AMIGLYDE-V- amikacin sulfate injection

Amiglyde-V by

Drug Labeling and Warnings

Amiglyde-V by is a Animal medication manufactured, distributed, or labeled by Zoetis Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Caution

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

DESCRIPTION

Amikacin sulfate is a semi-synthetic aminoglycoside
antibiotic derived from kanamycin. It is C22H43N5O132H2SO4,  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  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.

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.

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.

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.

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 of
AMIGLYDE-V in horses other than a history of hypersensitivity to amikacin.

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.

.

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 mL

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

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).

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.

SPL UNCLASSIFIED SECTION

Approved by FDA under NADA # 127-892

zoetis

Manufactured and Distributed by:
Zoetis Inc.
Kalamazoo, MI 49007

Revised: July 2019

40028299

PRINCIPAL DISPLAY PANEL - Carton Label

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)