Gonflu Capsule 75 mg (Oseltamivir Phosphate)

Adult dose

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 administered regardless of food intake; tolerability may improve in some patients when taken with food. 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 a powder for suspension. Patients with renal impairment (treatment): 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 intermittent 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 occur 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 less than 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment (treatment): No dose adjustment is necessary 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 oseltamivir 75 mg orally once daily for 10 days. Initiate 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 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 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 every other day is recommended. Patients receiving intermittent 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 once-weekly 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 (prevention): No dose adjustment is necessary for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

Treatment, children aged 1 year through 12 years: Pediatric patients weighing more than 40 kg who can swallow capsules may take 75mg capsules twice daily or 30mg capsules and 45mg capsules twice daily instead of the recommended dose of this medicine as a suspension. Treatment, children aged 1 year through 12 years, ≤ 15 kg: 30 mg per dose twice daily; suspension (6mg/mL) 5.0 mL per dose twice daily Treatment, children aged 1 year through 12 years, 15 kg<, ≤ 23 kg: 45 mg per dose twice daily; suspension (6mg/mL) 7.5 mL per dose twice daily Treatment, children aged 1 year through 12 years, 23 kg<, ≤ 40 kg: 60 mg per dose twice daily; suspension (6mg/mL) 10.0 mL per dose twice daily Treatment, children aged 1 year through 12 years, > 40 kg: 75 mg per dose twice daily; suspension (6mg/mL) 12.5 mL per dose twice daily Treatment, children 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. Treatment, children aged 2 weeks to under 1 year, 3 kg: 9 mg per dose twice daily; suspension (6mg/mL) 1.5 mL per dose twice daily Treatment, children aged 2 weeks to under 1 year, 4 kg: 12 mg per dose twice daily; suspension (6mg/mL) 2.0 mL per dose twice daily Treatment, children aged 2 weeks to under 1 year, 5 kg: 15 mg per dose twice daily; suspension (6mg/mL) 2.5 mL per dose twice daily Treatment, children aged 2 weeks to under 1 year, 6 kg: 18 mg per dose twice daily; suspension (6mg/mL) 3.0 mL per dose twice daily Treatment, children aged 2 weeks to under 1 year, 7 kg: 21 mg per dose twice daily; suspension (6mg/mL) 3.5 mL per dose twice daily Treatment, children aged 2 weeks to under 1 year, 8 kg: 24 mg per dose twice daily; suspension (6mg/mL) 4.0 mL per dose twice daily Treatment, children aged 2 weeks to under 1 year, 9 kg: 27 mg per dose twice daily; suspension (6mg/mL) 4.5 mL per dose twice daily Treatment, children aged 2 weeks to under 1 year, 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 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 the suspension of this medicine before administration to the patient. Prevention, children aged 1 year through 12 years: Pediatric patients weighing more than 40 kg who can 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 medicine as a suspension. Prevention, children aged 1 year through 12 years, ≤ 15 kg: 30 mg per dose once daily; suspension (6mg/mL) 5.0 mL per dose once daily Prevention, children aged 1 year through 12 years, 15 kg<, ≤ 23 kg: 45 mg per dose once daily; suspension (6mg/mL) 7.5 mL per dose once daily Prevention, children aged 1 year through 12 years, 23 kg<, ≤ 40 kg: 60 mg per dose once daily; suspension (6mg/mL) 10.0 mL per dose once daily Prevention, children aged 1 year through 12 years, > 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 medicine before administration to the patient. ※ The safety and efficacy of prevention of influenza A and B virus infections in children under 1 year of age have not been evaluated.

This medication is used for the treatment or prevention of influenza and cannot replace the influenza vaccine. It is effective only against influenza A and B viruses, and safety and efficacy have not been established for other infections. Especially in children and adolescents, abnormal behavior or neuropsychiatric symptoms may occur after taking this medication, so caregivers should observe closely during treatment. Patients with allergies to this medication or its components should not take it. Patients with impaired kidney function may require dosage adjustments, and it is not recommended for severely renally impaired patients. Common side effects may include nausea, vomiting, headaches, etc., but are usually temporary. Rarely, serious side effects such as shock, anaphylaxis, liver dysfunction, skin rash, acute renal failure, and neuropsychiatric abnormalities may occur; patients should consult healthcare providers if any abnormal symptoms arise. Pregnant or breastfeeding women who need to take this medication should carefully consider the risks and benefits to the fetus or infant. Use is not recommended for children under 1 year of age as safety and efficacy have not been adequately proven. Elderly patients typically have decreased bodily functions, so close monitoring during administration is necessary. This medication has a low potential for drug interactions, but caution may be warranted when used with certain medications. If abnormal behavior or neurological symptoms occur while taking this medication, patients should stop taking it immediately and consult healthcare providers. This medication is most effective when taken early in the onset of influenza symptoms, and if a dose is missed, it should be taken as soon as possible. It should be stored out of reach of children and should not be transferred to another container.

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

This medication should be stored in a tightly closed container to protect it from air and moisture. It is best to maintain storage temperature between 1 and 30 degrees Celsius to preserve the medication's effectiveness and safety for a long time.

Appearance

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

Package unit

10 capsules/PTP