Surpass Topical Cream for Horses 124 gram
RX Only
Prescription items are NON-RETURNABLE and NON-REFUNDABLE
Surpass™ Topical Cream is indicated for the control of
pain and inflammation associated with osteoarthritis (OA) in tarsal, carpal,
metacarpophalangeal, metatarsophalangeal and proximal interphalangeal (hock,
knee, fetlock and pastern) joints in horses.
sage: Apply a five-inch (5") ribbon of Surpass topical cream
twice daily over the affected joint for up to ten days.
Surpass™ topical cream contains 1% diclofenac sodium. Diclofenac
is a non-steroidal anti-inflammatory drug of the phenylacetic acid class. The
chemical name for diclofenac is sodium [o- (2,6-dichloroanilino)phenyl]acetate.
The empirical formula is C14H10Cl2NNaO2 and the molecular weight is 318.13.
Surpass™ topical cream contains 1% diclofenac sodium
in a base composed of Phospholipon 90H, propylene glycol, alcohol (5.94%),
vitamin E acetate, benzethonium chloride and purified water in the Wisdom® liposomal formulation.
Administration: Wear rubber gloves to prevent absorption into the
hands. Rub the cream thoroughly into the hair covering the joint until it
disappears.
In a controlled field study, 82 horses with osteoarthritis were
treated with Surpass™ topical cream (42 horses) or placebo (40 horses).
Lameness examinations were performed in horses with osteoarthritis associated
with the tarsal, carpal, metacarpophalangeal, metatarsophalangeal and proximal
interphalangeal joints. Investigators were masked to treatment. Investigators
and owners were instructed to apply the test article over the affected joint
twice daily (BID) for five days. Actual doses received by individual horses
were calculated using tube weight measurements. The mean dose applied during
the study was 73 mg per application. Average lameness scores showed
statistically significant improvement following treatment with Surpass topical
cream.
One diclofenac-treated horse developed colic and responded to
symptomatic treatment on day four of the study. Day five bloodwork for the
horse that colicked showed decreases in RBC, Hb and HCT, with an increase in
PMNs, compared to pretreatment values. One placebo-treated horse exhibited
mildly jaundiced mucous membranes on day five. No other adverse reactions were
noted during the study.
Animal
Safety
A controlled safety study was conducted with Surpass topical
cream. Four groups of six healthy adult horses received 0, 0.6, 1.7 or 2.8X the
recommended daily dose for twenty-eight days. The daily dose was divided into
two applications on day one of the study. For the remainder of the study, the
entire daily dose was given at one time on 0, 1, 3 or 5 joints (tarsal, carpal,
metacarpophalangeal, metatarsophalangeal, and proximal interphalangeal joints),
depending on the dosage group. The control group of six horses was sham-dosed
by rubbing the joints daily for twenty-eight days. An additional study group
evaluated six horses that received 5.6X the recommended daily dose of Surpass
topical cream distributed over five joints on a single day. This dose group was
observed for fourteen days without additional treatment.
Clinical examinations, hematology, serum chemistry, synovial fluid
analyses, gross necropsy and histopathology were performed. At necropsy, one
horse in the 5.6X group had a glandular gastric ulcer. A horse in the 2.8X
group had diarrhea and uterine discharge throughout the study. Four of the six
horses in the 5.6X group lost weight during the study.
Dose-dependent increases in diclofenac plasma concentrations were
detected in horses in the 1.7X and 2.8X treatment groups.