Comiflu Capsule 75 mg (Oseltamivir Phosphate)

Adult dose

Treatment of 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, taking it with food may improve tolerability. Adults and adolescents aged 13 years and older: Administer oseltamivir 75 mg orally twice daily for 5 days. Adults and adolescents aged 13 years and older who have difficulty swallowing capsules should use this medicine as powder for suspension. Patients with renal impairment (treatment): No dose 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 30mg dose of this medicine 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, this medicine may 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 < 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment (treatment): No dose 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: For close contact with an infected person, administer oseltamivir 75 mg 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 protective effect continues while this medicine is being taken. Patients with renal impairment (prevention): No dose 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 every other day is recommended. Patients receiving regular hemodialysis should receive a 30mg 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 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 < 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment (prevention): No dose adjustment is necessary for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

Treatment 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 twice daily or 30mg and 45mg capsules twice daily instead of the recommended dose of this medicine as a suspension. Weight ≤ 15 kg: 30 mg per dose twice daily; suspension (6mg/mL) 5.0 mL per dose twice daily Weight 15 kg<, ≤ 23 kg: 45 mg per dose twice daily; suspension (6mg/mL) 7.5 mL per dose twice daily Weight 23 kg<, ≤ 40 kg: 60 mg per dose twice daily; suspension (6mg/mL) 10.0 mL per dose twice daily Weight > 40 kg: 75 mg per dose twice daily; suspension (6mg/mL) 12.5 mL per dose twice daily Infants aged 2 weeks to less than 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 post-conceptional age of less than 36 weeks. Weight 3 kg: 9 mg per dose twice daily; suspension (6mg/mL) 1.5 mL per dose twice daily Weight 4 kg: 12 mg per dose twice daily; suspension (6mg/mL) 2.0 mL per dose twice daily Weight 5 kg: 15 mg per dose twice daily; suspension (6mg/mL) 2.5 mL per dose twice daily Weight 6 kg: 18 mg per dose twice daily; suspension (6mg/mL) 3.0 mL per dose twice daily Weight 7 kg: 21 mg per dose twice daily; suspension (6mg/mL) 3.5 mL per dose twice daily Weight 8 kg: 24 mg per dose twice daily; suspension (6mg/mL) 4.0 mL per dose twice daily Weight 9 kg: 27 mg per dose twice daily; suspension (6mg/mL) 4.5 mL per dose twice daily Weight 10 kg: 30 mg per dose twice daily; suspension (6mg/mL) 5.0 mL per dose 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. 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 30mg and 45mg capsules once daily for 10 days instead of the recommended dose of this medicine as a suspension. Weight ≤ 15 kg: 30 mg per dose once daily; suspension (6mg/mL) 5.0 mL per dose once daily Weight 15 kg<, ≤ 23 kg: 45 mg per dose once daily; suspension (6mg/mL) 7.5 mL per dose once daily Weight 23 kg<, ≤ 40 kg: 60 mg per dose once daily; suspension (6mg/mL) 10.0 mL per dose once daily Weight > 40 kg: 75 mg per dose once daily; suspension (6mg/mL) 12.5 mL per dose once daily ※ The safety and efficacy of preventing influenza A and B virus infections in children under 1 year of age have not been evaluated.

This medication cannot replace influenza vaccination and should only be used for treatment and prevention in areas where influenza viruses are prevalent. Safety and efficacy have not been established for infections other than influenza A and B. In children and adolescents, especially those over 10 years of age, unusual behaviors or neuropsychiatric side effects have been reported, so careful observation is required, and guardians should not leave them alone for at least 2 days. Patients with hypersensitivity to this medication or its ingredients should not be administered this drug. Patients with impaired kidney function or undergoing dialysis require dose adjustment, and it is not recommended for patients with end-stage renal disease. Caution should be exercised when administering to high-risk patients with asthma, chronic bronchitis, or immunocompromised states. During treatment, side effects such as nausea, vomiting, and headaches may frequently occur, although serious side effects such as shock, anaphylaxis, hepatic dysfunction, skin rashes, and neuropsychiatric issues may also arise rarely, so immediate consultation with healthcare professionals is necessary if abnormal symptoms appear. Women who are pregnant or breastfeeding should consider the benefits and risks of treatment after consulting a physician. Safety in children has been established for those aged 1 year and older, but safety and efficacy have not been established for children under 1 year. Although elderly patients do not require dose adjustment, careful monitoring is necessary due to declining physical functions. This medication has a low potential for clinically significant interactions with other drugs, but caution may be needed when used concurrently with specific medications. Serious side effects are rarely reported in cases of overdose, but it is important to adhere to the recommended dosage. In storage, keep it out of reach of children and avoid transferring it to other containers. This medication should be taken early in the treatment of influenza, and if unusual behaviors or neuropsychiatric symptoms occur during treatment, it should be immediately discontinued and consultation with healthcare professionals should be sought.

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

This medication must be stored in an airtight container to avoid exposure to air or moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius to preserve its effectiveness.

Appearance

Hard capsules with a lower gray part and an upper light yellow part containing a white or pale yellow powder

Package unit

10 capsules/PTP