Label: AMIGLYDE-V- amikacin sulfate injection

  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated February 14, 2018

If you are a consumer or patient please visit this version.

  • Caution

    NADA 127-892, Approved by FDA

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

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  • DESCRIPTION

    Amikacin sulfate is a semi-synthetic aminoglycoside
    antibiotic derived from kanamycin. It is C22H43N5O13•2H2SO4,  D-streptamine, 0-3-amino-3-
    deoxy-α-D-glucopyranosyl-(1→6)-0-[6-amino-6- deoxy-α-D-glucopyranosyl-(1→4)]-N1-(4-amino-2-
    hydroxy-1-oxobutyl)-2-deoxy-, (S)-, sulfate (1:2) (salt).

    Structure


    The dosage form supplied is a sterile, colorless solution.
    The solution contains, in addition to amikacin sulfate, USP, 2.5% sodium citrate, USP with pH
    adjusted to 4.5 with sulfuric acid and 0.66% sodium bisulfite added. The multi-dose 12 gram–48 mL
    vial contains 0.01% benzethonium chloride, USP as a preservative.

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  • ACTION


    Antibacterial  Activity

    The effectiveness of AMIGLYDE-V (amikacin sulfate injection) in infections caused by Escherichia
    coli
    , Pseudomonas sp and Klebsiella sp has been demonstrated clinically in the horse. In addition,
    the following microorganisms have been shown to be susceptible to amikacin in vitro1, although the
    clinical significance of this action has not been demonstrated in animals:
    • Enterobacter sp
    • Proteus mirabilis
    • Proteus sp (indole positive)
    • Serratia marcescens
    • Salmonella sp
    • Shigella sp
    • Providencia sp
    • Citrobacter freundii
    • Listeria monocytogenes
    ureus
    (both penicillin-
    resistant and penicillin-sensitive)


    The aminoglycoside antibiotics in general have limited
    activity against gram-positive pathogens, although Staphylococcus aureus and Listeria monocytogenes
    are susceptible to amikacin as noted above.

    Amikacin has been shown to be effective against

    many aminoglycoside-resistant strains due to its

    ability to resist degradation by aminoglycoside

    inactivating enzymes known to affect gentamicin,

    tobramycin and kanamycin2.



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  • CLINICAL PHARMACOLOGY


    Endometrial  Tissue  Concentrations

    Comparisons of amikacin activity in endometrial biopsy tissue following intrauterine infusion with
    that following intramuscular injection of AMIGLYDE-V in mares demonstrate superior endometrial
    tissue concentrations when the drug is administered by
    the intrauterine route.
    Intrauterine infusion of 2 grams AMIGLYDE-V daily for three consecutive days in mares results in
    peak concentrations typically exceeding 40 mcg/g of endometrial biopsy tissue within one hour after
    infusion. Twenty-four hours after each treatment amikacin activity is still detectable at
    concentrations averaging 2 to 4 mcg/g. However, the drug is not appreciably absorbed systemically
    following intrauterine infusion. Endometrial tissue concentrations following intramuscular
    injection are roughly parallel, but are typically somewhat lower
    than corresponding serum concentrations of amikacin.

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  • SAFETY


    AMIGLYDE-V is non-irritating to equine endometrial
    tissue when infused into the uterus as directed (see ADMINISTRATION AND DOSAGE). In laboratory
    animals as well as equine studies, the drug was generally found not to be irritating when injected
    intravenously, subcutaneously or intramuscularly.
    Although amikacin, like other aminoglycosides, is potentially nephrotoxic, ototoxic and neurotoxic,
    parenteral (intravenous) administration of AMIGLYDE-V (amikacin sulfate injection) twice daily at
    dosages of up to 10 mg/lb for 15 consecutive days in horses resulted in no clinical, laboratory or
    histopathologic evidence of toxicity.
    Intrauterine infusion of 2 grams of AMIGLYDE-V
    8 hours prior to breeding by natural service did not impair fertility in mares. Therefore, mares
    should not be bred for at least 8 hours following uterine infusion.

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  • INDICATIONS


    AMIGLYDE-V is indicated for the treatment of uterine
    infections (endometritis, metritis and pyometra) in mares, when caused by susceptible organisms
    including Escherichia coli, Pseudomonas sp and Klebsiella sp. The use of AMIGLYDE-V in eliminating
    infections caused by the above organisms has been shown clinically to improve fertility in infected
    mares.
    While nearly all strains of Escherichia coli,
    Pseudomonas sp and Klebsiella sp, including those that are resistant to gentamicin, kanamycin or other
    aminoglycosides, are susceptible to amikacin at levels achieved following treatment, it is
    recommended that the invading organism be cultured and its susceptibility demonstrated as a guide
    to therapy. Amikacin susceptibility discs, 30 mcg, should be used for determining in vitro susceptibility.

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  • ADMINISTRATION AND DOSAGE


    For treatment of uterine infections in mares, 2 grams
    (8 mL) of AMIGLYDE-V, mixed with 200 mL 0.9% Sodium chloride injection, USP and aseptically infused
    into the uterus daily for three consecutive days, has been found to be the most efficacious dosage.


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  • CONTRAINDICATIONS

    There are no known contraindications for the use of
    AMIGLYDE-V in horses other than a history of hypersensitivity to amikacin.


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  • PRECAUTIONS

    Although AMIGLYDE-V is not absorbed to an appreciable
    extent following intrauterine infusion, concurrent use of other aminoglycosides should              
     be avoided because of the potential for additive effects.

    .

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  • ADVERSE REACTIONS

    No adverse reactions or other side effects have been reported.

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  • WARNINGS


    Do not use in horses intended for human consumption.

    In vitro studies have demonstrated that when sperm are exposed to the preservative which is present in the 48 mL

    vials (250 mg/mL) sperm viability is impaired.

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  • HOW SUPPLIED

    AMIGLYDE-V (amikacin sulfate injection) Veterinary

    Solution is supplied as a colorless solution which is stable

    when stored at or below 25°C (77°F). Use contents within

    3 months of first vial puncture.

    48 mL vial, 250 mg/mL

    Store at or below 25°C (77°F).

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  • REFERENCES

    1. Price, K.E., et al: Microbiological Evaluation of BB-K8,

        a New Semisynthetic Aminoglycoside.

        J Antibiot 25: 709–731, 1972.

    2. Davies, J., Courvalin, P.: Mechanisms of Resistance to

        Aminoglycosides. Am J Med 62: 868–872, 1977.

    Distributed by:

    Zoetis Inc.

    Kalamazoo, MI 49007

    Revised: March 2017 40017969

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  • PRINCIPAL DISPLAY PANEL

    Amiglyde-V®

    (amikacin sulfate injection)

    FOR INTRAUTERINE USE IN

    THE HORSE ONLY

    Veterinary Solution

    Equivalent to 250 mg

    amikacin per mL

    12 gram - 48 mL

    50128800

    Zoetis

    Amiglyde-V Carton Label
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  • INGREDIENTS AND APPEARANCE
    AMIGLYDE-V 
    amikacin sulfate injection
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54771-2332
    Route of Administration INTRAUTERINE
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AMIKACIN SULFATE (UNII: N6M33094FD) (AMIKACIN - UNII:84319SGC3C) AMIKACIN 250 mg  in 1 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54771-2332-1 1 in 1 CARTON
    1 48 mL in 1 VIAL
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NADA NADA127892 02/01/2017
    Labeler - Zoetis Inc. (828851555)
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