Label: AMPICILLIN- ampicillin injection, powder, for suspension

  • NDC Code(s): 10515-946-25
  • 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 for injectable suspension, veterinary is a broad-spectrum penicillin which has bactericidal activity against a wide range of common gram-positive and gram-negative bacteria.

    Each 25 g vial contains: 25 g ampicillin activity as ampicillin trihydrate, 90 mg methylparaben (as preservative), 10 mg propylparaben (as preservative), 200 mg lecithin, 500 mg povidone, 200 mg sodium chloride, 600 mg sodium citrate anhydrous.

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  • CLINICAL PHARMACOLOGY:

    The antimicrobial action of ampicillin is bactericidal, and only a small percentage of the antibiotic is serum-bound. Peak serum levels in dogs and cats are reached approximately one-half hour following subcutaneous or intramuscular injection, and in cattle 1 hour to 2 hours following intramuscular injection.

    In vitro studies have demonstrated sensitivity of the following organisms to ampicillin: gram-positive bacteria - alpha- and beta-hemolytic streptococci, staphylococci (non-penicillinase-producing), Bacillus anthracis and most strains of enterococci and clostridia; gram-negative bacteria - Proteus mirabilis, E. coli and many strains of Salmonella and Pasteurella multocida.

    The drug does not resist destruction by penicillinase and, hence, is not effective against strains of staphylococci resistant to penicillin G. Susceptibility tests should be conducted to estimate the in vitro susceptibility of bacterial isolates to ampicillin.

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  • INDICATIONS:

    Ampicillin for injectable suspension has proved effective in the treatment of many infections previously beyond the spectrum of penicillin therapy. This drug is particularly indicated in the treatment of the following infections caused by susceptible strains of organisms:

    Dogs and Cats - Respiratory Tract Infections: Upper respiratory infections, tonsillitis and bronchopneumonia due to hemolytic streptococci, Staphylococcus aureus, Escherichia coli, Proteus mirabilis and Pasteurella spp.

    Urinary Tract Infections due to Proteus mirabilis, Escherichia coli, Staphylococcus spp., hemolytic streptococci and Enterococcus spp.

    Gastrointestinal Infections due to Enterococcus spp., Staphylococcus spp. and Escherichia coli.

    Skin, Soft Tissue and Post-Surgical Infections: Abscesses, pustular dermatitis, cellulitis and infections of the anal gland, due to Escherichia coli, Proteus mirabilis, hemolytic streptococci, Staphylococcus spp. and Pasteurella spp.

    Cattle and Calves Including Non-Ruminating (Veal Calves) - Respiratory Tract Infections: Bacterial pneumonia (shipping fever, calf pneumonia and bovine pneumonia) caused by Aerobacter spp., Klebsiella spp., Staphylococcus spp., Streptococcus spp., Pasteurella multocida and E. coli susceptible to ampicillin trihydrate.

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  • CONTRAINDICATIONS:

    A history of allergic reactions to penicillin, cephalosporins or their analogues should be considered a contraindication for the use of this agent.

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  • PRECAUTIONS:

    Because it is a derivative of 6-aminopenicillanic acid, ampicillin for injectable suspension has the potential for producing allergic reactions. If they should occur, ampicillin for injectable suspension should be discontinued and the subject treated with the usual agents (antihistamines, pressor amines, corticosteroids).

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  • RESIDUE WARNINGS

    DO NOT TREAT CATTLE FOR MORE THAN 7 DAYS.

    MILK FROM TREATED COWS MUST NOT BE USED FOR FOOD DURING TREATMENT, AND FOR 48 HOURS (4 MILKINGS) AFTER THE LAST TREATMENT.

    CATTLE MUST NOT BE SLAUGHTERED FOR FOOD DURING TREATMENT, AND FOR 144 HOURS (6 DAYS) AFTER THE LAST TREATMENT.

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  • DOSAGE:

    The dosage of ampicillin for injectable suspension will vary according to the animal being treated, the severity of the infection and the animal’s response.

    Dogs and Cats - The recommended dose for dogs or cats is 3 mg/lb of body weight administered twice daily by subcutaneous or intramuscular injection.

    Cattle and Calves Including Non-Ruminating (Veal Calves) - From 2 mg to 5 mg/lb of body weight once daily by intramuscular injection. Do not treat for more than 7 days.

    In all species, 3 days treatment is usually adequate, but treatment should be continued for 48 to 72 hours after the animal has become afebrile or asymptomatic.

    DIRECTIONS FOR USE:

    The multi-dose dry-filled vials should be reconstituted to the desired concentration by adding the required amount of Sterile Water for Injection, USP, according to label directions. SHAKE WELL.

    After reconstitution this product is stable for 3 months under refrigeration and will be white to pale yellow in color.

    At the time of reconstitution the vial should be dated and the concentration noted on the label.

    CAUTION:

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

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  • STORAGE:

    Store at controlled room temperature (25ºC), with excursions permitted from 15 - 30ºC (59 - 86ºF). After reconstitution, store under refrigeration.

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  • HOW SUPPLIED:

    Ampicillin for injectable suspension, veterinary is supplied in vials containing 25 grams ampicillin activity as ampicillin trihydrate.

     
    NDC 10515-946-25 25 g per vial
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    Manufactured by:

    G.C. Hanford Manufacturing Co., Syracuse, NY 13201

     
    LBL16155 01 01/2017
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  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    Ampicillin for Injectable Suspension, Veterinary 25g expanded content vial label

    NDC 10515-946-25 Hanford's U.S. Vet Sterile Ampicillin for Injectable Suspension, Veterinary, Equivalent to 25 g Ampicillin. Caution: Federal Law restricts this drug to use by or on the order of a licensed veterinarian. ANADA 200-180, Approved by FDA. Each vial contains: 25 g ampicillin activity as ampicillin trihydrate, 90 mg methylparaben (as preservative), 10 mg propylparaben (as preservative), 200 mg lecithin, 500 mg povidone, 200 mg sodium chloride, 600 mg sodium citrate anhydrous.

    After reconstitution, this product is stable for 3 months under refrigeration. SHAKE WELL. Date Reconstituted__________ / ________mg/mL READ INNER PANEL. Dosage: Dogs and Cats - 3 mg/lb of body weight twice daily by subcutaneous or intramuscular injection. Cattle and Calves Including Non-Ruminating (Veal Calves) - From 2 mg to 5 mg/lb of body weight once daily by intramuscular injection. Do not treat for more than 7 days. See inner panel for additional dosage recommendations. Residue Warnings: Do not treat cattle for more than 7 days. Milk from treated cows must not be used for food during treatment, and for 48 hours (4 milkings) after the last treatment. Cattle must not be slaughtered for food during treatment, and for 144 hours (6 days) after the last treatment. Store at controlled room temperature (25ºC), with excursions permitted from 15 - 30ºC (59 - 86ºF). After reconstitution, store under refrigeration. Manufactured by:

    G.C. Hanford Manufacturing Co. Syracuse, NY 13201 LBL16155 01 01/2017

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  • INGREDIENTS AND APPEARANCE
    AMPICILLIN 
    ampicillin injection, powder, for suspension
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:10515-946
    Route of Administration INTRAMUSCULAR, SUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AMPICILLIN TRIHYDRATE (UNII: HXQ6A1N7R6) (AMPICILLIN - UNII:7C782967RD) AMPICILLIN 25 g
    Inactive Ingredients
    Ingredient Name Strength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10515-946-25 1 in 1 VIAL, GLASS
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANADA ANADA200180 03/31/2015
    Labeler - GC Hanford Manufacturing Company (002238863)
    Establishment
    Name Address ID/FEI Business Operations
    GC Hanford Manufacturing Company 002238863 ANALYSIS, MANUFACTURE, LABEL
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