Donghwa Fluene Capsule 75 mg (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 drug may be taken with or without food; in some patients, taking it with food may improve tolerability. Adults and adolescents aged 13 years or older: Administer oseltamivir 75 mg orally twice daily for 5 days. Adults and adolescents aged 13 years or older who have difficulty swallowing capsules should use this drug as a powder for suspension. Patients with renal impairment: No dose adjustment is required in patients with a creatinine clearance of 60 mL/min or greater. For patients with a creatinine clearance of 30 ~ 60 mL/min, a reduced dose of 30 mg twice daily for 5 days is recommended. For patients with a 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 drug 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, the dose may also be given before dialysis begins. For peritoneal dialysis, a single 30mg dose of this drug 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 less than 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment: No dose adjustment is required 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 or older: For those in 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 outbreak is 75 mg once daily. The safety and efficacy of this drug have been demonstrated for up to 6 weeks. The preventive effect continues while this drug is being taken. Patients with renal impairment: No dose adjustment is required in patients with a creatinine clearance of 60 mL/min or greater. For patients with a creatinine clearance of 30 ～ 60 mL/min, a reduced dose of 30 mg once daily is recommended. For patients with a 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 drug after every 2 dialysis sessions to maintain therapeutic plasma concentrations. The first dose may also be given before dialysis begins. For peritoneal dialysis, administration of 30mg of this drug 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 less than 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 are able to swallow capsules may take 75mg capsules twice daily or 30mg capsules and 45mg capsules twice daily instead of the recommended dose of this drug suspension. Treatment, ≤ 15 kg: 30 mg per dose twice daily; suspension (6mg/mL) 5.0 mL per dose twice daily Treatment, 15 kg<, ≤ 23 kg: 45 mg per dose twice daily; suspension (6mg/mL) 7.5 mL per dose twice daily Treatment, 23 kg<, ≤ 40 kg: 60 mg per dose twice daily; suspension (6mg/mL) 10.0 mL per dose twice daily Treatment, > 40 kg: 75 mg per dose twice daily; suspension (6mg/mL) 12.5 mL per dose twice daily Children 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 drug orally twice daily for 5 days. This does not apply to infants with a postconceptional age of less than 36 weeks. Treatment, 3 kg: 9 mg per dose twice daily; suspension (6mg/mL) 1.5 mL per dose twice daily Treatment, 4 kg: 12 mg per dose twice daily; suspension (6mg/mL) 2.0 mL per dose twice daily Treatment, 5 kg: 15 mg per dose twice daily; suspension (6mg/mL) 2.5 mL per dose twice daily Treatment, 6 kg: 18 mg per dose twice daily; suspension (6mg/mL) 3.0 mL per dose twice daily Treatment, 7 kg: 21 mg per dose twice daily; suspension (6mg/mL) 3.5 mL per dose twice daily Treatment, 8 kg: 24 mg per dose twice daily; suspension (6mg/mL) 4.0 mL per dose twice daily Treatment, 9 kg: 27 mg per dose twice daily; suspension (6mg/mL) 4.5 mL per dose twice daily Treatment, 10 kg: 30 mg per dose twice daily; suspension (6mg/mL) 5.0 mL per dose twice daily * This table does not include all possible weights in this patient group. For children younger than 1 year, 3mg/kg of this drug is recommended. It is recommended that a pharmacist prepare the suspension of this drug before it is administered to the patient. Children aged 1 to 12 years: Pediatric patients weighing more than 40 kg who are able to swallow capsules may take 75mg capsules once daily or 30mg capsules and 45mg capsules once daily for 10 days instead of the recommended dose of this drug suspension. Prevention, ≤ 15 kg: 30 mg per dose once daily; suspension (6mg/mL) 5.0 mL per dose once daily Prevention, 15 kg<, ≤ 23 kg: 45 mg per dose once daily; suspension (6mg/mL) 7.5 mL per dose once daily Prevention, 23 kg<, ≤ 40 kg: 60 mg per dose once daily; suspension (6mg/mL) 10.0 mL per dose once daily Prevention, > 40 kg: 75 mg per dose once daily; suspension (6mg/mL) 12.5 mL per dose once daily It is recommended that a pharmacist prepare the suspension of this drug before it is administered to the patient. The safety and efficacy of this drug for prevention of influenza A and B virus infections in children younger than 1 year have not been evaluated.

This medication is used for the treatment and prevention of influenza virus infections. However, it cannot substitute for influenza vaccinations and should be used separately from them. This medication is only effective for influenza A and B viruses, and its safety and efficacy have not been established for other infections. Rarely, neuropsychiatric adverse reactions may occur in children and adolescents, so caregivers should closely supervise patients for unusual behavior. It is recommended not to use this medication in pediatric patients aged 10 years and older unless under special circumstances. Patients who are allergic to this medication or any of its ingredients should not use it. Dosage adjustments are necessary for patients with impaired renal function or those undergoing dialysis, and it is not recommended for patients with end-stage renal failure. Common side effects such as nausea, vomiting, headache may occur during treatment, but most are temporary and not severe enough to discontinue the medication. Rarely, serious adverse events like shock, anaphylaxis, liver dysfunction, skin rash, acute renal failure, blood abnormalities, and neurological symptoms may occur, so immediate consultation with healthcare professionals is necessary if any unusual symptoms arise. Pregnant or nursing women should consider the risks and benefits of administering this medication carefully, as safety data are limited. This medication should not be used in infants under 1 year of age, as its safety and efficacy have not been established. No dosage adjustment is needed for elderly patients, but they should be closely monitored due to bodily function decline and various comorbidities. There is no specific treatment for overdose, but patients should seek medical attention immediately if adverse effects occur. This medication has a low potential for drug interactions, but caution may be necessary when used with certain medications, so inform healthcare professionals about any other medications being taken. No reports exist regarding its effect on driving or operating machinery, but influenza itself may affect these abilities, so caution is advised. This medication should be stored out of reach of children and should not be transferred to other containers.

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

Store this medication in a tightly sealed container to prevent air or moisture ingress, ideally in a cool place below 25 degrees Celsius. Proper storage will help maintain the effectiveness of the medication for a longer time.

Appearance

A hard capsule with a beige upper and gray lower part, containing white or light yellow powder.

Package unit

10 capsules (10 capsules/PTP packaging x 1)