Tamiflu Capsule 30 mg (Oseltamivir Phosphate)

Adult dose

1. Treatment of 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 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 dose 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 receiving regular hemodialysis should receive a 30mg dose of this medicine after each dialysis session to maintain therapeutic plasma concentrations; the treatment duration 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. Patients with hepatic impairment: No dose adjustment is required for treatment in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9). Immunocompromised patients: No dose adjustment is required for treatment in immunocompromised patients; administration for 10 days is recommended. 2. Prevention of influenza A and influenza B virus infections Adults and adolescents 13 years of age and older: If 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 influenza outbreaks 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 taking this medicine. Patients with renal impairment: No dose 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 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 first dose may also be administered before the start of dialysis. 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 receiving 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 required for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

1. 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 capsules and 45mg capsules twice daily, instead of the recommended dose of this medicine as a suspension. ≤ 15 kg: 30 mg per dose twice daily; suspension (6mg/mL) 5.0 mL per dose twice daily 15 kg<, ≤ 23 kg: 45 mg per dose twice daily; suspension (6mg/mL) 7.5 mL per dose twice daily 23 kg<, ≤ 40 kg: 60 mg per dose twice daily; suspension (6mg/mL) 10.0 mL per dose twice daily > 40 kg: 75 mg per dose twice daily; suspension (6mg/mL) 12.5 mL per dose twice daily Infants 2 weeks to less than 1 year of age: The recommended dose for infants 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 per dose twice daily; suspension (6mg/mL) 1.5 mL per dose twice daily 4 kg: 12 mg per dose twice daily; suspension (6mg/mL) 2.0 mL per dose twice daily 5 kg: 15 mg per dose twice daily; suspension (6mg/mL) 2.5 mL per dose twice daily 6 kg: 18 mg per dose twice daily; suspension (6mg/mL) 3.0 mL per dose twice daily 7 kg: 21 mg per dose twice daily; suspension (6mg/mL) 3.5 mL per dose twice daily 8 kg: 24 mg per dose twice daily; suspension (6mg/mL) 4.0 mL per dose twice daily 9 kg: 27 mg per dose twice daily; suspension (6mg/mL) 4.5 mL per dose twice daily 10 kg: 30 mg per dose twice daily; suspension (6mg/mL) 5.0 mL per dose twice daily * This table does not include all possible weights in this patient group. A dose of 3mg/kg of this medicine is recommended for children less than 1 year of age. It is recommended that a pharmacist prepare the suspension of this medicine before administration to the patient. 2. 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 capsules and 45mg capsules once daily for 10 days, instead of the recommended dose of this medicine as a suspension. ≤ 15 kg: 30 mg per dose once daily; suspension (6mg/mL) 5.0 mL per dose once daily 15 kg<, ≤ 23 kg: 45 mg per dose once daily; suspension (6mg/mL) 7.5 mL per dose once daily 23 kg<, ≤ 40 kg: 60 mg per dose once daily; suspension (6mg/mL) 10.0 mL per dose once daily > 40 kg: 75 mg per dose once daily; suspension (6mg/mL) 12.5 mL per dose once daily It is recommended that a pharmacist prepare the suspension of this medicine before administration to the patient. ※ The safety and efficacy of this medicine for prevention of influenza A and B virus infections in children less than 1 year of age have not been evaluated. No dose adjustment is required for seasonal prevention in immunocompromised patients 1 year of age and older; administration for 12 weeks is recommended.

This medication is used for the treatment or prevention of influenza viruses but cannot replace influenza vaccinations. This medication is effective only against influenza A and B, and its safety and efficacy against other types of infections have not been confirmed. Special care should be taken with pediatric and adolescent patients, as abnormal behavior or neuropsychiatric symptoms may occur during treatment; caregivers should observe patients carefully after administration. It should not be used in cases of hypersensitivity to this medication or its components. Dose adjustments may be necessary for patients with reduced renal function or those on dialysis, and it is not recommended for patients with severe renal impairment. Precaution is necessary for high-risk patients such as those with asthma or chronic bronchitis. Common side effects may include nausea, vomiting, headache, and pain, most of which are temporary. Rarely, serious adverse reactions such as shock, anaphylaxis, liver dysfunction, skin rash, acute kidney failure, and neuropsychiatric symptoms may occur; in such cases, medical consultation should be sought immediately. Pregnant or nursing women should discuss the use of this medication with their physician, as its effects on the fetus or infant have not been well studied. The safety and efficacy for children under 1 year of age have not been established, and caution should be exercised in the elderly due to potential decline in physical function; however, dose adjustments are generally not necessary. This medication has a low potential for interactions with other drugs, but caution may be required when used in conjunction with certain medications, so patients should inform their physician or pharmacist of any current medications. If abnormal behaviors or neurological symptoms occur during treatment, discontinuation should be initiated, and medical consultation is recommended. This medication should be stored out of the reach of children and should not be transferred to another container for safety. It is effective to take the medication early when influenza symptoms begin; if a dose is missed, take it as soon as possible while avoiding taking it too close to the next scheduled dose.

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

This medication should be stored in a tightly sealed container to protect it from air and moisture, preferably at a cool temperature below 25 degrees Celsius. This will help retain the medication’s effectiveness and safety for a longer time.

Appearance

A hard capsule of light yellow color containing a white or off-white powder

Package unit

10 capsules (10 capsules/1 PTP package)