Oseltamivir Phosphate 75 mg

Adult dose

1. Influenza A and influenza B virus infections: Begin treatment on the first or second day after the onset of influenza symptoms. This medicine may be taken with or without food; tolerability may improve in some patients when it is taken with food. 1) Adults and adolescents 13 years of age and older: Administer 75 mg of oseltamivir orally twice daily for 5 days. Adults and adolescents 13 years of age and older who have difficulty swallowing capsules should use this medicine for dosing. 4) Patients with renal impairment No dosage adjustment is required for 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 regular hemodialysis should receive a 30mg dose of this medicine after each dialysis session to maintain therapeutic plasma concentrations; treatment should not exceed 5 days. If influenza symptoms develop during the 48 hours between dialysis sessions, the dose may also 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 less than 10mL/min); therefore, no recommended dose is available for these patients. 5) Patients with hepatic impairment No dosage 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 1) Adults and adolescents 13 years of age and older: For those in close contact with 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 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. 3) Patients with renal impairment No dosage adjustment is required for 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 once daily every other day is recommended. Patients receiving regular hemodialysis should receive a 30mg dose of this medicine after every 2 dialysis sessions to maintain therapeutic plasma concentrations. The initial dose may be administered before the start of dialysis. For peritoneal dialysis, 30mg of this medicine 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. 4) Patients with hepatic impairment No dosage adjustment is required for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

1. Influenza A and influenza B virus infections 2) Pediatric patients 1 to 12 years of age: 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. ≤ 15 kg — 30 mg (sachet) twice daily 15 kg<, ≤ 23 kg — 45 mg (sachet) twice daily 23 kg<, ≤ 40 kg — 60 mg (two 30mg sachets) twice daily > 40 kg — 75 mg (sachet) twice daily 3) Pediatric patients 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 medicine orally twice daily for 5 days. This does not apply to pediatric patients with a postconceptional age of less than 36 weeks. Pediatric patients who have difficulty taking this medicine as a powder should use the suspension. 3 kg — 9 mg twice daily; 1.5mL twice daily 4 kg — 12 mg twice daily; 2.0mL twice daily 5 kg — 15 mg twice daily; 2.5mL twice daily 6 kg — 18 mg twice daily; 3.0mL twice daily 7 kg — 21 mg twice daily; 3.5mL twice daily 8 kg — 24 mg twice daily; 4.0mL twice daily 9 kg — 27 mg twice daily; 4.5mL twice daily 10 kg — 30 mg twice daily; 5.0mL 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 pediatric patients under 1 year of age. 2. Prevention of influenza A and influenza B virus infections 2) Pediatric patients 1 to 12 years of age: 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. ≤ 15 kg — 30 mg (sachet) once daily 15 kg<, ≤ 23 kg — 45 mg (sachet) once daily 23 kg<, ≤ 40 kg — 60 mg (two 30mg sachets) once daily > 40 kg — 75 mg (sachet) once daily ※ The safety and efficacy of prevention of influenza A and B virus infections in pediatric patients under 1 year of age have not been evaluated.

This medication is used for the treatment and prevention of influenza virus infections. This medication cannot replace influenza vaccination and should be used in addition to it. It has only been shown to be effective against influenza A and B viruses, and its safety and efficacy for other infections have not been studied. Particularly in children and adolescents, neuropsychiatric adverse reactions such as convulsions and delirium have been reported during use, so caregivers must observe for unusual behaviors closely. Except in special circumstances, this medication is not recommended for children over 10 years of age, and they should not be left alone for at least 2 days to minimize the risk of unusual behavior and accidents. It should not be administered to patients with a known hypersensitivity to this medication or its ingredients. Patients with renal impairment or those undergoing hemodialysis require dose adjustments, and it is not recommended for patients with end-stage renal disease. Caution should be exercised when administering to high-risk patients with asthma, chronic bronchitis, or immunocompromised conditions. Generally, side effects such as nausea, vomiting, headache, pain, unstable angina, anemia, colitis, pneumonia, peritonsillar abscess, humeral fracture, hallucinations, convulsions, dermatitis, rash, eczema, erythema, itching, petechial hemorrhage, cheilitis, stomatitis, blood in stool, melena, hematemesis, peptic ulcers, abdominal bloating, abnormal stool, oral discomfort, loss of appetite, agitation, tremors, numbness, lethargy, drowsiness, ventricular tachycardia, ventricular ectopic beats, abnormal electrocardiogram, and palpitations may occur; most are temporary and mild symptoms. Rarely, severe side effects such as shock, anaphylaxis, liver function abnormalities, skin symptoms, acute renal failure, and neuropsychiatric abnormalities may occur, so if unusual symptoms arise, consultation with medical personnel should be sought immediately. Use by pregnant or breastfeeding women should only occur when the therapeutic benefits outweigh the potential risks, as the effects on embryos or infants have not been sufficiently studied. In children, effectiveness has not been established in those under 1 year of age, while safety has been confirmed in those over 1 year.</n Elderly patients should be closely observed for changes in bodily functions. This medication contains sorbitol, making it unsuitable for patients with fructose intolerance. While drug interactions are limited, caution may be necessary when used in conjunction with specific medications; patients should inform healthcare professionals of any other medications they are taking. This medication should be stored out of the reach of children and should not be transferred to other containers.

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

This medication must be stored in a tightly sealed container to prevent exposure to air and moisture. It is important to maintain a storage temperature of between 1 to 30 degrees Celsius. This will help maintain the effectiveness of the medication for a longer period.

Appearance

White or yellowish powder

Package unit

10 packs/box