Metacam (meloxicam) 5 mg/mL Solution for Injection is indicated in dogs
for the control of pain and inflammation associated with osteoarthritis.
Carefully consider the
potential benefits and risk of Metacam and other treatment options
before deciding to use Metacam. Use the lowest effective dose for the
shortest duration consistent with individual response.
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 Metacam Oral
Suspension at the daily dose of 0.045 mg/lb (0.1 mg/kg) body weight,
either mixed with food or placed directly in the mouth.
Contraindications: Dogs with known hypersensitivity to meloxicam
should not receive Metacam 5 mg/mL Solution for Injection.
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.
For IV or SQ injectable use in dogs. All dogs should undergo a thorough
history and physical examination before administering any NSAID.
Appropriate laboratory testing to establish hematological and serum
biochemical baseline data is recommended prior to, and periodically
during use of any NSAID in dogs.
should be advised to observe their dogs for signs of potential drug
The safe use of Metacam 5
mg/mL Solution for Injection in dogs younger than 6 months of age, dogs
used for breeding, or in pregnant or lactating bitches has not been
evaluated. Meloxicam is not recommended for use in dogs with bleeding
disorders, as safety has not been established in dogs with these
disorders. Safety has not been established for intramuscular (IM)
administration in dogs. When administering Metacam 5 mg/mL Solution for
Injection, use a syringe of appropriate size to ensure precise dosing.
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 antiprostaglandin
effects may result in clinically significant disease in patients with
underlying or pre-existing disease that has not been previously
Since NSAIDs possess the
potential to produce 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 the administration of the total daily dose of Metacam Oral
Suspension, 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 in dogs. The use of concomitantly protein-bound
drugs with Metacam 5 mg/mL Solution for Injection 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 Metacam 5 mg/mL Solution for
Injection has not been evaluated. Drug compatibility should be monitored
in patients requiring adjunctive therapy. The effect of cyclo-oxygenase
inhibition and the potential for thromboembolic occurrence or a
hypercoagulable state has not been studied.
A field study involving 224 dogs was conducted. Based on the results of
this study, GI abnormalities (vomiting, soft stools, diarrhea, and
inappetance) were the most common adverse reactions associated with the
administration of meloxicam. The following table lists adverse reactions
and the numbers of dogs that experienced them during the study. Dogs may
have experienced more than one episode of the adverse reaction during
Information For Dog Owners: Meloxicam, like other NSAIDs, 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 NSAID intolerance. Adverse reactions may include vomiting,
diarrhea, lethargy, decreased appetite and behavioral changes.
Dog owners should be
advised when their pet has received a meloxicam injection. Dog owners
should contact their veterinarian immediately if possible adverse
reactions are observed, and dog owners should be advised to discontinue
Post-Approval Experience: The following adverse reactions are based
on voluntary post-approval reporting. The categories are listed in
decreasing order of frequency by body system.
Gastrointestinal: vomiting, anorexia, diarrhea, melena,
Urinary: azotemia, elevated creatinine, renal failure
Neurological/Behavioral/Special Sense: lethargy, depression
Hepatic: elevated liver enzymes
In rare situations, death
has been reported as an outcome of the adverse events listed above.
Renal failure has been reported as an outcome of repeated oral dosing of
Pharmacology: Meloxicam has nearly 100% bioavailability when
administered orally or after subcutaneous injection in dogs. The
terminal elimination half life after a single dose is estimated to be
approximately 24 hrs (+/-30%) in dogs regardless of route of
administration. Drug bioavailability, volume of distribution, and total
systemic clearance remain constant up to 5 times the recommended dose
for use in dogs. However, there is some evidence of enhanced drug
accumulation and terminal elimination 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
0.2 mg/kg subcutaneous injection in dogs. Based upon intravenous
administration in Beagle dogs, the meloxicam volume of distribution in
dogs (Vdl) 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.
The effectiveness of Metacam 5 mg/mL Solution for Injection was
demonstrated in a field study involving a total of 224 dogs representing
various breeds, all diagnosed with osteoarthritis. This
placebo-controlled, masked study was conducted for 14 days. Dogs
received a subcutaneous injection of 0.2 mg/kg Metacam 5 mg/mL Solution
for Injection on day 1. The dogs were maintained on 0.1 mg/kg oral
meloxicam from days 2 through 14. Variables evaluated by veterinarians
included lameness, weight-bearing, pain on palpation, and overall
improvement. Variables assessed by owners included mobility, ability to
rise, limping, and overall improvement.
In this field study, dogs
showed clinical improvement with statistical significance after 14 days
of meloxicam treatment for all parameters.
Day Target Animal Safety Study - In a three day safety study,
Metacam 5 mg/mL Solution for Injection 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 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 significantly increased in one 1X dog and two of the 5X dogs. One
dog in the 5X group had a steadily increasing GGT over 4 days, although
the values remained within the reference range. Decreases in total
protein and albumin occurred in 2 of 6 dogs in the 3X group and 3 of 6
dogs in the 5X group. Increases 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 of 6 dogs
in the 5X group. Increased creatinine occurred in 2 dogs in the 5X
group. Increased urine protein excretion was noted in 2 of 6 dogs in the
control group, 2 of 6 dogs in the 1X group, 2 of 6 dogs in the 3X group,
and 5 of 6 dogs in the 5X group. Two dogs in the 5X group developed
acute renal failure by Day 4. Bicarbonate levels were at or above normal
levels in 1 of the 3X dogs and 2 of the 5X dogs.
revealed gastrointestinal lesions ranging from superficial mucosal
hemorrhages and congestion to erosions. Mesenteric lymphadenopathy was
identified in 2 of 6 dogs in the 1X group, 4 of 6 dogs in the 3X group,
and 5 of 6 dogs in the 5X group. Renal changes ranged from dilated
medullary and cortical tubules and inflammation of the interstitium, to
necrosis of the tip of the papilla 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.
Site Tolerance - Metacam 5 mg/mL Solution for Injection was
administered once subcutaneously to Beagle dogs at the recommended dose
of 0.2 mg/kg and was well-tolerated by the dogs. Pain upon injection was
observed in one of eight dogs treated with meloxicam. No pain or
inflammation were observed post-injection. Long term use of Metacam 5
mg/mL Solution for Injection in dogs has not been evaluated.
Information: Store at controlled room temperature, 68-77°F
Metacam 5 mg/mL Solution
for Injection: 10 mL vialBoehringer Ingelheim