Respiratory Functiion Deterioration
Experienced Physician and Support Staff
- Use of aerosolized virazole in patients requiring mechanical ventilator assistance should be undertaken only by physicians and support staff faimilary with the specific ventilator being used and this mode of administration of the drug.
- Strict attention myst be paid to the procedures that have been shown to minimize the accumulation of drug precipitate, which can result in mechanical ventilator dysfunction and associated increased pulmonary pressures.
Respiratory Function Deterioration
- Sudden deterioration of respiratory function has been associated with the initiation of aerosolized virazole in infants. Respiratory function should be carefully monitored during treatment.
- If initiation of aerosolized virazole treatment appears to produce sudden deterioration of respiratory function, treatment should be stopped and reinstituted only with extreme caution, continuous monitoring, and consideration of concomitantt bronchodilators
Pediatric Use Only
- Virazole is not indicated for use in adults.
- Physicians and patients should be aware that ribavirin has been shown to produced testicular lesions in rodents and to be teratogenic in all animal species in which adequate studies have been conducted (Rodents and Rabbits)
MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA
- Respiratory function should be carefully monitored during therapy. If sudden deterioration occurs, stop drug and restart only with extreme caution. Continue monitoring and consider concurrent therapy with bronchodilators.
Patient Counseling Information