Tamiflu Capsule 75mg (Oseltamivir Phosphate)

Adult dose

Influenza A and influenza B virus infections: Start treatment on the first or second day after the onset of influenza symptoms. This medicine may be administered regardless of food intake, and tolerability may improve in some patients when it is taken with food. 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 an oral suspension. Patients with renal impairment: 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 30mg dose of this medicine after each dialysis session to maintain plasma concentrations within the therapeutic range; 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 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 below 10mL/min); therefore, no recommended dose is available for these patients. 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 those in close contact with 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 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 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 the start of dialysis. For peritoneal dialysis, administration of 30mg of this medicine 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 below 10mL/min); therefore, no recommended dose is available for these patients. No dose adjustment is required for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

Children aged 1 year to 12 years: Pediatric patients weighing more than 40 kg who can swallow capsules may take a 75 mg capsule twice daily or a 30 mg capsule and a 45 mg capsule twice daily instead of the recommended dose of this drug 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 Children 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 drug orally twice daily for 5 days. This does not apply to infants with a postmenstrual 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. The recommended dose for children under 1 year of age is 3mg/kg of this drug. 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 75 mg capsule once daily or a 30 mg capsule and a 45 mg capsule once daily for 10 days instead of the recommended dose of this drug 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 ※ The safety and efficacy of this drug for the prevention of influenza A and B virus infections in children under 1 year of age have not been evaluated.

This medication is used to treat or prevent influenza virus infections, but it cannot replace influenza vaccinations. This medication is only effective against influenza A and B viruses, and its safety and efficacy have not been established for other viral infections. Neuropsychiatric adverse reactions such as seizures, delirium, and abnormal behavior have been rarely reported in children and adolescents, so guardians should carefully monitor for unusual behaviors during treatment. Particularly, children over 10 years of age are at risk for incidents related to abnormal behavior, so it is recommended not to use it unless circumstances demand it. This medication should not be administered to patients with known allergies to it or its components. Patients with impaired renal function, especially those with moderate to severe renal insufficiency or on dialysis, require dosage adjustments, and it is not recommended for patients with end-stage renal failure. Use with caution in high-risk patients with respiratory diseases such as asthma or chronic bronchitis or in immunocompromised states. Common side effects during consumption may include nausea, vomiting, headache, and pain, most of which are temporary. Rarely, allergic reactions, liver function abnormalities, skin rashes, acute renal failure, and neuropsychiatric symptoms can occur, so if any unusual symptoms appear, consult a healthcare professional immediately. This medication is only used in pregnant or nursing women when the benefit is deemed greater than the risk, as the safety for the fetus or newborn has not been adequately established. The efficacy and safety have not been established for infants under 1 year of age, so caution is needed when using it. Elderly patients generally do not require dose adjustments, but monitoring is needed as they may have declining physical function and underlying diseases. Reported side effects from overdose are similar to common side effects, and while there isn't a specific treatment, appropriate care should be taken based on symptoms. The potential for interaction with other drugs is low, but caution may be needed when used with certain medications, so inform your healthcare provider of any medications you are taking. There have been no reported effects on driving or operating machinery, but flu symptoms themselves can affect these abilities, so caution is advised. Keep out of reach of children, and do not transfer to other containers for safety.

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

This medication should be stored in a tightly closed container to protect it from air and moisture, ideally at a cool temperature below 25 degrees Celsius. Storing it this way will help maintain the drug's effectiveness over time.

Appearance

Hard capsule with a light gray upper part and a gray lower part containing a white or light yellow powder.

Package unit

10 capsules/PTP