Unitamivir 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 medicine may be administered with or without food; tolerability may improve in some patients when taken with food. Adults and adolescents aged 13 years or older: Administer oseltamivir 75 mg orally twice daily for 5 days. Adults and adolescents aged 13 years or older who have difficulty swallowing capsules should use this medicine as a powder for suspension. Patients with renal impairment: No dose adjustment is required in 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 periodic hemodialysis should receive a 30mg dose of this medicine after each dialysis session to maintain blood concentrations within the therapeutic range, and the duration of treatment should not exceed 5 days. If influenza symptoms develop during the 48 hours between dialysis sessions, the dose may 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 dose adjustment is necessary 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 or older: For those in close contact with an infected person, administer oseltamivir 75 mg 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 the medicine is being taken. Patients with renal impairment: No dose adjustment is required in 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 once daily every other day is recommended. Patients receiving periodic 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 also be administered before the start of dialysis. For peritoneal dialysis, administration of 30mg 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 adult patients 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: Pediatric patients weighing more than 40 kg who are able to swallow capsules may take 75mg capsules twice daily or 30mg and 45mg capsules twice daily instead of the recommended dose of this medicine as a suspension. Body weight ≤ 15 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily; for 5 days. Body weight 15 kg<, ≤ 23 kg: 45 mg twice daily; suspension (6mg/mL) 7.5 mL twice daily; for 5 days. Body weight 23 kg<, ≤ 40 kg: 60 mg twice daily; suspension (6mg/mL) 10.0 mL twice daily; for 5 days. Body weight > 40 kg: 75 mg twice daily; suspension (6mg/mL) 12.5 mL twice daily; for 5 days. Infants 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. Body weight 3 kg: 9 mg twice daily; suspension (6mg/mL) 1.5 mL twice daily; for 5 days. Body weight 4 kg: 12 mg twice daily; suspension (6mg/mL) 2.0 mL twice daily; for 5 days. Body weight 5 kg: 15 mg twice daily; suspension (6mg/mL) 2.5 mL twice daily; for 5 days. Body weight 6 kg: 18 mg twice daily; suspension (6mg/mL) 3.0 mL twice daily; for 5 days. Body weight 7 kg: 21 mg twice daily; suspension (6mg/mL) 3.5 mL twice daily; for 5 days. Body weight 8 kg: 24 mg twice daily; suspension (6mg/mL) 4.0 mL twice daily; for 5 days. Body weight 9 kg: 27 mg twice daily; suspension (6mg/mL) 4.5 mL twice daily; for 5 days. Body weight 10 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily; for 5 days. * This table does not include all possible body weights in this patient group. A dose of 3mg/kg of this medicine is recommended for infants under 1 year of age. It is recommended that the pharmacist prepare this medicine as a suspension before administration to the patient. Prevention of influenza A and influenza B virus infections — Children aged 1 to 12 years: Pediatric patients weighing more than 40 kg who are able to 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 medicine as a suspension. Body weight ≤ 15 kg: 30 mg once daily; suspension (6mg/mL) 5.0 mL once daily; for 10 days. Body weight 15 kg<, ≤ 23 kg: 45 mg once daily; suspension (6mg/mL) 7.5 mL once daily; for 10 days. Body weight 23 kg<, ≤ 40 kg: 60 mg once daily; suspension (6mg/mL) 10.0 mL once daily; for 10 days. Body weight > 40 kg: 75 mg once daily; suspension (6mg/mL) 12.5 mL once daily; for 10 days. It is recommended that the pharmacist prepare this medicine as a suspension before administration to the patient. ※ The safety and efficacy of prevention of influenza A and B virus infections in infants under 1 year of age have not been evaluated.

This medication cannot replace influenza vaccination and is used for treatment and prevention purposes in areas where influenza viruses are prevalent. This medication is effective only for influenza A and B, and its safety or efficacy for other infections has not been established. Neurological and psychiatric adverse reactions, such as seizures, delirium, and abnormal behavior, have been rarely reported in children and adolescents, particularly requiring caution in children over 10 years old. Abnormal behavior may occur during treatment, so caregivers should carefully monitor children or adolescents to ensure they are not left unattended. This medication should not be administered to patients with hypersensitivity. Patients with impaired kidney function or those on dialysis may require dosage adjustments, and it is not recommended for patients with end-stage renal failure. Caution should be exercised when administering to high-risk patients with asthma, chronic bronchitis, or immune suppression. Nausea, vomiting, headache, and pain are common side effects, although they are mostly temporary and mild. Rarely, shock, anaphylaxis, hepatitis, skin symptoms, acute renal failure, leukopenia, and neuropsychiatric symptoms may occur, necessitating immediate consultation with a doctor if any abnormal signs are observed. Women who are pregnant or breastfeeding should carefully consider the therapeutic benefits and risks of using this medication. Safety and efficacy for children under 1 year old have not been established, necessitating caution in their use. Elderly patients can use it without special dosage adjustments, but monitoring is required due to potential declines in physical function. The likelihood of drug interactions is low, but caution may be needed when combined with specific medications. No effects on driving or operating machinery have been reported, but caution is warranted due to influenza symptoms itself. If abnormal behavior or neurological symptoms appear during treatment, the medication should be discontinued immediately and medical attention sought. Keep this medication out of reach of children and avoid transferring it to other containers.

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

This medication should be stored in a tightly sealed container that blocks air and moisture, and kept in a cool place below 25 degrees Celsius. Storing it this way can help maintain its effectiveness for a longer time.

Appearance

Hard capsule with a pale gray upper and lower part containing white or light yellow powder

Package unit

10 capsules (10 capsules/PTP x 1)