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Zinc Sulfate (American Regent, Inc.)

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INJECTION, SOLUTION 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-8105-25) > 5 mL in 1 VIAL, SINGLE-DOSE Label Information

Complete Zinc Sulfate Information

  • SPL UNCLASSIFIED SECTION

    Rx Only

    STERILE, NONPYROGENIC TRACE ELEMENT ADDITIVE FOR INTRAVENOUS USE AFTER DILUTION

    (Zinc 5 mg/mL)


  • DESCRIPTION

    Concentrated Zinc Sulfate Injection, USP is a sterile, non-pyrogenic solution intended for use as an additive to solutions for Total Parenteral Nutrition (TPN). Each mL contains Zinc Sulfate (Anhydrous) 12.32 mg, Water for Injection q.s.  pH adjusted with Sulfuric Acid. It contains no preservatives. Discard unused portion. It delivers elemental zinc 5 mg per mL.


  • CLINICAL PHARMACOLOGY

    Zinc has been identified as a cofactor for over 70 different enzymes, including alkaline phosphatase, lactic dehydrogenase and both RNA and DNA polymerase. Zinc facilitates wound healing, helps maintain normal growth rates, normal skin hydration and the senses of taste and smell.

    Providing zinc during TPN prevents development of the following deficiency symptoms: Parakeratosis, hypogeusia, anorexia, dysosmia, geophagia, hypogonadism, growth retardation and hepatosplenomegaly. At plasma levels below 20 mcg zinc/100 mL, dermatitis followed by alopecia has been reported for TPN patients.


  • INDICATIONS AND USAGE

    Concentrated Zinc Sulfate Injection, USP is indicated for use as a supplement to intravenous solutions given for TPN. Administration helps to maintain plasma levels and to prevent depletion of endogenous stores.


  • CONTRAINDICATIONS

    Concentrated Zinc Sulfate Injection, USP should not be given undiluted by direct injection into a peripheral vein because of the likelihood of infusion phlebitis and the potential to increase renal loss of zinc from a bolus injection.


  • WARNINGS

    This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired.  Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

    Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.


  • PRECAUTIONS

    Administration of zinc in the absence of copper may cause a decrease in serum copper levels. Periodic determination of serum copper as well as zinc are suggested as a guideline for subsequent zinc administration. Zinc is eliminated via the intestine and kidneys. The possibility of retention should be considered in patients with malfunctioning excretory routes.


  • ADVERSE REACTIONS

    The amount of zinc present in Concentrated Zinc Sulfate Injection, USP is very small, symptoms of toxicity from zinc are considered unlikely to occur.

    USE IN PREGNANCY

    Safety for use in pregnancy has not been established. Use of zinc in women of childbearing potential requires that anticipated benefits be weighed against possible hazards.


  • DOSAGE AND ADMINISTRATION

    Concentrated Zinc Sulfate Injection, USP provides 5 mg zinc/mL. For metabolically stable adults receiving TPN, the suggested intravenous dosage is 2.5 to 4 mg zinc/day. An additional 2 mg zinc/day is suggested for acute catabolic states. For the stable adult with fluid loss from the small bowel, an additional 12.2 mg zinc/liter of small bowel fluid lost, or an additional 17.1 mg zinc/kg of stool or ileostomy output is recommended. Frequent monitoring of zinc blood levels is suggested for patients receiving more than the usual maintenance dosage level of zinc.

    For full term infants and children up to 5 years of age, 100 mcg zinc/kg/day is recommended. For premature infants (birth weight less than 1500 g) up to 3 kg in body weight, 300 mcg zinc/kg/day is suggested.

    Aseptic addition of Concentrated Zinc Sulfate Injection, USP to the TPN solution under a laminar flow hood is recommended. Zinc is physically compatible with the electrolytes and vitamins usually present in the amino acid/dextrose solution used for TPN.

    Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit.


  • OVERDOSAGE

    Symptoms of zinc overdosage resulting from oral ingestion of zinc sulfate in large amounts (30 and 44 grams, respectively) have resulted in death. Symptoms included nausea, vomiting, dehydration, electrolyte imbalances, dizziness, abdominal pain, lethargy and incoordination. Single intravenous doses of 1 to 2 mg zinc/kg body weight have been given to adult leukemic patients without toxic manifestations. Normal plasma levels for zinc vary from approximately 88 to 112 mcg/100 mL. Plasma levels sufficient to produce symptoms of toxic manifestations in humans are not known. Calcium supplements may confer a protective effect against zinc toxicity.


  • HOW SUPPLIED

    Concentrated Zinc Sulfate Injection, USP, 5 mg zinc/mL

    NDC 0517-8105-25     5 mL Vials     Packed in a box of 25

    Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F)

    (See USP Controlled Room Temperature).

    AMERICAN
    REGENT, INC.
    SHIRLEY, NY 11967

    IN8105
    Rev. 1/09
    MG #14229


  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISLAY PANEL – 5 mL Carton

    CONCENTRATED ZINC SULFATE
    INJECTION, USP

    Zinc 25 mg/5 mL (5 mg/mL)

    Trace Element Additive

    NDC 0517-8105-25

    25 x 5 mL SINGLE DOSE VIALS

    FOR INTRAVENOUS USE AFTER DILUTION

    PRESERVATIVE FREE

    Rx Only

    Each mL contains: Zinc Sulfate (Anhydrous) 12.32 mg, Water for Injection q.s.

    pH adjusted with Sulfuric Acid, if necessary. Sterile, nonpyrogenic.

    WARNING: DISCARD UNUSED PORTION.

    Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) (See USP

    Controlled Room Temperature).

    Directions for Use: See Package Insert.

    AMERICAN REGENT, INC.
    SHIRLEY, NY 11967

    Rev. 11/05

    366c9858-figure-01

  • INGREDIENTS AND APPEARANCE
    ZINC SULFATE 
    zinc sulfate injection, solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0517-8105
    Route of Administration INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC SULFATE ANHYDROUS (UNII: 0J6Z13X3WO) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    SULFURIC ACID (UNII: O40UQP6WCF)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0517-8105-25 25 in 1 TRAY 09/30/1990
    1 5 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 09/30/1990
    Labeler - American Regent, Inc. (622781813)
    Establishment
    Name Address ID/FEI Business Operations
    Luitpold Pharmaceuticals, Inc. 002033710 ANALYSIS(0517-8105) , MANUFACTURE(0517-8105) , STERILIZE(0517-8105)