Oseltamivir Capsule 45mg (Oseltamivir Phosphate)

Adult dose

1. 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 with or without food; in some patients, taking it with food may improve tolerability. 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 medicine as powder for suspension. Patients with renal impairment: No dose adjustment is necessary in 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 30mg dose of this medicine after each dialysis session to maintain plasma concentrations within the therapeutic range; treatment must not exceed 5 days. If influenza symptoms develop during the 48-hour interval between dialysis sessions, the dose may also 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 undergoing dialysis (e.g., creatinine clearance less than 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment: No dose adjustment is necessary for treatment in adults with mild to moderate hepatic impairment (Child-Pugh score ≤ 9). 2. Prevention of influenza A and influenza B virus infections Adults and adolescents aged 13 years and older: Following close contact with 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: No dose adjustment is necessary in 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 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 plasma concentrations within the therapeutic range. The first dose may also be administered before dialysis begins. For peritoneal dialysis, a 30mg dose 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 undergoing dialysis (e.g., creatinine clearance less than 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment: No dose adjustment is necessary for prevention in adults with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

1. Influenza A and influenza B virus infections Children aged 1 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 medicine as a suspension. ≤ 15 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily 15 kg<, ≤ 23 kg: 45 mg twice daily; suspension (6mg/mL) 7.5 mL twice daily 23 kg<, ≤ 40 kg: 60 mg twice daily; suspension (6mg/mL) 10.0 mL twice daily > 40 kg: 75 mg twice daily; suspension (6mg/mL) 12.5 mL twice daily 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 medicine orally twice daily for 5 days. This does not apply to infants with a postconceptional age of less than 36 weeks. 3 kg: 9 mg twice daily; suspension (6mg/mL) 1.5 mL twice daily 4 kg: 12 mg twice daily; suspension (6mg/mL) 2.0 mL twice daily 5 kg: 15 mg twice daily; suspension (6mg/mL) 2.5 mL twice daily 6 kg: 18 mg twice daily; suspension (6mg/mL) 3.0 mL twice daily 7 kg: 21 mg twice daily; suspension (6mg/mL) 3.5 mL twice daily 8 kg: 24 mg twice daily; suspension (6mg/mL) 4.0 mL twice daily 9 kg: 27 mg twice daily; suspension (6mg/mL) 4.5 mL twice daily 10 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL 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 this medicine as a suspension before administration to the patient. 2. Prevention of influenza A and influenza B virus infections Children aged 1 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 medicine as a suspension. ≤ 15 kg: 30 mg once daily; suspension (6mg/mL) 5.0 mL once daily 15 kg<, ≤ 23 kg: 45 mg once daily; suspension (6mg/mL) 7.5 mL once daily 23 kg<, ≤ 40 kg: 60 mg once daily; suspension (6mg/mL) 10.0 mL once daily > 40 kg: 75 mg once daily; suspension (6mg/mL) 12.5 mL once daily It is recommended that a pharmacist prepare this medicine as a suspension 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 drug cannot replace influenza vaccination, and should only be used during periods of influenza virus outbreaks. Safety and efficacy have not been confirmed for infections other than influenza A and B. Particularly in children and adolescents, abnormal behavior or neuropsychiatric adverse reactions have been reported, so vigilance is needed in this age group, and caregivers should not leave them unattended for two days. This drug should not be used in patients with allergic reactions to this drug or its components. Patients with reduced kidney function or dialysis patients may require dose adjustment, and it is not recommended for patients with end-stage renal failure. High-risk patients with asthma, chronic bronchitis, or immunosuppressive conditions should use this medication cautiously. The most common side effects include nausea, vomiting, headache, which are mostly transient and mild symptoms. Rarely, shock, anaphylaxis, liver dysfunction, skin rashes, acute renal failure, neuropsychiatric symptoms may occur, so if any unusual symptoms occur, the use should be stopped immediately and healthcare providers should be consulted. Pregnant or breastfeeding women should only use this drug when the therapeutic benefits outweigh the risks, and caution is needed while breastfeeding. The safety and efficacy for children under 1 year old have not been established. Generally, elderly patients do not require dose adjustment, but should be closely monitored, especially if they have declining physical function and multiple diseases. While serious side effects have rarely been reported in cases of overdose, any adverse reactions should be reported to healthcare providers immediately. This drug has not been reported to have significant drug interactions when used with other medications, but caution may be needed when used concurrently with specific drugs. When used with the influenza vaccine, a period must be allowed between this drug and live intranasal vaccines, while inactivated vaccines can be administered at any time. This drug is most effective when administered early during influenza treatment, and if a dose is missed, it should be taken as soon as possible while maintaining a consistent schedule for subsequent doses. No direct impact on driving or operating machinery has been reported, but caution is needed due to the nature of influenza itself.

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

This drug should be stored in a tightly sealed container to protect it from air and moisture and is best kept at a cool temperature below 25 degrees Celsius. This will help maintain the drug's effectiveness and prevent deterioration.

Appearance

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

Package unit

10 capsules (10 capsules/PTPx1)