Tamiflu Capsule 30mg (Oseltamivir Phosphate)

Adult dose

Treatment of influenza A and influenza B virus infections — Initiate treatment on the first or second day of onset of influenza symptoms. This medicine may be taken with or without food; in some patients, taking it with food may improve tolerability. Adults and adolescents 13 years of age and older: Administer oseltamivir 75 mg 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 powder for suspension. Patients with renal impairment: No dosage adjustment is required for 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 undergoing periodic hemodialysis should receive a 30mg dose of this medicine after each dialysis session to maintain plasma concentrations within the therapeutic range, and 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 undergoing dialysis (e.g., creatinine clearance below 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment: No dosage adjustment is required for treatment of 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 oseltamivir 75 mg 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 dosage adjustment is required for 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 once daily every other day is recommended. Patients undergoing periodic 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, administration of 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 undergoing dialysis (e.g., creatinine clearance below 10mL/min); therefore, no recommended dose is available for these patients. 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

Treatment of influenza A and influenza B virus infections — Children 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 and 45mg capsules 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 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 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 the suspension of this medicine before it is administered to the patient. Prevention of influenza A and influenza B virus infections — Children 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 and 45mg capsules 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 the suspension of this medicine before it is administered 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 is used to treat or prevent infections caused by influenza viruses. However, this drug cannot replace influenza vaccinations and must be administered separately from them. This drug is effective only against influenza A and B viruses, and safety or efficacy for other types of infections has not been confirmed. Notably, neuropsychiatric reactions such as seizures, delirium, and abnormal behavior may rarely occur during treatment with this drug in children and adolescents, hence careful monitoring is required. In principle, this drug should not be used in pediatric patients aged 10 years or older except in special cases. Due to the risk of abnormal behavior during treatment with this drug, children and adolescents must be accompanied by a guardian for at least 2 days. Patients with a hypersensitivity to this drug or its ingredients should not take it. Patients with decreased kidney function or those undergoing hemodialysis require dosage adjustments, and it is not recommended for patients with end-stage renal failure. It should be administered cautiously to high-risk patients such as those with asthma, chronic bronchitis, or immunocompromised conditions. This drug can commonly cause side effects such as nausea, vomiting, headache, and is typically transient and mild. Rarely, shock, anaphylaxis, liver function abnormalities, skin rashes, acute kidney failure, and neuropsychiatric symptoms may occur, and any abnormal symptoms should immediately be discussed with a healthcare professional. Pregnant or breastfeeding women should only take this drug when the therapeutic benefits outweigh the risks, as safety data is limited. The safety and efficacy for children, especially for those under 1 year old, have not been established, hence careful use is needed. Elderly patients may have decreased physical function; therefore, careful monitoring is necessary during administration, but dosage adjustments are generally not required. Significant drug interactions are not greatly concerning; however, caution may be needed when used with specific medications, so be sure to inform about other medications being taken. This drug should be stored out of reach of children and should not be transferred to another container for safety. It is effective to start treatment as soon as possible at the onset of symptoms, and if a dose is missed, it should be taken as soon as possible, ensuring there is not too close a gap to the next dose time. No special effect on driving or operating machinery has been reported; however, influenza itself may affect physical ability, so caution is advised.

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

This medication should be stored in a tightly closed container to protect it from air and moisture, preferably in a cool place below 25 degrees Celsius. Proper storage will help maintain the drug's effectiveness for a long time.

Appearance

A light yellow hard capsule containing white or light yellow powder

Package unit

10 capsules/PTP