Tamirex Capsule 45mg (Oseltamivir Phosphate)

Adult dose

Influenza A and influenza B virus infections: Begin treatment on the first or second day after the onset of influenza symptoms. This medicine may be administered regardless of food intake; tolerability may improve in some patients when taken with food. Adults and adolescents 13 years of age and older: Administer 75 mg of oseltamivir 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: No dose adjustment is necessary for patients with creatinine clearance of 60 mL/min or more. 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 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 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 necessary for treatment in adults 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 75 mg of oseltamivir orally once daily for 10 days. Begin administration within 2 days of contact with the infected person. The recommended dose for prevention during an influenza epidemic 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 for patients with creatinine clearance of 60 mL/min or more. 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 initial 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 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 necessary for prevention in adults with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

Children aged 1 to 12 years: Pediatric patients weighing more than 40 kg who can swallow capsules may take 75 mg capsules twice daily or 30 mg and 45 mg capsules twice daily instead of the recommended dose of this product 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 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 product 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 Children aged 1 to 12 years: Pediatric patients weighing more than 40 kg who can swallow capsules may take 75 mg capsules once daily or 30 mg and 45 mg capsules once daily for 10 days instead of the recommended dose of this product 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 The safety and efficacy of this product for the prevention of influenza A and B virus infections in children under 1 year of age have not been evaluated.

This medicine cannot replace influenza vaccination and should only be used in areas where the influenza virus is prevalent. This medication has only been proven effective against influenza A and B and its safety and efficacy have not been confirmed for other infections. Especially in children and adolescents, psychiatric side effects have been reported during use of this medicine; hence caregivers should carefully observe for unusual behaviors. It is generally advised not to use it in pediatric patients over 10 years of age except in special cases. Patients with allergies to this medicine or its components should not take it. Patients with reduced kidney function may need to adjust the dosage, and it is not recommended for patients with end-stage renal failure. Great caution should be exercised in administering to high-risk groups, such as patients with asthma or chronic bronchitis. Common side effects include nausea, vomiting, and headache, which are usually temporary. Rarely, skin rashes, liver dysfunction, and psychiatric symptoms may occur, so any unusual symptoms should be reported to a medical professional immediately. During pregnancy or breastfeeding, the benefits and risks should be carefully considered before administration. Its safety and efficacy in children under 1 year old have not been established, thus, it is advisable not to use it. Generally, elderly patients do not require dosage adjustment; however, they should be carefully monitored considering reduced body functions. There is no specific antidote for overdose, so it is essential to visit a medical facility to receive appropriate treatment immediately. This medicine does not have significant interactions with other drugs, but caution may be needed when used with certain medications, so inform your healthcare provider about any concurrent medications. There have been no reports on the impact on driving or operating machinery, but caution is needed due to symptoms caused by influenza itself. Keep out of reach of children and do not transfer to another container.

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

This medicine 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 helps to maintain the effectiveness of the medicine for a longer period.

Appearance

A light gray hard capsule filled with a white or light yellow powder.

Package unit

10 capsules/PTP