Vistide

SECTION 2: Hazards identification

Patients/Consumers: Please refer to the product information insert or product label for appropriate consumer-specific information about this product when used according to the physician’s directions. Emergency Overview Pharmaceutical Agent – Handling of this product in its final form presents minimal occupational exposure risk.

Potential health effects

Finished Pharmaceutical Product Contraindications: In patients with a serum creatinine > 1.5 mg/dL, a calculated creatinine clearance ≤ 55 mL/min, or a urine protein ≥ 100 mg/dL. Cidofovir is also contraindicated in patients with nephrotoxic potential or those with known hypersensitivity to cidofovir, probenecid, or other sulfa-containing medications.

Precautionary statements

Dose-dependent nephrotoxicity is the dose-limiting toxicity related to cidofovir injection administration. Neutropenia, decreased intraocular pressure, or decreased serum bicarbonate may occur during cidofovir injection therapy. Adverse Reactions: During clinical trials, nephrotoxicity, neutropenia, decreased intraocular pressure/ocular hypotony, anterior uveitis/iritis, and metabolic acidosis were reported. Overdosage: Two cases of overdose have been reported. Patients received single doses of cidofovir injection at 16.3 mg/kg and 17.4 mg/kg, respectively, with concomitant oral probenecid and intravenous hydration. In both cases, the patients were hospitalized and received oral probenecid and vigorous intravenous hydration with normal saline for 3-5 days. Significant changes in renal function were not observed in either patient.