What is the concentration of ganciclovir in the USP?
Ganciclovir for Injection, USP is supplied in 10 mL sterile single-dose vials, each containing 543 mg Ganciclovir sodium equivalent to 500 mg of Ganciclovir as a white to off-white powder. The concentration of Ganciclovir in the reconstituted solution is 50 mg/mL.
What should I know about ganciclovir before taking it?
Ganciclovir should also be used with caution in patients with pre-existing cytopenias and in patients receiving myelosuppressive drugs or irradiation. Granulocytopenia (neutropenia) usually occurs during the first or second week of treatment but may occur at any time during treatment.
What is the initial dosage of ganciclovir for renal failure?
Induction Dosage: The recommended initial dosage of Ganciclovir for patients with normal renal function is 5 mg/kg (given intravenously at a constant rate over 1 hour) every 12 hours for 14 to 21 days.
What should be included in patient education about ganciclovir?
Inform patients that Ganciclovir may cause hematologic toxicity, including granulocytopenia (neutropenia), anemia, and thrombocytopenia. Inform patients that their blood counts and platelet counts should be closely monitored while on treatment [see Warnings and Precautions ( 5.1 )].
How much Ganciclovir is in a 10ml vial?
Each 10 mL clear glass vial contains 543 mg Ganciclovir sodium equivalent to 500 mg of Ganciclovir. Wearing disposable gloves is recommended during reconstitution and when wiping the outer surface of the vial and the table after reconstitution. The contents of the vial should be prepared for administration in the following manner:
How long does it take for ganciclovir to be administered?
To avoid phlebitis/pain at the infusion site, Ganciclovir for injection must only be administered by intravenous infusion over 1 hour, preferably via plastic cannula, into a vein with adequate blood flow to permit rapid dilution and distribution.
How long does valanciclovir last after transplant?
In a small, open-label, non-randomized clinical study, adult male renal transplant patients receiving valGanciclovir (the prodrug of Ganciclovir) for CMV prophylaxis for up to 200 days post-transplantation were compared to an untreated control group. Patients were followed-up for six months after valGanciclovir discontinuation. Among 24 evaluable patients in the valGanciclovir group, the mean sperm density at the end of treatment visit decreased by 11 million/mL from baseline, whereas, among 14 evaluable patients in the control group the mean sperm density increased by 33 million/mL. However, at the follow-up visit among 20 evaluable patients in the valGanciclovir group, the mean sperm density was comparable to that observed among 10 evaluable patients in the untreated control group (the mean sperm density at the end of follow-up visit increased by 41 million/mL from baseline in the valGanciclovir group and by 43 million/mL in the untreated group).
What is the phosphorylation of Ganciclovir?
Ganciclovir is a synthetic analogue of 2'-deoxyguanosine, which inhibits replication of human CMV in cell culture and in vivo. In CMV-infected cells, Ganciclovir is initially phosphorylated to Ganciclovir monophosphate by the viral protein kinase, pUL97. Further phosphorylation occurs by cellular kinases to produce Ganciclovir triphosphate, which is then slowly metabolized intracellularly. As the phosphorylation is largely dependent on the viral kinase, phosphorylation of Ganciclovir occurs preferentially in virus-infected cells. The virustatic activity of Ganciclovir is due to inhibition of the viral DNA polymerase, pUL54, by Ganciclovir triphosphate.
What is USP in ganciclovir?
Ganciclovir for Injection, USP is indicated for the treatment of cytomegalovirus (CMV) retinitis in immunocompromised adult patients , including patients with acquired immunodeficiency syndrome (AIDS) [see Clinical Studies ( 14.1 )].
How long does ganciclovir last?
Maintenance Dosage: Following induction, the recommended maintenance dosage of Ganciclovir is 5 mg/kg (given intravenously at a constant rate over 1 hour) once daily for 7 days per week, or 6 mg/kg once daily for 5 days per week until 100 to 120 days post-transplantation.
What is the infusion fluid for Ganciclovir?
Infusion concentrations greater than 10 mg/mL are not recommended. The following infusion fluids have been determined to be chemically and physically compatible with Ganciclovir for injection solution: 0.9% Sodium Chloride, 5% Dextrose, Ringer’s Injection and Lactated Ringer’s Injection, USP.
Indications and Usage For Ganciclovir
Ganciclovir Dosage and Administration
Dosage Forms and Strengths
Contraindications
Warnings and Precautions
- Hematologic Toxicity
Granulocytopenia (neutropenia), anemia, thrombocytopenia and pancytopenia have been observed in patients treated with Ganciclovir. The frequency and severity of these events vary widely in different patient populations [see Adverse Reactions (6.1)]. Ganciclovir is not recomme… - Renal Impairment
Ganciclovir should be used with caution in patients with impaired renal function because the half-life and plasma/serum concentrations of Ganciclovir will be increased due to reduced renal clearance. If renal function is impaired, dosage adjustments are recommended [see Dosage an…
Adverse Reactions
Drug Interactions
Use in Specific Populations
Overdosage
Ganciclovir Description