Ganciclovir clinical pharmacology
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Clinical Pharmacology
Pharmacokinetics
In a clinical trial of Vitrasert Implants, 26 patients (30 eyes) received a total of 39 primary implants and 12 exchange implants (performed 32 weeks after the implant was inserted or earlier if progression of CMV retinitis occurred). Because most of the exchanged implants were empty, the time the implant actually ran out of drug was unknown, and a precise in-vivo release rate could not be calculated. However, approximate in-vivo release rates could be determined for the exchanged implants, which ranged from 1.00 µg/h to more than 1.62 µg/h.
In 14 implants (3 exchanged, 11 autopsy) in which the in-vivo release rate could accurately be calculated, the mean release rate was 1.40 µg/h, with a range from 0.5 to 2.88 µg/h. The mean vitreous drug levels in eight eyes (4 collected at the time of retinal detachment surgery; 2 collected from autopsy eyes within 6 hours of death and prior to fixation; 2 collected from implant exchanges) was 4.1 µg/mL.[1]
References
- ↑ "http://www.drugbank.ca/system/fda_labels/DB01004.pdf?1265922812" (PDF). External link in
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Adapted from the FDA Package Insert.