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Zinc Sulfate is a brand name for Zinc Sulfate. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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…
Verbatim from this product's FDA label. Tap a section to expand.
2 DOSAGE AND ADMINISTRATION • Pharmacy Bulk Package. Not for direct intravenous infusion. 1 ) • See full prescribing information for information on preparation, administration, and general dosing considerations. 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. • 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.
Population Estimated Weight for Age Recommended Daily Dosage Pediatric Patients 10 kg and above 50 mcg/kg (up to 3 mg/day) 5 kg to less than 10 kg 100 mcg/kg Term Neonates 3 kg to less than 5 kg 250 mcg/kg* Preterm Neonates Less than 3 kg 400 mcg/kg *Term neonates have higher requirements in the first 3 months of life • Monitor zinc concentrations and signs and symptoms of zinc deficiency, especially in pediatric patients, during treatment.
Zinc concentrations may vary depending on the assay used and the laboratory reference range. The collection, processing, and storage of the blood samples for zinc analysis should be performed according to the laboratory’s sample requirements.
Zinc concentrations in hemolyzed samples are falsely elevated due to release of zinc from erythrocytes. The lower end of the reported range in healthy adults in serum is 60 mcg/dL. 1 Important Administration Information Zinc Sulfate Injection is supplied as a pharmacy bulk package for admixing use only.
It is not for direct intravenous infusion . Prior to administration, Zinc Sulfate Injection must be transferred to a separate parenteral nutrition container, diluted and used as an admixture in parenteral nutrition solutions. The final parenteral nutrition solution is for intravenous infusion into a central or peripheral vein.
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. 6 ) ] No zinc-related adverse reactions in patients receiving intravenously administered parenteral nutrition solutions containing zinc within the recommended dosage range.
gov/medwatch . See 17 for PATIENT COUNSELING INFORMATION. Revised: 06/2023
5 WARNINGS AND PRECAUTIONS • Pulmonary Embolism due to Pulmonary Vascular Precipitates : If signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation. 1 ) • Vein Damage and Thrombosis : Solutions with osmolarity of 900 mOsmol/L or more must be infused through a central catheter.
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. 4 ) • Copper Deficiency : If signs and symptoms develop, interrupt treatment with Zinc Sulfate Injection and check zinc, copper, and ceruloplasmin levels.
5 ) • Hypersensitivity Reactions : If reactions occur, discontinue Zinc Sulfate Injection and initiate appropriate medical treatment. 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 infusion and initiate a medical evaluation. 3 )] , the infusion set and catheter should also periodically be checked for precipitates. 2 Vein Damage and Thrombosis Zinc Sulfate Injection has a low pH and must be prepared and used as an admixture in parenteral nutrition solutions.
It is not for direct intravenous infusion. In addition, consider the osmolarity of the final parenteral nutrition solution in determining peripheral versus central administration. 1)] . The infusion of hypertonic nutrient solutions into a peripheral vein may result in vein irritation, vein damage, and/or thrombosis.
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The choice of a central or peripheral venous route should depend on the osmolarity of the final infusate. 2 )] . 2 Preparation and Administration Instructions • Zinc Sulfate Injection is not for direct intravenous infusion . Prior to administration, Zinc Sulfate Injection must be prepared and used as an admixture in parenteral nutrition solutions.
• Zinc Sulfate Injection is to be prepared only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area). The key factor in the preparation is careful aseptic technique to avoid inadvertent touch contamination during mixing of solutions and addition of other nutrients.
• Visually inspect the diluted parenteral nutrition solution containing Zinc Sulfate Injection for particulate matter before admixing, after admixing, and prior to administration. 3 Preparation Instructions for Admixing Using a Parenteral Nutrition Container • Inspect Zinc Sulfate Injection Bulk Pharmacy Package for particulate matter.
• Transfer Zinc Sulfate Injection to the parenteral nutrition container following the admixture of amino acids, dextrose, lipid emulsion (if added), and electrolytes solutions. • Because additives may be incompatible, evaluate all additions to the parenteral nutrition container for compatibility and stability of the resulting preparation.
Questions about compatiblity may be directed to Piramal Critical Care. If it is deemed advisable to introduce additives to the parenteral nutrition container, use aseptic technique. • Inspect the final parenteral nutrition solution containing Zinc Sulfate Injection to ensure that: • Precipitates have not formed during mixing or addition on additives.
• The emulsion has not separated, if lipid emulsion has been added. Separation of the emulsion can be visibly identified by a yellowish streaking or the accumulation of yellowish droplets in the admixed emulsion. • Discard if any precipitates are observed.
Stability and Storage • Penetrate vial closure only one time with a suitable sterile transfer device or dispensing set that allows measured dispensing of the contents. • Use Zinc Sulfate Injection for admixing promptly once the sterile transfer set has been inserted into the Pharmacy Bulk Package container or not more than 4 hours at room temperature 20°C to 25°C (68°F to 77°F) (25ºC/77ºF) after the container closure has been penetrated.
Discard any remaining drug. • Use parenteral nutrition solutions containing Zinc Sulfate Injection promptly after mixing. Any storage of the admixture should be under refrigeration from 2ºC to 8ºC (36ºF to 46ºF) and limited to a period of time no longer than 9 days.
After removal from refrigeration, use promptly and complete the infusion within 24 hours. Discard any remaining admixture. • Protect the admixed parenteral nutrition solution from light. 5)] . Consult the prescribing information of all added components to determine the recommended nutritional requirements for dextrose and lipid emulsion, as applicable.
• Prior to administration of parenteral nutrition solution containing Zinc Sulfate Injection, correct severe fluid, electrolyte and acid-base disorders. 5 Recommended Dosage and Monitoring in Adult and Pediatric Patients • 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 • 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. Pediatric Patients The recommended pediatric dosage is shown in Table 1 by age and estimated weight.
The dosages in Table 1 are general recommendations intended for most pediatric patients. However, based on clinical requirements, some patients may require a higher dosage.
Table 1:
Recommended Dosage of Zinc Sulfate Injection for Pediatric Patients by Age and Estimated Weight Population Estimated Weight for Age Recommended Daily Dosage Pediatric Patients 10 kg and above 50 mcg/kg (up to 3 mg/day) 5 kg to less than 10 kg 100 mcg/kg Term Neonates 3 kg to less than 5 kg 250 mcg/kg* Preterm Neonates Less than 3 kg 400 mcg/kg *Term neonates have higher requirements in the first 3 months of life Monitoring Monitor zinc concentrations during treatment.
Also monitor patients clinically for signs and symptoms of zinc deficiency, especially in pediatrics. Zinc concentrations may vary depending on the assay used and the laboratory reference range. The collection, processing, and storage of the blood samples for zinc analysis should be performed according to the laboratory’s sample requirements.
Zinc concentrations in hemolyzed samples are falsely elevated due to release of zinc from erythrocytes. The lower end of the reported range in healthy adults in serum is 60 mcg/dL.
The primary complication of peripheral access is venous thrombophlebitis, which manifests as pain, erythema, tenderness or a palpable cord. Remove the catheter as soon as possible, if thrombophlebitis develops. 3 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 the kidneys are immature, and they require large amounts of calcium and phosphate solutions, which also contain aluminum.
Patients with impaired kidney function, including preterm infants, who receive greater than 4 to 5 mcg/kg/day of parenteral aluminum can accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
6 mcg/kg/day. 4 )] . 4 )] . , months to years) may result in decreased enteral copper absorption and copper deficiency. The cases reported the following complications of copper deficiency: anemia, leukopenia, thrombocytopenia, myeloneuropathy, and nephrotic-range proteinuria [ see Adverse Reactions ( 6 ) ].
If a patient develops signs and symptoms of copper deficiency during treatment with Zinc Sulfate Injection, interrupt zinc treatment and check zinc, copper, and ceruloplasmin levels. Copper deficiency should be treated with supplemental copper administration and discontinuation of zinc supplementation.
6 Hypersensitivity Reactions Hypersensitivity reactions to subcutaneously administered zinc-containing insulin products were identified in postmarketing case reports. Reported reactions included injection site induration, erythema, pruritus, papular rash, generalized urticaria, facial swelling, and dyspnea.
Patients did not manifest symptoms after changing to zinc-free insulin or another insulin product with a reduced amount of zinc. In some cases, allergy testing confirmed the allergy to the zinc component of the insulin product. If hypersensitivity reactions occur, discontinue Zinc Sulfate Injection and initiate appropriate medical treatment [ see Contraindications ( 4 ) ].