Method of administration: Respiratory (inhalation), Oral
FDA approval date: January 01, 1986
Classification: Nucleoside Analog Antiviral
Ribavirin for Inhalation Solution, USP is indicated for the treatment of hospitalized infants and young children with severe lower respiratory tract infections due to RSV. Treatment early in the course of severe lower respiratory tract infection may be necessary to achieve efficacy. Only severe RSV lower respiratory tract infection should be treated with Ribavirin for Inhalation Solution, USP. The vast majority of infants and children with RSV infection have disease that is mild, self-limited, and does not require hospitalization or antiviral treatment. Many children with mild lower respiratory tract involvement will require shorter hospitalization than would be required for a full course of Ribavirin for Inhalation Solution, USP aerosol (3 to 7 days) and should not be treated with the drug. Thus the decision to treat with Ribavirin for Inhalation Solution, USP should be based on the severity of the RSV infection. The presence of an underlying condition such as prematurity, immunosuppression or cardiopulmonary disease may increase the severity of clinical manifestations and complications of RSV infection. Use of aerosolized Ribavirin for Inhalation Solution, USP in patients requiring mechanical ventilator assistance should be undertaken only by physicians and support staff familiar with this mode of administration and the specific ventilator being used. Diagnosis RSV infection should be documented by a rapid diagnostic method such as demonstration of viral antigen in respiratory tract secretions by immunofluorescence 3,4 or ELISA 5 before or during the first 24 hours of treatment. Treatment may be initiated while awaiting rapid diagnostic test results. However, treatment should not be continued without documentation of RSV infection. Non-culture antigen detection techniques may have false positive or false negative results. Assessment of the clinical situation, the time of year and other parameters may warrant reevaluation of the laboratory diagnosis. Description of Studies Non-Mechanically Ventilated Infants: In two placebo-controlled trials in infants hospitalized with RSV lower respiratory tract infection, aerosolized Ribavirin for Inhalation Solution, USP treatment had a therapeutic effect, as judged by the reduction in severity of clinical manifestations of disease by treatment day 3. 3,4 Treatment was most effective when instituted within the first 3 days of clinical illness. Virus titers in respiratory secretions were also significantly reduced with Ribavirin for Inhalation Solution, USP in one of these original studies. 4 Additional controlled studies conducted since these initial trials of aerosolized Ribavirin for Inhalation Solution, USP in the treatment of RSV infection have supported these data. Mechanically Ventilated Infants: A randomized, double-blind, placebo-controlled evaluation of aerosolized Ribavirin for Inhalation Solution, USP at the recommended dose was conducted in 28 infants requiring mechanical ventilation for respiratory failure caused by documented RSV infection. 6 Mean age was.