b'BRIEF SUMMARY OF PRESCRIBING INFORMATION CLINICAL PHARMACOLOGY:Betamethasone is a potent glucocorticoid steroid (Betamethasone Sodium Phosphate and Betamethasone Acetate Injectablewith anti-inammatory and immunosuppressive properties. Depending upon their Suspension) 6 mg betamethasone per mL physico-chemical properties, drugs administered intra-articularly may enter the For Intra-Articular (I.A.) Use in Horses general circulation because the synovial joint cavity is in direct equilibrium with the surrounding blood supply. After the intra-articular administration of 9 mg BetaVet in CAUTION: Federal law restricts this drug to use by or on the order of a licensedhorses, there were quantiable concentrations of betamethasone (above veterinarian. 1.0 ng/mL) in the plasma.INDICATION: BetaVet is indicated for the control of pain and inammationEFFECTIVENESS: A negative control, randomized, masked eld study provided data to associated with osteoarthritis in horses. evaluate the effectiveness of BetaVet administered at 1.5 mL (9 mg betamethasone) once intra-articularly for the control of pain and inammation associated with DOSAGE AND ADMINISTRATION:Shake well immediately before use. osteoarthritis in horses. Clinical success was dened as improvement in one lameness grade according to the AAEP lameness scoring system on Day 5 following treatment. CONTRAINDICATIONS:BetaVet is contraindicated in horses with hypersensitivity The success rate for horses in the BetaVet group was statistically signicantly to betamethasone. Intra-articular injection of corticosteroids for local effect isdifferent (p=0.0061) than that in the saline group, with success rates of 75.73% and contraindicated in the presence of septic arthritis. 52.52%, respectively (back-transformed from the logistic regression).WARNINGS: Do not use in horses intended for human consumption. ANIMAL SAFETY: A 3-week target animal safety (TAS) study was conducted to Clinical and experimental data have demonstrated that corticosteroids administeredevaluate the safety of BetaVet in mature, healthy horses. Treatment groups included orally or parenterally to animals may induce the rst stage of parturition whena control (isotonic saline at a volume equivalent to the 4x group); 1X (0.0225 mg administered during the last trimester of pregnancy and may precipitate prematurebetamethasone per pound bodyweight; BetaVet); 2X (0.045 mg betamethasone per parturition followed by dystocia, fetal death, retained placenta, and metritis.pound bodyweight; BetaVet) and 4X (0.09 mg betamethasone per pound bodyweight; Additionally, corticosteroids administered to dogs, rabbits and rodents duringBetaVet). Treatments were administered by intra-articular injection into the left middle pregnancy have resulted in cleft palate in offspring. Corticosteroids administered tocarpal joint once every 5-days for 3 treatments. Injection site reactions were the most dogs during pregnancy have also resulted in other congenital anomaliesincludingcommon observations in all treatment groups. Injection site reactions were observed deformed forelegs, phocomelia and anasarca. Therefore, before use of corticosteroidswithin 1 hour of dosing and included swelling at the injection site, lameness/stiffness in pregnant animals, the possible benets to the pregnant animal should be weighedof the left front limb, and exing the left front knee at rest. The injection site reactions against potential hazards to its developing embryo or fetus. Human Warnings: Not forranged from slight swelling (in many horses on multiple days in all treatment groups) use in humans. For use in animals only. Keep this and all medications out of the reachto excessive uid with swelling, pain, and lameness (4x group only). Injection site of children. Consult a physician in the case of accidental human exposure. reactions were observed most commonly on treatment days, and generally decreased in number and severity over subsequent days. The incidence of injection site reactions PRECAUTIONS: Corticosteroids, including BetaVet, administered intra-articularly areincreased after the second and third injection (number of abnormalities noted on day 10 systemically absorbed. Do not use in horses with acute infections. Acute moderate to> day 5 > day 0). In the BetaVet treated groups the number and severity of the injection severe exacerbation of pain, further loss of joint motion, fever, or malaise within severalsite reactions were dose dependent. The 4X BetaVet group had the highest overall days following intra-articular injection may indicate a septic process. Because of theincidence of and severity of injection site reactions, which included heat, swelling, anti-inammatory action of corticosteroids, signs of infection in the treated joint maypain, bleeding, and holding the limb up at rest. The control group and 4X group (which be masked. Appropriate examination of joint uid is necessary to exclude a septicreceived similar injection volumes) had a similar incidence of injection site reactions; process. If a bacterial infection is present, appropriate antibacterial therapy should behowever, the severity of reactions was greater in the 4X group. Absolute neutrophils instituted immediately. Additional doses of corticosteroids should not be administeredwere statistically signicantly higher in the BetaVet treated groups as compared to until joint sepsis has been denitively ruled out. Due to the potential for exacerbationthe control group. Trends toward a decrease in lymphocytes and eosinophils, and an of clinical signs of laminitis, glucocorticoids should be used with caution in horsesincrease in monocytes were identied in the BetaVet treated groups after the initial with a history of laminitis, or horses otherwise at a higher risk for laminitis. Use withdose of BetaVet. Individual animal values for white blood cells generally remained caution in horses with chronic nephritis, equine pituitary pars intermedia dysfunctionwithin the reference range. BetaVet treated horses also had a trend toward increased (PPID), and congestive heart failure. Concurrent use of other anti-inammatory drugs,blood glucose after the initial dose. Some individual animals showed mild increases in such as NSAIDs or other corticosteroids, should be approached with caution. Due toblood glucose above the reference range.the potential for systemic exposure, concomitant use of NSAIDs and corticosteroids may increase the risk of gastrointestinal, renal, and other toxicity. Consider appropriateSHAKE WELL BEFORE USINGwash out times prior to administering additional NSAIDs or corticosteroids. NADA 141-418, Approved by FDAADVERSE REACTIONS:Adverse reactions reported during a eld study of 239 horsesFor customer care or to obtain product information visit of various breeds which had been administered either BetaVet (n=119) or a salinewww.betavetequine.com or call 1-800-458-0163.control (n=120) were: acute joint effusion and/or local injection site swelling (within 2 days of injection), 15% BetaVet and 13% saline control; increased lameness (within theTo report an adverse event please contact American Regent Animal Health at rst 5 days), 6.7% BetaVet and 8.3% saline control; loose stool, 5.9% BetaVet and 8.3%(800) 734-9236 or email firstname.lastname@example.org control; increased heat in joint, 2.5% BetaVet and 5% saline control; depression, 5.9% BetaVet and 1.6% saline control; agitation/anxiety, 4.2% BetaVet and 2.5% saline control; delayed swelling of treated joint (5 or more days after injection), 2.5% BetaVet and 3.3% saline control; inappetance, 3.4% BetaVet and 2.5% saline control; dry stool, 1.7% BetaVet and 0% saline control; excessive sweating, 0.8% BetaVet and 0% saline control; acute non-weight bearing lameness, 0.8% BetaVetand 0% saline control; andA Division of American Regent, Inc.laminitis, 0.8% BetaVet and 0% saline control. 5 Ramsey Rd. | Shirley, NY 11967'