b'CLINICAL PHARMACOLOGY:Betamethasone is a potent glucocorticoid steroid with anti-inflammatory and immunosuppressive properties. Depending upon their physico-chemical properties, drugs administered intra-articularly may enter the 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 horses, there were quantifiable concentrations of betamethasone (above BRIEF SUMMARY OF PRESCRIBING INFORMATION 1.0 ng/mL) in the plasma.(Betamethasone Sodium Phosphate and Betamethasone Acetate InjectableEFFECTIVENESS: A negative control, randomized, masked field study provided Suspension) 6 mg betamethasone per mL data to evaluate the effectiveness of BetaVet administered at 1.5 mL For Intra-Articular (I.A.) Use in Horses (9 mg betamethasone) once intra-articularly for the control of pain and CAUTION: Federal law restricts this drug to use by or on the order of ainflammation associated with osteoarthritis in horses. Clinical success was defined as improvement in one lameness grade according to the AAEP lameness scoring licensed veterinarian. system on Day 5 following treatment. The success rate for horses in the BetaVet INDICATION: BetaVet is indicated for the control of pain and inflammationgroup was statistically significantly different (p=0.0061) than that in the saline associated with osteoarthritis in horses. group, with success rates of 75.73% and 52.52%, respectively (back-transformed DOSAGE AND ADMINISTRATION:Shake well immediately before use. from the logistic regression).CONTRAINDICATIONS:BetaVet is contraindicated in horses with hypersensitivity ANIMAL SAFETY: A 3-week target animal safety (TAS) study was conducted to betamethasone. Intra-articular injection of corticosteroids for local effect isto evaluate the safety of BetaVet in mature, healthy horses. Treatment groups contraindicated in the presence of septic arthritis. included a control (isotonic saline at a volume equivalent to the 4x group); 1X (0.0225 mg betamethasone per pound bodyweight; BetaVet); 2X (0.045 WARNINGS: Do not use in horses intended for human consumption.mg betamethasone per pound bodyweight; BetaVet) and 4X (0.09 mg Clinical and experimental data have demonstrated that corticosteroidsbetamethasone per pound bodyweight; BetaVet). Treatments were administered administered orally or parenterally to animals may induce the first stage ofby intra-articular injection into the left middle carpal joint once every 5-days for parturition when administered during the last trimester of pregnancy and may3 treatments. Injection site reactions were the most common observations in all precipitate premature parturition followed by dystocia, fetal death, retainedtreatment groups. Injection site reactions were observed within 1 hour of dosing placenta, and metritis. Additionally, corticosteroids administered to dogs,and included swelling at the injection site, lameness/stiffness of the left front limb, rabbits and rodents during pregnancy have resulted in cleft palate in offspring.and flexing the left front knee at rest. The injection site reactions ranged from slight Corticosteroids administered to dogs during pregnancy have also resulted in otherswelling (in many horses on multiple days in all treatment groups) to excessive congenital anomaliesincluding deformed forelegs, phocomelia and anasarca.fluid with swelling, pain, and lameness (4x group only). Injection site reactions Therefore, before use of corticosteroids in pregnant animals, the possible benefitswere observed most commonly on treatment days, and generally decreased to the pregnant animal should be weighed against potential hazards to itsin number and severity over subsequent days. The incidence of injection site developing embryo or fetus. Human Warnings: Not for use in humans. For use inreactions increased after the second and third injection (number of abnormalities animals only. Keep this and all medications out of the reach of children. Consult anoted on day 10 > day 5 > day 0). In the BetaVet treated groups the number physician in the case of accidental human exposure. and severity of the injection site reactions were dose dependent. The 4X BetaVet PRECAUTIONS: Corticosteroids, including BetaVet, administered intra-articularlygroup had the highest overall incidence of and severity of injection site reactions, are systemically absorbed. Do not use in horses with acute infections. Acutewhich included heat, swelling, pain, bleeding, and holding the limb up at rest. moderate to severe exacerbation of pain, further loss of joint motion, fever, orThe control group and 4X group (which received similar injection volumes) had a malaise within several days following intra-articular injection may indicate asimilar incidence of injection site reactions; however, the severity of reactions was septic process. Because of the anti-inflammatory action of corticosteroids, signsgreater in the 4X group. Absolute neutrophils were statistically significantly higher of infection in the treated joint may be masked. Appropriate examination of jointin the BetaVet treated groups as compared to the control group. Trends toward fluid is necessary to exclude a septic process. If a bacterial infection is present,a decrease in lymphocytes and eosinophils, and an increase in monocytes were appropriate antibacterial therapy should be instituted immediately. Additionalidentified in the BetaVet treated groups after the initial dose of BetaVet. Individual doses of corticosteroids should not be administered until joint sepsis has beenanimal values for white blood cells generally remained within the reference range. definitively ruled out. Due to the potential for exacerbation of clinical signs ofBetaVet treated horses also had a trend toward increased blood glucose after laminitis, glucocorticoids should be used with caution in horses with a history ofthe initial dose. Some individual animals showed mild increases in blood glucose laminitis, or horses otherwise at a higher risk for laminitis. Use with caution inabove the reference range.horses with chronic nephritis, equine pituitary pars intermedia dysfunction (PPID),SHAKE WELL BEFORE USINGand congestive heart failure. Concurrent use of other anti-inflammatory drugs,NADA 141-418, Approved by FDAsuch as NSAIDs or other corticosteroids, should be approached with caution. Due to the potential for systemic exposure, concomitant use of NSAIDs andFor customer care or to obtain product information visit corticosteroids may increase the risk of gastrointestinal, renal, and other toxicity.www.betavetequine.com or call 1-800-458-0163.Consider appropriate wash out times prior to administering additional NSAIDs or corticosteroids. To report an adverse event please contact Luitpold Animal Health at ADVERSE REACTIONS:Adverse reactions reported during a field study of 239(800) 734-9236 or email pv@luitpold.com.horses of various breeds which had been administered either BetaVet (n=119) or a saline 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 the first 5 days), 6.7% BetaVet and 8.3% saline control; loose stool, 5.9% BetaVet and 8.3% saline control; increased heat in joint, 2.5% BetaVet and 5% saline control; depression, 5.9% BetaVet and 1.6%A Division of Luitpold Pharmaceuticals, Inc.saline control; agitation/anxiety, 4.2% BetaVet and 2.5% saline control;One Luitpold Drive | P.O. Box 9001 | Shirley, NY 11967delayed 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; and laminitis, 0.8% BetaVet and 0% saline control.'