Medication info

Anaplu Powder for Suspension 6mg/mL (Oseltamivir Phosphate)

Prescription medicationSuspensionOral
Ingredient · strength
Oseltamivir Phosphate›3.94g / 100g
Manufacturer / importer
Aju Pharmaceutical Co., Ltd.
Appearance
White or pale yellow granules contained in a brown glass bottle for reconstitution
Packaging
10g/bottle (50mL)
Approval status
Active

MFDS item code 201708437 · Approved 2017.12.20

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: Initiate treatment on the first or second day after the onset of influenza symptoms. This medication may be administered regardless of food intake, and tolerability may improve in some patients when taken with food. Adults and adolescents 13 years of age or older: Administer 75 mg of oseltamivir orally twice daily for 5 days. Adults and adolescents 13 years of age or older who have difficulty swallowing capsules should use this medication. Patients with renal impairment (treatment): No dose adjustment is required in patients with creatinine clearance of 60 mL/min or greater. A reduced dose of 30 mg twice daily for 5 days is recommended for patients with creatinine clearance of 30 ~ 60 mL/min. A reduced dose of 30 mg once daily for 5 days is recommended for patients with creatinine clearance of 10 ~ 30 mL/min. Patients receiving periodic hemodialysis should receive a 30mg dose of this medication after each dialysis session to maintain therapeutic plasma concentrations, and the treatment period should not exceed 5 days. If influenza symptoms develop 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 medication 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. No dose 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 13 years of age or older: For close contacts of an infected person, administer 75 mg of oseltamivir orally once daily for 10 days. Begin 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 medication have been demonstrated for up to 6 weeks. The preventive effect continues while the medication is being taken. Patients with renal impairment (prevention): No dose adjustment is required in patients with creatinine clearance of 60 mL/min or greater. A reduced dose of 30 mg once daily is recommended for patients with creatinine clearance of 30 ~ 60 mL/min. A reduced dose of 30 mg once every other day is recommended for patients with creatinine clearance of 10 ~ 30 mL/min. Patients receiving periodic hemodialysis should receive a 30mg dose of this medication after every 2 dialysis sessions to maintain therapeutic plasma concentrations. The initial dose may be administered before the start of dialysis. For peritoneal dialysis, administration of 30mg of this medication 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. No dose adjustment is required for prevention in adults with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).
Child dose
Children 1 to 12 years of age (treatment), body weight ≤ 15 kg: 30 mg per dose twice daily; suspension (6mg/mL) 5.0 mL per dose twice daily Children 1 to 12 years of age (treatment), body weight 15 kg<, ≤ 23 kg: 45 mg per dose twice daily; suspension (6mg/mL) 7.5 mL per dose twice daily Children 1 to 12 years of age (treatment), body weight 23 kg<, ≤ 40 kg: 60 mg per dose twice daily; suspension (6mg/mL) 10.0 mL per dose twice daily Children 1 to 12 years of age (treatment), body weight > 40 kg: 75 mg per dose twice daily; suspension (6mg/mL) 12.5 mL per dose twice daily Pediatric patients weighing more than 40 kg: If they can swallow capsules, they may take a 75mg capsule twice daily or a 30mg capsule and a 45mg capsule twice daily instead of the recommended dose of this medication. Infants 2 weeks to less than 1 year of age (infants 2 weeks to 12 months): Administer 3mg/kg of this medication orally twice daily for 5 days. This does not apply to infants with a postconceptional age of less than 36 weeks. Infants 2 weeks to less than 1 year of age, body weight 3 kg: 9 mg per dose twice daily; suspension (6mg/mL) 1.5 mL per dose twice daily Infants 2 weeks to less than 1 year of age, body weight 4 kg: 12 mg per dose twice daily; suspension (6mg/mL) 2.0 mL per dose twice daily Infants 2 weeks to less than 1 year of age, body weight 5 kg: 15 mg per dose twice daily; suspension (6mg/mL) 2.5 mL per dose twice daily Infants 2 weeks to less than 1 year of age, body weight 6 kg: 18 mg per dose twice daily; suspension (6mg/mL) 3.0 mL per dose twice daily Infants 2 weeks to less than 1 year of age, body weight 7 kg: 21 mg per dose twice daily; suspension (6mg/mL) 3.5 mL per dose twice daily Infants 2 weeks to less than 1 year of age, body weight 8 kg: 24 mg per dose twice daily; suspension (6mg/mL) 4.0 mL per dose twice daily Infants 2 weeks to less than 1 year of age, body weight 9 kg: 27 mg per dose twice daily; suspension (6mg/mL) 4.5 mL per dose twice daily Infants 2 weeks to less than 1 year of age, body weight 10 kg: 30 mg per dose twice daily; suspension (6mg/mL) 5.0 mL per dose twice daily Infants less than 1 year of age: A dose of 3mg/kg of this medication is recommended. Children 1 to 12 years of age (prevention), body weight ≤ 15 kg: 30 mg per dose once daily; suspension (6mg/mL) 5.0 mL per dose once daily Children 1 to 12 years of age (prevention), body weight 15 kg<, ≤ 23 kg: 45 mg per dose once daily; suspension (6mg/mL) 7.5 mL per dose once daily Children 1 to 12 years of age (prevention), body weight 23 kg<, ≤ 40 kg: 60 mg per dose once daily; suspension (6mg/mL) 10.0 mL per dose once daily Children 1 to 12 years of age (prevention), body weight > 40 kg: 75 mg per dose once daily; suspension (6mg/mL) 12.5 mL per dose once daily Pediatric patients weighing more than 40 kg: If they can swallow capsules, they 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 medication. The safety and efficacy of prevention of influenza A and B virus infections in infants less than 1 year of age have not been evaluated.

Ingredients

Manufacturer
Aju Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of influenza A and B infections; prevention of influenza

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

This medication is used to treat influenza A and B virus infections in newborns over 2 weeks old up to adults. Treatment should begin within 48 hours of the onset of symptoms for it to be effective. Additionally, it can be used for the prevention of influenza virus in individuals aged 1 year and older, particularly when vaccination has not been possible or the efficacy of the vaccine is uncertain. However, this medication cannot replace vaccination, so it is crucial to remember that vaccinations take precedence. It helps to safely and effectively prevent and treat influenza infections.

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 medication may be administered regardless of food intake, and tolerability may improve in some patients when taken with food. Adults and adolescents 13 years of age or older: Administer 75 mg of oseltamivir orally twice daily for 5 days. Adults and adolescents 13 years of age or older who have difficulty swallowing capsules should use this medication. Patients with renal impairment (treatment): No dose adjustment is required in patients with creatinine clearance of 60 mL/min or greater. A reduced dose of 30 mg twice daily for 5 days is recommended for patients with creatinine clearance of 30 ~ 60 mL/min. A reduced dose of 30 mg once daily for 5 days is recommended for patients with creatinine clearance of 10 ~ 30 mL/min. Patients receiving periodic hemodialysis should receive a 30mg dose of this medication after each dialysis session to maintain therapeutic plasma concentrations, and the treatment period should not exceed 5 days. If influenza symptoms develop 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 medication 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. No dose 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 13 years of age or older: For close contacts of an infected person, administer 75 mg of oseltamivir orally once daily for 10 days. Begin 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 medication have been demonstrated for up to 6 weeks. The preventive effect continues while the medication is being taken. Patients with renal impairment (prevention): No dose adjustment is required in patients with creatinine clearance of 60 mL/min or greater. A reduced dose of 30 mg once daily is recommended for patients with creatinine clearance of 30 ~ 60 mL/min. A reduced dose of 30 mg once every other day is recommended for patients with creatinine clearance of 10 ~ 30 mL/min. Patients receiving periodic hemodialysis should receive a 30mg dose of this medication after every 2 dialysis sessions to maintain therapeutic plasma concentrations. The initial dose may be administered before the start of dialysis. For peritoneal dialysis, administration of 30mg of this medication 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. No dose adjustment is required for prevention in adults with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

Children 1 to 12 years of age (treatment), body weight ≤ 15 kg: 30 mg per dose twice daily; suspension (6mg/mL) 5.0 mL per dose twice daily Children 1 to 12 years of age (treatment), body weight 15 kg<, ≤ 23 kg: 45 mg per dose twice daily; suspension (6mg/mL) 7.5 mL per dose twice daily Children 1 to 12 years of age (treatment), body weight 23 kg<, ≤ 40 kg: 60 mg per dose twice daily; suspension (6mg/mL) 10.0 mL per dose twice daily Children 1 to 12 years of age (treatment), body weight > 40 kg: 75 mg per dose twice daily; suspension (6mg/mL) 12.5 mL per dose twice daily Pediatric patients weighing more than 40 kg: If they can swallow capsules, they may take a 75mg capsule twice daily or a 30mg capsule and a 45mg capsule twice daily instead of the recommended dose of this medication. Infants 2 weeks to less than 1 year of age (infants 2 weeks to 12 months): Administer 3mg/kg of this medication orally twice daily for 5 days. This does not apply to infants with a postconceptional age of less than 36 weeks. Infants 2 weeks to less than 1 year of age, body weight 3 kg: 9 mg per dose twice daily; suspension (6mg/mL) 1.5 mL per dose twice daily Infants 2 weeks to less than 1 year of age, body weight 4 kg: 12 mg per dose twice daily; suspension (6mg/mL) 2.0 mL per dose twice daily Infants 2 weeks to less than 1 year of age, body weight 5 kg: 15 mg per dose twice daily; suspension (6mg/mL) 2.5 mL per dose twice daily Infants 2 weeks to less than 1 year of age, body weight 6 kg: 18 mg per dose twice daily; suspension (6mg/mL) 3.0 mL per dose twice daily Infants 2 weeks to less than 1 year of age, body weight 7 kg: 21 mg per dose twice daily; suspension (6mg/mL) 3.5 mL per dose twice daily Infants 2 weeks to less than 1 year of age, body weight 8 kg: 24 mg per dose twice daily; suspension (6mg/mL) 4.0 mL per dose twice daily Infants 2 weeks to less than 1 year of age, body weight 9 kg: 27 mg per dose twice daily; suspension (6mg/mL) 4.5 mL per dose twice daily Infants 2 weeks to less than 1 year of age, body weight 10 kg: 30 mg per dose twice daily; suspension (6mg/mL) 5.0 mL per dose twice daily Infants less than 1 year of age: A dose of 3mg/kg of this medication is recommended. Children 1 to 12 years of age (prevention), body weight ≤ 15 kg: 30 mg per dose once daily; suspension (6mg/mL) 5.0 mL per dose once daily Children 1 to 12 years of age (prevention), body weight 15 kg<, ≤ 23 kg: 45 mg per dose once daily; suspension (6mg/mL) 7.5 mL per dose once daily Children 1 to 12 years of age (prevention), body weight 23 kg<, ≤ 40 kg: 60 mg per dose once daily; suspension (6mg/mL) 10.0 mL per dose once daily Children 1 to 12 years of age (prevention), body weight > 40 kg: 75 mg per dose once daily; suspension (6mg/mL) 12.5 mL per dose once daily Pediatric patients weighing more than 40 kg: If they can swallow capsules, they 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 medication. The safety and efficacy of prevention of influenza A and B virus infections in infants less than 1 year of age have not been evaluated.

Precautions

This medication is used to treat or prevent influenza virus infections, but it cannot replace influenza vaccination. This medication is only effective against influenza A and B, and its safety and efficacy have not been established for other infections. Particularly in children and adolescents, there may be rare occurrences of abnormal behavior or neurological adverse reactions, so caregivers should observe for unusual behaviors after administration. Patients with allergies to this drug or its components should not take it. Patients with impaired kidney function or those undergoing hemodialysis need dosage adjustments, and it is not recommended for patients with end-stage renal failure. High-risk patients, such as those with asthma, chronic bronchitis, and immunosuppressed individuals, should use this drug with caution. Common side effects may include nausea, vomiting, headache, and these symptoms are usually transient. Rarely, anaphylaxis, liver dysfunction, skin rashes, acute renal failure, and neurological symptoms may occur, so report any unusual symptoms to healthcare professionals immediately. This medication contains sorbitol, so patients with hereditary fructose intolerance should avoid it. While interactions with other medications are unlikely, caution is advised when used in conjunction with specific medications. Women who are pregnant or breastfeeding should consult a doctor about the use of this drug, and it should only be used when the therapeutic benefits outweigh the risks. Safety and efficacy for infants under 1 year have not been established, so it is advisable not to use this drug in this age group. Elderly patients should be closely monitored considering physical function decline and pre-existing conditions. Adhere to the prescribed dosage and administration and take missed doses as soon as possible but not too close to the next scheduled dose. This drug is most effective when used at the onset of influenza symptoms. If unusual behavior or severe side effects occur after taking it, discontinue use and consult a healthcare provider. Store this medication out of the reach of children and follow the storage period after preparation.

Side effects

  • nausea
  • vomiting
  • headache
  • pain
  • unstable angina
  • anemia
  • pseudomembranous colitis
  • pneumonia
  • peritonsillar abscess
  • humeral fracture
Show 93 more
  • hallucinations
  • seizures
  • dermatitis
  • rash
  • hives
  • eczema
  • dizziness
  • fatigue
  • fever
  • influenza-like symptoms
  • limb pain
  • insomnia
  • cough
  • runny nose
  • congestion
  • sore throat
  • abdominal pain
  • epigastric pain
  • diarrhea
  • dyspepsia
  • back pain
  • joint pain
  • myalgia
  • dysmenorrhea
  • dizziness
  • fatigue
  • fever
  • pain
  • influenza-like symptoms
  • limb pain
  • pneumonia
  • sinusitis
  • bronchitis
  • otitis media
  • asthma
  • epistaxis
  • conjunctivitis
  • ear pain
  • dermatitis
  • erythema
  • redness
  • itching
  • petechiae
  • cheilitis
  • stomatitis
  • melena
  • hematemesis
  • peptic ulcer
  • abdominal distension
  • abnormal stool
  • oral malodor
  • loss of appetite
  • agitation
  • tremor
  • paresthesia
  • lethargy
  • drowsiness
  • ventricular tachycardia
  • ventricular extrasystole
  • ECG abnormality
  • palpitations
  • elevated AST
  • elevated ALT
  • increased γ-GTP
  • elevated ALP
  • hematuria
  • positive proteinuria
  • eosinophilia
  • visual disturbances
  • fever
  • hypothermia
  • edema
  • elevated blood glucose
  • abdominal pain
  • chest pain
  • shock
  • anaphylactic reaction
  • hepatitis
  • abnormal liver function
  • jaundice
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • acute renal failure
  • leukopenia
  • thrombocytopenia
  • neuropsychological symptoms
  • altered consciousness
  • abnormal behavior
  • delirium
  • hallucinations
  • delusions
  • hemorrhagic colitis
  • sleep disorders

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

Storage

Store this medication in a tightly sealed container to prevent air or moisture ingress and keep it at room temperature between 1 and 30 degrees Celsius. Proper storage maintains the drug's effectiveness and prevents deterioration.

Appearance and packaging

Appearance

White or pale yellow granules contained in a brown glass bottle for reconstitution

Package unit

10g/bottle (50mL)

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

No questions yet.

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

Related searches

Search tags

Suggested searches

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.