Metacam: Product Information (Page 2 of 4)

Effectiveness:

Dogs: The effectiveness of METACAM 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 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 variables.

Animal Safety:

Dogs: 3 Day Target Animal Safety Study — In a three day safety study, METACAM 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.

Histological examination 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.

Injection Site Tolerance — METACAM 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 was observed post-injection. Long term use of METACAM Injection in dogs has not been evaluated.

Effect on Buccal Mucosal Bleeding Time (BMBT) — METACAM 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 two groups.

Storage Information:

Store at controlled room temperature, 68-77°F (20-25°C). When used as labeled, there is no limit on the number of punctures throughout the full expiry period.

How Supplied:

METACAM 5 mg/mL Solution for Injection: 10 mL vial, NDC 0010-6013-01 – 10 mL

Approved by FDA under NADA # 141-219

Marketed by:
Boehringer Ingelheim Animal Health USA Inc.
Duluth, GA 30096

METACAM is a registered trademark of Boehringer Ingelheim Vetmedica GmbH, used under license.

601307-09
Revised 09/2019
86560313

Package Insert for Cats

Non-steroidal anti-inflammatory drug for use in dogs and cats only

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 additional injectable or oral meloxicam to cats. See Contraindications, Warnings, and Precautions for detailed information.

Description:

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class. Each mL of this sterile product for injection contains meloxicam 5.0 mg, alcohol 15%, glycofurol 10%, poloxamer 188 5%, sodium chloride 0.6%, glycine 0.5% and meglumine 0.3%, in water for injection, pH adjusted with sodium hydroxide and hydrochloric acid.

Diagram of empirical formulation of meloxicamDiagram of empirical formulation of meloxicam

Indications:

Cats: For the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy and castration when administered prior to surgery.

Dosage and Administration:

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.

Cats: Administer a single, one-time subcutaneous dose of METACAM Injection to cats at a dose of 0.14 mg/lb (0.3 mg/kg) body weight. Use of additional meloxicam or other NSAIDs is contraindicated. (See Contraindications). To ensure accuracy of dosing, the use of a 1 mL graduated syringe is recommended.

Contraindications:

Cats with known hypersensitivity to meloxicam should not receive METACAM Injection. Additional doses of meloxicam or other NSAIDs in cats are contraindicated, as no safe dosage for repeated NSAID administration has been established (See Animal Safety). Do not use meloxicam in cats with pre-existing renal dysfunction.

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 subcutaneous (SQ) injectable use in cats. Do not use IV in cats.

►Do not administer a second dose of meloxicam.◄

►Do not follow the single, one-time dose of meloxicam with any other NSAID.◄

►Do not administer METACAM Oral Suspension following the single, one-time injectable dose of meloxicam.◄

When administering any NSAID, appropriate laboratory testing to establish hematological and serum biochemical baseline data is recommended prior to use in dogs and cats. All cats should undergo a thorough history and physical examination before administering meloxicam. Do not repeat the single, one-time dose of meloxicam in cats.
Owner should be advised to observe their cats for signs of potential drug toxicity.

Precautions:

The safe use of METACAM Injection in cats younger than 4 months of age, cats used for breeding, or in pregnant or lactating queens has not been evaluated.

Meloxicam is not recommended for use in cats with bleeding disorders, as safety has not been established in cats with these disorders. Safety has not been established for intravenous (IV) or intramuscular (IM) use in cats. When administering METACAM 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. Cats that have experienced adverse reactions from one NSAID may experience adverse reactions from another NSAID. 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.

Patients at greatest risk for adverse events 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 and monitored. Anesthetic drugs may affect renal perfusion; approach concomitant use of anesthetics and NSAIDs cautiously. Appropriate monitoring procedures should be employed during all surgical procedures. The use of perioperative parenteral fluids is recommended to decrease potential renal complications when using NSAIDs. If additional pain medication is needed after the single one-time dose of meloxicam, a non-NSAID class of analgesic may be necessary.

In one study1 , one cat in each NSAID treatment group had increased intraoperative hemorrhage.

Since NSAIDs possess the potential to induce gastrointestinal ulcerations and/or gastrointestinal perforation, concomitant use of meloxicam with other anti-inflammatory drugs, such as NSAIDs or corticosteroids, should be avoided.

Consider appropriate washout times when switching from corticosteroid use to meloxicam in cats. As a single use product in cats, meloxicam should not be followed by additional NSAIDs or corticosteroids.

The use of concomitantly protein-bound drugs with METACAM Injection has not been studied in cats. Commonly used protein-bound drugs include cardiac, anticonvulsant, and behavioral medications. The influence of concomitant drugs that may inhibit metabolism of METACAM 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.

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