. 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, prevention of influenza A and B infections
Who takes it
Adults · Children
Adult dose
Influenza A and influenza B virus infections: Initiate treatment on the first or second day after the onset of influenza symptoms. This medicine may be administered with or without food; in some patients, taking it with food may improve tolerability. Treatment — 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. Treatment — Patients with renal impairment: No dosage 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 periodic hemodialysis should receive a 30mg dose of this medicine after each dialysis session to maintain blood concentrations within the therapeutic range, and the treatment period should not exceed 5 days. If influenza symptoms develop during the 48 hours between dialysis sessions, the medicine may also 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 less than 10mL/min); therefore, no recommended dose is available for these patients. Treatment — Patients with hepatic impairment: No dosage adjustment is required for treatment in adult patients 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 those in close contact with an infected person, administer 75 mg of oseltamivir 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 taking this medicine. Prevention — Patients with renal impairment: No dosage 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 on alternate days is recommended. Patients receiving periodic hemodialysis should receive a 30mg dose of this medicine after every 2 dialysis sessions to maintain blood concentrations within the therapeutic range. 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. Prevention — Patients with hepatic impairment: No dosage 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 are able to swallow capsules may take 75 mg capsules twice daily or 30 mg and 45 mg capsules twice daily instead of the recommended dose of this medication. ≤ 15 kg : 30 mg (packet) twice daily, for 5 days 15 kg<, ≤ 23 kg : 45 mg (packet) twice daily, for 5 days 23 kg<, ≤ 40 kg : 60 mg (2 packets of 30 mg) twice daily, for 5 days > 40 kg : 75 mg (packet) 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 3 mg/kg of this medication, administered orally twice daily for 5 days. This does not apply to infants with a postconceptional age of less than 36 weeks. However, pediatric patients who have difficulty taking this medication as a powder should be given 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 medication is recommended for children under 1 year of age. Prevention — Children aged 1 year to 12 years: Pediatric patients weighing more than 40 kg who are able to swallow capsules may take 75 mg capsules once daily or 30 mg and 45 mg capsules once daily for 10 days instead of the recommended dose of this medication. ≤ 15 kg : 30 mg (packet) once daily, for 10 days 15 kg<, ≤ 23 kg : 45 mg (packet) once daily, for 10 days 23 kg<, ≤ 40 kg : 60 mg (2 packets of 30 mg) once daily, for 10 days > 40 kg : 75 mg (packet) once daily, for 10 days ※ 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
Ankuk Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of influenza A and B infections, prevention of influenza A and B infections

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

This medication is used to treat influenza A and B virus infections in newborns from 2 weeks old to adults. Treatment should start within 48 hours after the onset of influenza symptoms for it to be effective. It is also used for the prevention of influenza virus infections in individuals over 1 year old, but this is only applicable when the vaccine is ineffective or cannot be given. However, this medicine cannot replace the vaccine and it is recommended to use it in conjunction with vaccination. In summary, this medication is used for the treatment of influenza infections and limited prevention.

How to take

Adult dose

Influenza A and influenza B virus infections: Initiate treatment on the first or second day after the onset of influenza symptoms. This medicine may be administered with or without food; in some patients, taking it with food may improve tolerability. Treatment — 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. Treatment — Patients with renal impairment: No dosage 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 periodic hemodialysis should receive a 30mg dose of this medicine after each dialysis session to maintain blood concentrations within the therapeutic range, and the treatment period should not exceed 5 days. If influenza symptoms develop during the 48 hours between dialysis sessions, the medicine may also 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 less than 10mL/min); therefore, no recommended dose is available for these patients. Treatment — Patients with hepatic impairment: No dosage adjustment is required for treatment in adult patients 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 those in close contact with an infected person, administer 75 mg of oseltamivir 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 taking this medicine. Prevention — Patients with renal impairment: No dosage 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 on alternate days is recommended. Patients receiving periodic hemodialysis should receive a 30mg dose of this medicine after every 2 dialysis sessions to maintain blood concentrations within the therapeutic range. 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. Prevention — Patients with hepatic impairment: No dosage 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 are able to swallow capsules may take 75 mg capsules twice daily or 30 mg and 45 mg capsules twice daily instead of the recommended dose of this medication. ≤ 15 kg : 30 mg (packet) twice daily, for 5 days 15 kg<, ≤ 23 kg : 45 mg (packet) twice daily, for 5 days 23 kg<, ≤ 40 kg : 60 mg (2 packets of 30 mg) twice daily, for 5 days > 40 kg : 75 mg (packet) 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 3 mg/kg of this medication, administered orally twice daily for 5 days. This does not apply to infants with a postconceptional age of less than 36 weeks. However, pediatric patients who have difficulty taking this medication as a powder should be given 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 medication is recommended for children under 1 year of age. Prevention — Children aged 1 year to 12 years: Pediatric patients weighing more than 40 kg who are able to swallow capsules may take 75 mg capsules once daily or 30 mg and 45 mg capsules once daily for 10 days instead of the recommended dose of this medication. ≤ 15 kg : 30 mg (packet) once daily, for 10 days 15 kg<, ≤ 23 kg : 45 mg (packet) once daily, for 10 days 23 kg<, ≤ 40 kg : 60 mg (2 packets of 30 mg) once daily, for 10 days > 40 kg : 75 mg (packet) once daily, for 10 days ※ 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 cannot replace influenza vaccination, and its preventive effect is only valid during the period it is used. The safety and efficacy of this medication for infections other than influenza A and B have not been confirmed. Particularly in pediatric and adolescent patients, neurological and psychiatric adverse reactions have been reported after taking this medication, so caution is needed and guardians should closely monitor the patients for any abnormal behavior. Patients with hypersensitivity to this medication or its components should not use it. Patients with decreased renal function require dosage adjustment, and it is not recommended for patients with end-stage renal failure. Caution is required when administering to high-risk patients with asthma, chronic bronchitis, or immunocompromised states. Side effects such as nausea, vomiting, headache, and pain may commonly occur during the use of this medication, and most are temporary. Severe adverse reactions such as shock, anaphylaxis, pneumonia, liver dysfunction, skin abnormalities, acute renal failure, blood disorders, and psychiatric symptoms may occur, so any unusual symptoms should be reported to healthcare professionals immediately. This medication is not a substitute for the influenza vaccine, and it is important to use it in conjunction with vaccination. Women who are pregnant or breastfeeding should consult with a doctor regarding the use of this medication, and it should only be used if the therapeutic benefits outweigh the risks. The safety and efficacy for children under 1 year of age have not been established, so caution is advised when using it in this age group. Elderly patients do not require dosage adjustments but should be closely monitored as they may have decreased physical function. In case of overdose, there is no specific treatment, but any occurrence of side effects should be reported to healthcare professionals immediately. Keep out of reach of children and be careful not to transfer 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
  • hallucination
  • dermatitis
  • rash
  • urticaria
  • eczema
  • shock
  • anaphylactic reaction
  • hepatitis
  • abnormal liver function
  • jaundice
  • mucocutaneous syndrome
  • toxic epidermal necrolysis
  • acute renal failure
  • leukopenia
  • thrombocytopenia
  • neuropsychiatric syndrome
  • hemorrhagic colitis
  • erythema
  • redness
  • itching
  • petechiae
  • cheilitis
  • stomatitis
  • hematochezia
  • melena
  • hematemesis
  • peptic ulcer
  • abdominal distension
  • abnormal stool
  • oral discomfort
  • loss of appetite
  • agitation
  • tremor
  • paresthesia
  • lethargy
  • drowsiness
  • ventricular tachycardia
  • ventricular extrasystole
  • abnormal electrocardiogram
  • 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 disturbances

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

Storage

This medication can be sensitive to air or moisture, so it must be stored in a tightly closed container. It is recommended to maintain the storage temperature between 1 degrees and 30 degrees Celsius to prolong the effectiveness of the medication.

Appearance and packaging

Appearance

white or pale yellow powder

Package unit

10 packets per 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.