Label: NEUT- sodium bicarbonate injection, solution

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

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Drug Label Information

Updated August 21, 2018

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  • SPL UNCLASSIFIED SECTION

    To adjust acidic parenteral solutions to a more nearly neutral pH.

    Fliptop Vial

    Rx Only

    (0.2 g in 5 mL)

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  • DESCRIPTION

    Neut (4% sodium bicarbonate additive solution) is a sterile, nonpyrogenic solution of sodium bicarbonate in water for injection. It is administered by the intravenous route only after addition as a neutralizing agent to an acidic large volume parenteral solution. Each 5 mL contains sodium bicarbonate 0.2 g (2.4 mEq each of Na+ and HCO3 ); edetate disodium, anhydrous 10 mg added as a stabilizer. Total sodium (Na+) content of each 5 mL is 56.1 mg (11.2 mg/mL).

    The solutions contain no bacteriostat, antimicrobial agent or added buffer; pH 8.0 (7.0 to 8.5).

    Sodium Bicarbonate, USP is chemically designated as NaHCO3, a white crystalline powder soluble in water.

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  • CLINICAL PHARMACOLOGY

    The acid pH of most intravenous solutions has been implicated as a factor in the production of postinfusion (chemical) phlebitis not caused by obvious infection. Vein irritation, with local redness and tenderness near the site of venipuncture or along the course of a vein, appears to be related to the nature of the substances in the infusion and the speed (insufficient dilution by the bloodstream) as well as the duration (prolonged exposure of the intima) of infusion. Other contributing factors include the size of the vein used for venipuncture, shape or method of insertion of the venipuncture needle, the use or type of indwelling catheter, infection at the infusion site and the age of the patient (children and females seem to be more susceptible).

    The pH of commonly used dextrose infusion solutions ranges from 3.5 to 6.5. Other commonly used solutions also may have an acid pH. Since non-neutral parenteral solutions with a low (acid) pH are known to cause chemical irritation of tissues, it is not surprising that chemical phlebitis may occur as a complication with their infusion. Vein irritation is most likely when the duration of infusion is long or when hemodilution is minimized by a large needle in a small vein.

    The amount of sodium bicarbonate recommended as an additive to neutralize acid parenteral solutions is too small to exert a clinically significant increase in electrolyte content.

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  • INDICATIONS AND USAGE

    Neut (4% sodium bicarbonate additive solution) is indicated for use as an additive to raise the pH of acid solutions administered intravenously to reduce the incidence of chemical phlebitis and patient discomfort due to vein irritation at or near the site of infusion.

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  • CONTRAINDICATIONS

    Not for use as a systemic alkalizer.

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  • WARNINGS

    None known.

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  • PRECAUTIONS

    Do not administer unless solution is clear and seal is intact. Discard unused portion.

    Solutions prepared with Neut (4% sodium bicarbonate additive solution) should be administered promptly. When introducing additives, use aseptic technique, mix thoroughly and do not store.

    When Neut is added to Hospira solutions, the compatibility of these solutions with other drugs may be altered. (See section on COMPATIBILITY, etc., for listing of additives tested with Neut added D5-W.)

    Raising the pH of I.V. fluids with Neut will only reduce the incidence of chemical irritation caused by the infusate; it will not diminish any foreign body effects caused by the needle or catheter.

    Pregnancy

    Animal reproduction studies have not been conducted with sodium bicarbonate. It is also not known whether sodium bicarbonate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium bicarbonate should be given to a pregnant woman only if clearly needed.

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  • ADVERSE REACTIONS

    None known.

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  • DRUG ABUSE AND DEPENDENCE

    None known.

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  • OVERDOSAGE

    None known.

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  • DOSAGE AND ADMINISTRATION

    One vial (5 mL) of Neut added to a liter (1000 mL) of any of the following Hospira parenteral solutions will increase the pH to a more physiologic range. Specific pH may vary slightly from lot to lot.

    Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

    Product List
    5% Alcohol in 5% Dextrose Injection, USP 1500
    2.5% Dextrose Inj., USP 1508
    5% Dextrose Inj., USP 1522
    10% Dextrose Inj., USP 1530
    20% Dextrose Inj., USP 1535
    Ringer's Injection, USP 1582
    0.9% Sodium Chloride Inj., USP 1583
    Sodium Lactate Inj., USP (1/6 Molar) 1587

    Addition of one vial of Neut to one-half liter (500 mL) is recommended to achieve a more physiologic pH of the following Hospira parenteral solutions:

    Product List
    6% Dextran 70 and 0.9% Sodium Chloride Injection 1505
    6% Dextran 70 and 5% Dextrose Injection 1507

    Note: Some products, e.g., Aminosyn® solutions and those Ionosol® and Normosol® formulas containing dextrose will NOT be brought to near physiologic pH by the addition of Neut. This is due to the relatively high buffer capacity of these fluids.

    COMPATIBILITY & EFFECTIVENESS OF NEUT WITH ADDITIVES TO 5% DEXTROSE INJECTION (D5-W)

    When medications are added to intravenous solutions, the resultant admixtures may or may not be compatible in solutions containing Neut (4% sodium bicarbonate additive solution).

    Following is a list of medications each added to one liter of 5% Dextrose Injection, USP (D5-W) classified according to their effect with Neut (4% sodium bicarbonate additive solution).

    1. Neut Compatible with Admixtures for 24 Hours Conc./liter
    *
    Requires 2 vials of Neut to bring admixture to approximate neutrality.
    ACTHAR® (ACTH) 40 units
    Aqua-Mephyton® (Vitamin K1) 10 mg
    Aramine® (metaraminol) Bitartrate 100 mg*
    Atropine Sulfate 0.4 mg
    Calcium Chloride 1 g
    Calcium Gluceptate 1.1 g
    Compazine® (prochlorperazine) Edisylate 10 mg
    Crystodigin® (digitoxin) 0.2 mg
    Demerol® (meperidine) HCl 100 mg
    Ergonovine Maleate 0.2 mg
    Erythrocin® (erythromycin) Lactobionate 1 g
    Fungizone® (amphotericin B) 50 mg
    Ilotycin® (erythromycin) Gluceptate 1 g
    Innovar® (droperidol and fentanyl) 1.0 mL
    Keflin® (cephalothin) Sodium 4 g
    Lidocaine HCl 1 g
    M.V.I.® (multivitamin infusion) 10 mL*
    Neosynephrine® (phenylephrine) HCl 10 mg
    Panheparin® (heparin sodium) 20,000 units
    Penicillin G Potassium 100,000,000 units
    Pitocin® (oxytocin) 5 units
    Potassium Chloride 120 mEq
    Sodium Iodide 1 g
    (promazine) HCl 100 mg
    Vancocin® (vancomycin) HCl 500 mg
    Wydase® (hyaluronidase) 150 units
    2. Neut Incompatible –
    Additive Inactivated at Neutral pH
    Conc./liter
    Epinephrine 4 mg
    Isuprel® (isoproterenol) HCl 1 mg
    Levophed® (levarterenol) Bitartrate 8 mg
    Quelicin® (succinylcholine chloride) 1 g
    3. Neut Ineffective -
    Additive High in Titratable Acidity
    Conc./liter
    Achromycin® (tetracycline) HCl 500 mg
    Aureomycin® (chlortetracycline) HCl 500 mg
    Bejectal w/C (B complex and C) 10 mL
    Kantrex® (kanamycin) Sulfate 1 g
    4. Neut Not Indicated –
    Admixture Already At or Near Neutrality
    Conc./liter
    Gantrisin® (sulfisoxazole) Diethanolamine 4 g
    Hydrocortone® (hydrocortisone) Phosphate 100 mg
    Prostaphlin® (oxacillin) Sodium 500 mg
    Sodium Bicarbonate 3.75 g
    Solu-Cortef ® (hydrocortisone sodium succinate) 250 mg
    5. Neut Not Indicated –
    Admixture Already Alkaline
    Conc./liter
    Aminophylline 500 mg
    Amytal® (amobarbital) Sodium 500 mg
    Dilantin® (diphenylhydantoin) Sodium 250 mg
    Diuril® (chlorothiazide) 0.5 g
    Emivan® (ethimivan) 2 g
    Furadantin® (nitrofurantoin) Sodium 180 mg
    Nembutal® (pentobarbital) Sodium 500 mg
    Pentothal® (thiopental sodium) 1 g
    Phenobarbital Sodium 320 mg
    Polycillin® N (ampicillin sodium) 500 mg
    Sulfadiazine Sodium 1 g

    It should be noted that the admixtures were evaluated for physical compatibility, not for pharmacological compatibility. It, therefore, would be erroneous to circumvent medical judgment which must be involved in administering any solution that appears to be compatible on the basis of having no visible haze or precipitate. The inclusion of drugs in this study of their compatibility in solution does not imply their therapeutic usefulness or safety. This matter remains the judgment of the prescribing physician.

    NOTE: The compatibility information contained herein is based on the studies involving Hospira dextrose only. Variations in compatibility could occur due to lot-to-lot variations or formula changes in the additives or dextrose solutions of other manufacturers.

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  • HOW SUPPLIED

    Neut (4% sodium bicarbonate additive solution) is supplied in partial-fill single-dose containers 5 mL fliptop vial. Unit of Sale is a Tray containing 25 vials (NDC: 0409-6609-02).

    Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

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  • SPL UNCLASSIFIED SECTION

    Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

    Logo

    LAB-1233-2.0

    Revised: 06/2018

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  • PRINCIPAL DISPLAY PANEL

    RL-0672

    Label NDC 0409-6609-02

     

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  • PRINCIPAL DISPLAY PANEL - 5 mL Vial Tray

    5 mL

    Neut®
    Sodium Bicarbonate 4% (2.4 mEq)
    Additive Solution

    Single-dose

    25 Units/NDC 0409-6609-02

    Rx only

    Hospira, Inc., Lake Forest, IL 60045 USA

    Hospira

    PRINCIPAL DISPLAY PANEL - 5 mL Vial Tray
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  • INGREDIENTS AND APPEARANCE
    NEUT 
    sodium bicarbonate injection, solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-6609
    Route of Administration INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20, SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE 0.2 g  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0409-6609-02 25 in 1 TRAY 08/22/2005
    1 5 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 08/22/2005
    Labeler - Hospira, Inc. (141588017)
    Establishment
    Name Address ID/FEI Business Operations
    Hospira, Inc. 093132819 ANALYSIS(0409-6609) , LABEL(0409-6609) , MANUFACTURE(0409-6609) , PACK(0409-6609)
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