Zinc sulfate

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 )

• Pharmacy Bulk Package
• Not for direct intravenous infusion. • See full prescribing information for information on preparation, administration, and general dosing considerations
• Recommended Dosage and Monitoring • 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. • Individualize the dosage based upon the patient's clinical condition, nutritional requirements, and the contribution of oral or enteral zinc intake. • The dosage of Zinc Sulfate Injection should be individualized based on the patient’s clinical condition, nutritional requirements, and the contribution of oral or enteral zinc intake. • Adults : The recommended adult dosage is 3 mg/day for metabolically stable patients, with potential need for a higher daily dosage in monitored patients with small bowel fluid loss or excess stool or ileostomy output. • Pediatrics: The recommended dosage
• In pediatric patients is shown by age and estimated weight
• The dosages in the table are general recommendations intended for most
• Pediatric patients
• However, based on clinical requirements, some patients may require a higher dosage. …

Zinc Sulfate Injection, USP: • 10 mg/10 mL (1 mg/mL) of zinc as a clear, colorless solution in a 10 mL Pharmacy Bulk Package vial. Zinc Sulfate Injection, USP: • 10 mg/10 mL (1 mg/mL) of zinc as a Pharmacy Bulk Package vial. ( 3 )

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. …

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 parenteral nutrition solutions: • Pulmonary embolism due to pulmonary vascular precipitates [see Warnings and Precautions ( 5.1 ) …

IN SPECIFIC POPULATIONS 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. …

There are reported cases of overdosage with intravenous zinc in parenteral nutrition: • Seven adult patients received an inadvertent overdosage of 50 mg to 75 mg elemental zinc per day in parenteral nutrition solution for 26 to 60 days; 6 of the 7 patients developed hyperamylasemia (peak amylase values of 557 to 1850 Klein units; normal: 130 to 310). Amylase was not reported in one patient. Serum zinc concentrations ranged from 310 to 670 mcg/dL. None of the patients developed clinical signs of pancreatitis. Five of the 7 patients died of septic complications. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.