Afluzan 45 mg (Oseltamivir Phosphate)

Adult dose

Begin treatment on the first or second day after the onset of influenza symptoms. This medicine may be administered regardless of food intake, although taking it with food may improve tolerability in some patients. 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 for dosing. Patients with renal impairment (treatment): No dosage adjustment is necessary for patients with creatinine clearance ≥ 60 mL/min. 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 30 mg dose of this medicine after each dialysis session to maintain therapeutic plasma concentrations, and treatment should not exceed 5 days. If influenza symptoms develop during the 48 hours between dialysis sessions, the dose may be administered before dialysis begins. For peritoneal dialysis, a single 30 mg 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 < 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment (treatment): No dosage adjustment is necessary 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: If in close contact with 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 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 taking this medicine. Patients with renal impairment (prevention): No dosage adjustment is necessary for patients with creatinine clearance ≥ 60 mL/min. 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 regular hemodialysis should receive a 30 mg dose of this medicine after every 2 dialysis sessions to maintain therapeutic plasma concentrations. The first dose may also be administered before dialysis begins. For peritoneal dialysis, administration of 30 mg 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 10mL/min or less); therefore, no recommended dose is available for these patients. Patients with hepatic impairment (prevention): No dosage adjustment is necessary for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

Children aged 1 to 12 years (treatment): 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. Children aged 1 to 12 years (treatment), body weight ≤ 15 kg: 30 mg (sachet) twice daily for 5 days. Children aged 1 to 12 years (treatment), body weight 15 kg<, ≤ 23 kg: 45 mg (sachet) twice daily for 5 days. Children aged 1 to 12 years (treatment), body weight 23 kg<, ≤ 40 kg: 60 mg (two 30mg sachets) twice daily for 5 days. Children aged 1 to 12 years (treatment), body weight > 40 kg: 75 mg (sachet) twice daily for 5 days. 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 the powder form of this medicine should use the suspension. Infants aged 2 weeks to under 1 year, body weight 3 kg: 9 mg twice daily; suspension (6mg/mL) dose 1.5mL twice daily. Infants aged 2 weeks to under 1 year, body weight 4 kg: 12 mg twice daily; suspension (6mg/mL) dose 2.0mL twice daily. Infants aged 2 weeks to under 1 year, body weight 5 kg: 15 mg twice daily; suspension (6mg/mL) dose 2.5mL twice daily. Infants aged 2 weeks to under 1 year, body weight 6 kg: 18 mg twice daily; suspension (6mg/mL) dose 3.0mL twice daily. Infants aged 2 weeks to under 1 year, body weight 7 kg: 21 mg twice daily; suspension (6mg/mL) dose 3.5mL twice daily. Infants aged 2 weeks to under 1 year, body weight 8 kg: 24 mg twice daily; suspension (6mg/mL) dose 4.0mL twice daily. Infants aged 2 weeks to under 1 year, body weight 9 kg: 27 mg twice daily; suspension (6mg/mL) dose 4.5mL twice daily. Infants aged 2 weeks to under 1 year, body weight 10 kg: 30 mg twice daily; suspension (6mg/mL) dose 5.0mL twice daily. A dose of 3mg/kg of this medicine is recommended for children under 1 year of age. 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. Children aged 1 to 12 years (prevention), body weight ≤ 15 kg: 30 mg (sachet) once daily for 10 days. Children aged 1 to 12 years (prevention), body weight 15 kg<, ≤ 23 kg: 45 mg (sachet) once daily for 10 days. Children aged 1 to 12 years (prevention), body weight 23 kg<, ≤ 40 kg: 60 mg (two 30mg sachets) once daily for 10 days. Children aged 1 to 12 years (prevention), body weight > 40 kg: 75 mg (sachet) once daily for 10 days. The safety and efficacy of prevention of influenza A and B virus infections in children under 1 year of age have not been evaluated.

This medication is used to treat or prevent infections caused by the influenza virus, but it cannot replace influenza vaccination. This medication has been proven effective only against Influenza A and B, and its safety and efficacy have not been confirmed for other types of infections. Especially in children and adolescents, rare neuropsychiatric adverse reactions, such as seizures or delirium and abnormal behavior, have been reported, necessitating caution. It is generally not recommended for children over 10 years old, except in special cases, due to the risk of these abnormal behaviors and accidents. During the course of treatment with this medication, parents must ensure that children or adolescents are not left alone for at least 2 days. This medication should not be administered to patients with hypersensitivity to it, and dose adjustments are necessary for patients with reduced kidney function or dialysis patients. It should be used cautiously in high-risk patients, such as those with asthma, chronic bronchitis, or immunosuppression. The most common side effects of this medication are nausea, vomiting, headache, and pain, which are mostly transient and mild symptoms. Rarely, symptoms such as shock, anaphylaxis, liver function abnormalities, skin adverse reactions, acute kidney failure, blood abnormalities, and neuropsychiatric symptoms may occur, so if unusual symptoms arise, immediate consultation with a medical professional is required. The use of this medication in pregnant or nursing women should be carefully considered regarding the limited data on its effects on the fetus or infant, weighing the benefits and risks of treatment. Safety and efficacy in children, especially infants under 1 year old, have not been sufficiently established. There is no need for special dose adjustments in elderly patients, but careful monitoring is needed in cases of decreased bodily function or multiple diseases. This medication contains sorbitol, making it unsuitable for patients with hereditary fructose intolerance. Drug interactions are relatively minimal, but caution is necessary when combined with drugs that may affect renal elimination. This medication can be used alongside the influenza vaccine, but a gap should be maintained with live vaccines such as the intranasal influenza vaccine. When taking the medication, the prescribed dosage and administration should be followed, and if a dose is missed, it should be taken as soon as possible, but care should be taken not to take it too close to the next scheduled dose. Store it out of reach of children and do not transfer to other containers for safety.

• Convulsions
• delirium
• abnormal behavior
• nausea
• vomiting
• headache
• pain
• unstable angina
• anemia
• pseudomembranous colitis

Store this medication in a tightly sealed container to prevent exposure to air and moisture. It is best to maintain a storage temperature of room temperature between 1 to 30 degrees Celsius.

Appearance

White or pale yellow powder

Package unit

10 packets per box