Oseltamivir Capsule 30 mg (Oseltamivir Phosphate)

Adult dosage

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 regardless of food intake, although taking it with food may improve tolerability in some patients. Adults and adolescents 13 years of age and older: The recommended dose is 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 as a powder for suspension. Patients with renal impairment (treatment): No dose adjustment is required for patients with creatinine clearance ≥ 60 mL/min. 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 30 mg dose of this medicine after each dialysis session to maintain blood concentrations within the therapeutic range, and treatment should not exceed 5 days. If influenza symptoms develop during the 48 hours between dialysis sessions, the dose may be administered before the start of dialysis. For peritoneal dialysis, a single 30 mg 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), so no recommended dose is available for these patients. Patients with hepatic impairment (treatment): No dose adjustment is required 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 13 years of age and older: For close contacts of an infected person, administer 75 mg of oseltamivir 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 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 required for patients with creatinine clearance ≥ 60 mL/min. 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 regular hemodialysis should receive a 30 mg dose of this medicine after every 2 dialysis sessions to maintain blood concentrations within the therapeutic range. The first dose may also be administered before the start of dialysis. For peritoneal dialysis, 30 mg 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), so no recommended dose is available for these patients. Patients with hepatic impairment (prevention): No dose adjustment is required for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Children's dosage

Influenza A and influenza B virus infections—Children 1 to 12 years of age: Pediatric patients weighing more than 40 kg who are able to swallow capsules may take 75mg capsules twice daily or 30mg and 45mg capsules twice daily instead of the recommended dose of this medicine as a suspension. Children 1 to 12 years of age, body weight ≤ 15 kg: 30 mg twice daily; suspension (6mg/mL), 5.0 mL twice daily Children 1 to 12 years of age, body weight 15 kg<, ≤ 23 kg: 45 mg twice daily; suspension (6mg/mL), 7.5 mL twice daily Children 1 to 12 years of age, body weight 23 kg<, ≤ 40 kg: 60 mg twice daily; suspension (6mg/mL), 10.0 mL twice daily Children 1 to 12 years of age, body weight > 40 kg: 75 mg twice daily; suspension (6mg/mL), 12.5 mL twice daily Children 2 weeks to under 1 year of age: The recommended dose for pediatric patients 2 weeks to 12 months of age is 3mg/kg of this medicine orally twice daily for 5 days. This does not apply to children with a post-conceptional age of less than 36 weeks. Children 2 weeks to under 1 year of age, body weight 3 kg: 9 mg twice daily; suspension (6mg/mL), 1.5 mL twice daily Children 2 weeks to under 1 year of age, body weight 4 kg: 12 mg twice daily; suspension (6mg/mL), 2.0 mL twice daily Children 2 weeks to under 1 year of age, body weight 5 kg: 15 mg twice daily; suspension (6mg/mL), 2.5 mL twice daily Children 2 weeks to under 1 year of age, body weight 6 kg: 18 mg twice daily; suspension (6mg/mL), 3.0 mL twice daily Children 2 weeks to under 1 year of age, body weight 7 kg: 21 mg twice daily; suspension (6mg/mL), 3.5 mL twice daily Children 2 weeks to under 1 year of age, body weight 8 kg: 24 mg twice daily; suspension (6mg/mL), 4.0 mL twice daily Children 2 weeks to under 1 year of age, body weight 9 kg: 27 mg twice daily; suspension (6mg/mL), 4.5 mL twice daily Children 2 weeks to under 1 year of age, body weight 10 kg: 30 mg twice daily; suspension (6mg/mL), 5.0 mL twice daily Prevention of influenza A and influenza B virus infections—Children 1 to 12 years of age: Pediatric patients weighing more than 40 kg who are able to swallow capsules may take 75mg capsules once daily or 30mg and 45mg capsules once daily for 10 days instead of the recommended dose of this medicine as a suspension. Children 1 to 12 years of age, body weight ≤ 15 kg: 30 mg once daily; suspension (6mg/mL), 5.0 mL once daily Children 1 to 12 years of age, body weight 15 kg<, ≤ 23 kg: 45 mg once daily; suspension (6mg/mL), 7.5 mL once daily Children 1 to 12 years of age, body weight 23 kg<, ≤ 40 kg: 60 mg once daily; suspension (6mg/mL), 10.0 mL once daily Children 1 to 12 years of age, body weight > 40 kg: 75 mg once daily; suspension (6mg/mL), 12.5 mL once daily

This medication cannot replace influenza vaccinations and should only be used for treatment and prevention during influenza outbreaks. The safety and efficacy have not been confirmed for infections other than influenza A and B. Rarely, neurological or psychiatric adverse reactions such as seizures or delirium have been reported, particularly in children and adolescents, so patients in this age group should be closely monitored for unusual behavior. Patients with known allergies to this medication or its components should not take it. Patients with decreased kidney function need dose adjustment, and it is not recommended for patients with end-stage renal failure. Patients with asthma, chronic bronchitis, or immunocompromised states should use this medication with caution. Common side effects during administration may include nausea, vomiting, or headache, which are mostly transient. Rare side effects may include shock, anaphylaxis, liver dysfunction, skin adverse reactions, acute renal failure, mental and neurological symptoms, and any abnormal symptoms should be reported to a healthcare professional immediately. This medication does not substitute influenza vaccines, and vaccinations should continue as scheduled. Pregnant or breastfeeding women should carefully consider the necessity and risks of this medication and consult with healthcare professionals whenever possible. Caution is advised for children, especially those under 1 year of age, as safety and efficacy have not been sufficiently established for this population. Generally, elderly patients do not require dose adjustment, but should be closely monitored due to potential declining physical function or existing health conditions. There is no specific antidote for overdose, but appropriate measures should be taken if adverse reactions occur. The likelihood of drug interactions is low, but caution may be needed with certain medications, so inform healthcare providers.

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

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture. It is also recommended to store the medication in a cool place, below 25 degrees Celsius.

Appearance

A hard capsule in light yellow color containing white or light yellow powder

Package unit

10 capsules/PTP