Alloxate: Product Information

ALLOXATE- meloxicam injection, solution
Aspen Veterinary Resources

Approved by FDA under ANADA # 200-491

Alloxate

(meloxicam)

5 mg/mL Solution for Injection

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.

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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 Alloxate and other treatment options before deciding to use Alloxate. Use the lowest effective dose for the shortest duration consistent with individual response.

Cats: Administer a single, one-time subcutaneous dose of Alloxate™ 5 mg/mL Solution for 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 Alloxate 5 mg/mL Solution for 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 meloxicam 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 Alloxate 5 mg/mL Solution for 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 Alloxate 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. 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 Alloxate 5 mg/mL Solution for 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 Alloxate 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 hyper-coagulable state has not been studied.

Adverse Reactions:

Cats: A field study involving 138 cats was conducted. Of the 72 cats receiving meloxicam injection, six cats (8.3%) experienced post-treatment elevated serum blood urea nitrogen (BUN) levels. The pre-treatment values were in the normal range. Of the 66 cats in the butorphanol treatment group, no cats experienced post-treatment elevated serum blood urea nitrogen levels. Nine cats (12.5%) receiving meloxicam injection had post-treatment anemia. Pre-treatment, these cats all had hematocrit and hemoglobin values in the normal range. Four cats (6.1 %) in the butorphanol treatment group had post-treatment anemia. All but one cat, who had a mild anemia pre-treatment (hematocrit=21% and hemoglobin=7.0 g/dL) had normal pre-treatment values. Twenty-four hours after the injection with meloxicam injection, one cat experienced pain upon palpation of the injection site.

Foreign Experience:

Repeated use in cats has been associated with acute renal failure and death. In studies used for the foreign approval of meloxicam injection in cats, lethargy, vomiting, inappetance, and transient pain immediately after injection were noted. Diarrhea and fecal occult blood have also been reported.

Post-Approval Experience (Rev. 2009):

The following adverse reactions are based on post-approval adverse drug event reporting. The categories are listed in decreasing order of frequency by body system:

Urinary: azotemia, elevated creatinine, elevated phosphorus, renal failure

Gastrointestinal: anorexia, vomiting, diarrhea

Neurologic/Behavioral: lethargy, depressio n

Hematologic: anemia

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 drug events, for technical assistance or to obtain a copy of the SDS, call 1-866-591-5777.

For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/AnimalVeterinary/SafetyHealth.

Information For Cat 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.

Cat owners should be advised when their pet has received a meloxicam injection.

Cat owners should contact their veterinarian immediately if possible adverse reactions are observed.

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