Always provide the client information sheet with prescription. Carefully consider the potential benefits and risks of OroCAM and other treatment options before deciding to use 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).
Particular care should be given with regard to the accuracy of dosing and to selecting the correct bottle size based on the weight of the dog. See the Dosing Table below.
| Weight range (kg) |
Weight range (lbs) |
Bottle Size ( mL)/ mg per spray |
No. of sprays/ treatment |
Dose amount (mg) |
| 2.5-3.7 |
5.5-8.3 |
6/0.25 |
1 |
0.25 |
| 3.8-6.2 |
8.4-13.8 |
6/0.25 |
2 |
0.50 |
| 6.3-8.3 |
13.9-18.4 |
6/0.25 |
3 |
0.75 |
| 8.4-12.5 |
18.5-27.6 |
11/0.50 |
2 |
1 |
| 12.6-18.8 |
27.7-41.5 |
11/0.50 |
3 |
1.50 |
| 18.9-27.1 |
41.6-59.7 |
33/1.075 |
2 |
2.15 |
| 27.2-40.5 |
59.8-89.1 |
33/1.075 |
3 |
3.23 |
| 40.6-54.0 |
89.2-118.8 |
33/1.075 |
4 |
4.3 |
| 54.1-57.2 |
118.9-125.8 |
33/1.075 |
5 |
5.38 |
Bottle/Pump Assembly Instructions for Veterinarians
Prior to dispensing, the pump should be screwed on to the bottle securely, the bottle gently shaken, and then the pump primed by actuating ten times (or until a fine spray appears) into an absorbent material. Once a bottle is assembled, the assembly date should be written on the bottle and the owner instructed to discard the bottle after 6 months. Wash hands after assembly.
Caution:
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
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.
Administration Instructions for Owners
OroCAM should be given according to your veterinarian’s instructions. Prior to each use, shake the bottle gently. If OroCAM is not used for two days or more, owners should re-prime with one spray into an absorbent material, or until a fine spray appears. In case of pump failure, wipe nozzle and then re-prime the pump. If a partial dose has been administered to the pet due to pump failure, do not redose; wait until the next dosing time to adminsiter OroCAM.
To administer OroCAM, grasp the corner of your dog’s mouth and gently pull it away from the gums, opening the cheek space. Place the tip of the applicator just inside the cheek space, directed towards the back of the cheek space. Holding the bottle and pump upright, fully depress the spray head taking special care to ensure no spray escapes from the mouth. If multiple sprays have been prescribed by your veterinarian, allow the pump to fully reflate before administering consecutive sprays. Immediately after administration of the spray, use a moist paper towel or tissue to clean the tip of the pump. Wash hands after administration of the product.
The end of the center tube should be covered by the fluid level. Once the fluid falls below the level of the center tube, sprays will not be adequate and the container should be replaced. There will be a residual volume of fluid at the bottom of the bottle which cannot be used.
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. Acute renal failure and death have been associated with the use of meloxicam in cats.
Warnings:
Animals Warnings
For oral use in dogs only.
Due to the pump sizes, dogs weighing less than 5.5 pounds (2.5 kg) cannot be accurately dosed. All dogs should undergo a thorough history and physical examination before the initiation of NSAID therapy. Appropriate laboratory testing to establish hematological and serum biochemical baseline data is recommended prior to and periodically during administration of any NSAID. Owners should be advised to observe for signs of potential drug toxicity (see Adverse Reactions and Animal Safety) and be given a Client Information Sheet about OroCAM Transmucosal Oral Spray.
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.
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. As a class, cyclo-oxygenase inhibitory NSAIDs may be associated with gastrointestinal, renal and hepatic toxicity. Sensitivity to drug-associated adverse events varies with the individual patient. Dogs that have experienced adverse reactions from one NSAID may experience adverse reactions from another NSAID. Patients at greatest risk for renal toxicity are those that are dehydrated, on concomitant diuretic therapy, or those with existing renal, cardiovascular, and/or hepatic dysfunction. Concurrent administration of potentially nephrotoxic drugs should be carefully approached. NSAIDs may inhibit the prostaglandins that maintain normal homeostatic function. Such anti-prostaglandin effects may result in clinically significant disease in patients with underlying or pre-existing disease that has not been previously diagnosed. Because NSAIDs possess the potential to induce gastrointestinal ulcerations and/or perforations, concomitant use with other anti-inflammatory drugs, such as NSAIDs or corticosteroids, should be avoided.
If additional pain medication is needed after administration of the total daily dose of OroCAM (meloxicam) Transmucosal Oral Spray, a non-NSAID, or non-corticosteroid class of analgesia, should be considered. The use of another NSAID is not recommended. Consider appropriate washout times when switching from corticosteroid use or from one NSAID to another.
The use of concomitantly protein-bound drugs with OroCAM™ (meloxicam) Transmucosal Oral Spray has not been studied in dogs. Commonly used protein-bound drugs include cardiac, anticonvulsant and behavioral medications. The influence of concomitant drugs that may inhibit metabolism of OroCAM (meloxicam) Transmucosal Oral Spray has not been evaluated. Drug compatibility should be monitored in patients requiring adjunctive therapy.
Information for Dog Owners
OroCAM (meloxicam) Transmucosal Oral Spray, like other drugs of its class, is not free from adverse reactions. Owners should be advised of the potential for adverse reactions and be informed of the clinical signs associated with drug intolerance. Adverse reactions may include vomiting; diarrhea; decreased appetite; dark or tarry stools; increased water consumption; increased urination; anemia; yellowing of gums, skin, or white of the eye due to jaundice; lethargy; incoordination; seizure; or behavioral changes. Serious adverse reactions associated with this drug class can occur without warning, and in rare situations, result in death (see Warnings and Adverse Reactions). Owners should be advised to discontinue OroCAM (meloxicam) Transmucosal Oral Spray and contact their veterinarian immediately if signs of intolerance are observed. The vast majority of patients with drug related adverse reactions have recovered when the signs are recognized, the drug is withdrawn, and veterinary care, if appropriate, is initiated. Owners should be advised of the importance of periodic follow-up for all dogs during administration of any NSAID.
Storage
Store at controlled room temperature, between 20°-25°C (68°-77°F). Brief excursions between 15° and 30°C (59° and 86°F) are permitted. Shelf-life after first opening the container: 6 months. At the time of pump/bottle assembly, the assembly date should be written on the label and the owner should be instructed to discard the bottle after 6 months. Do not use after the expiry date stated on the carton and the bottle. Keep out of the reach and sight of children.
