Tamiflu Capsule 75mg (Oseltamivir Phosphate)

Adult dose

Treatment of 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 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 oral suspension. Patients with renal impairment (treatment): No dosage adjustment is necessary 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 therapeutic plasma concentrations; the treatment period 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 dosage is available for these patients. Patients with hepatic impairment (treatment): No dosage adjustment is necessary 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 dosage 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 dosage adjustment is necessary 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 therapeutic plasma concentrations. The initial 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 less than 10mL/min); therefore, no recommended dosage is available for these patients. Patients with hepatic impairment (prevention): No dosage adjustment is necessary 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 are able to 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 an oral suspension. Body weight ≤ 15 kg: 30 mg twice daily; oral suspension (6mg/mL) 5.0 mL twice daily. Body weight 15 kg<, ≤ 23 kg: 45 mg twice daily; oral suspension (6mg/mL) 7.5 mL twice daily. Body weight 23 kg<, ≤ 40 kg: 60 mg twice daily; oral suspension (6mg/mL) 10.0 mL twice daily. Body weight > 40 kg: 75 mg twice daily; oral 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 infants with a postconceptional age of less than 36 weeks. Body weight 3 kg: 9 mg twice daily; oral suspension (6mg/mL) 1.5 mL twice daily. Body weight 4 kg: 12 mg twice daily; oral suspension (6mg/mL) 2.0 mL twice daily. Body weight 5 kg: 15 mg twice daily; oral suspension (6mg/mL) 2.5 mL twice daily. Body weight 6 kg: 18 mg twice daily; oral suspension (6mg/mL) 3.0 mL twice daily. Body weight 7 kg: 21 mg twice daily; oral suspension (6mg/mL) 3.5 mL twice daily. Body weight 8 kg: 24 mg twice daily; oral suspension (6mg/mL) 4.0 mL twice daily. Body weight 9 kg: 27 mg twice daily; oral suspension (6mg/mL) 4.5 mL twice daily. Body weight 10 kg: 30 mg twice daily; oral 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. 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 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 an oral suspension. Body weight ≤ 15 kg: 30 mg once daily; oral suspension (6mg/mL) 5.0 mL once daily. Body weight 15 kg<, ≤ 23 kg: 45 mg once daily; oral suspension (6mg/mL) 7.5 mL once daily. Body weight 23 kg<, ≤ 40 kg: 60 mg once daily; oral suspension (6mg/mL) 10.0 mL once daily. Body weight > 40 kg: 75 mg once daily; oral suspension (6mg/mL) 12.5 mL once daily. 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 be used separately from vaccination. It is only effective against influenza A and B viruses, and its safety and efficacy have not been established for other infections. Particularly in children and adolescents, abnormal behavior or neurological and psychiatric adverse reactions may occur after taking this medication, so caregivers should closely monitor their condition. Generally, children over 10 years of age should not use this medication except in special cases. Patients with hypersensitivity to this drug or specific renal function impairments should avoid or adjust the dosage of this medication. Side effects such as nausea, vomiting, headache, etc., may commonly occur, but they are mostly temporary and mild. Rarely, shock, liver dysfunction, skin reactions, and neurological symptoms may occur, so immediate consultation with medical personnel is required if abnormal symptoms appear. Women who are pregnant or breastfeeding must carefully consider the risks and benefits of taking this medication and consult with healthcare professionals. Elderly patients or those with chronic conditions require caution during administration due to decreased bodily functions. Although the likelihood of drug interactions is low with this medication, caution may be required when used in combination with specific drugs. If abnormal behavior or serious side effects are suspected during use, it is necessary to stop taking the medication immediately and visit a medical institution. Keep this medication out of reach of children and adhere to the prescribed dosage and administration.

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

This medication should be stored in a sealed container to protect it from air and moisture. Moreover, it is crucial to store it in a cool place at temperatures below 25 degrees Celsius to maintain its effectiveness.

Appearance

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

Package unit

10 capsules/PTP