OroCAM™
(meloxicam) Transmucosal Oral Spray Non-steroidal anti-inflammatory drug for oral use in dogs only.
Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
BRIEF SUMMARY: This summary does not include all the information needed to use OroCAM safely and effectively. See the Package Insert and Client Information Sheet for complete prescribing and other information.
For Animal Use Only For Oral Use in Dogs Only
WARNING Repeated use of meloxicam in cats has been
associated with acute renal failure and death. Do not administer meloxicam transmucosal oral spray to cats. See Contraindications for detailed information.
Description: Meloxicam belongs to the oxicam class of non-narcotic, non-steroidal anti-inflammatory drugs (NSAID). Each milliliter of OroCAM contains 5 mg meloxicam.
Indication: OroCAM (meloxicam) Transmucosal Oral Spray is indicated for the control of pain and inflammation associated with osteoarthritis in dogs.
Dosage and Administration: Always provide the client information sheet when prescribing and dispensing OroCAM. Use the lowest effective dose for the shortest duration consistent with individual response. Due to the pump sizes, dogs weighing less than 5.5 pounds (2.5 kg) cannot be accurately dosed. OroCAM should be administered once daily at a dose of 0.1 mg/kg (0.045 mg/lb). See Bottle/Pump Assembly Instructions for Veterinarians and Adminis- tration Instructions for Owners.
Contraindications: OroCAM (meloxicam) Transmucosal Oral Spray should not be used in dogs that have a hypersensitivity to meloxicam or known intolerance to NSAIDs. Do not use OroCAM in cats.
Do not use OroCAM in cats. Acute renal failure and death have been associated with the use of meloxicam in cats.
Human Warnings: Not for use in humans. Keep this and all medications out of reach of children. Consult a physician in case of accidental ingestion by humans or contact with mucous membranes. Direct contact with skin, eyes, and mucous membranes should be avoided. If contact occurs with skin, the area should be washed immediately with soap and water for at least 20 seconds. In case of contact with eyes, flush immediately with water. Women in late pregnancy should avoid contact with this product.
Other Precautions: The use of OroCAM (meloxicam) Transmucosal Oral Spray has not been evaluated in dogs younger than 6 months of age, dogs weighing less than 5.5 lbs (2.5 kg), dogs used for breeding, or in pregnant or lactating dogs. Meloxicam is not recommended for use in dogs with bleeding disorders, as safety has not been established in dogs with these disorders. Concurrent administration of potentially nephrotoxic drugs should be carefully approached. Please refer to the full package insert for more complete information on possible interactions and other pertinent information.
Common Side Effects: The most common adverse reactions involved the gastrointestinal system (see the Table in the package insert). Non-gastrointestinal adverse reactions were rare and included increased liver enzymes, hematuria, lethargy, polydipsia, and dehydration.
The incidence of adverse reactions observed in a clinical study is tabulated in the package insert. The pattern suggests some gastro- intestinal effects (vomiting, diarrhea) are associated with OroCAM. The clinical signs were generally mild, transient (lasted 1-4 days during the 28-day study period), and resulted in complete recovery. There were no clinical signs related to the increased liver enzymes.
Effectiveness: Effectiveness was demonstrated using OroCAM in a masked, placebo-controlled, multi-site field study involving client-owned dogs. In this study, 280 dogs diagnosed with osteo- arthritis were randomly administered OroCAM, or a placebo. Dogs received a daily meloxicam dose or placebo for 28 days. Effective- ness was evaluated in 258 dogs and field safety was evaluated in 280 dogs. After 28 days the treatment group showed a success rate (improvement of clinical signs) of approximately 73% and the placebo group showed a success rate of about 47%.
See full package insert for more details, as well as for results of safety studies.
ORO-053 March 2013 © Abbott Laboratories
LEARNING CURVE / Cancer Treatment
or canine, are rather dismal. Since the disease ultimately leads to death for most patients, affected dogs and dogs at risk (as well as affected children and children at risk) would clearly benefit, respec- tively, from improved options for treat- ment and prevention. We surmised that we could probe
the molecular features of this disease to reduce heterogeneity and improve pre- diction. Considering the similar clinical presentation, we postulated that evolu- tionarily conserved molecular traits for this disease would be present in dogs and humans. Thus, the narrower genetic diversity of dogs would enhance our abil- ity to define biologically and clinically significant traits. Defining genome-wide gene expression
profiles allowed us to define two distinct molecular subgroups of osteosarcoma (Scott et al. 2011). The clustering defined by this signature was seen repeatedly in three and five unrelated data sets from dogs and humans, respectively, although bone tumors may have more complex behavior in humans than in dogs. Nonetheless, when we consider
known differences between canine and human osteosarcoma, such as the age of disease onset and the palliative ver- sus curative treatment applied to these species, respectively, the similarities observed in their molecular signatures and associated biological behaviors are remarkable. Despite repeated attempts and the application of numerous algo- rithms, previous unsupervised analyses failed to segregate samples from intact tumor tissues (i.e., including tumor cells and stroma) from dogs or humans into meaningful groups. Thus, even though the gene expres-
sion signature was present in these intact tumor samples from both species, it was masked by stromal signatures, which can modulate the balance of expression for some of the genes (Tamburini et al. 2010). The significance of this restricted gene list is further underscored by its capac- ity to segregate independent cohorts into
Trends magazine, April 2013
distinct branches, where each branch likely represents a molecular subtype with unique and potentially predictable biological behavior. Now that we can define a group of
dogs with more indolent (or less aggres- sive) osteosarcomas that are likely to have more favorable response to therapy, the next step is to develop tests that can be used by practitioners in general and specialty practice. Genome-wide gene expression profil-
ing is not practical for clinical cases. It is expensive and labor intensive, and turn- around is not consistent with therapeutic needs. We thus sought to develop addi- tional tests that would be translatable to the needs of commercial diagnostic labo- ratories and the clinicians who constitute their principal clientele. We have developed two molecular
approaches that can be used in produc- tive fine-needle aspirate samples and that can robustly predict biological behavior. As was true for lymphoma, this will eventually help dog owners make deci- sions and improve care and quality of life for patients with less aggressive tumors. Yet, access to more effective therapies is needed for dogs with aggressive forms of osteosarcoma. We are addressing this with support from Morris Animal Foun- dation by exploring novel treatments that specifically target cells with aggressive phenotypes. We identified a central path- way that appears to regulate the biological behavior of osteosarcoma. Our ongoing work is testing the hypothesis that dereg- ulation of this pathway can be reversed, at least in part, using combinatorial therapy with FDA-approved drugs that are being used in human clinical trials. We also are working to develop immuno- therapy approaches that will enhance the options available for pet owners seeking cures for dogs with osteosarcoma.
Hemangiosarcoma: Who art thou? Hemangiosarcoma is perhaps the most
aggressive vascular tumor diagnosed in dogs. Although systematic surveys are
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