Tamir Capsule 45mg (Oseltamivir Phosphate)

Adult dose

Influenza A and influenza B virus infections: Initiate treatment on the first or second day after the onset of influenza symptoms. This drug may be administered with or without food; in some patients, tolerability may improve when taken with food. Adults and adolescents aged 13 years and older: Administer 75 mg of oseltamivir orally twice daily for 5 days. Adults and adolescents aged 13 years and older who have difficulty swallowing capsules should use this drug as a powder for suspension. Patients with renal impairment: No dosage adjustment is required for patients with creatinine clearance ≥ 60 mL/min. For patients with creatinine clearance of 30 ~ 60 mL/min, reducing the dose to 30 mg twice daily for 5 days is recommended. For patients with creatinine clearance of 10 ~ 30 mL/min, reducing the dose to 30 mg once daily for 5 days is recommended. Patients receiving periodic hemodialysis should receive a 30 mg dose of this drug after each dialysis session to maintain plasma concentrations within the therapeutic range; 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 30 mg dose of this drug 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 10mL/min or less); therefore, no recommended dose is available for these patients. Patients with hepatic impairment: No dosage 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 aged 13 years and older: For those in close contact with 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 drug have been demonstrated for up to 6 weeks. The preventive effect persists while taking this drug. Patients with renal impairment: No dosage adjustment is required for patients with creatinine clearance ≥ 60 mL/min. For patients with creatinine clearance of 30 ～ 60 mL/min, reducing the dose to 30 mg once daily is recommended. For patients with creatinine clearance of 10 ～ 30 mL/min, reducing the dose to 30 mg once daily and administering it every other day is recommended. Patients receiving periodic hemodialysis should receive a 30 mg dose of this drug 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 30 mg of this drug 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 10mL/min or less); 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

Children aged 1 to 12 years, treatment: 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 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 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 weights in this patient group. For children under 1 year of age, a dose of 3mg/kg of this drug is recommended. It is recommended that a pharmacist prepare this drug suspension before it is administered to the patient. Children aged 1 to 12 years, prevention: 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 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 It is recommended that a pharmacist prepare this drug suspension 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 medication cannot replace influenza vaccination and is only for treatment and prevention of influenza. This medication is effective only against influenza A and B viruses, and its safety or efficacy for other infections has not been established. Especially in pediatric and adolescent patients, rare neuropsychiatric adverse reactions such as seizures, delirium, and abnormal behavior have been reported, so caution is needed. If abnormal behavior occurs during treatment with this medication, the guardian must immediately observe and take necessary actions. Patients with allergies to this medication or its components should not use it. Dose adjustments are necessary for patients with impaired kidney function or who are dialysis patients, and it is not recommended for patients with end-stage renal failure. Precautions should be taken when administering to high-risk patients such as those with asthma, chronic bronchitis, or immunosuppressive conditions. Common side effects during use include nausea, vomiting, headaches, etc., which are mostly temporary. Serious adverse reactions may include allergic reactions, liver function abnormalities, skin symptoms, acute renal failure, and neuropsychiatric symptoms, for which immediate consultation with healthcare professionals is necessary. Women who are pregnant or breastfeeding should carefully consider the therapeutic benefits and risks before using this medication. For children under 1 year of age, safety and efficacy have not been established, and it is generally not used in pediatric patients over 10 years due to the risk of abnormal behavior unless special circumstances arise. Elderly patients may have reduced physical function, so caution is needed during administration, but generally no specific dose adjustment is required. This medication has a low potential for drug interactions, but caution may be needed when used with certain medications. No special influence has been reported when driving vehicles or operating machinery; however, attention should be paid to potential impairment caused by the influenza itself. In case of overdose, symptoms similar to common adverse reactions may occur, and healthcare professionals should be informed immediately. When storing, keep out of reach of children, and take care not to transfer to other containers.

• 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, preferably at a cool temperature below 25 degrees Celsius. Storing it this way can help maintain the effectiveness of the medication for a long time.

Appearance

Hard gray capsules containing a white or light yellow powder.

Package unit

10 capsules (10 capsules/PTP) x 1