Tamiflu M Capsule 45 mg (Oseltamivir Phosphate)

Adult dose

1. Influenza A and influenza B virus infections: Treatment should be initiated on the first or second day after the onset of influenza symptoms. This medicine may be taken with or without food; in some patients, taking it with food may improve tolerability. Adults and adolescents aged 13 years and older: The recommended dose is 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 medicine as an oral suspension. Patients with renal impairment: No dosage adjustment is required for patients with a creatinine clearance of 60 mL/min or greater. For patients with a creatinine clearance of 30 ～ 60 mL/min, a reduced dose of 30 mg twice daily for 5 days is recommended. For patients with a 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 blood 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 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 dosage adjustment is required for treatment in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9). 2. 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. Initiate 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 dosage adjustment is required for patients with a creatinine clearance of 60 mL/min or greater. For patients with a creatinine clearance of 30 ～ 60 mL/min, a reduced dose of 30 mg once daily is recommended. For patients with a 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 blood concentrations within the therapeutic range. The initial dose may 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 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: Pediatric patients weighing > 40 kg who are able to swallow capsules may take 75 mg capsules 2 times daily or 30 mg capsules and 45 mg capsules 2 times daily instead of the recommended dose of this drug suspension. ≤ 15 kg: 30 mg 2 times daily; suspension (6mg/ml) 5.0 mL 2 times daily 15 kg<, ≤ 23 kg: 45 mg 2 times daily; suspension (6mg/ml) 7.5 mL 2 times daily 23 kg<, ≤ 40 kg: 60 mg 2 times daily; suspension (6mg/ml) 10.0 mL 2 times daily > 40 kg: 75 mg 2 times daily; suspension (6mg/ml) 12.5 mL 2 times 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 2 times daily for 5 days. This does not apply to infants with a postconceptional age of less than 36 weeks. 3 kg: 9 mg 2 times daily; suspension (6mg/mL) 1.5 mL 2 times daily 4 kg: 12 mg 2 times daily; suspension (6mg/mL) 2.0 mL 2 times daily 5 kg: 15 mg 2 times daily; suspension (6mg/mL) 2.5 mL 2 times daily 6 kg: 18 mg 2 times daily; suspension (6mg/mL) 3.0 mL 2 times daily 7 kg: 21 mg 2 times daily; suspension (6mg/mL) 3.5 mL 2 times daily 8 kg: 24 mg 2 times daily; suspension (6mg/mL) 4.0 mL 2 times daily 9 kg: 27 mg 2 times daily; suspension (6mg/mL) 4.5 mL 2 times daily 10 kg: 30 mg 2 times daily; suspension (6mg/mL) 5.0 mL 2 times daily * This table does not include all possible weights in this patient group. A dose of 3mg/kg of this drug is recommended for children younger than 1 year. It is recommended that a pharmacist prepare this drug suspension before administration to the patient. Children aged 1 to 12 years: Pediatric patients weighing > 40 kg who are able to swallow capsules may take 75 mg capsules once daily or 30 mg capsules and 45 mg 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 administration to the patient. * The safety and efficacy of preventing influenza A and B virus infections in children younger than 1 year have not been evaluated.

This medication cannot replace influenza vaccinations and is used as a distinct treatment. This drug has only been confirmed to be effective against influenza A and B, and safety and efficacy have not yet been established for children under 1 year old. Neuropsychiatric adverse reactions, such as seizures or delirium, have been reported in children and adolescents, so particular caution is needed if abnormal behaviors occur in children older than 10 years. Caregivers must ensure that children or adolescents do not remain alone during treatment, and should immediately consult a healthcare professional if abnormal behaviors occur. Patients who are allergic to this drug or its components should not take it. Dose adjustment is necessary for patients with impaired renal function or those undergoing dialysis, and it is not recommended for patients with end-stage renal failure. Caution should be exercised when administering to high-risk patients with asthma or chronic bronchitis or immune-compromised conditions. The most common side effects include nausea, vomiting, and headache, which are mostly temporary and mild symptoms. Rarely, serious side effects such as skin rash, liver dysfunction, neurological symptoms, or hemorrhagic colitis may occur; immediate medical attention should be sought if abnormal symptoms appear. This medication is most effective when taken as soon as influenza symptoms begin, and the dosage instructions must be strictly adhered to. It does not have a special influence when driving or operating machinery, but caution is needed due to symptoms resulting from influenza itself. This drug has a low potential for drug interactions, but caution is necessary when used in combination with certain medicines that affect renal excretion. Pregnant or breastfeeding women should carefully consider the therapeutic benefits and risks of using this medication. Elderly patients can use it without special dose adjustments, but must be observed closely considering their overall health condition. Generally, serious side effects have not been reported in case of overdose, but immediate consultation with a healthcare professional is recommended if adverse reactions occur. Keep out of reach of children, and it is advisable not to transfer it to another container.

• Nausea
• vomiting
• headache
• pain
• unstable angina
• anemia
• membranous colitis
• pneumonia
• peritonsillar abscess
• humeral fracture

Store this medication in a tightly closed container to prevent exposure to air or moisture. Additionally, it is best to keep the medication at a cool temperature below 25 degrees Celsius. Proper storage helps maintain the effectiveness of the medicine for a longer duration.

Appearance

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

Package unit

10 capsules (10 capsules/PTP×1)