|
From Dynamed:
1. BLACK BOX WARNING:
aerosolized ribavirin in infants has resulted in sudden deterioration of respiratory function; not indicated in adults; drug precipitate may result in mechanical ventilator dysfunction and increased pulmonary pressure
2. Pediatric Use:
Aerosolized ribavirin: Safety and efficacy established for treatment of RSV infection in children.1
Capsules: Safety and efficacy of Rebetol® capsules in conjunction with interferon alfa-2b (Intron® A) established for treatment of chronic HCV infection in children ≥5 years of age with compensated liver disease who have not previously received or have relapsed after interferon alfa treatment.349 Safety and efficacy of ribavirin capsules in conjunction with peginterferon alfa-2b (PEG-Intron®) not established in pediatric patients.b
Oral solution: Safety and efficacy of Rebetol® oral solution in conjunction with interferon alfa-2b (Intron® A) established for treatment of chronic HCV infection in children ≥3 years of age with compensated liver disease who have not previously received or have relapsed after interferon alfa treatment.349
Tablets: Safety and efficacy not established in children <18 years of age.377 a c
Consider evidence of disease progression (hepatic inflammation, fibrosis) and prognostic factors for response, HCV genotype, and viral load when deciding whether to use oral ribavirin (Rebetol®) in a child with HCV infection.349 Weigh benefits of such treatment against adverse effects reported in pediatric patients.349
Adverse effects reported with oral ribavirin (Rebetol®) in pediatric patients generally similar to those reported in adults.349 Suicidal ideation or attempts reported more frequently during or after oral ribavirin in pediatric patients (primarily adolescents) than in adults receiving the drug.349 Other adverse psychiatric effects (depression, emotional lability, somnolence), anemia, and neutropenia reported as in adults.349 Decrease in rate of linear growth and in rate of weight gain reported during 48-week treatment regimen; a general reversal of these trends noted during 24-week posttreatment period.349
3. Use of aerosolized ribavirin for treatment of RSV in infants has resulted in sudden deterioration of respiratory function.1 Monitor respiratory function carefully.1 If sudden deterioration of respiratory function occurs, discontinue therapy.1 Reinstitute with extreme caution and continuous monitoring; consider concomitant administration of a bronchodilator.1
Optimum monitoring and attention to respiratory and fluid status needed in patients with severe lower respiratory tract infection due to RSV.1
看来只有胶囊是安全的 |
|