Untitled-

C Flat: 10.0" x 12.5" Folded: 1.125" x 5.0" PMS Black 7/07/10 Package Insert for Dogs
Metacam®
(meloxicam)
5 mg/mL Solution for Injection
Non-steroidal anti-inflammatory drug for use in dogs and cats only
For a complete listing of adverse reactions for meloxicam reported to the CVM see:http://www.fda.gov/AnimalVeterinary/SafetyHealth/ProductSafetyInformation/ucm055394.htm Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Information For Dog Owners: Meloxicam, like other NSAIDs, is not free from adverse reactions. Own-
Warning: Repeated use of meloxicam in cats has been associated with acute renal failure and
ers should be advised of the potential for adverse reactions and be informed of the clinical signs asso- death. Do not administer additional injectable or oral meloxicam to cats. See Contraindications,
ciated with NSAID intolerance. Adverse reactions may include vomiting, diarrhea, lethargy, decreased Warnings, and Precautions for detailed information.
appetite and behavioral changes. Dog owners should be advised when their pet has received a meloxi-cam injection. Dog owners should contact their veterinarian immediately if possible adverse reactions Description: Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class. Each
are observed, and dog owners should be advised to discontinue Metacam therapy.
mL of this sterile product for injection contains meloxicam 5.0 mg, alcohol 15%, glycofurol 10%, polox-amer 188 5%, sodium chloride 0.6%, glycine 0.5% and meglumine 0.3%, in water for injection, pH ad- Clinical Pharmacology: Meloxicam has nearly 100% bioavailability when administered orally or after
justed with sodium hydroxide and hydrochloric acid.
subcutaneous injection in dogs. The terminal elimination half life after a single dose is estimated to beapproximately 24 hrs (+/-30%) in dogs regardless of route of administration. Drug bioavailability, vol-ume of distribution, and total systemic clearance remain constant up to 5 times the recommendeddose for use in dogs. However, there is some evidence of enhanced drug accumulation and terminalelimination half-life prolongation when dogs are dosed for 45 days or longer. Peak drug concentrations of 0.734 mcg/mL can be expected to occur within 2.5 hours following a 0.2mg/kg subcutaneous injection in dogs. Based upon intravenous administration in Beagle dogs, themeloxicam volume of distribution in dogs (Vdλ) is approximately 0.32 L/kg and the total systemic clearance is 0.01 L/hr/kg. The drug is 97% bound to canine plasma proteins.
Effectiveness:
Dogs: The effectiveness of Metacam 5 mg/mL Solution for Injection was demonstrated in a field study
Indications:
involving a total of 224 dogs representing various breeds, all diagnosed with osteoarthritis. This Dogs: Metacam (meloxicam) 5 mg/mL Solution for Injection is indicated in dogs for the control of pain
placebo-controlled, masked study was conducted for 14 days. Dogs received a subcutaneous injection and inflammation associated with osteoarthritis.
of 0.2 mg/kg Metacam 5 mg/mL Solution for Injection on day 1. The dogs were maintained on 0.1 Dosage and Administration:
mg/kg oral meloxicam from days 2 through 14. Variables evaluated by veterinarians included lameness, Carefully consider the potential benefits and risk of Metacam and other treatment options before de- weight-bearing, pain on palpation, and overall improvement. Variables assessed by owners included ciding to use Metacam. Use the lowest effective dose for the shortest duration consistent with individ- mobility, ability to rise, limping, and overall improvement. In this field study, dogs showed clinical improvement with statistical significance after 14 days ofmeloxicam treatment for all variables.
Dogs: Metacam 5 mg/mL Solution for Injection should be administered initially as a single dose at 0.09
mg/lb (0.2 mg/kg) body weight intravenously (IV) or subcutaneously (SQ), followed, after 24 hours, by
Animal Safety:
Metacam Oral Suspension at the daily dose of 0.045 mg/lb (0.1 mg/kg) body weight, either mixed with Dogs: 3 Day Target Animal Safety Study - In a three day safety study, Metacam 5 mg/mL Solution for In-
food or placed directly in the mouth.
jection was administered intravenously to Beagle dogs at 1, 3, and 5 times the recommended dose (0.2,0.6 and 1.0 mg/kg) for three consecutive days. Vomiting occurred in 1 of 6 dogs in the 5X group. Fecal Contraindications: Dogs with known hypersensitivity to meloxicam should not receive Metacam
occult blood was detected in 3 of 6 dogs in the 5X group. No clinically significant hematologic changes were seen, but serum chemistry changes were observed. Serum alkaline phosphatase (ALP) was signifi- Warnings: Not for use in humans. Keep this and all medications out of reach of children. Consult a
cantly increased in one 1X dog and two of the 5X dogs. One dog in the 5X group had a steadily increas- physician in case of accidental ingestion by humans. For IV or SQ injectable use in dogs. All dogs ing GGT over 4 days, although the values remained within the reference range. Decreases in total should undergo a thorough history and physical examination before administering any NSAID. Appro- protein and albumin occurred in 2 of 6 dogs in the 3X group and 3 of 6 dogs in the 5X group. Increases priate laboratory testing to establish hematological and serum biochemical baseline data is recom- in blood urea nitrogen (BUN) occurred in 3 of 6 dogs in the 1X group, 2 of 6 dogs in the 3X group and 2 mended prior to, and periodically during use of any NSAID in dogs.
of 6 dogs in the 5X group. Increased creatinine occurred in 2 dogs in the 5X group. Increased urine pro- Owner should be advised to observe their dogs for signs of potential drug toxicity.
tein excretion was noted in 2 of 6 dogs in the control group, 2 of 6 dogs in the 1X group, 2 of 6 dogs inthe 3X group, and 5 of 6 dogs in the 5X group. Two dogs in the 5X group developed acute renal failure Precautions:
by Day 4. Bicarbonate levels were at or above normal levels in 1 of the 3X dogs and 2 of the 5X dogs.
The safe use of Metacam 5 mg/mL Solution for Injection in dogs younger than 6 months of age, dogsused for breeding, or in pregnant or lactating bitches has not been evaluated. Meloxicam is not recom- Histological examination revealed gastrointestinal lesions ranging from superficial mucosal hemor- mended for use in dogs with bleeding disorders, as safety has not been established in dogs with these rhages and congestion to erosions. Mesenteric lymphadenopathy was identified in 2 of 6 dogs in the 1X disorders. Safety has not been established for intramuscular (IM) administration in dogs. When admin- group, 4 of 6 dogs in the 3X group, and 5 of 6 dogs in the 5X group. Renal changes ranged from dilated istering Metacam 5 mg/mL Solution for Injection, use a syringe of appropriate size to ensure precise medullary and cortical tubules and inflammation of the interstitium, to necrosis of the tip of the papilla dosing. As a class, cyclo-oxygenase inhibitory NSAIDs may be associated with gastrointestinal, renal in 2 of 6 dogs in the 1X group, 2 of 6 dogs in the 3X group, and 4 of 6 dogs in the 5X group.
and hepatic toxicity. Sensitivity to drug-associated adverse events varies with the individual patient.
Injection SiteTolerance - Metacam 5 mg/mL Solution for Injection was administered once subcuta-
Dogs that have experienced adverse reactions from one NSAID may experience adverse reactions from neously to Beagle dogs at the recommended dose of 0.2 mg/kg and was well-tolerated by the dogs. another NSAID. Patients at greatest risk for renal toxicity are those that are dehydrated, on concomitant Pain upon injection was observed in one of eight dogs treated with meloxicam. No pain or inflamma- diuretic therapy, or those with existing renal, cardiovascular, and/or hepatic dysfunction. Concurrent tion was observed post-injection. Long term use of Metacam 5 mg/mL Solution for Injection in dogs administration of potentially nephrotoxic drugs should be carefully approached. NSAIDs may inhibit the prostaglandins that maintain normal homeostatic function. Such anti-prostaglandin effects may re-sult in clinically significant disease in patients with underlying or preexisting disease that has not been Effect on Buccal Mucosal Bleeding Time (BMBT) - Metacam 5 mg/mL Solution for Injection (0.2 mg/kg)
and placebo (0.4 mL/kg) were administered as single intravenous injections to 8 female and 16 male
Beagle dogs. There was no statistically significant difference (p>0.05) in the average BMBT between the Since NSAIDs possess the potential to induce gastrointestinal ulcerations and/or perforations, con- comitant use with other anti-inflammatory drugs, such as NSAIDs or corticosteroids, should beavoided. If additional pain medication is needed after the administration of the total daily dose of Storage Information: Store at controlled room temperature, 68-77°F (20-25°C).
Metacam Oral Suspension, a non-NSAID or noncorticosteriod class of analgesia should be considered.
How Supplied:
The use of another NSAID is not recommended. Consider appropriate washout times when switching Metacam 5 mg/mL Solution for Injection: 10 mL vial from corticosteroid use or from one NSAID to another in dogs. The use of concomitantly protein-bounddrugs with Metacam 5 mg/mL Solution for Injection has not been studied in dogs. Commonly used pro- Manufactured for:
tein-bound drugs include cardiac, anticonvulsant and behavioral medications. The influence of con- Boehringer Ingelheim Vetmedica, Inc.
comitant drugs that may inhibit metabolism of Metacam 5 mg/mL Solution for Injection has not been evaluated. Drug compatibility should be monitored in patients requiring adjunctive therapy. The effect Metacam® is a registered trademark of Boehringer Ingelheim Vetmedica GmbH, licensed to Boehringer of cyclo-oxygenase inhibition and the potential for thromboembolic occurrence or a hypercoagulable Adverse Reactions:
Dogs: A field study involving 224 dogs was conducted. Based on the results of this study, GI abnormali-
ties (vomiting, soft stools, diarrhea, and inappetance) were the most common adverse reactions asso-ciated with the administration of meloxicam. The following table lists adverse reactions and thenumbers of dogs that experienced them during the study. Dogs may have experienced more than oneepisode of the adverse reaction during the study.
Adverse Reactions Observed During Field Study
Clinical Observation
Meloxicam (n =109)
Placebo (n = 115)
In foreign suspected adverse drug reaction (SADR) reporting, adverse reactions related to meloxicamadministration included: auto-immune hemolytic anemia (1 dog), thrombocytopenia (1 dog), poly-arthritis (1 dog), nursing puppy lethargy (1 dog), and pyoderma (1 dog).
Post-Approval Experience (Rev. 2009):
The following adverse reactions are based on post-approval adverse drug event reporting. The cate-
gories are listed in decreasing order of frequency by body system:
Gastrointestinal: vomiting, diarrhea, melena, gastrointestinal ulcerationUrinary: azotemia, elevated creatinine, renal failureNeurological/Behavioral: lethargy, depressionHepatic: elevated liver enzymesDermatologic: pruritus Death has been reported as an outcome of the adverse events listed above. Acute renal failure and
death have been associated with the use of meloxicam in cats.
To report suspected adverse reactions, to obtain a Material Safety Data Sheet, or for technical assis-
tance, call 1-866-METACAM (1-866-638-2226).

Source: http://www.metacam.com/index.php/documents/Package_Insert_Dogs_NADA-141-219.pdf