Mediflu Capsule 30 mg (Oseltamivir Phosphate)

Adult dose

1. Influenza A and influenza B virus infections: Initiate treatment on the first or second day of influenza symptom onset. 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 oral suspension. Patients with renal impairment: No dose adjustment is required for patients with creatinine clearance of 60 mL/min or higher. 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 undergoing regular hemodialysis should receive a 30mg dose of this medicine after each dialysis session to maintain therapeutic plasma concentrations; treatment must 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 dose adjustment is required 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 aged 13 years and older: For close contacts of 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 preventive effect continues while this medicine is being taken. Patients with renal impairment: No dose adjustment is required for patients with creatinine clearance of 60 mL/min or higher. 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 undergoing regular hemodialysis should receive a 30mg dose of this medicine after every 2 dialysis sessions to maintain therapeutic plasma concentrations. 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 dose 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 as an oral suspension. Treatment dosage table for children aged 1 to 12 years (recommended dose for 5 days): Weight ≤ 15 kg — 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily Treatment dosage table for children aged 1 to 12 years (recommended dose for 5 days): Weight 15 kg<, ≤ 23 kg — 45 mg twice daily; suspension (6mg/mL) 7.5 mL twice daily Treatment dosage table for children aged 1 to 12 years (recommended dose for 5 days): Weight 23 kg<, ≤ 40 kg — 60 mg twice daily; suspension (6mg/mL) 10.0 mL twice daily Treatment dosage table for children aged 1 to 12 years (recommended dose for 5 days): 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 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 postconceptional age of less than 36 weeks. Dosage table for infants aged 2 weeks to under 1 year (recommended dose for 5 days): Weight 3 kg — 9 mg twice daily; suspension (6mg/mL) 1.5 mL twice daily Dosage table for infants aged 2 weeks to under 1 year (recommended dose for 5 days): Weight 4 kg — 12 mg twice daily; suspension (6mg/mL) 2.0 mL twice daily Dosage table for infants aged 2 weeks to under 1 year (recommended dose for 5 days): Weight 5 kg — 15 mg twice daily; suspension (6mg/mL) 2.5 mL twice daily Dosage table for infants aged 2 weeks to under 1 year (recommended dose for 5 days): Weight 6 kg — 18 mg twice daily; suspension (6mg/mL) 3.0 mL twice daily Dosage table for infants aged 2 weeks to under 1 year (recommended dose for 5 days): Weight 7 kg — 21 mg twice daily; suspension (6mg/mL) 3.5 mL twice daily Dosage table for infants aged 2 weeks to under 1 year (recommended dose for 5 days): Weight 8 kg — 24 mg twice daily; suspension (6mg/mL) 4.0 mL twice daily Dosage table for infants aged 2 weeks to under 1 year (recommended dose for 5 days): Weight 9 kg — 27 mg twice daily; suspension (6mg/mL) 4.5 mL twice daily Dosage table for infants aged 2 weeks to under 1 year (recommended dose for 5 days): 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 children under 1 year of age. Prevention in 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 as an oral suspension. Prevention dosage table for children aged 1 to 12 years (recommended dose for 10 days): Weight ≤ 15 kg — 30 mg once daily; suspension (6mg/mL) 5.0 mL once daily Prevention dosage table for children aged 1 to 12 years (recommended dose for 10 days): Weight 15 kg<, ≤ 23 kg — 45 mg once daily; suspension (6mg/mL) 7.5 mL once daily Prevention dosage table for children aged 1 to 12 years (recommended dose for 10 days): Weight 23 kg<, ≤ 40 kg — 60 mg once daily; suspension (6mg/mL) 10.0 mL once daily Prevention dosage table for children aged 1 to 12 years (recommended dose for 10 days): Weight > 40 kg — 75 mg once daily; suspension (6mg/mL) 12.5 mL once daily ※ The safety and efficacy of this medicine for 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 be used separately from vaccination. This medication is effective only against influenza A and B viruses, and safety or efficacy has not been established for other infections. Particular caution must be taken in observing children and adolescents due to reported neuropsychiatric adverse reactions; in this age group, it is essential to have a guardian present if abnormal behavior occurs. Patients with hypersensitivity to this medication or its components should not use it. Patients with impaired renal function or dialysis patients require dose adjustments and its use is not recommended in end-stage renal failure. Careful use is necessary in high-risk patients such as those with asthma, chronic bronchitis, or immunocompromised states. Common side effects include nausea, vomiting, headache, but these are usually transient and not severe. Serious adverse reactions such as skin rashes, liver function abnormalities, and neuropsychiatric symptoms can occur rarely; if symptoms appear, immediate consultation with a healthcare professional is necessary. Pregnant or nursing women should carefully consider the benefits and risks of using this medication, as data regarding its impact on fetuses or infants is limited. In children, especially those under 1 year of age, safety and efficacy have not been sufficiently established; caution is advised in their use. Elderly patients do not require dose adjustments, but they should be observed carefully considering their physical function and underlying diseases. Reported adverse reactions from overdose are similar to common side effects, and as there are no specific antidotes, immediate medical attention is required. This medication has a low potential for drug interactions, but caution may be necessary when used in conjunction with certain other medications, so patients should inform their healthcare providers about any ongoing medications. The effect on driving or operating machinery has not been observed, but caution is necessary due to the symptoms of influenza itself. Store in a tightly closed container to prevent air and moisture from entering, and keep out of reach of children; do not transfer to other containers.

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

Store this medication in a tightly closed container that prevents air and moisture from entering. Avoid extremely hot or cold places and store at room temperature between 1 to 30 degrees Celsius.

Appearance

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

Package unit

10 capsules/PTP