Amiglyde-V Dailymed

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 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.

Administrationand 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.

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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.

Approved by FDA under NADA # 127-892 zoetis Manufactured and Distributed by:Zoetis Inc.Kalamazoo, MI 49007

Revised: July 2019

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