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Zinc sulfate injection is 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. Zinc sulfate injection 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. (1)

Zinc sulfate injection is contraindicated in patients with known hypersensitivity to zinc [see Warnings and Precautions (5.6) ]. Known hypersensitivity to zinc. ( 4 , 5.6 )

• Pulmonary Embolism due to Pulmonary Vascular Precipitates: If signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation. ( 5.1 ) • Vein Damage and Thrombosis: Solutions with osmolarity of 900 mOsmol/L or more must be infused through a central catheter. ( 2.1 , 5.2 ) • Aluminum Toxicity: Increase risk in patients with renal impairment, including preterm infants ( 5.3 , 8.4 ) • Monitoring and Laboratory Tests: Monitor fluid and electrolyte status, serum osmolarity, blood glucose, liver and kidney function, blood count and coagulation parameters throughout treatment. ( 5.4 , 2.4 ) • Copper Deficiency: If signs and symptoms develop, interrupt treatment with zinc sulfate injection and check zinc, copper, and ceruloplasmin levels. ( 5.5 ) • Hypersensitivity Reactions: If reactions occur, discontinue zinc sulfate injection and initiate appropriate medical treatment. ( 5.6 ) 5.1 Pulmonary Embolism due to Pulmonary Vascular Precipitates Pulmonary vascular precipitates causing pulmonary vascular emboli and pulmonary distress have been reported in patients receiving parenteral nutrition. The cause of precipitate formation has not been determined in all cases; however, in some fatal cases, pulmonary emboli occurred as a result of calcium phosphate precipitates. Precipitation has occurred following passage through an in-line filter; in vivo precipitate formation may also have occurred. If signs of pulmonary distress occur, stop the parenteral nutrition …

8.1 Pregnancy Risk Summary Administration of the approved recommended dose of zinc sulfate injection in parenteral nutrition is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with intravenous zinc sulfate. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical …