Label: AMPICILLIN SODIUM- ampicillin sodium injection, powder, for solution

  • NDC Code(s): 10515-335-01
  • Packager: GC Hanford Manufacturing Company
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Animal Drug Application

Drug Label Information

Updated October 26, 2017

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  • DESCRIPTION

    Ampicillin sodium is a semisynthetic penicillin with a broad spectrum of activity. Ampicillin is derived from the penicillin nucleus, 6-aminopenicillanic acid (6 APA). Chemically it is D(-)α-aminobenzyl penicillin sodium salt.

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  • ACTION

    Ampicillin sodium provides bactericidal activity against a wide range of common Gram-positive and Gram-negative pathogens. Ampicillin’s activity occurs during the stage of active multiplication of the pathogen and acts through inhibition of biosynthesis of cell wall mucopeptide. In vivo studies have demonstrated the susceptibility of many strains of the following Gram-positive bacteria: Staphylococcus spp. and Streptococcus spp. (including S. equi). In vivo studies have also demonstrated the susceptibility of many strains of the following Gram-negative bacteria: E. coli and Proteus mirabilis. Because it does not resist destruction by penicillinase, it is not effective against penicillinase-producing bacteria, particularly resistant staphylococci. Most strains of Pseudomonas, Klebsiella and Aerobacter are resistant.

    Ampicillin sodium diffuses readily into all body tissues and fluids, with the exception of brain and spinal fluid except when the meninges are inflamed. It produces high and persistent blood levels. Most of the ampicillin is excreted unchanged in the urine.

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  • INDICATIONS

    Ampicillin sodium is indicated in the treatment of susceptible strains of the organisms causing the following infections in the horse: Respiratory tract infections (pneumonia and strangles) due to Staphylococcus spp., Streptococcus spp. (including S. equi), E. coli, and Proteus mirabilis.

    Skin and soft tissue infections (abscesses and wounds) due to Staphylococcus spp., Streptococcus spp., E. coli, and Proteus mirabilis.

    As with all antibiotics, appropriate in vitroculturing and susceptibility testing of samples taken before treatment should be conducted.

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  • CONTRAINDICATIONS

    The use of this drug is contraindicated in animals with a history of an allergic reaction to penicillin.

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  • ADVERSE REACTIONS

    Ampicillin is a semisynthetic penicillin and has the potential for producing allergic reactions. If an allergic reaction occurs, administer epinephrine and/or steroids. Possible minor irritation at the injection site may occur.

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  • WARNINGS

    Restricted Drug (California) - Use only as Directed.

    Do not use in horses intended for human consumption.

    Not for human use.

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  • CAUTION

    Federal law restricts this drug to use by or on the order of a licensed veterinarian.

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  • DOSAGE AND ADMINISTRATION

    HORSES - The recommended dose is 3 mg per pound of body weight administered twice a day. Ampicillin sodium may be administered by either the intravenous or intramuscular route. Treatment should be continued 48 hours after all symptoms have subsided. If no response is seen in 4-5 days, diagnosis should be re-evaluated.

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  • DIRECTIONS FOR USE

    The dry filled vials should be reconstituted immediately before use by the addition of the appropriate amount of Sterile Water for Injection, USP indicated below. This results in a final concentration of approximately 300 mg per mL.

    Vial Size

    Amount of Diluent to be Added

    1 Gram

    2.6 mL

    3 Gram

    7.6 mL

    Stability studies with the concentrated product (300 mg/mL) demonstrated that ampicillin is stable for 1 hour at room temperature (70° - 75° F).

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  • HOW SUPPLIED

    Ampicillin Sodium is supplied in vials containing 1 gram and 3 grams of ampicillin activity.

    Store dry powder at room temperature, 15° to 30°C (59° to 86°F).

    NDC 10515-335-01                   1 gm vial
    NDC 10515-335-03                   3 gm vial

    ANADA 200-335       Approved by FDA

    Manufactured by:
    G.C. Hanford Mfg. Co.

    Syracuse, NY 13201                   INS15793 03           7/2011

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  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    1g Ampicillin Sodium vial label

    NDC 10515-335-01

    AMPICILLIN SODIUM

    For Intravenous or Intramuscular Use in Horses Only

    1 GRAM

    Each vial contains: Ampicillin sodium equivalent to 1 gram ampicillin.

    CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

    Mfd. By G.C. Hanford Mfg. Co.
    Syracuse, NY 13201

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  • INGREDIENTS AND APPEARANCE
    AMPICILLIN SODIUM 
    ampicillin sodium injection, powder, for solution
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:10515-335
    Route of Administration INTRAVENOUS, INTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AMPICILLIN SODIUM (UNII: JFN36L5S8K) (AMPICILLIN - UNII:7C782967RD) AMPICILLIN 1 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10515-335-01 10 in 1 TRAY
    1 1 in 1 VIAL, GLASS
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANADA ANADA200335 01/30/2009
    Labeler - GC Hanford Manufacturing Company (002238863)
    Establishment
    Name Address ID/FEI Business Operations
    GC Hanford Manufacturing Company 002238863 MANUFACTURE, ANALYSIS
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