ZINC SULFATE injection, solution

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Piramal Critical Care Inc.

Vía de administración:

INTRAVENOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 Disease-associated Maternal and/or Embryo-Fetal Risk Deficiency of trace elements, including zinc, is associated with adverse pregnancy and fetal outcomes. Pregnant women have an increased metabolic demand for trace elements, including zinc. Parenteral nutrition with zinc should be considered if a pregnant woman’s nutritional requirements cannot be fulfilled by oral or enteral intake. Risk summary Zinc is present in human milk. Administration of the approved recommended dose of Zinc Sulfate Injection in parenteral nutrition is not expected to cause harm to a breastfed infant. There is no information on the effects of zinc sulfate on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Zinc Sulfate Injection and any potential adverse effects on the breastfed infant from Zinc Sulfate Injection or from the underlying maternal condition. Zinc Sulfate Injection is approved for use in the pediatric population, including neonates, as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Safety and dosing recommendations in pediatric patients are based on published literature describing controlled studies of zinc-containing products in pediatric patients [see Dosage and Administration ( 2.2)] . Because of immature renal function, preterm infants receiving prolonged parenteral nutrition treatment with Zinc Sulfate Injection may be at higher risk of aluminum toxicity [see Warnings and Precautions ( 5.3)] . Reported clinical experience with intravenous zinc sulfate has not identified a difference in zinc requirements between elderly and younger patients. In general, dose selection should be individualized based on the patient’s clinical condition, nutritional requirements, and additional nutritional intake provided orally or enterally to the patient.

Resumen del producto:

Zinc Sulfate Injection, USP is a clear, colorless solution supplied as: • 30 mg/10 mL (3 mg/mL) of zinc in a 10 mL Pharmacy Bulk Package vial. Cartons of 25 vials (NDC 66794-240-42). • 25 mg/5 mL (5 mg/mL) of zinc in a 5 mL Pharmacy Bulk Package vial. Cartons of 25 vials (NDC 66794-239-42). Vial closure is not made with natural rubber latex. Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) [ see USP Controlled Room Temperature ]. For storage of admixed solution s ee Dosage and Administration ( 2.3) .

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

ZINC SULFATE- ZINC SULFATE INJECTION, SOLUTION
PIRAMAL CRITICAL CARE INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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
RECENT MAJOR CHANGES
Dosage and Administration
Preparation Instructions for Admixing Using a Parenteral Nutrition
Container ( 2.3)10/2020
Recommended Dosage and Monitoring in Adult and Pediatric Patients (
2.5)
10/2020
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 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.
• 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.
_o 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.
_o 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.