Gumpflu Capsule 45 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 of influenza A and influenza B virus infections — 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. Aged 1 year through 12 years, ≤ 15 kg: 30 mg per dose twice daily; suspension (6mg/mL) 5.0 mL per dose twice daily. 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. 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. Aged 1 year through 12 years, > 40 kg: 75 mg per dose twice daily; suspension (6mg/mL) 12.5 mL per dose twice daily. 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. 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. 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. 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. 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. 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. 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. 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. 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. Prevention of influenza A and influenza B virus infections — 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. Aged 1 year through 12 years, ≤ 15 kg: 30 mg per dose once daily; suspension (6mg/mL) 5.0 mL per dose once daily. 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. 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. Aged 1 year through 12 years, > 40 kg: 75 mg per dose once daily; suspension (6mg/mL) 12.5 mL per dose once daily. ※ 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 cannot replace influenza vaccination, and the preventive effect only lasts while taking this medication. Safety and efficacy have not been established for infections other than influenza A and B. Rare reports of neurological and psychiatric adverse reactions such as seizures or abnormal behavior have been noted after taking this medication in children and adolescents, necessitating careful monitoring by guardians for patients in this age group. Administration should not be done for patients with allergies to this medication or its components. Dose adjustments are required for patients with renal failure or those on dialysis, and it is not recommended for patients with end-stage renal failure. Use in high-risk patients (e.g., asthma, chronic bronchitis, immunocompromised states) should be done with caution. Common side effects during administration include nausea, vomiting, headaches, most of which are temporary. Rarely, symptoms such as shock, anaphylaxis, liver function abnormalities, skin rashes, acute renal failure, or neuropsychiatric symptoms can occur; thus, contact a healthcare provider immediately if any unusual symptoms arise. This medication should only be used in pregnant women if the therapeutic benefits outweigh the risks, and for breastfeeding women, administration should be done after consulting a specialist. It can be used in children older than 1 year, and safety and efficacy have not been established for children under 1 year. Elderly patients can be administered without special dosage adjustments, but careful monitoring should be conducted considering physical functional decline and existing diseases. This medication has a low potential for drug interactions, but caution may be necessary when used with specific medications. Patients experiencing unusual behavior or neurological symptoms should inform their doctor immediately and consider discontinuation of treatment. This medication is most effective when taken early in the course of influenza treatment. If a dose is missed, it should be taken as soon as possible, but if the next dose is very close, the missed dose should be skipped. Keep out of reach of children and do not transfer to other containers.

• nausea
• vomiting
• headache
• pain
• unstable angina
• anemia
• pseudomembranous colitis
• pneumonia
• peritonsillar abscess
• humeral fracture

This medication should be stored in a tightly sealed container to prevent contact with air and moisture. It is important to maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance

A hard capsule with gray upper and lower parts containing white or light yellow powder

Package unit

10 capsules / PT/P