Overview
11 DESCRIPTION Zinc Sulfate Injection, USP is a sterile, non-pyrogenic, clear, colorless, and odorless solution intended for use as a trace element and an additive to intravenous solutions for parenteral nutrition. 10 mg/10 mL Pharmacy Bulk Package vial: Each mL contains 1 mg of zinc present as 2.46 mg of zinc sulfate and water for injection q.s. All presentations do not contain preservatives.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Zinc is an essential trace element. Zinc functions as a cofactor of various enzymes including DNA polymerases, RNA polymerases, alcohol dehydrogenase, and alkaline phosphatases. Zinc is a coordinator of protein structural folding, such as folding of “Zinc finger” motif that interacts with a variety of proteins, lipids, and nucleic acids. In addition, zinc is a catalyst of essential biochemical reactions, including activation of substrates of carbonic anhydrase in erythrocyte. Also, zinc is a signaling mediator modulating multiple signaling pathways. 12.2 Pharmacodynamics Zinc sulfate exposure-response relationships and the time course of pharmacodynamic responses are unknown. 12.
Indications
- 1 INDICATIONS AND USAGE 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 )
Common Doses
- 1 mg
- 3 mg
- 50 mcg
- 100 mcg
Dosage
2 DOSAGE AND ADMINISTRATION • Pharmacy Bulk Package. Not for direct intravenous infusion. ( 2.1 ) • See full prescribing information for information on preparation, administration, and general dosing considerations. ( 2.1 , 2.2 , 2.3 , 2.4 ) Recommended Dosage and Monitoring ( 2.5 ) • Zinc Sulfate Injection provides 1 mg/mL of zinc. • Zinc Sulfate Injection in a concentration of 1 mg/mL is recommended for use in pediatric patients, particularly those weighing less than 12 kg.
Contraindications
- 4 CONTRAINDICATIONS 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 ).
Side Effects
- 6 ADVERSE REACTIONS No zinc-related adverse reactions have been reported in clinical studies or post-marketing reports in patients receiving intravenously administered parenteral nutrition solutions containing zinc sulfate within the recommended dosage range. The following were identified in clinical studies or post-marketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Adverse reactions with other components of...
Interactions
- No major interactions listed on the FDA label. Always consult a healthcare professional.