ZINC SULFATE- zinc sulfate injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ZINC SULFATE (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37)

Available from:

Fresenius Kabi USA, LLC

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 contraindicated in patients with known hypersensitivity to zinc [see Warnings and Precautions (5.6) ] 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 Considerations Disea

Product summary:

Zinc Sulfate Injection, USP is a sterile, clear, colorless solution, essentially free from visible particles supplied as: The container closure is not made with natural rubber latex. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. For storage of admixed solution see Dosage and Administration (2.3). Discard unused portion.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ZINC SULFATE - ZINC SULFATE INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ZINC
SULFATE INJECTION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZINC
SULFATE INJECTION.
ZINC SULFATE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1957
INDICATIONS AND USAGE
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 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, 3 mg/mL, or 5 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.
_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.
*Term neonates have higher requirements in the first 3 months of life
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