increased lameness (within the first 5 days), 6.7% BetaVet® control; loose stool, 5.9% BetaVet®


saline control; agitation/anxiety, 4.2% BetaVet®


and 8.3% saline and 8.3% saline control; increased heat in


joint, 2.5% BetaVet® and 5% saline control; depression, 5.9% BetaVet® and 2.5% saline control;


and 2.5% saline


BRIEF SUMMARY OF PRESCRIBING INFORMATION (Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension) 6 mg betamethasone per mL For Intra-Articular (I.A.) Use in Horses


CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.


DESCRIPTION: BetaVet® is a sterile aqueous suspension of betamethasone


acetate in betamethasone sodium phosphate injection. The combined betamethasone content of the suspension is 6 mg/mL where each mL contains 3.15 mg betamethasone (as betamethasone sodium phosphate); 2.85 mg betamethasone (as betamethasone acetate); 7.1 mg dibasic sodium phosphate; 3.4 mg monobasic sodium phosphate; 0.1 mg edetate disodium; and 0.2 mg benzalkonium chloride, as a preservative in water for injection. The pH is adjusted to between 6.8 and 7.2.


INDICATION: BetaVet® is indicated for the control of pain and inflammation associated with osteoarthritis in horses.


DOSAGE AND ADMINISTRATION: Shake well immediately before use. Using strict aseptic technique, administer 1.5 mL BetaVet® per joint by intra-articular injection. BetaVet®


(9 mg total betamethasone) may be administered concurrently


in up to 2 joints per horse. Use immediately after opening, then discard any remaining contents.


CONTRAINDICATIONS: BetaVet® is contraindicated in horses with hypersensitivity


to betamethasone. Intra-articular injection of corticosteroids for local effect is contraindicated in the presence of septic arthritis.


WARNINGS: Do not use in horses intended for human consumption. Clinical and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis. Additionally, corticosteroids administered to dogs, rabbits and rodents during pregnancy have resulted in cleft palate in offspring. Corticosteroids administered to dogs during pregnancy have also resulted in other congenital anomalies including deformed forelegs, phocomelia and anasarca. Therefore, before use of corticosteroids in pregnant animals, the possible benefits to the pregnant animal should be weighed against potential hazards to its developing embryo or fetus. Human Warnings: Not for use in humans. For use in animals only. Keep this and all medications out of the reach of children. Consult a physician in the case of accidental human exposure.


PRECAUTIONS: Corticosteroids, including BetaVet® , administered intra-articularly


are systemically absorbed. Do not use in horses with acute infections. Acute moderate to severe exacerbation of pain, further loss of joint motion, fever, or malaise within several days following intra-articular injection may indicate a septic process. Because of the anti-inflammatory action of corticosteroids, signs of infection in the treated joint may be masked. Appropriate examination of joint fluid is necessary to exclude a septic process. If a bacterial infection is present, appropriate antibacterial therapy should be instituted immediately. Additional doses of corticosteroids should not be administered until joint sepsis has been definitively ruled out. Due to the potential for exacerbation of clinical signs of laminitis, glucocorticoids should be used with caution in horses with a history of laminitis, or horses otherwise at a higher risk for laminitis. Use with caution in horses with chronic nephritis, equine pituitary pars intermedia dysfunction (PPID), and congestive heart failure. Concurrent use of other anti-inflammatory drugs, such as NSAIDs or other corticosteroids, should be approached with caution. Due to the potential for systemic exposure, concomitant use of NSAIDs and corticosteroids may increase the risk of gastrointestinal, renal, and other toxicity. Consider appropriate wash out times prior to administering additional NSAIDs or corticosteroids.


ADVERSE REACTIONS: Adverse reactions reported during a field study of 239 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;


One Luitpold Drive | P.O. Box 9001 | Shirley, NY 11967 A Division of Luitpold Pharmaceuticals, Inc.


and 1.6%


delayed swelling of treated joint (5 or more days after injection), 2.5% BetaVet® and 3.3% saline control; inappetance, 3.4% BetaVet® control; dry stool, 1.7% BetaVet® 0.8% BetaVet®


and 0% saline control; excessive sweating, BetaVet®and 0% saline control; and laminitis, 0.8% BetaVet®


and 0% saline control; acute non-weight bearing lameness, 0.8% and 0% saline control.


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 1.0 ng/mL) in the plasma.


EFFECTIVENESS: A negative control, randomized, masked field study provided data to evaluate the effectiveness of BetaVet®


administered at 1.5 mL


(9 mg betamethasone) once intra-articularly for the control of pain and inflammation associated with osteoarthritis in horses. Clinical success was defined as improvement in one lameness grade according to the AAEP lameness scoring system on Day 5 following treatment. The success rate for horses in the BetaVet® group was statistically significantly different (p=0.0061) than that in the saline group, with success rates of 75.73% and 52.52%, respectively (back-transformed from the logistic regression).


ANIMAL SAFETY: A 3-week target animal safety (TAS) study was conducted to evaluate the safety of BetaVet®


) and 4X (0.09 mg


included a control (isotonic saline at a volume equivalent to the 4x group); 1X (0.0225 mg betamethasone per pound bodyweight; BetaVet® mg betamethasone per pound bodyweight; BetaVet®


in mature, healthy horses. Treatment groups ); 2X (0.045


betamethasone per pound bodyweight; BetaVet®). Treatments were administered


by intra-articular injection into the left middle carpal joint once every 5-days for 3 treatments. Injection site reactions were the most common observations in all treatment groups. Injection site reactions were observed within 1 hour of dosing and included swelling at the injection site, lameness/stiffness of the left front limb, and flexing the left front knee at rest. The injection site reactions ranged from slight swelling (in many horses on multiple days in all treatment groups) to excessive fluid with swelling, pain, and lameness (4x group only). Injection site reactions were observed most commonly on treatment days, and generally decreased in number and severity over subsequent days. The incidence of injection site reactions increased after the second and third injection (number of abnormalities noted on day 10 > day 5 > day 0). In the BetaVet®


treated groups the number


and severity of the injection site reactions were dose dependent. The 4X BetaVet® group had the highest overall incidence of and severity of injection site reactions, which included heat, swelling, pain, bleeding, and holding the limb up at rest. The control group and 4X group (which received similar injection volumes) had a similar incidence of injection site reactions; however, the severity of reactions was greater in the 4X group. Absolute neutrophils were statistically significantly higher in the BetaVet®


treated groups as compared to the control group. Trends toward a decrease in lymphocytes and eosinophils, and an increase in monocytes were identified in the BetaVet®


treated groups after the initial dose of BetaVet® . Individual


animal values for white blood cells generally remained within the reference range. BetaVet®


treated horses also had a trend toward increased blood glucose after the initial dose. Some individual animals showed mild increases in blood glucose above the reference range.


STORAGE CONDITIONS


Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from light. Use carton to protect contents from light until used.


HOW SUPPLIED BetaVet®


, One 5 mL vial containing 30 mg betamethasone; packaged in boxes of 1.


SHAKE WELL BEFORE USING NADA 141-418, Approved by FDA

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