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New Topical Anti-Inflammatory Equine Pain Treatment Approved for Use
Horse Health Press Release
IDEXX Laboratories, Inc., today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market and sell SURPASS™ (1% diclofenac sodium) Topical Anti-Inflammatory Cream, a new treatment for horses with pain and lameness due to osteoarthritis. SURPASS topical cream represents the first equine pharmaceutical use of a topical liposomal formulation of the FDA-approved nonsteroidal anti-inflammatory drug, diclofenac. The product is labeled as a veterinary-only prescription medication to be used under the supervision of a licensed, practicing veterinarian.
"Used in a comprehensive pain management program, SURPASS topical cream offers localized pain relief without many of the side effects seen with systemic products," commented IDEXX President and CEO, Jonathan Ayers. "SURPASS is manufactured to exacting standards for incorporation of the powerful pain reliever, diclofenac, in a proprietary liposomal formulation. This means practitioners can count on consistency in every tube."
Label information for the product follows. Please check back for updates on the medication.
SURPASS™ (1% diclofenac sodium)
Topical Anti-Inflammatory Cream for Use in Horses
Please consult the full package insert for more information.
Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Description: SURPASS™ topical cream contains 1% diclofenac sodium in a liposomal formulation.
Indications: 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.
Contraindications: SURPASS topical cream is contraindicated in animals with known hypersensitivity to diclofenac.
Warnings: Not for horses intended for human consumption. Keep out of reach of children. Not for human use.
Precautions: Treatment with SURPASS should be terminated if signs such as inappetence, colic, fecal abnormalities, anemia or depression are observed. The safety of SURPASS has not been investigated in breeding, pregnant or lactating horses or in horses under one year of age.
Adverse Reactions: During the field study one diclofenac horse developed colic on day four of the study. Adverse reactions during the safety study included a gastric ulcer in one horse that received 5.6X the recommended dosage, diarrhea and uterine discharge in one horse that received 2.8X the recommended dosage, and weight loss in four of the six horses in the 5.6X dosage group.
To report suspected adverse reactions, to obtain a Material Safety Data Sheet or for technical assistance, call 800/374-8006.
Storage Information: Store at up to 25 degrees C (77°F). Protect from freezing.
How Supplied: SURPASS topical cream is white to pinkish-white and is packaged in 124-gram trilaminate tubes.
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