Source: FDA, National Drug Code (US) Revision Year: 2020
CYTOVENE-IV contains ganciclovir, in the form of the sodium salt for intravenous injection. Ganciclovir is a synthetic guanine derivative active against cytomegalovirus (CMV).
Chemically, ganciclovir is 9-[[2-hydroxy-1-(hydroxymethyl)ethoxy]methyl]guanine and ganciclovir sodium is 9[[2-hydroxy-1-(hydroxymethyl)-ethoxy]methyl]guanine, monosodium salt.
The chemical structures of ganciclovir sodium and ganciclovir are:
ganciclovir sodium
C9H12N5NaO4
M.W. = 277.22
ganciclovir
C9H13N5O4
M.W. = 255.23
Ganciclovir is a white to off-white crystalline powder. 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.
CYTOVENE-IV (ganciclovir), formulated as monosodium salt, using sodium hydroxide as a salt forming agent, is a sterile white to off-white lyophilized powder. 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.
Each vial contains 543 mg ganciclovir sodium equivalent to 500 mg ganciclovir.
Inactive ingredients may include hydrochloric acid (QS) and sodium hydroxide (QS) added to adjust the pH.
All doses in this package insert are specified in terms of ganciclovir.
| Dosage Forms and Strengths |
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For injection: Single-dose vial containing 500 mg of ganciclovir as a sterile lyophilized white to off-white powder for reconstitution with 10 mL of preservative-free sterile water for injection, USP for intravenous use. The concentration of ganciclovir in the reconstituted solution is 50 mg/mL [see Dosage and Administration (2.6)]. |
| How Supplied |
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CYTOVENE-IV (ganciclovir) for injection 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. Because ganciclovir shares some of the properties of antitumor agents (i.e., carcinogenicity and mutagenicity), consideration should be given to handling and disposal according to guidelines issued for antineoplastic drugs. CYTOVENE-IV is supplied in cartons of 5 single-dose vials (NDC 61269-450-50 for 5-vial carton, NDC 61269-450-20 for single-dose vial). Distributed by: H2-Pharma, LLC, Montgomery, AL 36117 Licensed by: CHEPLAPHARM Arzneimittel GmbH, 17489 Greifswald, Germany |
| Drug | Countries | |
|---|---|---|
| CYTOVENE | Canada, United States |
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