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Indications1
BETAVET is indicated for the control of pain and inflammation associated with osteoarthritis in horses.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34067-9 (INDICATIONS & USAGE SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Dose regimens2
This calculator performs arithmetic only on the sourced dosing field shown for each result — it does not verify the field's accuracy, does not select which field to use for a patient, and does not replace a veterinarian's order. Not for clinical use. Confirm every result against the primary source before dispensing.
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Adverse effects202
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) are summarized in Table 1. One BETAVET treated horse was removed from the study for onset of acute non-weight bearing lameness on Day 4. Treatment for presumed joint sepsis was instituted immediately, but the horse was eventually euthanized several weeks later due to a thromboembolic event associated with prolonged intravenous catheter placement. One BETAVET treated horse developed bilateral forelimb lameness on Day 8, with snow packed in the shoes and poor hoof conformation noted by the investigator. The horse was diagnosed with laminitis. Radiographs showed no abnormalities, and the horse was sound shortly after shoeing changes were implemented. Table 1. Adverse Reactions Adverse Reaction Number (%) of BETAVETtreatedhorses Number (%)of saline treatedhorses Acute joint effusionand/or local injection site swelling (within 2 days of injection) 18 (15%) 16 (13%) Increased lameness(within the first 5 days) 8 (6.7%) 10 (8.3%) Loose stool 7 (5.9%) 10 (8.3%) Increased heat in joint 3 (2.5%) 6 (5%) Depression 7 (5.9%) 2 (1.6%) Agitation/anxiety 5 (4.2%) 3 (2.5%) Delayed swelling of treated joint (5 or moredays after injection) 3 (2.5%) 4 (3.3%) Inappetance 4 (3.4%) 3 (2.5%) Dry stool 2 (1.7%) 0 (0%) Excessive sweating 1 (0.8%) 0 (0%) Acute non-weightbearing lameness 1 (0.8%) 0 (0%) Laminitis 1 (0.8%) 0 (0%)
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34084-4 (ADVERSE REACTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
The following adverse reactions were reported during the course of a US field study for treatment of otitis externa in dogs treated with DuOtic™ with 1 tube per affected ear(s) and repeated after 7 days: Number (%) of dogs with Adverse Reactions by Treatment Adverse Reaction DuOtic™(n=120) Control(n=119) Four dogs were reported to have an increase in alanine aminotransferase at Study Exit. The levels reported in subsequent clinical chemistries returned to normal in three dogs, while no follow up was performed for the fourth dog. Elevated alanine aminotransferase 4 (3.3%) 0 (0.0%) Conjunctivitis 1 (0.8%) 0 (0.0%) Ocular discharge 1 (0.8%) 2 (1.7%) Ear discharge 0 (0.0%) 1 (0.8%) Ear pruritus 3 (2.5%) 4 (3.4%)
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34084-4 (ADVERSE REACTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
These are counts of spontaneously reported events, not proven adverse effects, causal relationships, or incidence rates.
Bars compare report counts within each species; they do not show incidence.
More reportsFewer reportsDog
- Deafness83 reports
- Lack of efficacy - NOS76 reports
- Loss of hearing44 reports
- Head shake - ear disorder41 reports
- Vomiting40 reports
- Corneal ulcer36 reports
- Head tilt - ear disorder29 reports
- Schirmer tear test26 reports
- Lethargy (see also Central nervous system depression in 'Neurological')25 reports
- Ear discharge24 reports
- Not eating23 reports
- Ocular discharge22 reports
Cat
- Horner's syndrome31 reports
- Not eating27 reports
- Third eyelid protrusion27 reports
- Ataxia24 reports
- Anisocoria20 reports
- Lethargy (see also Central nervous system depression in 'Neurological')19 reports
- Anorexia17 reports
- Decreased appetite16 reports
- Weight loss16 reports
- Hiding13 reports
- Vomiting13 reports
- Falling12 reports
Contraindications2
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.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34070-3 (CONTRAINDICATIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Precautions Do not use in dogs with known tympanic perforation (see). Do not use in dogs with a hypersensitivity to terbinafine or corticosteroids.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34070-3 (CONTRAINDICATIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Precautions3
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.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34071-1 (WARNINGS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Corticosteroids, including BETAVET, administered intraarticularly 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.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 42232-9 (PRECAUTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Wear eye protection when administering DuOtic™ and restrain the dog Human Safety Warnings Post-approval Experience , Target Animal Safety to minimize post-application head shaking. Reducing the potential for splatter of product will help prevent accidental eye exposure in people and dogs and help to prevent eye injury (seeand). Avoid hand-to-eye contact. Proper patient selection is important when considering the benefits and risks of using DuOtic™. The use of DuOtic™ in dogs with perforated tympanic membranes has not been evaluated. The integrity of the tympanic membrane should be confirmed before administering each dose of this product. Reevaluate the dog if hearing loss or signs of vestibular dysfunction are observed during treatment. ® ® Target Animal Safety Changes to the middle ear, such as ulceration of the mucosal lining, have been associated with administration of Osurnia(florfenicol, terbinafine, betamethasone acetate). The presentation and concentrations of terbinafine and betamethasone acetate in DuOtic™ are identical to the concentrations of these active ingredients in Osurnia(see). ® Post-approval Experience Signs of tympanic membrane rupture, internal ear disease such as head tilt, ataxia, nystagmus, facial paralysis, and keratoconjunctivitis sicca have also been reported in relation to the administration of Osurnia(see). Do not administer orally. Target Animal Safety Use of topical otic corticosteroids has been associated with adrenocortical suppression and iatrogenic hyperadrenocorticism in dogs (see). Target Animal Safety Adverse Reactions Use with caution in dogs with impaired hepatic function (seeand). The safe use of DuOtic™ has not been evaluated in dogs that are pregnant, lactating or intended for breeding.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 42232-9 (PRECAUTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Pharmacokinetics2
max max max LOQ 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. Maximum plasma concentrations (C) and time to C(T) values ranged from 2.70 to 3.88 ng/mL and 4.5 to 8 hours, respectively. The effective plasma terminal elimination half-life ranged from 4 to 8 hours. The non-compartmental area-underthe curve to the limit of quantification (AUC) ranged from 29.24 to 42.96 hr*ng/mL. In contrast, most of the betamethasone disodium phosphate concentrations and all of the betamethasone acetate concentrations were below the limit of quantification in plasma.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34090-1 (CLINICAL PHARMACOLOGY SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
DuOtic™ is a fixed combination of two active ingredients: terbinafine (antifungal) and betamethasone acetate (steroidal anti-inflammatory). Terbinafine is an antifungal which selectively inhibits the early synthesis of ergosterol. Betamethasone acetate is a glucocorticosteroid with anti-inflammatory activity. DuOtic™ dissolves in ear wax and is slowly eliminated from the ear mechanically. Ear inflammation can increase the percutaneous absorption of active substances in DuOtic™. ® Target Animal Safety In a laboratory study conducted in healthy dogs administered Osurnia(see), low plasma concentrations of florfenicol, terbinafine, and betamethasone acetate were measurable during the first 2-4 days after administration of 1X dose, and during the first 2-7 days after administration of 5X dose. No quantifiable plasma concentrations of any of the three active ingredients were observed in the pre-dose samples of most dogs prior to second and third administrations. Although total and peak exposure in the blood tended to be highly variable between dogs, systemic drug concentrations tended to increase in a less than dose-proportional manner as the administered dose increased from 1X to 5X. The systemic exposure of terbinafine and betamethasone are not expected to be affected by the removal of florfenicol from the formulation.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34090-1 (CLINICAL PHARMACOLOGY SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Literature references14
References are linked to this drug. Species applicability is not recorded here, so the species filter does not narrow this list. Imported dates do not retain their original precision; confirm dates in the original citation.
- Clinical safety and efficacy of a single-dose gentamicin, posaconazole and mometasone furoate otic suspension for treatment of canine otitis externa.
Study summary not available in the imported record. Open the original citation to review the study.
- One percent of the clinical dose used for antenatal steroid therapy is sufficient to induce lung maturation when administered directly to the preterm ovine fetus.
Study summary not available in the imported record. Open the original citation to review the study.
- Betamethasone phosphate reduces the efficacy of antenatal steroid therapy and is associated with lower birthweights when administered to pregnant sheep in combination with betamethasone acetate.
Study summary not available in the imported record. Open the original citation to review the study.
- Antenatal corticosteroids: a reappraisal of the drug formulation and dose.
Study summary not available in the imported record. Open the original citation to review the study.
- The duration of fetal antenatal steroid exposure determines the durability of preterm ovine lung maturation.
Study summary not available in the imported record. Open the original citation to review the study.
Sources: DailyMed, U.S. National Library of Medicine; PubMed, National Library of Medicine; openFDA, U.S. Food and Drug Administration.
Available products
Products listed in the Health Canada Drug Product Database for this active ingredient. A listing does not establish that a product is authorized for the clinical uses described on this page.