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GANCICLOVIR USP
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DOSAGE FORM: Lyophilized Injection, 500mg/vial.

BIOLOGICAL SIGNIFICANCE

Ganciclovir is a synthetic guanine derivative active against cytomegalovirus (CMV).

CLINICAL USE

Ganciclovir has sometimes caused severe blood problems, including a decrease in red blood cells (anemia), white blood cells (neutropenia), and platelets (thrombocytopenia).

MODE OF ACTION

Ganciclovir is an acyclic nucleoside analogue of 2'-deoxyguanosine that inhibits replication of herpes viruses. Ganciclovir has been shown to be active against cytomegalovirus (CMV) and herpes simplex virus (HSV) in human clinical studies.

To achieve anti-CMV activity, ganciclovir is phosphorylated first to the monophosphate form by a CMV-encoded (UL97 gene) protein kinase homologue, then to the di- and triphosphate forms by cellular kinases. Ganciclovir triphosphate concentrations may be 100-fold greater in CMV-infected than in uninfected cells, indicating preferential phosphorylation in infected cells. Ganciclovir triphosphate, once formed, persists for days in the CMV-infected cell. Ganciclovir triphosphate is believed to inhibit viral DNA synthesis by (1) competitive inhibition of viral DNA polymerases; and (2) incorporation into viral DNA, resulting in eventual termination of viral DNA elongation.

STRUCTURE:

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SPECIFICATIONS
Assay NLT 90% - NMT 110%
Identification Complies to USP
BET NMT 0.84 EU / mg of ganciclovir
Sterility Complies to USP
PH 10.8 – 11.4
Water content NMT 3.0%
Particulate matter Complies to USP
   
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