Comiflu Powder 75 mg (Oseltamivir Phosphate)

Adult dose

Influenza A and influenza B virus infections: Start treatment on the first or second day after the onset of influenza symptoms. This medicine may be taken with or without food; tolerability may improve in some patients when it is taken with food. 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 required for patients with creatinine clearance of 60 mL/min or greater. For patients with creatinine clearance of 30 ~ 60 mL/min, reducing the dose to 30 mg twice daily for 5 days is recommended. For patients with creatinine clearance of 10 ~ 30 mL/min, reducing the dose to 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 plasma concentrations within the therapeutic range; treatment 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 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 below 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment: No dosage adjustment is required 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 contacts of 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 influenza outbreaks 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 this medicine is being taken. Patients with renal impairment: No dosage adjustment is required for patients with creatinine clearance of 60 mL/min or greater. For patients with creatinine clearance of 30 ～ 60 mL/min, reducing the dose to 30 mg once daily is recommended. For patients with creatinine clearance of 10 ～ 30 mL/min, reducing the dose to 30 mg once daily every other day is recommended. Patients receiving regular hemodialysis should receive a 30mg dose of this medicine after every 2 dialysis sessions to maintain plasma concentrations within the therapeutic range. The initial dose may also be administered before the start of dialysis. For peritoneal dialysis, administration of 30mg 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 below 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment: No dosage adjustment is required 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. ≤ 15 kg: 30 mg (packet) twice daily 15 kg<, ≤ 23 kg: 45 mg (packet) twice daily 23 kg<, ≤ 40 kg: 60 mg (two 30mg packets) twice daily > 40 kg: 75 mg (packet) twice daily Infants aged 2 weeks to under 1 year: The recommended dose for infants 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 of this medicine should use the suspension for dosing. 3 kg: 9 mg twice daily; suspension (6mg/mL) volume 1.5mL twice daily 4 kg: 12 mg twice daily; suspension (6mg/mL) volume 2.0mL twice daily 5 kg: 15 mg twice daily; suspension (6mg/mL) volume 2.5mL twice daily 6 kg: 18 mg twice daily; suspension (6mg/mL) volume 3.0mL twice daily 7 kg: 21 mg twice daily; suspension (6mg/mL) volume 3.5mL twice daily 8 kg: 24 mg twice daily; suspension (6mg/mL) volume 4.0mL twice daily 9 kg: 27 mg twice daily; suspension (6mg/mL) volume 4.5mL twice daily 10 kg: 30 mg twice daily; suspension (6mg/mL) volume 5.0mL twice daily 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. ≤ 15 kg: 30 mg (packet) once daily 15 kg<, ≤ 23 kg: 45 mg (packet) once daily 23 kg<, ≤ 40 kg: 60 mg (two 30mg packets) once daily > 40 kg: 75 mg (packet) 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 is used for the treatment and prevention of influenza, and cannot substitute for influenza vaccination. Therefore, it should be used in conjunction with the influenza vaccine and must not be used as a replacement for vaccination. This medication has been proven effective only against influenza A and B viruses, and safety and efficacy have not been established for other types of infections. Particularly in children and adolescents, rare neurological and psychiatric adverse reactions, such as seizures, delirium, and abnormal behavior, have been reported, requiring caution. These abnormal behaviors can lead to accidents; hence, its use in this age group is not recommended except in special cases. There is a risk of abnormal behavior appearing during treatment, so caregivers should closely monitor the patient for at least 2 days and should not leave them alone. Do not administer this medication to patients who have a hypersensitivity to it. For patients with impaired kidney function, especially those with moderate to severe renal failure or those undergoing dialysis, dosage adjustments are necessary, and it is not recommended for patients with severely impaired kidney function. Careful administration is required for high-risk patients with asthma, chronic bronchitis, or immunosuppressive states. Common side effects include nausea, vomiting, headache, and pain, most of which are temporary and mild. Rarely, shock, anaphylaxis, liver function abnormalities, skin rashes, acute renal failure, neurological symptoms, and other side effects may occur, requiring immediate consultation with medical personnel upon their appearance. Due to limited data on the safety of this medication in pregnant or breastfeeding women, it should be used cautiously only when the therapeutic benefit outweighs the risks. Safety and efficacy in children under 1 year of age have not been established, so its use in this age group is not recommended. In elderly patients, special dosage adjustments are not required; however, careful monitoring is necessary for those with diminished physical function or comorbid conditions. Dosage should adhere to the specified time and amount, and should a dose be missed, it should be taken as soon as possible, without dosing if the next scheduled dose is within 2 hours of the missed one. This medication contains sorbitol, making it unsuitable for patients with fructose intolerance. In general, the potential for drug interactions with this medication is low, but caution is necessary when combining it with specific drugs, so patients should inform healthcare providers of any medications being taken. Finally, store this medication out of reach of children and avoid transferring it to other containers.

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

This medication must be stored in a tightly closed container to prevent exposure to air and moisture. Additionally, it is important to maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance

White or light yellow powder

Package unit

10 sachets/box