Ganciclovir microbiology

Ganciclovir
VITRASERT® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Clinical Studies
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Microbiology

Virology

Ganciclovir is a synthetic nucleoside analogue of 2'-deoxyguanosine that inhibits replication of herpes viruses both in vitro and in vivo. Sensitive human viruses include cytomegalovirus (CMV), herpes simplex virus-1 and -2 (HSV-1, HSV-2), Epstein-Barr virus (EBV) and varicella zoster virus (VZV). Clinical studies have been limited to assessment of efficacy in patients with CMV infection.

Median effective inhibitory doses (ED 50 ) of ganciclovir for human CMV isolates tested in vitro in several cell lines ranged from 0.2 to 3.0 µg/mL. The relationship between in vitro sensitivity of CMV to ganciclovir and clinical response has not been established. Ganciclovir inhibits mammalian cell proliferation in vitro at higher concentrations (10 to 60 µg/mL) with bone marrow colony forming cells being the most sensitive (ID 50 >/=10 µg/mL) of those cell types tested.

Emergence of viral resistance has been reported based on in vitro sensitivity testing of CMV isolates from patients receiving intravenous ganciclovir treatment. The prevalence of resistant isolates is unknown, and there is a possibility that some patients may be infected with strains of CMV resistant to ganciclovir. Therefore, the possibility of viral resistance should be considered in patients who show poor clinical response.

References

Adapted from the FDA Package Insert.