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Virazole (Ribavirin) - Drug Interactions, Contraindications, Overdosage, etc

 
 



DRUG INTERACTIONS

Drug Interactions

Clinical studies of interactions of VIRAZOLE with other drugs commonly used to treat infants with RSV infections, such as digoxin, bronchodilators, other antiviral agents, antibiotics or anti-metabolites, have not been conducted. Interference by VIRAZOLE with laboratory tests has not been evaluated.

OVERDOSAGE

No overdosage with VIRAZOLE by aerosol administration has been reported in humans. The LD50 in mice is 2 g orally and is associated with hypoactivity and gastrointestinal symptoms (estimated human equivalent dose of 0.17 g/kg, based on body surface area conversion). The mean plasma half-life after administration of aerosolized VIRAZOLE for pediatric patients is 9.5 hours. VIRAZOLE is concentrated and persists in red blood cells for the life of the erythrocyte (see Pharmacokinetics).

CONTRAINDICATIONS

VIRAZOLE is contraindicated in individuals who have shown hypersensitivity to the drug or its components, and in women who are or may become pregnant during exposure to the drug. Ribavirin has demonstrated significant teratogenic and/or embryocidal potential in all animal species in which adequate studies have been conducted (rodents and rabbits). Therefore, although clinical studies have not been performed, it should be assumed that VIRAZOLE may cause fetal harm in humans. Studies in which the drug has been administered systemically demonstrate that ribavirin is concentrated in the red blood cells and persists for the life of the erythrocyte.

REFERENCES

  •  Hruska JF, Bernstein JM, Douglas Jr., RG, and Hall CB. Effects of Virazole on respiratory syncytial virus in vitro. Antimicrob Agents Chemother 17:770-775, 1 1980.
  •  Hruska JF, Morrow PE, Suffin SC, and Douglas Jr., RG. In vivo inhibition of respiratory syncytial virus by Virazole. Antimicrob Agents Chemother 21:125-130, 1982.
  •  Taber LH, Knight V, Gilbert BE, McClung HW et al. Virazole aerosol treatment of bronchiolitis associated with respiratory tract infection in infants. Pediatrics 72:613-618, 1983.
  •  Hall CB, McBride JT, Walsh EE, Bell DM et al. Aerosolized Virazole treatment of infants with respiratory syncytial viral infection. N Engl J Med 308:1443-7, 1983.
  •  Hendry RM, Mclntosh K, Fahnestock ML, and Pierik LT. Enzymelinked immunosorbent assay for detection of respiratory syncytial virus infection J Clin Microbiol 16:329-33, 1982.
  •  Smith, David W., Frankel, Lorry R., Mather, Larry H., Tang, Allen T.S., Ariagno, Ronald L., Prober, Charles G. A Controlled Trial of Aerosolized Ribavirin in Infants Receiving Mechanical Ventilation for Severe Respiratory Syncytial Virus Infection. The New England Journal of Medicine 1991; 325:24-29.
  •  Decker, John, Shultz, Ruth A., Health Hazard Evaluation Report: Florida Hospital, Orlando, Florida. Cincinnati OH: U.S. Department of Health and Human Services, Public Health Service, Centers for NIOSH Report No. HETA 91-104-2229.*
  •  Barnes, D.J. and Doursew, M. Reference dose: Description and use in health risk assessments. Regul Tox. and Pharm. Vol. 8; p. 471-486, 1988.
  •  Federal Register Vol. 53 No. 126 Thurs. June 30, 1988 p. 24834-24847.
  •  American Association for Respiratory Care [1991]. Aerosol Consensus Statement-1991. Respiratory Care 36(9): 916-921.

*Copies of the Report may be purchased from National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161;Ask for Publication PB 93119-345

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V3018E-00
Rev. 04/13

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