Amikacin Rx, 250 mg x 48 ml Liquid |  | 
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| | Product Details: | AMIKACIN SULFATE SOLUTION
Rx
Vet Tek
Solution
ANADA 200-181, Approved by FDA
Each mL contains:
| Amikacin (as the sulfate) |
250 mg |
| Sodium citrate, USP (as buffer) |
25.1 mg |
| Sodium bisulfite |
6.6 mg |
| Benzethonium chloride (as preservative) |
0.1 mg
|
| pH adjusted with sulfuric acid |
|
| Water for injection |
q.s.
|
DESCRIPTION
Amikacin sulfate is a semisynthetic 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).
The dosage form supplied is a sterile, colorless to light straw colored solution. The solution contains, in addition to amikacin sulfate, 2.5% sodium citrate with pH adjusted to 4.5 with sulfuric acid and 0.66% sodium bisulfate added. The multi-dose 12 gram vial contains 0.01% benzethonium chloride as a preservative.
ACTION
Antibacterial Activity
The effectiveness of Amikacin Sulfate Solution 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 vitro,(1) 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
Staphylococcus aureus (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 kanamycin.(2)
CLINICAL PHARMACOLOGY
Endometrial Tissue Concentrations
Comparisons of amikacin activity in endometrial biopsy tissue following intrauterine infusion with that following intramuscular injection of amikacin sulfate in mares demonstrate superior endometrial tissue concentrations when the drug is administered by the intrauterine route.
Intrauterine infusion of 2 grams Amikacin Sulfate Solution 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 roughly parallel, but are typically somewhat lower than corresponding serum concentrations of amikacin.
Safety
Amikacin Sulfate Solution is non-irritating to equine endometrial tissue when infused into the uterus as directed (see Dosage and Administration). 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 amikacin sulfate 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 Amikacin Sulfate Solution 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:
Amikacin Sulfate Solution 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 amikacin sulfate 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.
DOSAGE AND ADMINISTRATION
For treatment of uterine infections in mares, 2 grams (8 mL) of Amikacin Sulfate Solution, 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 amikacin sulfate in horses other than a history of hypersensitivity to amikacin.
PRECAUTIONS
Although amikacin sulfate 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.
WARNING
Not to be used in horses intended for food.
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.
SUPPLY
Amikacin Sulfate Solution is supplied as a colorless solution which is stable at room temperature. At times the solution may become pale yellow in color. This does not indicate a decrease in potency.
48 mL vial, 250 mg/mL
Store at controlled room temperature 15°-30°C (59°-86°F).
NOT FOR HUMAN USE
KEEP OUT OF REACH OF CHILDREN
FOR INTRAUTERINE USE IN THE HORSE ONLY
Prescription items are NON-RETURNABLE and NON-REFUNDABLE.
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