Dongkwang Oseltamivir Phosphate Suspension Powder 6mg/mL

Adult dose

Treatment of influenza A and influenza B virus infections: Begin treatment on the first or second day after the onset of influenza symptoms. This medication may be administered with or without food; in some patients, tolerability may improve when taken with food. Adults and adolescents aged 13 years and older: Administer 75 mg of oseltamivir orally twice daily for 5 days. Adults and adolescents aged 13 years and older who have difficulty swallowing capsules should use this medication for dosing. 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 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 outbreak is 75 mg once daily. The safety and efficacy of this medication have been demonstrated for up to 6 weeks. The preventive effect continues while taking this medication. Patients with renal impairment—treatment: No dose adjustment is required in patients with creatinine clearance of 60 mL/min or greater. 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 medication after each dialysis session to maintain therapeutic plasma concentrations; the treatment period should not exceed 5 days. If influenza symptoms occur during the 48 hours between dialysis sessions, the dose may be given before the start of dialysis. For peritoneal dialysis, a single 30mg dose of this medication 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 required for treatment in adults with mild to moderate hepatic impairment (Child-Pugh score ≤ 9). Patients with renal impairment—prevention: No dose adjustment is required in patients with creatinine clearance of 60 mL/min or greater. 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 medication after every 2 dialysis sessions to maintain therapeutic plasma concentrations. The initial dose may also be given before the start of dialysis. For peritoneal dialysis, 30mg of this medication 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 less than 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment—prevention: No dose adjustment is required for prevention in adults 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 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 medication. Weight ≤ 15 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily (for 5 days) Weight 15 kg<, ≤ 23 kg: 45 mg twice daily; suspension (6mg/mL) 7.5 mL twice daily (for 5 days) Weight 23 kg<, ≤ 40 kg: 60 mg twice daily; suspension (6mg/mL) 10.0 mL twice daily (for 5 days) Weight > 40 kg: 75 mg twice daily; suspension (6mg/mL) 12.5 mL twice daily (for 5 days) 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 medication orally twice daily for 5 days. This does not apply to infants with a postconceptional age of less than 36 weeks. Weight 3 kg: 9 mg twice daily; suspension (6mg/mL) 1.5 mL twice daily (for 5 days) Weight 4 kg: 12 mg twice daily; suspension (6mg/mL) 2.0 mL twice daily (for 5 days) Weight 5 kg: 15 mg twice daily; suspension (6mg/mL) 2.5 mL twice daily (for 5 days) Weight 6 kg: 18 mg twice daily; suspension (6mg/mL) 3.0 mL twice daily (for 5 days) Weight 7 kg: 21 mg twice daily; suspension (6mg/mL) 3.5 mL twice daily (for 5 days) Weight 8 kg: 24 mg twice daily; suspension (6mg/mL) 4.0 mL twice daily (for 5 days) Weight 9 kg: 27 mg twice daily; suspension (6mg/mL) 4.5 mL twice daily (for 5 days) Weight 10 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily (for 5 days) This table does not include all possible weights in this patient group. A dose of 3mg/kg of this medication is recommended for infants under 1 year of age. It is recommended that a pharmacist prepare the suspension of this medication before it is administered to the patient. Prevention of influenza A and influenza B virus infections—children aged 1 year 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 medication. Weight ≤ 15 kg: 30 mg once daily; suspension (6mg/mL) 5.0 mL once daily (for 10 days) Weight 15 kg<, ≤ 23 kg: 45 mg once daily; suspension (6mg/mL) 7.5 mL once daily (for 10 days) Weight 23 kg<, ≤ 40 kg: 60 mg once daily; suspension (6mg/mL) 10.0 mL once daily (for 10 days) Weight > 40 kg: 75 mg once daily; suspension (6mg/mL) 12.5 mL once daily (for 10 days) It is recommended that a pharmacist prepare the suspension of this medication before it is administered to the patient. The safety and efficacy of this medication for prevention of influenza A and B virus infections in infants under 1 year of age have not been evaluated.

This medication is used to treat or prevent influenza virus infections. However, it cannot replace influenza vaccination and should be used separately. This medication has been proven effective only against influenza A and B viruses, and its safety and efficacy have not been established for other viral infections. Specifically, unusual behavior or neuropsychiatric reactions have been reported in children and adolescents, requiring careful monitoring by caregivers for patients in this age group. Dose adjustments are needed for patients with impaired kidney function or those on dialysis, and it is not recommended for patients with severe renal failure. Additionally, caution is advised for high-risk patients with asthma, chronic bronchitis, or immunosuppressed states. Common side effects may include nausea, vomiting, and headache, which are mostly temporary. Rarely, allergic reactions, liver function abnormalities, skin rashes, or neuropsychiatric symptoms may occur, so immediate consultation with a healthcare professional is necessary if abnormal symptoms arise. Pregnant or breastfeeding women should use this medication with caution due to limited data on its effects on fetuses or infants, and it should only be used when the benefits of treatment outweigh the risks. The safety and efficacy of this medication have not been established for children under 1 year of age. While dose adjustments are not necessary for elderly patients, careful monitoring is recommended considering their reduced physical function. There is no specific treatment for overdose; however, if severe side effects occur, the patient should visit a medical facility immediately. The risk of drug interactions with this medication is low; however, caution is needed when used in combination with certain other medications, particularly live vaccines, which should be administered with an interval. When administering, the suspension should be shaken well to ensure the proper dosage is taken, and the storage temperature and duration after preparation should be adhered to. It is important to keep this medication out of the reach of children.

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

This medication should be stored in a tightly closed container to protect it from air and moisture. The storage temperature should be appropriate for room temperature between 1°C and 30°C, avoiding extremely hot or cold environments.

Appearance

A suspension that consists of white or pale yellow granules contained in a brown glass bottle, to be dissolved before use.

Package unit

10g/bottle (50mL), 13g/bottle (65mL)