Animal NDC 54771-2332-1 Amiglyde-v

Amikacin Sulfate

Animal NDC Product Code 54771-2332-1

Field Name Field Value
Animal NDC Code 54771-2332-1
Proprietary Name Amiglyde-v What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Amikacin Sulfate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Zoetis Inc.
Product Type Prescription Animal Drug
Active Ingredient(s)
  • Amikacin Sulfate
Marketing Category NADA - NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number NADA127892 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Amiglyde-v Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Caution

NADA 127-892, Approved by FDAFederal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

Description

Amikacin sulfate is a semi-synthetic aminoglycosideantibiotic 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).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.

Action

Antibacterial  ActivityThe 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 monocytogenesureus (both penicillin-resistant and penicillin-sensitive)The aminoglycoside antibiotics in general have limitedactivity 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 itsability to resist degradation by aminoglycosideinactivating enzymes known to affect gentamicin,tobramycin and kanamycin2.

Clinical Pharmacology

Endometrial  Tissue  ConcentrationsComparisons 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 bythe 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 lowerthan corresponding serum concentrations of amikacin.

Safety

AMIGLYDE-V is non-irritating to equine endometrialtissue when infused into the uterus as directed (see ADMINISTRATION AND DOSAGE). In laboratoryanimals 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-V8 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.

Indications

AMIGLYDE-V is indicated for the treatment of uterineinfections (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 otheraminoglycosides, 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.

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.

Contraindications

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

Precautions

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

Adverse Reactions

No adverse reactions or other side effects have been reported.

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

How Supplied

AMIGLYDE-V (amikacin sulfate injection) VeterinarySolution is supplied as a colorless solution which is stablewhen stored at or below 25°C (77°F). Use contents within3 months of first vial puncture.48 mL vial, 250 mg/mLStore at or below 25°C (77°F).

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 49007Revised: March 2017 40017969

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