Label: MANGANESE SULFATE- manganese sulfate injection, solution

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated December 20, 2018

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  • SPL UNCLASSIFIED SECTION

    Rx Only

    STERILE, NONPYROGENIC, TRACE ELEMENT ADDITIVE
    FOR IV USE AFTER DILUTION
    (MANGANESE 0.1 mg/mL)
    PRESERVATIVE FREE

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  • DESCRIPTION

    Manganese Sulfate Injection, USP is a sterile, nonpyrogenic solution intended for use as an additive to solutions for Total Parenteral Nutrition (TPN). Each mL contains 0.308 mg of Manganese Sulfate Monohydrate, USP, Water for Injection q.s. pH adjusted with Sulfuric Acid. It delivers elemental manganese 0.1 mg/mL. It is a single dose preservative free vial. Discard any unused portion.

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  • CLINICAL PHARMACOLOGY

    Manganese is an activator for enzymes such as polysaccharide polymerase, liver arginase, cholinesterase and pyruvate carboxylase. Providing manganese during TPN prevents development of the following deficiency symptoms: nausea and vomiting, weight loss, dermatitis and changes in growth and color of hair.

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  • INDICATIONS AND USAGE

    Manganese Sulfate Injection, USP is indicated for use as a supplement to intravenous solutions given for Total Parenteral Nutrition (TPN). Administration helps to maintain plasma levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms.

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  • CONTRAINDICATIONS

    Manganese Sulfate Injection, USP should not be given undiluted by direct injection into a peripheral vein because of the potential for infusion phlebitis.

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  • 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.

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  • PRECAUTIONS

    Manganese is eliminated via the bile. The possibility of manganese retention should be considered in patients with biliary tract obstruction. Decreasing or omitting manganese supplements entirely may be necessary for such patients. However, ancillary routes of manganese excretion include pancreatic juice, or reabsorption into the lumen of the duodenum, jejunum or ileum.

    Use in Pregnancy

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

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  • ADVERSE REACTIONS

    Adverse reactions to manganese at the dosage levels recommended have not been reported.

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  • DOSAGE AND ADMINISTRATION

    Manganese Sulfate Injection, USP provides 0.1 mg manganese/mL. For the metabolically stable adult receiving TPN, the suggested additive dosage level for manganese is 0.15 to 0.8 mg/day. For pediatric patients, a dosage level of 2 to 10 mcg manganese/kg/day is recommended.

    Aseptic addition of Manganese Sulfate Injection, USP to the TPN solution under a laminar flow hood is recommended. Manganese is physically compatible with the electrolytes and vitamins usually present in the amino acid/dextrose solution used for TPN. Periodic monitoring of manganese plasma levels is suggested as a guideline for subsequent administration.

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

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  • OVERDOSAGE

    Manganese toxicity has not been reported in patients receiving TPN. Neither have reports of manganese toxicity from excessive intake in foods and/or beverages been published.

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  • HOW SUPPLIED

    Manganese Sulfate Injection, USP 0.1 mg/mL

    NDC 0517-6410-25                                 10 mL SDV                        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).

    IN6410

    Rev. 1/09

    MG #14479

    AMERICAN
    REGENT, INC.
    SHIRLEY, NY 11967

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - Container Label

    NDC 0517-6410-25

    MANGANESE SULFATE INJECTION, USP

    Manganese 1 mg/10 mL

    (0.1 mg/mL)

    10 mL SINGLE DOSE VIAL

    Trace Element Additive

    FOR IV USE AFTER DILUTION

    PRESERVATIVE FREE

    Rx Only

    AMERICAN
    REGENT, INC.
    SHIRLEY, NY 11967

    Container Label

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  • PACKAGE LABEL PRINCIPAL DISPLAY PANEL - Carton Labeling

    NDC 0517-6410-25
    25 x 10 mL
    SINGLE DOSE VIALS

    MANGANESE SULFATE INJECTION, USP

    Manganese 1 mg/10 mL
    (0.1 mg/mL)

    10 mL SINGLE DOSE VIAL

    Trace Element Additive

    FOR IV USE AFTER DILUTION.  PRESERVATIVE FREE           

    Rx Only

    Each mL contains: Manganese Sulfate (Monohydrate) 0.308 mg, Water for Injection q.s.
    pH adjusted with Sulfuric Acid. Sterile, nonpyrogenic.
    WARNING: DISCARD UNUSED PORTION. 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). Directions for Use: See Package Insert.

    AMERICAN REGENT, INC.
    SHIRLEY, NY 11967

    Iss. 12/16


    Carton Labeling
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  • Serialization Label
  • INGREDIENTS AND APPEARANCE
    MANGANESE SULFATE 
    manganese sulfate injection, solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0517-6410
    Route of Administration INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MANGANESE SULFATE (UNII: W00LYS4T26) (MANGANESE CATION (2+) - UNII:H6EP7W5457) MANGANESE CATION (2+) 0.1 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:0517-6410-25 25 in 1 TRAY 09/30/1990
    1 10 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(0517-6410) , MANUFACTURE(0517-6410) , STERILIZE(0517-6410)
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