Vistide
VISTIDE®
(cidofovir) Injection
FOR INTRAVENOUS INFUSION ONLY.
NOT FOR INTRAOCULAR INJECTION.
WARNING:
RENAL IMPAIRMENT IS THE MAJOR TOXICITY OF VISTIDE. CASES OF ACUTE RENAL FAILURE RESULTING IN DIALYSIS AND/OR CONTRIBUTING TO DEATH HAVE OCCURRED WITH AS FEW AS ONE OR TWO DOSES OF VISTIDE. TO REDUCE POSSIBLE NEPHROTOXICITY, INTRAVENOUS PREHYDRATION WITH NORMAL SALINE AND ADMINISTRATION OF PROBENECID MUST BE USED WITH EACH VISTIDE INFUSION. RENAL FUNCTION (SERUM CREATININE AND URINE PROTEIN) MUST BE MONITORED WITHIN 48 HOURS PRIOR TO EACH DOSE OF VISTIDE AND THE DOSE OF VISTIDE MODIFIED FOR CHANGES IN RENAL FUNCTION AS APPROPRIATE (SEE DOSAGE AND ADMINISTRATION). VISTIDE IS CONTRAINDICATED IN PATIENTS WHO ARE RECEIVING OTHER NEPHROTOXIC AGENTS.
NEUTROPENIA HAS BEEN OBSERVED IN ASSOCIATION WITH VISTIDE TREATMENT. THEREFORE, NEUTROPHIL COUNTS SHOULD BE MONITORED DURING VISTIDE THERAPY.
VISTIDE IS INDICATED ONLY FOR THE TREATMENT OF CMV RETINITIS IN PATIENTS WITH ACQUIRED IMMUNODEFICIENCY SYNDROME.
IN ANIMAL STUDIES CIDOFOVIR WAS CARCINOGENIC, TERATOGENIC AND CAUSED HYPOSPERMIA (SEE CARCINOGENESIS, MUTAGENESIS, & IMPAIRMENT OF FERTILITY).
DRUG DESCRIPTION
VISTIDE® is the brand name for cidofovir injection. The chemical name of cidofovir is 1-[(S)-3-hydroxy-2-(phosphonomethoxy)propyl]cytosine dihydrate (HPMPC), with the molecular formula of C8H14N3O6P•2H2O and a molecular weight of 315.22 (279.19 for anhydrous). The chemical structure is:
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Cidofovir is a white crystalline powder with an aqueous solubility of ≥ 170 mg/mL at pH 6-8 and a log P (octanol/aqueous buffer, pH 7.1) value of -3.3.
VISTIDE is a sterile, hypertonic aqueous solution for intravenous infusion only. The solution is clear and colorless. It is supplied in clear glass vials, each containing 375 mg of anhydrous cidofovir in 5 mL aqueous solution at a concentration of 75 mg/mL. The formulation is pH-adjusted to 7.4 with sodium hydroxide and/or hydrochloric acid and contains no preservatives. The appropriate volume of VISTIDE must be removed from the single-use vial and diluted prior to administration (see DOSAGE AND ADMINISTRATION).
Generic Name: Cidofovir
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