Equisul-SDT Oral Suspension 400 mg/mL (280 mL)

Equisul-SDT Oral Suspension is a broad-spectrum antimicrobial from the potentiated sulfonamide class of chemotherapeutic agents. These two drugs block different sequential steps in the biosynthesis of nucleic acids. Sulfadiazine inhibits bacterial synthesis of dihydrofolic acid by competing with para-aminobenzoic acid. Trimethoprim blocks the production of tetrahydrofolic acid from dihydrofolic acid by reversibly inhibiting dihydrofolate reductase. The effect of the dual action is to reduce the minimum inhibitory concentration of each agent (synergism) and to convert a bacteriostatic action to a bactericidal action. Sulfadiazine is the non-proprietary name for 4-amino-N-2-pyrimidi-nylbenzenesulfonamide. Trimethoprim is the non-proprietary name for 5-[(3,4,5-trimethoxyphenyl)methyl]-2,4-pyrimidinediamine.

Key Benefits

• EQUISUL-SDT is proven effective in horses for the treatment of lower respiratory tract infections caused by susceptible strains of Streptococcus equi subsp. zooepidemicus in controlled field trials.
• EQUISUL-SDT safety was demonstrated in a controlled study in horses at 1X, 3X and 5X the recommended dose for 30 days.
• Easy-to-use liquid formulation.
• Significantly higher bioavailability on a mg-to-mg basis compared to an existing approved paste product, based on a pharmacokinetic crossover study.
• Low incidence of side effects in our controlled safety studies.

Indications

EQUISUL-SDT is indicated for the treatment of lower respiratory tract infections in horses caused by susceptible strains of Streptococcus equi subsp. zooepidemicus.

View Equisul-SDT Drug Facts Sheet.

Shake well before use.

Administer EQUISUL-SDT orally at the dosage of 24 mg combined active ingredients per kilogram body weight (10.9 mg/lb) twice daily for 10 days. EQUISUL-SDT can be administered by volume at 2.7 mL per 45.4 kg (2.7 mL/100 lb) body weight.

Caution:

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

Contraindications:

EQUISUL-SDT is contraindicated in horses with a known allergy to sulfadiazine, sulfonamide class antimicrobials, or trimethoprim.

Warning:

Do not use in horses intended for human consumption.

Human Warnings:

Not for use in humans. For use in animals only. Keep this and all drugs out of the reach of children. Consult a physician in the case of accidental human exposure.

Antimicrobial drugs, including sulfonamides, can cause mild to severe allergic reactions in some individuals. Avoid direct contact of the product with the skin, eyes, mouth, and clothing. Persons with a known sensitivity to sulfonamides or trimethoprim should avoid exposure to this product. If an allergic reaction occurs (e.g., skin rash, hives, difficulty breathing, facial swelling) seek medical attention.

Precautions:

Prescribing antibacterial drugs in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to treated animals and may increase the risk of development of drug-resistant animal pathogens.

The administration of antimicrobials, including sulfadiazine and trimethoprim, to horses under conditions of stress may be associated with acute diarrhea that can be fatal. If acute diarrhea or persistent changes in fecal consistency are observed, additional doses of EQUISUL-SDT should not be administered and appropriate therapy should be initiated.

The safe use of EQUISUL-SDT has not been evaluated in breeding, pregnant, or lactating horses. Potentiated sulfonamides should only be used in pregnant or lactating mares when the benefits to the mare justify the risks to the fetus. Use of potentiated sulfonamides during pregnancy has been associated with an increased risk of congenital abnormalities that may be related to folate deficiency. In humans, sulfonamides pass through the placenta, are excreted in milk, and may cause hyperbilirubinemia-induced neurotoxicity in nursing neonates.

Decreased hematopoetic activity and blood dyscrasias have been associated with the use of elevated doses and/or prolonged administration of potentiated sulfonamides. EQUISUL-SDT should be discontinued if prolonged clotting times, or decreased platelet, white blood cell or red blood cell counts are observed.

Sulfonamides should be used with caution in horses with impaired hepatic function. Although rare, sulfonamide use has been associated with fulminant hepatic necrosis in humans.

Neurologic abnormalities have been reported in several species following administration of potentiated sulfonamides. In horses, potentiated sulfonamides have been associated with gait alterations and behavior changes that resolved after discontinuation of the drug.

The safe use of EQUISUL-SDT has not been evaluated in horses less than 1 year of age.

Animal Safety:

In a target animal safety study, EQUISUL-SDT was administered orally to 32 healthy adult horses at 0 (0X), 24 (1X), 72 (3X), or 120 (5X) mg/kg twice daily for 30 days. Loose stool was the most common abnormal observation. Observations of loose stool (pellets with liquid or unformed/cowpile stool) occurred more often in horses treated with EQUISUL-SDT with the incidence of loose stool increasing in a dose related manner. All incidents of loose stool were self-limiting and resolved without treatment.

Horses in all EQUISUL-SDT groups demonstrated statistically significantly higher mean serum creatinine concentrations, and those in the 3X and 5X groups demonstrated statistically signifi-cantly higher mean serum albumin concentrations. Statistically higher mean neutrophil counts and mean serum gamma glutamyl transferase (GGT) activity were seen in the 1X and 5X groups. Individual animal creatinine, GGT, and albumin concentrations remained within the reference range. Individual animal elevations in absolute neutrophil counts ranged up to 7.09 x 10³/mcL (reference range: 1.96-5.31 x 10³/mcL).

Based upon blood concentrations obtained during the study, it was noted that the sulfadiazine and trimethoprim plasma concentrations did not increase in proportion to dose. For sulfadiazine, a 3X and 5X dose resulted in an average exposure of 2.0X and 2.6X the concentrations observed following a 1X dose. For trimethoprim, the corresponding values were 2.5X and 3.5X as compared to the 1X dose. Furthermore, marked intersubject variability, particularly with sulfadiazine, resulted in substantial overlap of individual subject blood levels across the three dosing groups.

Storage:

Store at 59°-86°F (15°-30°C). Brief periods up to 104° F (40° C) are permitted. Protect from freezing.