Comiflu Capsule 30 mg (Oseltamivir Phosphate)

Adult dose

1. 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: 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: No dose 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: 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: 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: No dose adjustment is necessary for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

1. 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 for 5 days Weight 15 kg<, ≤ 23 kg: 45 mg per dose twice daily; suspension (6mg/mL) 7.5 mL per dose twice daily for 5 days Weight 23 kg<, ≤ 40 kg: 60 mg per dose twice daily; suspension (6mg/mL) 10.0 mL per dose twice daily for 5 days Weight > 40 kg: 75 mg per dose twice daily; suspension (6mg/mL) 12.5 mL per dose twice daily for 5 days 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 for 5 days Weight 4 kg: 12 mg per dose twice daily; suspension (6mg/mL) 2.0 mL per dose twice daily for 5 days Weight 5 kg: 15 mg per dose twice daily; suspension (6mg/mL) 2.5 mL per dose twice daily for 5 days Weight 6 kg: 18 mg per dose twice daily; suspension (6mg/mL) 3.0 mL per dose twice daily for 5 days Weight 7 kg: 21 mg per dose twice daily; suspension (6mg/mL) 3.5 mL per dose twice daily for 5 days Weight 8 kg: 24 mg per dose twice daily; suspension (6mg/mL) 4.0 mL per dose twice daily for 5 days Weight 9 kg: 27 mg per dose twice daily; suspension (6mg/mL) 4.5 mL per dose twice daily for 5 days Weight 10 kg: 30 mg per dose twice daily; suspension (6mg/mL) 5.0 mL per dose twice daily for 5 days * 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. It is recommended that a pharmacist prepare this medicine as a suspension before it is administered to the patient. 2. 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 for 10 days Weight 15 kg<, ≤ 23 kg: 45 mg per dose once daily; suspension (6mg/mL) 7.5 mL per dose once daily for 10 days Weight 23 kg<, ≤ 40 kg: 60 mg per dose once daily; suspension (6mg/mL) 10.0 mL per dose once daily for 10 days Weight > 40 kg: 75 mg per dose once daily; suspension (6mg/mL) 12.5 mL per dose once daily for 10 days It is recommended that a pharmacist prepare this medicine as a suspension before it is administered to the patient. ※ 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 virus infections. This medication cannot substitute for the influenza vaccination and it is important to use it annually alongside vaccination. Its effectiveness has only been proven against influenza A and B viruses; safety and efficacy have not been established for other infections. Particularly in children and adolescents, neuropsychiatric adverse effects have been reported, and unusual behaviors or seizures should be closely monitored during treatment. For pediatric patients over 10 years of age, this medication is generally not used except in special cases. During treatment, caregivers should ensure that children and adolescents are not left alone, and seek medical advice immediately if unusual behaviors occur. Patients who are allergic to this medication or its components should not use it. Patients with reduced kidney function require dosage adjustments, and this medication is not recommended for patients with end-stage renal failure. Caution should be exercised in administering this medication to high-risk groups such as those with asthma, chronic bronchitis, or immunocompromised conditions. Commonly occurring side effects include nausea, vomiting, headache, and pain, which are mostly temporary and mild. Serious side effects such as skin rash, liver dysfunction, neuropsychiatric symptoms, and acute renal failure may occur rarely; hence, it is necessary to notify healthcare professionals if unusual symptoms arise. Women who are pregnant or breastfeeding should consult a physician regarding the use of this medication and should only use it when the therapeutic benefit outweighs the risk. Safety and efficacy in children under 1 year of age have not been sufficiently established, so caution in use is required. Elderly patients may have decreased physical function and multiple comorbidities, so careful monitoring is needed during administration. No serious side effects have been reported in cases of overdose, but if unusual symptoms occur, healthcare professionals should be notified immediately. This medication has a low potential for drug interactions; however, caution may be needed when used in conjunction with specific medications, and patients should inform healthcare providers of any other medications they are taking. No special effects on driving or operating machinery are expected, but physical ability reduction due to the influenza itself should be considered.

• 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 important to maintain storage temperatures between 1 and 30 degrees Celsius to preserve the drug's efficacy and safety.

Appearance

A hard capsule with yellowish exterior containing a white or pale yellow powder

Package unit

10 capsules/PTP