Shinil Oseltamivir Phosphate Capsules 75 mg

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 in 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 the powder for oral suspension. Patients with renal impairment (treatment): No dose adjustment is needed in patients with a creatinine clearance of 60 mL/min or higher. For patients with a creatinine clearance of 30 ~ 60 mL/min, reduction to 30 mg twice daily for 5 days is recommended. For patients with a creatinine clearance of 10 ~ 30 mL/min, reduction to 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 therapeutic plasma concentrations, and 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 below 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment (treatment): No dose adjustment is needed for treatment in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9). Prevention of influenza A and influenza B virus infections in adults and adolescents aged 13 years and older: For close contacts of an infected person, administer 75 mg of oseltamivir orally once daily for 10 days. Start treatment 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 protective effect continues while the medicine is being taken. Patients with renal impairment (prevention): No dose adjustment is needed in patients with a creatinine clearance of 60 mL/min or higher. For patients with a creatinine clearance of 30 ～ 60 mL/min, reduction to 30 mg once daily is recommended. For patients with a creatinine clearance of 10 ～ 30 mL/min, reduction to 30 mg every other day is recommended. Patients receiving periodic 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 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 below 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment (prevention): No dose adjustment is needed 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 medicine suspension. ≤ 15 kg: 30 mg per dose twice daily for 5 days; suspension (6mg/mL), 5.0 mL per dose twice daily 15 kg<, ≤ 23 kg: 45 mg per dose twice daily for 5 days; suspension (6mg/mL), 7.5 mL per dose twice daily 23 kg<, ≤ 40 kg: 60 mg per dose twice daily for 5 days; suspension (6mg/mL), 10.0 mL per dose twice daily > 40 kg: 75 mg per dose twice daily for 5 days; suspension (6mg/mL), 12.5 mL per dose 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. 3 kg: 9 mg per dose twice daily for 5 days; suspension (6mg/mL), 1.5 mL per dose twice daily 4 kg: 12 mg per dose twice daily for 5 days; suspension (6mg/mL), 2.0 mL per dose twice daily 5 kg: 15 mg per dose twice daily for 5 days; suspension (6mg/mL), 2.5 mL per dose twice daily 6 kg: 18 mg per dose twice daily for 5 days; suspension (6mg/mL), 3.0 mL per dose twice daily 7 kg: 21 mg per dose twice daily for 5 days; suspension (6mg/mL), 3.5 mL per dose twice daily 8 kg: 24 mg per dose twice daily for 5 days; suspension (6mg/mL), 4.0 mL per dose twice daily 9 kg: 27 mg per dose twice daily for 5 days; suspension (6mg/mL), 4.5 mL per dose twice daily 10 kg: 30 mg per dose twice daily for 5 days; suspension (6mg/mL), 5.0 mL per dose twice daily This table does not include all possible body 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 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 medicine suspension. ≤ 15 kg: 30 mg per dose once daily for 10 days; suspension (6mg/mL), 5.0 mL per dose once daily 15 kg<, ≤ 23 kg: 45 mg per dose once daily for 10 days; suspension (6mg/mL), 7.5 mL per dose once daily 23 kg<, ≤ 40 kg: 60 mg per dose once daily for 10 days; suspension (6mg/mL), 10.0 mL per dose once daily > 40 kg: 75 mg per dose once daily for 10 days; suspension (6mg/mL), 12.5 mL per dose once daily It is recommended that a pharmacist prepare this medicine 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 is used for the treatment and prevention of infections caused by the influenza virus. However, this medication cannot replace influenza vaccination and should be used separately from annual vaccinations. This medication has only been proven effective against influenza A and B viruses, and its safety and efficacy have not been confirmed for other infections. Neurological and psychiatric adverse reactions such as seizures and delirium have been reported rarely in pediatric and adolescent patients, so caution is especially required for pediatric patients over 10 years of age. If abnormal behavior appears during the course of this medication, caregivers should closely observe the patient and ensure they are not left alone. Patients with hypersensitivity to this medication or its components should not be administered this drug. Dose adjustment is necessary for patients with renal impairment or those undergoing dialysis, and it is not recommended for patients with end-stage renal failure. Caution is needed when administering to high-risk patients such as those with asthma, chronic bronchitis, or immunosuppression. The most common side effects occurring during administration are nausea, vomiting, and headache, which are mostly temporary and mild. Rarely, shock, anaphylaxis, hepatitis, Stevens-Johnson syndrome, acute renal failure, and psychiatric symptoms may occur, and if any unusual symptoms appear, treatment should be discontinued immediately, and medical advice should be sought. This medication should be kept out of reach of children and should not be transferred to other containers. Pregnant or breastfeeding women should use this medication only when the benefits outweigh the risks, as the effects on the fetus or infant are not fully understood. Safety and efficacy in children under 1 year of age have not been established, so administration should be avoided where possible. No special dose adjustments are necessary for the elderly, but careful monitoring is required if there are physical function declines or underlying diseases. This medication has a low potential for clinically significant interactions with other medications, but caution may be needed when used in combination with specific drugs. There have been no reports regarding the effect on the ability to drive or operate machinery, but influenza itself may impair these abilities, so caution is advised. It is effective to start taking it early upon the appearance of symptoms, and if a dose is missed, it should be taken as soon as possible. If the next dose is within 2 hours, the missed dose should be skipped.

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

This medication may be sensitive to air or moisture, so it should be stored in a sealed container. It is also important to store it in a cool place below 25 degrees to maintain its effectiveness.

Appearance

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

Package unit

10 capsules/ptp