Ganciclovir sodium is available as a lyophilized powder in single-dose vials containing the equivalent of 500 mg of ganciclovir.3361; 3366 Vials also may include hydrochloric acid and sodium hydroxide to adjust the pH.3361 Each vial should be reconstituted with 10 mL of sterile water for injection and swirled gently or shaken to fully wet the product and dissolve the drug to yield a 50-mg/mL solution of ganciclovir.3361; 3366 Paraben-containing diluents (e.g., bacteriostatic water for injection containing parabens) should not be used to reconstitute ganciclovir sodium because precipitation may result.3361; 3366 Reconstituted solutions should be visually inspected for particulate matter and discoloration prior to dilution; if particulate matter is present or discoloration occurs, the vial should be discarded.3361; 3366 The appropriate volume of the reconstituted solution should be withdrawn from the vial and diluted in an appropriate volume (usually 100 mL) of sodium chloride 0.9%, dextrose 5%, Ringer's injection, or Ringer's injection, lactated to obtain a ganciclovir concentration of 10 mg/mL or less prior to administration; concentrations greater than 10 mg/mL are not recommended.3361; 3366
Ganciclovir also is available as a 2-mg/mL premixed, ready-to-use solution in 250-mL single-dose (preservative-free) bags containing 500 mg of ganciclovir; this product does not contain the sodium salt of ganciclovir.3362 Each mL also contains sodium chloride 8 mg in water for injection and may contain sodium hydroxide and/or hydrochloric acid to adjust the pH.3362 Solutions should be visually inspected for particulate matter and discoloration prior to administration.3362
pH
Ganciclovir 50-mg/mL solution (reconstituted from ganciclovir sodium) has a pH of 11.3361; 3366
Ganciclovir 2-mg/mL premixed, ready-to-use solution has a pH of 7.5.3362
Sodium Content
Each 500-mg vial of ganciclovir sodium (Par) contains 46 mg of sodium.3366
Trade Name(s)
Cytovene-IV
Solutions of ganciclovir must be administered only by intravenous infusion at a constant rate over 1 hour.3361; 3362; 3366 The recommended infusion rate should not be exceeded.3361; 3362; 3366 The drug should not be administered by intramuscular, subcutaneous, or rapid or bolus intravenous injection.3361; 3362; 3366 Intramuscular or subcutaneous administration can result in severe tissue irritation due to the high pH of the drug; rapid or bolus intravenous injection can increase the risk of toxicity.3361; 3366
Administration of ganciclovir should be accompanied by adequate hydration.3361; 3362; 3366 The drug must only be infused into a vein with adequate blood flow, preferably through a plastic cannula, to permit rapid dilution and distribution of the drug in an attempt to avoid phlebitis and/or pain at the infusion site.3361; 3362; 3366 Phlebitis and/or pain at the site of intravenous infusion still may occur despite further dilution of the reconstituted solution of the drug in intravenous infusion solutions.3366
As with other toxic drugs, caution should be exercised in the handling and preparation of ganciclovir.3361; 3362; 3366 Direct contact of the drug with the skin or mucous membrane should be avoided, and the use of disposable gloves during handling has been recommended.3361; 3366 If skin or mucosal membrane contact with the solution occurs, the exposed area should be washed thoroughly with soap and water; for eye contact, the eyes should be flushed thoroughly with water.3361; 3366 Procedures and guidelines for the proper disposal of ganciclovir should be considered.3361; 3362; 3366
Ganciclovir sodium is a white to off-white powder that forms a clear solution upon reconstitution.3361; 3366 Intact vials should be stored at controlled room temperature.3361; 3366 The reconstituted solution is stable in the vial for 12 hours at room temperature (25°C).3361; 3366 Manufacturers do not recommend refrigeration of the reconstituted solution;3361; 3366 however, ganciclovir 500 mg/10 mL in sterile water for injection had no significant loss in 60 days when stored at 4°C.1637 One manufacturer states that diluted solutions of ganciclovir may be stored at 2 to 8°C for up to 24 hours.3361 Neither reconstituted nor diluted solutions of ganciclovir should be frozen.3361; 3362
Ganciclovir premixed, ready-to-use solution is clear and colorless.3362 Intact containers should be stored at controlled room temperature.3362 Crystals may form during transportation or storage at temperatures that are lower than those recommended for storage.3362 Bags should be gently shaken to redissolve such crystals.3362 The solution must be clear at the time of use.3362 Any unused portion should be discarded.3362
Ganciclovir sodium (Syntex) prepared at a ganciclovir concentration of 0.35 mg/mL in sodium chloride 0.9% and stored at 22°C did not exhibit a substantial antimicrobial effect on the growth of 4 organisms (Enterococcus faecium, Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans) inoculated into the solution. S. aureus and C. albicans remained viable for 24 hours, and the others remained viable to the end of the study at 120 hours. The author recommended that diluted solutions of ganciclovir be stored under refrigeration whenever possible and that the potential for microbiological growth should be considered when assigning expiration periods.2160
Freezing Solutions
The manufacturers do not recommend freezing reconstituted and/or diluted solutions of ganciclovir;3361; 3362 however, ganciclovir sodium (Syntex) prepared at ganciclovir concentrations of 1.4, 4, and 7 mg/mL in sodium chloride 0.9% and packaged in polypropylene syringes and 0.28 and 1.4 mg/mL in sodium chloride 0.9% and packaged in polyvinyl chloride (PVC) containers was evaluated. All samples exhibited 4% or less drug loss after 364 days at -20°C.1836
No ganciclovir loss occurred in a 10-mg/mL solution in sodium chloride 0.9% in 48 weeks when stored frozen at -8°C.2595
Syringes
Ganciclovir sodium (Syntex) prepared at a ganciclovir concentration of 5.8 mg/mL in sodium chloride 0.9% and packaged in polypropylene infusion-pump syringes (Healthtek) exhibited 3% or less drug loss in 10 days at 4°C and no loss in 12 hours at 25°C.1742
Ganciclovir sodium (Syntex) prepared at a ganciclovir concentration of 1.4, 4, and 7 mg/mL in sodium chloride 0.9% was packaged in polypropylene syringes and stored at 20, 4, and -20°C. Drug loss of 4% or less occurred in 7 days at 20°C, in 80 days at 4°C, and in 364 days at -20°C.1836
Ganciclovir sodium (Roche) prepared at a ganciclovir concentration of 5 mg/mL in sodium chloride 0.9% and packaged as 20 mL in 50-mL polypropylene syringes (Becton Dickinson) protected from light remained stable and clear for up to 185 days at 23 to 27°C and 2 to 8°C.3363
Central Venous Catheter
Ganciclovir sodium (Roche), prepared at a ganciclovir concentration of 5 mg/mL in dextrose 5% was found to be compatible with the ARROWg+ard Blue Plus (Arrow International) chlorhexidine-bearing triple-lumen central catheter. Essentially complete delivery of the drug was found with little or no drug loss occurring. Furthermore, chlorhexidine delivered from the catheter remained at trace amounts with no substantial increase due to the delivery of the drug through the catheter.2335
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