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(ganciclovir sodium) for Injection
THE CLINICAL TOXICITY OF CYTOVENE-IV INCLUDES GRANULOCYTOPENIA, ANEMIA AND THROMBOCYTOPENIA. IN ANIMAL STUDIES GANCICLOVIR WAS CARCINOGENIC, TERATOGENIC AND CAUSED ASPERMATOGENESIS.
CYTOVENE-IV IS INDICATED FOR USE ONLY IN THE TREATMENT OF CYTOMEGALOVIRUS (CMV) RETINITIS IN IMMUNOCOMPROMISED PATIENTS AND FOR THE PREVENTION OF CMV DISEASE IN TRANSPLANT PATIENTS AT RISK FOR CMV DISEASE (see INDICATIONS AND USAGE).
CYTOVENE-IV is available as sterile lyophilized powder in strength of 500 mg per vial for intravenous administration only. Each vial of CYTOVENE-IV contains the equivalent of 500 mg ganciclovir as the sodium salt (43 mg sodium). Reconstitution with 10 mL of Sterile Water for Injection, USP, yields a solution with pH 11 and a ganciclovir concentration of approximately 50 mg/mL. Further dilution in an appropriate intravenous solution must be performed before infusion (see DOSAGE AND ADMINISTRATION).
Ganciclovir is a white to off-white crystalline powder with a molecular formula of C9H13N504 and a molecular weight of 255.23. The chemical name for ganciclovir is 9-[[2-hydroxy-1-(hydroxymethyl)- ethoxy]methyl]guanine. Ganciclovir is a polar hydrophilic compound with a solubility of 2.6 mg/mL in water at 25°C and an n-octanol/water partition coefficient of 0.022. The pKas for ganciclovir are 2.2 and 9.4.
Ganciclovir, when formulated as monosodium salt in the IV dosage form, is a white to off-white lyophilized powder with the molecular formula of C9H12N5Na05, and a molecular weight of 277.22. The chemical name for ganciclovir sodium is 9-[[2-hydroxy-1-(hydroxymethyl)-ethoxy]methyl]guanine, monosodium salt. The lyophilized powder has an aqueous solubility of greater than 50 mg/mL at 25°C. At physiological pH, ganciclovir sodium exists as the un-ionized form with a solubility of approximately 6 mg/mL at 37°C.
The chemical structures of ganciclovir sodium and ganciclovir are:
All doses in this insert are specified in terms of ganciclovir.
What are the possible side effects of ganciclovir (Cytovene)?
Serious side effects affecting the blood have been reported with the use of ganciclovir. Decreased levels of blood cells (white blood cells, red blood cells, and platelets) have occurred. Your doctor may monitor your blood with blood tests.
Stop taking ganciclovir and seek emergency medical attention if you experience any of the following serious side effects:
- an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
- paleness and fatigue that may be signs of anemia (a low level of red blood...
What are the precautions when taking ganciclovir (Cytovene)?
Before using ganciclovir, tell your doctor or pharmacist if you are allergic to it; or to valganciclovir or acyclovir; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, a low number of blood cells (red or white blood cells, platelets), radiation treatment.
This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
Wash your hands well to prevent the spread of infection. Avoid contact with...
Last reviewed on RxList: 12/21/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Cytovene Information
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