Anaflu Capsule 75 mg (Oseltamivir Phosphate)

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 taken with or without food. In some patients, tolerability may improve when taken with food. Adults and adolescents 13 years of age and older: Administer oseltamivir 75 mg orally twice daily for 5 days. Adults and adolescents 13 years of age and older who have difficulty swallowing capsules should use this medicine as an oral suspension. Patients with renal impairment: No dosage adjustment is required in 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; treatment should not exceed 5 days. If influenza symptoms develop during the 48 hours between dialysis sessions, this medicine may also 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 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 and older: For close contact with an infected person, administer oseltamivir 75 mg 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 epidemic is 75 mg once daily. The safety and efficacy of this medicine have been demonstrated for up to 6 weeks. The protective effect continues while taking this medicine. Patients with renal impairment: No dosage adjustment is required in 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 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 initial dose may also be administered before dialysis begins. For peritoneal dialysis, 30 mg of this medicine once weekly 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 required for prevention in adults with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

Treatment of influenza A and influenza B virus infections — Children 1 to 12 years of age: Pediatric patients weighing more than 40 kg who can swallow capsules may take 75mg capsules twice daily or 30mg capsules and 45mg capsules twice daily instead of the recommended dose of this medicine as an oral suspension. ≤ 15 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily 15 kg<, ≤ 23 kg: 45 mg twice daily; suspension (6mg/mL) 7.5 mL twice daily 23 kg<, ≤ 40 kg: 60 mg twice daily; suspension (6mg/mL) 10.0 mL twice daily > 40 kg: 75 mg twice daily; suspension (6mg/mL) 12.5 mL twice daily Children 2 weeks to under 1 year of age: The recommended dose for pediatric patients 2 weeks to 12 months of age 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. 3 kg: 9 mg twice daily; suspension (6mg/mL) 1.5 mL twice daily 4 kg: 12 mg twice daily; suspension (6mg/mL) 2.0 mL twice daily 5 kg: 15 mg twice daily; suspension (6mg/mL) 2.5 mL twice daily 6 kg: 18 mg twice daily; suspension (6mg/mL) 3.0 mL twice daily 7 kg: 21 mg twice daily; suspension (6mg/mL) 3.5 mL twice daily 8 kg: 24 mg twice daily; suspension (6mg/mL) 4.0 mL twice daily 9 kg: 27 mg twice daily; suspension (6mg/mL) 4.5 mL twice daily 10 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily This table does not include all possible weights in this patient group. For children under 1 year of age, a dose of 3mg/kg of this medicine is recommended. It is recommended that a pharmacist prepare this medicine as a suspension before it is administered to the patient. Prevention of influenza A and influenza B virus infections — Children 1 to 12 years of age: Pediatric patients weighing more than 40 kg who can swallow capsules may take 75mg capsules once daily or 30mg capsules and 45mg capsules once daily for 10 days instead of the recommended dose of this medicine as an oral suspension. ≤ 15 kg: 30 mg once daily; suspension (6mg/mL) 5.0 mL once daily 15 kg<, ≤ 23 kg: 45 mg once daily; suspension (6mg/mL) 7.5 mL once daily 23 kg<, ≤ 40 kg: 60 mg once daily; suspension (6mg/mL) 10.0 mL once daily > 40 kg: 75 mg once daily; suspension (6mg/mL) 12.5 mL once daily It is recommended that a pharmacist prepare this medicine as a suspension before it is administered to the patient. 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 cannot replace the influenza vaccination and is only used for treatment or prevention when influenza viruses are prevalent. The safety and efficacy for infections other than influenza A and B viruses have not been established. Particularly in children and adolescents, neuropsychiatric adverse reactions have been rarely reported, and caregivers should carefully monitor for unusual behavior. Patients with impaired renal function or those on dialysis require dosage adjustments, and it is not recommended for patients with end-stage renal failure. While taking this medication, side effects such as nausea, vomiting, and headache may occur, but they are mostly transient. If allergic reactions, severe skin abnormalities, liver function abnormalities, renal failure, or neuropsychiatric symptoms occur, treatment should be stopped immediately and medical assistance should be sought. Data regarding the effects of this drug on fetuses or infants in pregnant or nursing women are limited, therefore it should only be used when the therapeutic benefits outweigh the risks. Caution should be taken as the safety and efficacy of this medication have not been sufficiently proven in children, especially those under 1 year of age. Elderly patients can use it without special dosage adjustments, but monitoring is necessary considering potential physical decline. This medication has a low potential for drug interactions, but caution is needed when used in conjunction with drugs that may affect renal excretion. No special effects have been reported when driving or operating machinery, but one should be mindful of the impairment caused by influenza itself. If unusual behavior or neurological symptoms occur while taking this medication, immediate notification to healthcare providers is important, and caregivers should closely observe the patient. Store in a place out of the reach of children, and avoid transferring to other containers.

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

This medication can be sensitive to air or moisture, so it should be stored in a tightly sealed container. Additionally, it is advisable to keep it at a temperature between 1 and 30 degrees Celsius at room temperature. Proper storage will help maintain the drug's effectiveness and safety.

Appearance

A hard capsule with gray at the bottom and light yellow at the top containing white or pale yellow powder

Package unit

10 capsules/PTP