VEPORINON TAB 10mg
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▶ Manufacturer: Ilhwa Co., Ltd.
▶Sold by: Ilhwa Co., Ltd.
▶Insurance code : 640902350
▶Storage : Airtight container, store at under 25℃
| + Appearance Hard capsule with light yellow top cap and grey bottom cap containing white or light yellow powder + Active ingredient(s) oseltamivir 75mg |
| + Administration and dose 1. Influenza A and influenza B virus infections: Begin therapy on the first or second day influenza symptoms have presented. This drug may be administered regardless of meals, and tolerance may be improved if taken with food in some patients. 1) Adults and youth 13 years or older: Orally administer 75mg oseltamivir twice a day for 5 days. For adults and youth 13 years or older with difficulty swallowing, administer using the powder for suspensions of this drug. 2) Infants and children from 1 to 12 years old: Children over 40kg and able to swallow capsules may be administered a 75mg capsules twice a day, or a 30mg capsule and 45mg capsule twice a day instead of the recommended dose of the suspension of this drug. Administer according to the following chart. Weight Recommended dose over 5 days Dose for suspension (6mg/mL) (as ostelamivir) ≤15kg: 30mg twice a day 5.0mL twice a day 15kg< and ≤23kg 45mg twice a day 7.5mL twice a day 23kg< and ≤40kg 60mg twice a day 10.0mL twice a day 40< 75mg twice a day 12.5mL twice a day 3) Infants from 2 weeks to 1 year old: Recommended dose for infants aged 2 weeks to 12 months is 3mg/kg of this drug per kg administered orally for 5 days. Do not use for infants whose postconceptional age is less than 36 weeks. Administer according to the following chart*. |
| Weight Recommended dose over 5 days Dose for suspension (6mg/mL) (as ostelamivir) 3kg 9mg twice a day 1.5mL twice a day 4kg 12mg twice a day 2.0mL twice a day 5kg 15mg twice a day 2.5mL twice a day 6kg 18mg twice a day 3.0mL twice a day 7kg 21mg twice a day 3.5mL twice a day 8kg 24mg twice a day 4.0mL twice a day 9kg 27mg twice a day 4.5mL twice a day 10kg 30mg twice a day 5.0mL twice a day *This chart does not include all possible body weights for this patient group. Administration of 3mg/kg of this drug is recommended for infants under 1 year of age. Formulation of a suspension of this drug by a pharmacist is recommended before administering to patients. 4) Patients with renal impairment Dose adjustment not necessary for patients whose creatinine clearance rate is 60mL/min or higher. For patients with creatinine clearance rates of 30 to 50mL/min, administration of a reduced dose of 30mg twice a day for 5 days is recommended. For patients with creatinine clearance rates of 10 to 30mL/min, administration of a reduced dose of 30mg once a day for 5 days is recommended. Patients who regularly undergo blood dialysis must be administered 30mg of this drug after every dialysis session to maintain effective blood concentrations, and duration of administration must not exceed 5 days. If influenza symptoms present between the 48 hours between dialysis sessions, administration prior to dialysis is possible. In the case of peritoneal dialysis, single administration of 30mg of this drug after dialysis is recommended. Pharmacokinetics of oseltamivir for terminal renal failure patients (e.g. creatinine clearance less than 10mL/min) not on dialysis have not been studied, and therefore no recommended dose is provided for such patients. 5) Patients with liver impairment No need for dose adjustment when treating adult patients with mild to moderately severe liver impairment (Child-Pugh score≤9). 2. Prevention of influenza A and influenza B virus infection 1) Adults and children 13 years or older: Administer 75mg oseltamivir once a day orally for 10 days if in close contact with an infected person. Begin administration within 2 days of contact with an infected person. Recommended dose for prevention during influenza outbreaks is 75mg once a day. Safety and efficacy of this drug is established up to 6 weeks. Preventive effect is sustained while this drug is administered. 2) Infants and children from 1 to 12 years old: Children over 40kg and able to swallow capsules may be administered a 75mg capsules twice a day, or a 30mg capsule and 45mg capsule twice a day instead of the recommended dose of the suspension of this drug. |
| Administer according to the following chart. Weight Recommended dose over 5 days Dose for suspension (6mg/mL) (as ostelamivir) ≤15kg: 30mg once a day 5.0mL once a day 15kg< and ≤23kg 45mg once a day 7.5mL once a day 23kg< and ≤40kg 60mg once a day 10.0mL once a day 40< 75mg once a day 12.5mL once a day Formulation of a suspension of this drug by a pharmacist is recommended before administering to patients. ※ Safety and efficacy of this drug in infants less than 1 year old in preventing influenza A and influenza B infections has not been evaluated. 3) Patients with renal impairment Dose adjustment not necessary for patients whose creatinine clearance rate is 60mL/min or higher. For patients with creatinine clearance rates of 30 to 50mL/min, administration of a reduced dose of 30mg twice a day for 5 days is recommended. For patients with creatinine clearance rates of 10 to 30mL/min, administration of a reduced dose of 30mg once a day for 5 days is recommended. Patients who regularly undergo blood dialysis must be administered 30mg of this drug after every dialysis session to maintain effective blood concentrations, and duration of administration must not exceed 5 days. If influenza symptoms present between the 48 hours between dialysis sessions, administration prior to dialysis is possible. In the case of peritoneal dialysis, single administration of 30mg of this drug after dialysis is recommended. Pharmacokinetics of oseltamivir for terminal renal failure patients (e.g. creatinine clearance less than 10mL/min) not on dialysis have not been studied, and therefore no recommended dose is provided for such patients. 4) Patients with liver impairment No need for dose adjustment when treating adult patients with mild to moderately severe liver impairment (Child-Pugh score≤9). + Indications 1. Influenza A and influenza B infection in children including neonates at least 2 weeks old (Do not use for infants whose postconceptional age is less than 36 weeks) and adults (administration must begin within 48 hours of presentation of early symptoms of influenza infection) 2. Prevention of influenza A and influenza B virus infections in patients aged 1 or older (Primary therapy for prevention of influenza virus infection is vaccine therapy; use this drug only when the vaccine does not contain the circulating strain, or in cases when the vaccine cannot be expected to be effective or when unable to receive vaccination; this drug is not a substitute for vaccination.) |
| + Appearance Hard capsule with light yellow top cap and grey bottom cap containing white or light yellow powder + Active ingredient(s) oseltamivir 75mg |
| + Administration and dose 1. Influenza A and influenza B virus infections: Begin therapy on the first or second day influenza symptoms have presented. This drug may be administered regardless of meals, and tolerance may be improved if taken with food in some patients. 1) Adults and youth 13 years or older: Orally administer 75mg oseltamivir twice a day for 5 days. For adults and youth 13 years or older with difficulty swallowing, administer using the powder for suspensions of this drug. 2) Infants and children from 1 to 12 years old: Children over 40kg and able to swallow capsules may be administered a 75mg capsules twice a day, or a 30mg capsule and 45mg capsule twice a day instead of the recommended dose of the suspension of this drug. Administer according to the following chart. Weight Recommended dose over 5 days Dose for suspension (6mg/mL) (as ostelamivir) ≤15kg: 30mg twice a day 5.0mL twice a day 15kg< and ≤23kg 45mg twice a day 7.5mL twice a day 23kg< and ≤40kg 60mg twice a day 10.0mL twice a day 40< 75mg twice a day 12.5mL twice a day 3) Infants from 2 weeks to 1 year old: Recommended dose for infants aged 2 weeks to 12 months is 3mg/kg of this drug per kg administered orally for 5 days. Do not use for infants whose postconceptional age is less than 36 weeks. Administer according to the following chart*. |
| Weight Recommended dose over 5 days Dose for suspension (6mg/mL) (as ostelamivir) 3kg 9mg twice a day 1.5mL twice a day 4kg 12mg twice a day 2.0mL twice a day 5kg 15mg twice a day 2.5mL twice a day 6kg 18mg twice a day 3.0mL twice a day 7kg 21mg twice a day 3.5mL twice a day 8kg 24mg twice a day 4.0mL twice a day 9kg 27mg twice a day 4.5mL twice a day 10kg 30mg twice a day 5.0mL twice a day *This chart does not include all possible body weights for this patient group. Administration of 3mg/kg of this drug is recommended for infants under 1 year of age. Formulation of a suspension of this drug by a pharmacist is recommended before administering to patients. 4) Patients with renal impairment Dose adjustment not necessary for patients whose creatinine clearance rate is 60mL/min or higher. For patients with creatinine clearance rates of 30 to 50mL/min, administration of a reduced dose of 30mg twice a day for 5 days is recommended. For patients with creatinine clearance rates of 10 to 30mL/min, administration of a reduced dose of 30mg once a day for 5 days is recommended. Patients who regularly undergo blood dialysis must be administered 30mg of this drug after every dialysis session to maintain effective blood concentrations, and duration of administration must not exceed 5 days. If influenza symptoms present between the 48 hours between dialysis sessions, administration prior to dialysis is possible. In the case of peritoneal dialysis, single administration of 30mg of this drug after dialysis is recommended. Pharmacokinetics of oseltamivir for terminal renal failure patients (e.g. creatinine clearance less than 10mL/min) not on dialysis have not been studied, and therefore no recommended dose is provided for such patients. 5) Patients with liver impairment No need for dose adjustment when treating adult patients with mild to moderately severe liver impairment (Child-Pugh score≤9). 2. Prevention of influenza A and influenza B virus infection 1) Adults and children 13 years or older: Administer 75mg oseltamivir once a day orally for 10 days if in close contact with an infected person. Begin administration within 2 days of contact with an infected person. Recommended dose for prevention during influenza outbreaks is 75mg once a day. Safety and efficacy of this drug is established up to 6 weeks. Preventive effect is sustained while this drug is administered. 2) Infants and children from 1 to 12 years old: Children over 40kg and able to swallow capsules may be administered a 75mg capsules twice a day, or a 30mg capsule and 45mg capsule twice a day instead of the recommended dose of the suspension of this drug. |
| Administer according to the following chart. Weight Recommended dose over 5 days Dose for suspension (6mg/mL) (as ostelamivir) ≤15kg: 30mg once a day 5.0mL once a day 15kg< and ≤23kg 45mg once a day 7.5mL once a day 23kg< and ≤40kg 60mg once a day 10.0mL once a day 40< 75mg once a day 12.5mL once a day Formulation of a suspension of this drug by a pharmacist is recommended before administering to patients. ※ Safety and efficacy of this drug in infants less than 1 year old in preventing influenza A and influenza B infections has not been evaluated. 3) Patients with renal impairment Dose adjustment not necessary for patients whose creatinine clearance rate is 60mL/min or higher. For patients with creatinine clearance rates of 30 to 50mL/min, administration of a reduced dose of 30mg twice a day for 5 days is recommended. For patients with creatinine clearance rates of 10 to 30mL/min, administration of a reduced dose of 30mg once a day for 5 days is recommended. Patients who regularly undergo blood dialysis must be administered 30mg of this drug after every dialysis session to maintain effective blood concentrations, and duration of administration must not exceed 5 days. If influenza symptoms present between the 48 hours between dialysis sessions, administration prior to dialysis is possible. In the case of peritoneal dialysis, single administration of 30mg of this drug after dialysis is recommended. Pharmacokinetics of oseltamivir for terminal renal failure patients (e.g. creatinine clearance less than 10mL/min) not on dialysis have not been studied, and therefore no recommended dose is provided for such patients. 4) Patients with liver impairment No need for dose adjustment when treating adult patients with mild to moderately severe liver impairment (Child-Pugh score≤9). + Indications 1. Influenza A and influenza B infection in children including neonates at least 2 weeks old (Do not use for infants whose postconceptional age is less than 36 weeks) and adults (administration must begin within 48 hours of presentation of early symptoms of influenza infection) 2. Prevention of influenza A and influenza B virus infections in patients aged 1 or older (Primary therapy for prevention of influenza virus infection is vaccine therapy; use this drug only when the vaccine does not contain the circulating strain, or in cases when the vaccine cannot be expected to be effective or when unable to receive vaccination; this drug is not a substitute for vaccination.) |
