Today's Veterinary Practice

NOV-DEC 2018

Today's Veterinary Practice provides comprehensive information to keep every small animal practitioner up to date on companion animal medicine and surgery as well as practice building and management.

Issue link: https://todaysveterinarypractice.epubxp.com/i/1042991

Contents of this Issue

Navigation

Page 52 of 81

Brief Summary NADA 141-213, Approved by FDA Metacam ® (meloxicam oral suspension ) 1.5 mg/mL (equivalent to 0.05 mg per drop) /0.5 mg/mL (equivalent to 0.02 mg per drop) Non-steroidal anti-inflammatory drug for oral use in dogs only Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Description: Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class. Each milliliter of METACAM Oral Suspension contains meloxicam equivalent to 0.5 or 1.5 milligrams and sodium benzoate (1.5 milligrams) as a preservative. The chemical name for Meloxicam is 4-Hydroxy-2- methyl-N-(5-methyl-2-thiazolyl)- 2H-1,2-benzothiazine-3-carboxamide-1, 1-dioxide. The formulation is wwa yellowish viscous suspension with the odor of honey. Indications: METACAM Oral Suspension is indicated for the control of pain and inflammation associated with osteoarthritis in dogs. Contraindications: Dogs with known hypersensitivity to meloxicam should not receive METACAM Oral Suspension. Do not use METACAM Oral Suspension in cats. Acute renal failure and death have been associated with the use of meloxicam 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 dog 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.¹ 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 adverse events are based on post-approval adverse drug experience reporting. Not all adverse reactions are reported to FDA/CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data. The following adverse events are listed in decreasing order of frequency by body system. Gastrointestinal: vomiting, diarrhea, melena, gastrointestinal ulceration Urinary: azotemia, elevated creatinine, renal failure Neurological/Behavioral: lethargy, depression Hepatic: elevated liver enzymes Dermatologic: pruritus Death has been reported as an outcome of the adverse events listed above. Acute renal failure and death have been associated with use of meloxicam in cats. Information for Dog Owners: METACAM, like other drugs of its class, 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 drug intolerance. Adverse reactions may include vomiting, diarrhea, decreased appetite, dark or tarry stools, increased water consumption, increased urination, pale gums due to anemia, yellowing of gums, skin or white of the eye due to jaundice, lethargy, incoordination, seizure, or behavioral changes. Serious adverse reactions associated with this drug class can occur without warning and in rare situations result in death (see Adverse Reactions). Owners should be advised to discontinue METACAM and contact their veterinarian immediately if signs of intolerance are observed. The vast majority of patients with drug related adverse reactions have recovered when the signs are recognized, the drug is withdrawn, and veterinary care, if appropriate, is initiated. Owners should be advised of the importance of periodic follow up for all dogs during administration of any NSAID. Effectiveness: 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 meloxicam 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. 1 Reference: 1. FOI for NADA 141-213 METACAM (meloxicam oral suspension). Manufactured for: Boehringer Ingelheim Vetmedica, Inc. St. Joseph, MO 64506 U.S.A. METACAM is a registered trademark of Boehringer Ingelheim Vetmedica GmbH, used under license. 601401-08/601413-04/6015161-10/6015268-04 Revised 07/2016 18490 06/2018 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. Brief Summary NADA 141-219, Approved by FDA Metacam ® (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. 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. Indications: Dogs: METACAM (meloxicam) 5 mg/mL Solution for Injection is indicated in dogs for the control of pain and inflammation associated with osteoarthritis. Contraindications: Dogs with known hypersensitivity to meloxicam should not receive METACAM 5 mg/ mL Solution for Injection. 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 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. Owner should be advised to observe their dogs for signs of potential drug toxicity. Precautions: 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 anti-prostaglandin effects may result in clinically significant disease in patients with underlying or preexisting 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 the administration of the total daily dose of METACAM Oral Suspension, a non-NSAID or noncorticosteriod 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. Adverse Reactions: Dogs: A field study involving 224 dogs was conducted. 1 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 adverse reactions are based on post-approval adverse drug event reporting. The categories are listed in decreasing order of frequency by body system: Gastrointestinal: vomiting, diarrhea, melena, gastrointestinal ulceration Urinary: azotemia, elevated creatinine, renal failure Neurological/Behavioral: lethargy, depression Hepatic: elevated liver enzymes Dermatologic: 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. 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 METACAM therapy. Effectiveness: Dogs: 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. 1 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 variables. Reference: 1. FOI for NADA 141-219 METACAM (meloxicam) 5 mg/mL Solution for Injection. Manufactured for: Boehringer Ingelheim Vetmedica, Inc. St. Joseph, MO 64506 U.S.A. METACAM is a registered trademark of Boehringer Ingelheim Vetmedica GmbH, licensed to Boehringer Ingelheim Vetmedica, Inc. 601307-07 Revised 08/2014 18490 06/2018 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.

Articles in this issue

Archives of this issue

view archives of Today's Veterinary Practice - NOV-DEC 2018