Oseltamivir Phosphate 30 mg Capsules

Adult dose

1. Influenza A and influenza B virus infections: Start treatment on the first or second day after the onset of influenza symptoms. This medicine may be administered with or without food; taking it with food may improve tolerability in some patients. Adults and adolescents 13 years of age and older: Administer 75 mg of oseltamivir orally twice daily for 5 days. Adults and adolescents 13 years of age and older who have difficulty swallowing capsules should use this medicine as an oral suspension prepared from the powder. Patients with renal impairment: No dose adjustment is required for 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 regular hemodialysis should receive a 30mg dose of this medicine after each dialysis session to maintain plasma concentrations within the therapeutic range, and the treatment duration 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: No dose 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 13 years of age and older: For close contacts of 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. Patients with renal impairment: No dose adjustment is required for 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 every other day is recommended. Patients receiving regular hemodialysis should receive a 30mg dose of this medicine after every 2 dialysis sessions to maintain plasma 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 below 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment: No dose adjustment is required for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

1. Influenza A and influenza B virus infections Children 1 to 12 years of age: Pediatric patients weighing more than 40 kg who can swallow capsules may take a 75mg capsule twice daily or one 30mg capsule and one 45mg capsule twice daily instead of the recommended dose of this medicine oral suspension. ≤ 15 kg: 30 mg per dose twice daily; 5.0 mL of suspension (6mg/mL) per dose twice daily 15 kg<, ≤ 23 kg: 45 mg per dose twice daily; 7.5 mL of suspension (6mg/mL) per dose twice daily 23 kg<, ≤ 40 kg: 60 mg per dose twice daily; 10.0 mL of suspension (6mg/mL) per dose twice daily > 40 kg: 75 mg per dose twice daily; 12.5 mL of suspension (6mg/mL) per dose twice daily Infants 2 weeks to less than 1 year: The recommended dose for pediatric patients 2 weeks to 12 months of age 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; 1.5 mL of suspension (6mg/mL) per dose twice daily 4 kg: 12 mg per dose twice daily; 2.0 mL of suspension (6mg/mL) per dose twice daily 5 kg: 15 mg per dose twice daily; 2.5 mL of suspension (6mg/mL) per dose twice daily 6 kg: 18 mg per dose twice daily; 3.0 mL of suspension (6mg/mL) per dose twice daily 7 kg: 21 mg per dose twice daily; 3.5 mL of suspension (6mg/mL) per dose twice daily 8 kg: 24 mg per dose twice daily; 4.0 mL of suspension (6mg/mL) per dose twice daily 9 kg: 27 mg per dose twice daily; 4.5 mL of suspension (6mg/mL) per dose twice daily 10 kg: 30 mg per dose twice daily; 5.0 mL of suspension (6mg/mL) per dose 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 younger than 1 year. It is recommended that a pharmacist prepare the suspension of this medicine before it is administered to the patient. 2. Prevention of influenza A and influenza B virus infections Children 1 to 12 years of age: Pediatric patients weighing more than 40 kg who can swallow capsules may take a 75mg capsule once daily or one 30mg capsule and one 45mg capsule once daily for 10 days instead of the recommended dose of this medicine oral suspension. ≤ 15 kg: 30 mg per dose once daily; 5.0 mL of suspension (6mg/mL) per dose once daily 15 kg<, ≤ 23 kg: 45 mg per dose once daily; 7.5 mL of suspension (6mg/mL) per dose once daily 23 kg<, ≤ 40 kg: 60 mg per dose once daily; 10.0 mL of suspension (6mg/mL) per dose once daily > 40 kg: 75 mg per dose once daily; 12.5 mL of suspension (6mg/mL) per dose once daily It is recommended that a pharmacist prepare the suspension of this medicine before it is administered to the patient. ※ The safety and efficacy of prevention of influenza A and B virus infections in children younger than 1 year have not been evaluated.

This medication cannot replace influenza vaccination and should be used separately from it. This medication has proven efficacy only against Influenza A and B viruses; safety and efficacy for other infections have not been verified. Particular caution is necessary as neurological and psychiatric adverse reactions such as seizures or abnormal behavior may occur in children and adolescents after taking this medication. During administration, it is important for caregivers to monitor for any unusual behaviors and not leave the child unattended. This medication should not be used if there is an allergy to the drug or its components. Patients with reduced kidney function or those on dialysis require dosage adjustment, and it is not recommended for patients with end-stage renal failure. High-risk patients with asthma or chronic bronchitis or immunocompromised states should use this medication with caution. Common side effects such as nausea, vomiting, headache may occur but are generally temporary. Rarely, severe adverse effects such as shock, hepatitis, skin rashes, acute renal failure, and neurological disorders may occur; consult a healthcare provider immediately if symptoms appear. Use of this medication during pregnancy or breastfeeding should be considered only when its therapeutic benefits outweigh the risks, and consultation with a healthcare professional is advised. Safety and efficacy in children under 1 year of age have not been established, so usage is not recommended. Elderly patients do not require dosage adjustments; however, careful monitoring is necessary considering physical function deterioration and underlying conditions. Serious side effects are rare in cases of overdose, but if unusual symptoms occur, it is imperative to visit a medical facility immediately. This medication has low potential for interactions with other drugs; however, caution is advised when used in conjunction with specific medications, so inform your healthcare provider about any concurrent medications. There have been no reports of effects on driving or operating machinery; however, impairment due to influenza symptoms should be taken into caution. Store this medication out of children's reach and do not transfer to other containers.

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

Store this medication in a tightly sealed container to prevent exposure to air or moisture and keep it in a cool place under 25 degrees Celsius to maintain efficacy.

Appearance

Hard capsules with a light yellow upper and lower part containing a white or light yellow powder

Package unit

10 capsules (10 capsules/PTP x 1)