Comiflusan 45 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 (treatment): 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 (treatment): 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 (prevention): 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 (prevention): 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 (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. Body weight ≤ 15 kg (treatment): 30 mg (packet) twice daily Body weight 15 kg<, ≤ 23 kg (treatment): 45 mg (packet) twice daily Body weight 23 kg<, ≤ 40 kg (treatment): 60 mg (two 30mg packets) twice daily Body weight > 40 kg (treatment): 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. Body weight 3 kg: 9 mg twice daily; suspension (6mg/mL) volume 1.5mL twice daily Body weight 4 kg: 12 mg twice daily; suspension (6mg/mL) volume 2.0mL twice daily Body weight 5 kg: 15 mg twice daily; suspension (6mg/mL) volume 2.5mL twice daily Body weight 6 kg: 18 mg twice daily; suspension (6mg/mL) volume 3.0mL twice daily Body weight 7 kg: 21 mg twice daily; suspension (6mg/mL) volume 3.5mL twice daily Body weight 8 kg: 24 mg twice daily; suspension (6mg/mL) volume 4.0mL twice daily Body weight 9 kg: 27 mg twice daily; suspension (6mg/mL) volume 4.5mL twice daily Body weight 10 kg: 30 mg twice daily; suspension (6mg/mL) volume 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 (prevention): 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. Body weight ≤ 15 kg (prevention): 30 mg (packet) once daily Body weight 15 kg<, ≤ 23 kg (prevention): 45 mg (packet) once daily Body weight 23 kg<, ≤ 40 kg (prevention): 60 mg (two 30mg packets) once daily Body weight > 40 kg (prevention): 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 cannot replace influenza vaccination and is only used for treatment and prevention during periods of influenza virus outbreaks. The safety and efficacy of this medication for treating infections other than influenza A and B have not been established. In pediatric and adolescent patients, neurological and psychiatric adverse reactions, such as seizures or delirium, have been reported, so caution is needed. Particularly in children aged 10 years and older, there is a risk of incidents related to abnormal behavior, so caregivers should closely monitor the patient. This medication should not be administered to patients with hypersensitivity to it, and caution should be exercised in patients with renal impairment or those at high risk. Common side effects include nausea, vomiting, headache, and pain, most of which are transient. Rarely, shock, liver dysfunction, skin abnormalities, acute renal failure, and neuropsychiatric symptoms can occur, and if any abnormal symptoms arise, immediate consultation with a healthcare professional is required. Women who are pregnant or breastfeeding should only use this medication after carefully considering the potential benefits and risks, as its effects on the fetus or infant are not fully understood. Safety and efficacy in children under 1 year of age have not been established, so use should be avoided. No special dose adjustment is necessary for the elderly, but careful observation is advised considering potential declines in physiological functioning. This medication contains sorbitol, making it unsuitable for patients with fructose intolerance. Drug interactions are not a major concern, but caution may be necessary when used with certain medications, so if taking other drugs, inform healthcare professionals. If neuropsychiatric symptoms or abnormal behavior occur while taking this medication, discontinue immediately and consult a healthcare professional, ensuring that children or adolescents are not left unsupervised after administration. The medication should be kept out of the reach of children, and transferring it to other containers should be avoided.

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

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is recommended to maintain the storage temperature between 1 degree to 30 degrees Celsius room temperature.

Appearance

White or pale yellow powder

Package unit

10 sachets/box