Afluza 30 mg (Oseltamivir Phosphate)

Adult dose

1. Influenza A and influenza B virus infections: 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: 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: No dosage adjustment is necessary for treatment in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9). 2. 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: 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); therefore, no recommended dose is available for these patients. Patients with hepatic impairment: 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: 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, body weight ≤ 15 kg: 30 mg (sachet) twice daily Children aged 1 to 12 years, body weight 15 kg<, ≤ 23 kg: 45 mg (sachet) twice daily Children aged 1 to 12 years, body weight 23 kg<, ≤ 40 kg: 60 mg (two 30mg sachets) twice daily Children aged 1 to 12 years, body weight > 40 kg: 75 mg (sachet) twice daily 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 * This table does not include all possible body weights in this patient group. A dose of 3mg/kg of this medicine is recommended for children under 1 year of age. 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, body weight ≤ 15 kg: 30 mg (sachet) once daily Children aged 1 to 12 years, body weight 15 kg<, ≤ 23 kg: 45 mg (sachet) once daily Children aged 1 to 12 years, body weight 23 kg<, ≤ 40 kg: 60 mg (two 30mg sachets) once daily Children aged 1 to 12 years, body weight > 40 kg: 75 mg (sachet) once daily ※ The safety and efficacy of this medicine for prevention of influenza A and B virus infections in children under 1 year of age have not been evaluated.

This medication is used for treatment and prevention when infected with the influenza virus. However, this drug cannot replace influenza vaccination and should be used separately from it. It is effective only against influenza A and B viruses, and safety or efficacy has not been confirmed for other infections. Particularly, neurological adverse reactions such as seizures and delirium have been reported in children and adolescents; thus, if unusual behavior appears, observers should watch attentively. The principle is not to use this medication in children or adolescents over 10 years old, except in special cases. Patients with reduced kidney function or those undergoing dialysis require dose adjustments, and it is not recommended for patients with end-stage renal failure. Nausea, vomiting, headaches, and pain may commonly occur during treatment, and most are temporary. Rarely, symptoms such as shock, anaphylaxis, liver function abnormalities, skin rash, acute renal failure, and neurological symptoms may occur, so immediate medical attention must be sought if these abnormal symptoms develop. Women who are pregnant or breastfeeding should only take this medication when the benefits outweigh the risks, as safety data is limited. This medication is not recommended for infants under 1 year of age as its safety and efficacy have not been established. Although no special dose adjustments are required for the elderly, they should be monitored carefully considering physical function decline and pre-existing conditions. This medication has a low potential for interactions with other drugs, but caution is needed when used concurrently with certain renal excretion-related medications. When taking this medication, it should be kept out of the reach of children and not transferred to other containers. Additionally, if unusual behavior or neurological symptoms occur during use, immediate consultation with healthcare professionals is necessary, and dosing instructions should be followed precisely for safe use.

• Cramps
• delirium
• abnormal behavior
• nausea
• vomiting
• headache
• pain
• unstable angina
• anemia
• membranous colitis

This medication may be sensitive to air and moisture, so it must be stored in a tightly closed container. The storage temperature should be maintained at room temperature between 1 degree and 30 degrees. Proper storage will safely maintain the effectiveness of the medication.

Appearance

White or pale yellow powder

Package unit

10 sachets/box