Clinical
Pharmacology: Meloxicam has nearly 100% bioavailability when
administered orally with food. The terminal elimination half life after
a single dose is estimated to be approximately 24 hrs (+/-30%)
regardless of route of administration. There is no evidence of
statistically significant gender differences in drug pharmacokinetics.
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
can be expected to occur within about 7.5 hrs after oral administration.
Corresponding peak concentration is approximately 0.464 mcg/mL following
a 0.2 mg/kg oral dose. The drug is 97% bound to canine plasma proteins.
Indications: Metacam® Oral Suspension
is indicated for the control of pain and inflammation associated with
osteoarthritis in dogs.
Dosage and
Administration: Always provide client information sheet with
prescription. 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® Oral
Suspension should be administered initially at 0.09 mg/lb (0.2 mg/kg)
body weight only on the first day of treatment. For all treatments after
day 1, Metacam® Oral Suspension should be
administered once daily at a dose of 0.045 mg/lb (0.1 mg/kg). The
syringe is calibrated to deliver the daily maintenance dose in pounds.
Directions for Administration:
Dogs
under 10 pounds (4.5 kg)
Shake well before use,
then remove cap. Particular care should be given with regard to the
accuracy of dosing. To prevent accidental overdosing of
small dogs, administer drops on food only, never directly into the
mouth. Carefully measure suspension onto food to assure that the
correct dose is given before presentation of the food to the dog. The
syringe provided with the meloxicam concentration of 0.5 mg/mL cannot be
used to measure doses for dogs weighing less than 1 lb (0.45 kg), and
the syringe provided with the meloxicam concentration of 1.5 mg/mL
cannot be used to measure doses for dogs weighing less than 5 lbs (2.3
kg).
Metacam®
0.5 mg/mL Oral Suspension
For dogs less than 1 lb
(0.45 kg), Metacam® Oral Suspension can
be given using the dropper bottle: two drops for each pound of body
weight for the 0.5 mg/mL concentration (five drops for each kilogram of
body weight), dropped directly onto the food.
For dogs between 1-10
pounds, Metacam® Oral Suspension can be
given by drops or by using the measuring syringe provided in the package
(see dosing procedure below). The syringe fits on to the bottle and has
a scale beginning at 1 lb, designed to deliver the daily maintenance
dose (0.05 mg/lb or 0.1 mg/kg). When using the syringe, the dog's weight
should be rounded down to the nearest 1 pound increment. Replace and
tighten cap after use.
Metacam®
1.5 mg/mL Oral Suspension
For dogs less than 5 lbs
(2.3 kg), Metacam® Oral Suspension can be
given using the dropper bottle: one drop for each pound of body weight
for the 1.5 mg/mL concentration (two drops for each kilogram of body
weight), dropped directly onto the food.
For dogs between 5-10
pounds, Metacam® Oral Suspension can be
given by drops or by using the measuring syringe provided in the package
(see dosing procedure below). The syringe fits on to the bottle and has
a scale beginning at 5 lbs, designed to deliver the daily maintenance
dose (0.05 mg/lb or 0.1 mg/kg). When using the syringe, the dog's weight
should be rounded down to the nearest 5 pound increment. Replace and
tighten cap after use.
Dogs over
10 pounds (4.5 kg)
Shake well before use then
remove cap. Metacam® Oral Suspension may
be either mixed with food or placed directly into the mouth. Particular
care should be given with regard to the accuracy of dosing. Metacam®
Oral Suspension can be given using the measuring syringe provided in the
package (see dosing procedure below). The syringe fits on to the bottle
and has a scale in pounds designed to deliver the daily maintenance dose
(0.05 mg/lb or 0.1 mg/kg). When using the syringe, the dog's weight
should be rounded down to the nearest 1 pound increment for Metacam®
0.5 mg/mL Oral Suspension, or the nearest 5 pound increment for Metacam®
1.5 mg/mL Oral Suspension. Alternatively, Metacam®
Oral Suspension can be given using the dropper bottle: two drops for
each pound of body weight for the 0.5 mg/mL concentration (five drops
for each kilogram of body weight), or one drop for each pound of body
weight for the 1.5 mg/mL concentration (two drops for each kilogram of
body weight). Replace and tighten cap after use.
1.
Shake bottle well. Push down and unscrew bottle top. Attach the dosing
syringe to the bottle by gently pushing the end onto the top of the
bottle.
Contraindications: Dogs with known hypersensitivity to meloxicam
should not receive Metacam® Oral
Suspension. Do not use in cats.
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.
For oral use in dogs only.
As with any NSAID 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. Owner should be advised to
observe their dogs for signs of potential drug toxicity and be given a
client information sheet about Metacam.
Precautions: The safe use of Metacam®
Oral Suspension in dogs younger than 6 months of age, dogs used for
breeding, or in pregnant or lactating dogs 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.
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. Since 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 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®
Oral Suspension 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® Oral Suspension
has not been evaluated. Drug compatibility should be monitored in
patients requiring adjunctive therapy.
Adverse
Reactions: Field safety was evaluated in 306 dogs. Based on the
results of two studies, 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 studies. Dogs may have experienced more than one episode of
the adverse reaction during the study.
|
Adverse Reactions Observed During Two Field Studies |
|
Clinical
Observation |
Meloxicam (n=157) |
Placebo (n=149) |
|
Vomiting |
40 |
23 |
|
Diarrhea/Soft
Stool |
19 |
11 |
|
Bloody Stool |
1 |
0 |
|
Inappetance |
5 |
1 |
|
Bleeding gums
after dental procedure |
1 |
0 |
|
Lethargy/Swollen
Carpus |
1 |
0 |
|
Epiphora |
1 |
0 |
In foreign suspected
adverse drug reaction (SADR) reporting over a 9 year period, incidences
of adverse reactions related to meloxicam administration included:
auto-immune hemolytic anemia (1 dog), thrombocytopenia (1 dog),
polyarthritis (1 dog), nursing puppy lethargy (1 dog), and pyoderma (1
dog).
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 contact their veterinarian immediately if possible adverse
reactions are observed, and dog owners should be advised to discontinue
Metacam therapy.
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,
gastrointestinal ulceration
Urinary: azotemia, elevated creatinine, renal failure
Neurological/Behavioral/Special Sense: lethargy, depression
Hepatic: elevated liver enzymes
Dermatological/Immunological: pruritus
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
cats.
Effectiveness: Proven safe and effective in millions of dogs for over 14
years. The effectiveness of meloxicam was demonstrated in two
field studies involving a total of 277 dogs representing various breeds,
between six months and sixteen years of age, all diagnosed with
osteoarthritis. Both of the placebo-controlled, masked studies were
conducted for 14 days. All dogs received 0.2 mg/kg on day 1. All dogs
were maintained on 0.1 mg/kg oral meloxicam from days 2 through 14 of
both studies. Parameters evaluated by veterinarians included lameness,
weight-bearing, pain on palpation, and overall improvement. Parameters
assessed by owners included mobility, ability to rise, limping, and
overall improvement.
In the first field study
(n=109), dogs showed clinical improvement with statistical significance
after 14 days of meloxicam treatment for all parameters. In the second
field study (n=48), dogs receiving meloxicam showed a clinical
improvement after 14 days of therapy for all parameters; however,
statistical significance was demonstrated only for the overall
investigator evaluation on day 7, and for the owner evaluation on day
14.
Palatability: Dogs love the sweet honey flavor. Metacam®
Oral Suspension was accepted by 100% of the dogs when veterinarians
administered the initial dose into the mouth. Metacam®
Oral Suspension was accepted by 90% of the dogs (123/136) when
administered by owners. Problems associated with administration included
refusal of food, resistance to swallowing and salivation.
How
Supplied:
Metacam®
Oral Suspension 0.5 mg/mL: 15 mL and 30 mL dropper bottle with measuring
syringe
Metacam®
Oral Suspension 1.5 mg/mL: 10, 32 and 100 mL dropper bottles with
measuring syringe
Storage:
Store at controlled room temperature 59-86°F (15-30°C).