Oseltamivir Capsule 30 mg (Oseltamivir Phosphate)

Adult dose

Start treatment 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. Treatment of influenza A and influenza B virus infections, 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 medicine as an oral suspension. Treatment in patients with renal impairment: No dose adjustment is required for patients with a creatinine clearance of 60 mL/min or higher. 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 therapeutic plasma concentrations; treatment should not exceed 5 days. If influenza symptoms develop during the 48-hour period 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. Treatment in patients with hepatic impairment: No dose adjustment is required 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 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. Start 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 taking this medicine. Prevention in patients with renal impairment: No dose adjustment is required for patients with a creatinine clearance of 60 mL/min or higher. 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 therapeutic plasma concentrations. The first 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. Prevention in patients with hepatic impairment: No dose adjustment is required for prevention in adults with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

Treatment of influenza A and influenza B virus infections, children aged 1 to 12 years, weighing more than 40 kg and able to swallow capsules: Instead of the recommended dose of this medicine as a suspension, 75mg capsules may be taken twice daily, or 30mg and 45mg capsules may be taken twice daily. Weight ≤ 15 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily Weight 15 kg<, ≤ 23 kg: 45 mg twice daily; suspension (6mg/mL) 7.5 mL twice daily Weight 23 kg<, ≤ 40 kg: 60 mg twice daily; suspension (6mg/mL) 10.0 mL twice daily Weight > 40 kg: 75 mg twice daily; suspension (6mg/mL) 12.5 mL twice daily Children aged 2 weeks to under 1 year: The recommended dose for pediatric patients aged 2 weeks to 12 months 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. Weight 3 kg: 9 mg twice daily; suspension (6mg/mL) 1.5 mL twice daily Weight 4 kg: 12 mg twice daily; suspension (6mg/mL) 2.0 mL twice daily Weight 5 kg: 15 mg twice daily; suspension (6mg/mL) 2.5 mL twice daily Weight 6 kg: 18 mg twice daily; suspension (6mg/mL) 3.0 mL twice daily Weight 7 kg: 21 mg twice daily; suspension (6mg/mL) 3.5 mL twice daily Weight 8 kg: 24 mg twice daily; suspension (6mg/mL) 4.0 mL twice daily Weight 9 kg: 27 mg twice daily; suspension (6mg/mL) 4.5 mL twice daily Weight 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. A dose of 3mg/kg of this medicine is recommended for children under 1 year of age. It is recommended that a pharmacist prepare this medicine as a suspension before it is administered to the patient. Prevention of influenza A and influenza B virus infections, children aged 1 to 12 years, weighing more than 40 kg and able to swallow capsules: Instead of the recommended dose of this medicine as a suspension, 75mg capsules may be taken once daily, or 30mg and 45mg capsules may be taken once daily for 10 days. Weight ≤ 15 kg: 30 mg once daily; suspension (6mg/mL) 5.0 mL once daily Weight 15 kg<, ≤ 23 kg: 45 mg once daily; suspension (6mg/mL) 7.5 mL once daily Weight 23 kg<, ≤ 40 kg: 60 mg once daily; suspension (6mg/mL) 10.0 mL once daily Weight > 40 kg: 75 mg once daily; suspension (6mg/mL) 12.5 mL once daily It is recommended that a pharmacist prepare this medicine as a 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 the influenza vaccine and should be used separately from influenza vaccination. This medication is effective only against influenza A and B viruses, and its safety or efficacy has not been confirmed for other infections. In pediatric and adolescent patients, there have been rare reports of neuropsychiatric adverse reactions, such as seizures or delirium, necessitating careful monitoring for abnormal behavior. Especially in pediatric patients over 10 years old, there is a risk of accidents due to abnormal behavior, so its use is not recommended except for high-risk patients. During the course of taking this medication, caregivers should ensure that children and adolescents are not alone in order to reduce the risk of abnormal behavior. It should not be administered to patients with hypersensitivity to this medication or its components. In patients with renal failure or undergoing hemodialysis, dose adjustment is necessary, and it is not recommended for patients with end-stage renal failure. It should be administered with caution to high-risk patients such as those with asthma, chronic bronchitis, or immunocompromised states. Common side effects include nausea, vomiting, and headache, which are usually transient and mild. Rarely, shock, anaphylaxis, liver function abnormalities, skin rashes, acute renal failure, and neurological symptoms may occur, so immediate consultation with medical personnel is required if symptoms arise. This medication should be kept out of reach of children and it is advisable not to transfer it to another container. Women who are pregnant or breastfeeding should carefully consider the benefits and risks of this medication and must consult with medical personnel. Safety and efficacy in children under 1 year of age have not been established, so caution is necessary. In elderly patients whose physical function may have declined, careful monitoring by medical personnel is required during administration. In case of overdose, symptoms similar to common side effects may appear, and immediate medical attention is necessary. This medication has a low potential for interactions with other drugs, but caution may be needed when used in combination with certain medications, so inform medical personnel of any medications being taken.

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

This medication should be stored in a tightly closed container to prevent air or moisture exposure, and it should be kept in a cool place at a temperature below 25 degrees Celsius. This will help maintain the medication’s efficacy for a longer time.

Appearance

Hard capsule of yellow-colored upper and lower parts containing white or yellowish powder

Package unit

10 capsules / PTPT