American Regent has announced the availability of Zinc Sulfate Injection, a trace element indicated as a source of zinc for parenteral nutrition in adult and pediatric patients when oral or enteral nutrition is not possible, insufficient, or contraindicated. 

Zinc Sulfate Injection is supplied in 25mg/5mL (5mg/mL) and 30mg/10mL (3mg/mL) pharmacy bulk package vials. The product must be transferred to a separate parenteral nutrition container, diluted and used as an admixture in parenteral nutrition solutions.

“We are pleased to offer the first FDA approved Zinc Sulfate Injection­ – developed to align with the American Society for Parenteral and Enteral Nutrition (ASPEN) recommendations for trace element supplementation. This launch demonstrates our commitment to meeting the high bar of a new drug approval, and addressing the FDA’s safety initiative for unapproved products,” stated Harsher Singh, VP, Chief Commercial and Strategic Officer at American Regent, Inc. “The 3mg/mL product represents a new concentration of Zinc Sulfate Injection.”

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Zinc Sulfate Injection contains aluminum that may be toxic. The product contains no more than 2500mcg/L of aluminum and has a calculated osmolarity of 96.5mOsmol/L for 3mg/mL and 157.2mOsmol/L for 5mg/mL. Patients with impaired kidney function, including preterm neonates, who receive >4 to 5 mcg/kg/day of parenteral aluminum can accumulate aluminum to levels associated with CNS and bone toxicity. Tissue loading may occur at even lower rates of administration.

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