Dosage Form: FOR ANIMAL USE ONLY
UNIPRIM® POWDER For Use in Horses Uniprim Powder Description
Uniprim Powder contains 67 mg trimethoprim and 333 mg sulfadiazine per gram.
Microbiology: Trimethoprim blocks bacterial production of tetrahydrofolic acid from dihydrofolic acid by binding to and reversibly inhibiting the enzyme dihydrofolate reductase.
Sensitive Moderately Sensitive Not Sensitive Escherichia Staphylococcus Moraxella Mycobacterium Streptococcus Neisseria Nocardia Leptospira Proteus Klebsiella Brucella Pseudomonas Salmonella Fusiformis
Erysipelothrix Pasteurella Corynebacterium
As a result of the sequential double blockade of the metabolism of susceptible organisms by trimethoprim and sulfadiazine, the minimum inhibitory concentration (MIC) of trimethoprim/sulfadiazine is markedly less than that of either of the components used separately. Many strains of bacteria that are not susceptible to one of the components are susceptible to trimethoprim/sulfadiazine. A synergistic effect between trimethoprim and sulfadiazine in combination has been shown experimentally both in vitro and in vivo (in dogs).
Trimethoprim/sulfadiazine is bactericidal against susceptible strains and is often effective against sulfonamide-resistant organisms. In vitro sulfadiazine is usually only bacteriostatic.
The precise in vitro MIC of the combination varies with the ratio of the drugs present, but action of trimethoprim/sulfadiazine occurs over a wide range of ratios with an increase in the concentration of one of its components compensating for a decrease in the other. It is usual, however, to determine MIC’s using a constant ratio of one part trimethoprim in twenty parts of the combination.
The following table shows, MIC’s using the above ratio, of bacteria which were susceptible to both trimethoprim (TMP) and sulfadiazine (SDZ). The organisms are those most commonly involved in conditions for which trimethoprim/sulfadiazine is indicated:
AVERAGE MINIMUM INHIBITORY CONCENTRATION (MIC-mcg/mL) Bacteria TMP
24.5 0.07 1.31
0.15 2.85 The following table demonstrates the marked effect of the trimethoprim and sulfadiazine combination against sulfadiazine-resistant strains of normally susceptible organisms:
AVERAGE MINIMUM INHIBITORY CONCENTRATION OF SULFADIAZINE-RESISTANT STRAINS (MIC-mcg/mL) Bacteria
Susceptibility Testing: In testing susceptibility to trimethoprim/sulfadiazine, it is essential that the medium used does not contain significant amounts of interfering substances which can bypass the metabolic blocking action, e.g., thymidine or thymine.
The standard SxT disc is appropriate for testing by the disc diffusion method.
Pharmacology: Following oral administration, trimethoprim/sulfadiazine is rapidly absorbed and widely distributed throughout body tissues. Concentrations of trimethoprim are usually higher in tissues than in blood. The levels of trimethoprim are high in lung, kidney, and liver, as would be expected from its physical properties.
Serum trimethoprim concentrations in horses following oral administration indicate rapid absorption of the drug; peak concentrations occur in 1.5 hours. The mean serum elimination half-life is 2 to 2.5 hours. Sulfadiazine absorption is slower, requiring 2.5 to 6 hours to reach peak concentrations. The mean serum elimination half-life for sulfadiazine is 4 to 5.5 hours.
Usually, the concentration of an antibacterial in the blood and the in vitro MIC of the infecting organism indicate an appropriate period between doses of a drug. This does not hold entirely for trimethoprim/sulfadiazine because trimethoprim, in contrast to sulfadiazine, localizes in tissues and therefore, its concentration and ratio to sulfadiazine are higher there than in blood.
The following table shows the average concentration of trimethoprim and sulfadiazine, as measured in either serum or plasma, in twenty-four adult horses observed after a single dose of Uniprim Powder: AVERAGE SERUM/PLASMA CONCENTRATION (mcg/mL) Trimethoprim (5 mg/kg)
1hr 3hr 6hr 10hr 24hr
1hr 3hr 6hr 10hr 24hr
0.82 0.69 0.36 0.12 Less than .025
9.9 18.8 17.3 9.0 1.6
Excretion of trimethoprim/sulfadiazine is chiefly by the kidneys, by both glomerular filtration and tubular secretion. Urine concentrations of both trimethoprim and sulfadiazine are severalfold higher than blood concentrations. Neither trimethoprim nor sulfadiazine interferes with the excretion pattern of the other. Indications and Usage for Uniprim Powder
Trimethoprim/sulfadiazine is indicated in horses where potent systemic antibacterial action against sensitive organisms is required. Trimethoprim/sulfadiazine is indicated where control of bacterial infections is required during treatment of:Acute Strangles
Acute Urogenital Infections
Respiratory Tract Infections
Wound Infections and Abscesses
Trimethoprim/sulfadiazine is well tolerated by foals. Contraindications
Trimethoprim/sulfadiazine should not be used in horses showing marked liver parenchymal damage, blood dyscrasias, or in those with history of sulfonamide sensitivity.Warning
Do not use in horses intended for human consumption.Adverse Reactions
No adverse reactions of consequence have been noted following administration of trimethoprim/sulfadiazine. During clinical trials, one case of anorexia and one case of loose feces following treatment with the drug were reported.
Water should be readily available to horses receiving sulfonamide therapy.TOXICITY AND SIDE EFFECTS
Toxicity is low. The acute toxicity of trimethoprim/sulfadiazine is more than 5 g/kg orally in rats and mice. No significant changes were recorded in rats given doses of 600 mg/kg per day for 90 days.
The effect of trimethoprim/sulfadiazine on pregnancy has not been determined. Studies to date show there is no detrimental effect on stallion spermatogenesis with or following the recommended dose of trimethoprim/sulfadiazine.Uniprim Powder Dosage and Administration
The recommended dose is 3.75 g trimethoprim/sulfadiazine per 110 lbs (50 kg) body weight per day. Administer trimethoprim/sulfadiazine Powder orally once a day in a small amount of palatable feed.
Uniprim Powder is available in 37.5 g packets, 1125 g packets, 200g jars, 400g jars, 1200 g jars, 2000 g pails and 12 kg boxes.CAUTION
Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.
ANADA # 200-033, approved by FDA
UP093759 Rev. 9/07 PRINCIPAL DISPLAY PANEL - 400 g jar (Apple Flavored)
MACLEOD PHARMACEUTICALS, INC.
Each gram contains: 67mg Trimethoprim, 333mg Sulfadiazine
trimethoprim and sulfadiazine powder Product Information Product Type PRESCRIPTION ANIMAL DRUG NDC Product Code (Source) 58711-3011 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Trimethoprim (Trimethoprim) Trimethoprim 67 mg in 1 g Sulfadiazine (Sulfadiazine) Sulfadiazine 333 mg in 1 g Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color Score Shape Size Flavor APPLE (Apple Flavored) Imprint Code Contains Packaging # NDC Package Description Multilevel Packaging 1 58711-3011-3 400 g In 1 JAR None 2 58711-3011-4 200 g In 1 JAR None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200033 08/04/2010
Labeler - Macleod Pharmaceuticals Inc. (609248240) Establishment Name Address ID/FEI Operations Macleod Pharmaceuticals Inc. 609248240 manufacture Establishment Name Address ID/FEI Operations Alpharma, LLC. 090610770 manufacture Establishment Name Address ID/FEI Operations Celsis Analytical Services 052618063 analysis Revised: 12/2010Macleod Pharmaceuticals Inc.
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