Colmiflu Powder for Suspension 6mg/mL (Oseltamivir Phosphate)

Adult dose

1. 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 administered regardless of food intake, although tolerability may improve in some patients when taken with food. Adults and adolescents 13 years of age and older: Administer 75 mg of oseltamivir orally twice daily for 5 days. Adults and adolescents 13 years of age and older who have difficulty swallowing capsules should use this medicine. Patients with renal impairment: No dose adjustment is necessary in patients with creatinine clearance of 60 mL/min or more. 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 periodic 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 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 below 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment: No dose adjustment is necessary for treatment of 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 13 years of age and older: For close contact with an infected person, administer 75 mg of oseltamivir 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 preventive effect continues while taking this medicine. Patients with renal impairment: No dose adjustment is necessary in patients with creatinine clearance of 60 mL/min or more. 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 daily every other day is recommended. Patients receiving periodic 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 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 below 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 75mg capsules twice daily or 30mg and 45mg capsules twice daily instead of the recommended dose of this medicine. Body weight ≤ 15 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily Body weight 15 kg<, ≤ 23 kg: 45 mg twice daily; suspension (6mg/mL) 7.5 mL twice daily Body weight 23 kg<, ≤ 40 kg: 60 mg twice daily; suspension (6mg/mL) 10.0 mL twice daily Body weight > 40 kg: 75 mg twice daily; suspension (6mg/mL) 12.5 mL 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 below 36 weeks. Body weight 3 kg: 9 mg twice daily; suspension (6mg/mL) 1.5 mL twice daily Body weight 4 kg: 12 mg twice daily; suspension (6mg/mL) 2.0 mL twice daily Body weight 5 kg: 15 mg twice daily; suspension (6mg/mL) 2.5 mL twice daily Body weight 6 kg: 18 mg twice daily; suspension (6mg/mL) 3.0 mL twice daily Body weight 7 kg: 21 mg twice daily; suspension (6mg/mL) 3.5 mL twice daily Body weight 8 kg: 24 mg twice daily; suspension (6mg/mL) 4.0 mL twice daily Body weight 9 kg: 27 mg twice daily; suspension (6mg/mL) 4.5 mL twice daily Body weight 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. A dose of 3mg/kg of this medicine is recommended for infants under 1 year of age. It is recommended that a pharmacist prepare this medicine as a suspension before administration 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 75mg capsules once daily or 30mg and 45mg capsules once daily for 10 days instead of the recommended dose of this medicine. Body weight ≤ 15 kg: 30 mg once daily; suspension (6mg/mL) 5.0 mL once daily Body weight 15 kg<, ≤ 23 kg: 45 mg once daily; suspension (6mg/mL) 7.5 mL once daily Body weight 23 kg<, ≤ 40 kg: 60 mg once daily; suspension (6mg/mL) 10.0 mL once daily Body weight > 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 administration to the patient. ※ The safety and efficacy of prevention of influenza A and B virus infections in infants under 1 year of age have not been evaluated.

This medication cannot replace influenza vaccination and should be used separately from vaccination. It should be used only in regions where the influenza virus is currently circulating for treatment and prevention purposes. This medication is proven effective only for Influenza A and B, and its safety and efficacy have not been confirmed for other infections. Particularly in pediatric and adolescent patients, neuropsychiatric adverse reactions, such as seizures or delirium, have been reported, necessitating caution. Because abnormal behavior may occur, it is a principle not to use this medication in children or adolescents aged 10 and above except in special cases. Due to the risk of abnormal behavior or accidents after using this medication, caregivers should ensure that the patient is not alone for at least 2 days after the initiation of treatment. Patients with allergies to this drug or its components, as well as individuals with hereditary lactase deficiency, should not take this medication. Patients with compromised renal function require dosage adjustment, and it is not recommended for patients with end-stage renal disease. Caution is required when administering to high-risk patients such as those with asthma or chronic bronchitis. The most common side effects upon taking this medication are nausea, vomiting, and headache, which are mostly transient. Rarely, shock, anaphylaxis, liver dysfunction, rash, acute kidney failure, and neuropsychiatric symptoms may occur, so if any abnormal symptoms arise, immediate consultation with healthcare professionals is necessary. Pregnant or breastfeeding women should take this medication only if the therapeutic benefits outweigh the risks, and the safety for the fetus or newborn has not been sufficiently established. In children, it is advisable not to use it for those under 1 year of age, as safety and efficacy have not been confirmed. Older adults can use it without special dosage adjustments, but should be cautious due to decreased bodily function. Drug interactions are minimal, but caution is advised when used with certain drugs that affect renal excretion. This medication is not used simultaneously with the Influenza vaccine, and there should be a certain interval before and after vaccination. Although severe side effects from overdose are rare, if any abnormal symptoms are present, individuals should inform healthcare professionals immediately. This medication must be properly dissolved and shaken before administration, and after preparation, it should be stored in a refrigerator or used within the specified period. It is safest to store in a tightly sealed container out of reach of children and not transfer it to another container.

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

This medication must be stored in a tightly sealed container to avoid exposure to air or humidity. It is important to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance

White to light yellow powder or powder with lumps in a brown glass bottle

Package unit

10 grams/bottle [(50mL)]