FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
AmiMax™ E Solution (amikacin sulfate) 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.
History
There is currently no drug history available for this drug.
Other Information
Amikacin sulfate is a semi-synthetic aminoglycoside antibiotic derived from kanamycin. It is C22H43N5O13•2H2SO4, D-streptamine, O-3-amino-3-deoxy-α-D-glucopyranosyl-(1→6)-O-[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, 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 AmiMaxTM E Solution (amikacin sulfate) 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
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 kanamycin2.
Sources
Colgate Sensitive Maximum Strength Whitening Manufacturers
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Mission Hills S.a. De C.v.
Colgate Sensitive Maximum Strength Whitening | Bayer Healthcare Llc
For treatment of uterine infections in mares, 2 grams (8 mL) of AmiMax™ E Solution (amikacin sulfate), 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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