zinc sulfate 3 mg/mL
zinc sulfate injection, · SOLUTION · Zydus Pharmaceuticals USA Inc.
Zinc sulfate injection is a prescription medication administered intravenously that provides zinc supplementation for patients who cannot obtain adequate zinc through oral intake, such as those on long-term intravenous nutrition. It is used to help prevent or treat zinc deficiency, which can occur in critically ill patients or those with certain medical conditions affecting nutrient absorption.
Key Facts
- Brand Name
- zinc sulfate
- Generic Name
- zinc sulfate injection,
- NDC Code (Product)
70710-1877- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Strength
- 3 mg/mL
- Dosage Form
- SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA217074
- Marketing Start
- 12/07/2023
Recall History
Lincare, Inc.
Lack of Assurance of Sterility: Sterility of product is not assured.
Promise Pharmacy, LLC
Lack of sterility assurance.
Aidapak Services, LLC
Labeling:Label Mixup; ZINC SULFATE Capsule, 220 mg may be potentially mislabeled as CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD52778_10, EXP: 5/20/2014; CALCITRIOL, Capsule, 0.25 mcg, NDC 00054000725, Pedigree: W003638, EXP: 6/25/2014.
Medtech Products, Inc.
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
Aidapak Services, LLC
Labeling: Label Mixup; ZINC SULFATE, Capsule, 50 mg may be potentially mislabeled as SERTRALINE HCL, Tablet, 50 mg, NDC 16714061204, Pedigree: AD30993_14, EXP: 5/9/2014.
Beacon Hill Medical Pharmacy, P.C.
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
Lack of Assurance of Sterility
Medtech Products, Inc.
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
Medtech Products, Inc.
CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.
Aidapak Services, LLC
Labeling: Label Mixup; ZINC SULFATE, Capsule, 220 mg (50 mg Elem Zn) may be potentially mislabeled as PHOSPHORUS, Tablet, 250 mg, NDC 64980010401, Pedigree: AD56916_1, EXP: 5/21/2014.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 )
Dosage & Administration
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. • 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…
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 ).
Adverse Reactions
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 parenteral nutrition solutions: • Pulmonary embolism due to pulmonary vascular precipitates [see Warnings and Precautions ( 5.1 )] • Vein damage and thrombosis [see Warnings and Precautions ( 5.2 )] • Aluminum toxicity [see Warnings and Precautions ( 5.3 )] Adverse reactions with the use of zinc-containing products administered by other routes of administration: • Copper deficiency [ see Warnings and Precautions ( 5.5 ) ] • Hypersensitivity reactions [ see Warnings and Precautions ( 5.6 ) ] No zinc-related adverse reactions in patients receiving intravenously administered parenteral nutrition solutions…
Frequently Asked Questions
What is zinc sulfate used for?
Zinc sulfate injection is a prescription medication administered intravenously that provides zinc supplementation for patients who cannot obtain adequate zinc through oral intake, such as those on long-term intravenous nutrition. It is used to help prevent or treat zinc deficiency, which can occur in critically ill patients or those with certain medical conditions affecting nutrient absorption.
Is zinc sulfate a controlled substance?
zinc sulfate is not classified as a controlled substance by the DEA.
What is the generic name for zinc sulfate?
The generic name for zinc sulfate is zinc sulfate injection,. There are no other listed brand versions of zinc sulfate injection,.
What is the NDC code for zinc sulfate 3 mg/mL?
The NDC (National Drug Code) for zinc sulfate 3 mg/mL is 70710-1877, listed by Zydus Pharmaceuticals USA Inc..
Other zinc sulfate Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)