American Regent Introduces FDA Approved Zinc Sulfate Injection, USP
SHIRLEY, N.Y., Jan. 28, 2020 /PRNewswire/ -- American Regent, Inc. announced the introduction of FDA approved Zinc Sulfate Injection, USP.1 Zinc Sulfate is a trace element indicated in adult and pediatric patients as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.2
"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.3 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,4" stated Harsher Singh, Vice President, Chief Commercial and Strategic Officer at American Regent, Inc. "The 3 mg/mL product represents a new concentration of Zinc Sulfate Injection."
Product is available for immediate shipment. Customers can order Zinc Sulfate Injection, USP through their wholesaler/distributor, or by contacting our Customer Support Group at 1-800-645-1706.
Zinc Sulfate Injection, USP is supplied as follows:
See the following Important Safety Information, in addition to the product's Full Prescribing Information.
For additional information, please visit www.americanregent.com.
ZINC SULFATE INJECTION, USP
INDICATIONS AND USAGE
Zinc Sulfate Injection is supplied as a pharmacy bulk package for admixing use only. It is not for direct intravenous infusion.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Vein Damage and Thrombosis: Zinc Sulfate Injection has a low pH and must be prepared and used as an admixture in PN solutions. Solutions with osmolarity of 900 mOsm/L or more must be infused through a central venous catheter.
Aluminum Toxicity: Zinc Sulfate Injection contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Preterm infants are particularly at risk for aluminum toxicity because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which also contain aluminum.
Monitoring and Laboratory Tests: Monitor Zinc concentrations, fluid and electrolyte status, serum osmolarity, blood glucose, liver and kidney function, blood count and coagulation parameters throughout treatment.
Copper Deficiency: Several post-marketing cases have reported that high doses of supplemental zinc (approximately 10 times the recommended dosage of 3 mg/day Zinc Sulfate Injection in adults) taken over extended periods of time (i.e., months to years) may result in decreased enteral copper absorption and copper deficiency.
Hypersensitivity Reactions: If hypersensitivity reactions occur, discontinue Zinc Sulfate Injection and initiate appropriate medical treatment.
USE IN SPECIFIC POPULATIONS
Lactation: Risk Summary: Zinc is present in human milk. There is no information on the effects of zinc sulfate on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Zinc Sulfate Injection and any potential adverse effects on the breastfed infant from Zinc Sulfate Injection or from the underlying maternal condition.
Pediatric Use: Safety and dosing recommendations in pediatric patients are based on published literature describing controlled studies of zinc-containing products in pediatric patients.
Geriatric Use: Dose selection should be individualized based on the patient's clinical condition, nutritional requirements, and additional nutritional intake provided orally or enterally to the patient.
OVERDOSAGE: There are reported cases of overdosage with intravenous zinc in parenteral nutrition.
For additional safety information, please see Full Prescribing Information.
You are encouraged to report Adverse Drug Events (ADEs) to American Regent:
ADEs may also be reported to the FDA:
For urgent drug information outside of normal business hours,
About American Regent
Supporting patient health is the guiding principle of American Regent, and their promise is to provide the healthcare marketplace with a steady supply and broad portfolio of branded and generic specialty injectables. American Regent is a top-10 injectable supplier in therapeutic areas, including IV additives, anti-inflammatories, diuretics, cytotoxics and diagnostic dyes. Additionally, for nearly 20 years, American Regent has been a leader in IV iron therapy, and supplies two of the top-selling brands in the U.S. today.
For more information, please visit www.americanregent.com.
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SOURCE American Regent, Inc.