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NOW AVAILABLE IN 2 x 100 mL SIZE LOXICOM ® (MELOXICAM) ORAL SUSPENSION Contains the same active ingredient and is bioequivalent to Metacam ® (meloxicam) Oral Suspension Also available in 10 mL, 32 mL and 100 mL sizes Each carton contains:
›› 2 Bottles of LoxicomOral Suspension 100 mL ›› 1 Calibrated Syringe for Dogs 30 lbs or More ›› 1 Calibrated Syringe for Dogs 30 lbs or Less ›› 1 package insert
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Observe Label Directions. Do not use Loxicom Oral Suspension in cats.Acute renal failure and death have been associated with the use of meloxicam in cats. As with any medication,side effects may occur.These are usually mild but may be serious.The most common side effects reported in field studies were vomiting,soft stool/diarrhea and decreased appetite. If side effects occur,discontinue treatment immediately and consult a veterinarian.Dogs should be evaluated for pre-existing medical conditions prior to treatment and monitored during therapy.See product labeling for full product information. ©2019 Norbrook Laboratories Limited.All rights reserved.Norbrook logos and Loxicom are registered trademarks of Norbrook Laboratories Limited.Metacam is a trademark of Boehringer IngelheimVetmedica, Inc. 0519-497-I01A
Precautions: The safe use of Loxicom Oral Suspension in dogs younger than 6 months of age, dogs used for breeding, or in pregnant or lactating dogs has not been evaluated. 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. Patients at great- est 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 prosta- glandins that maintain normal homeostatic function. Such anti-prostaglandin effects may result in clinically signifi- cant 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 corti- costeroids, should be avoided or closely monitored. The use of concomitantly protein-bound drugs with Loxicom Oral Suspension has not been studied in dogs. Commonly used protein-bound drugs include cardiac, anticonvulsant and behavioral medications. The influence of concomi- tant drugs that may inhibit metabolism of Loxicom 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 abnormali- ties (vomiting, soft stools, diarrhea, and inappetance) were the most common adverse reactions associated with the administration of meloxicam. Of the dogs that took meloxicam (n=157), forty experienced vomiting, nineteen experienced diarrhea/soft stool, five experienced inappetance, and one each experienced bloody stool, bleeding gums after dental procedure, lethargy/swollen carpus, and epiphora. Of the dogs that took the placebo (n=149), twenty-three experienced vomiting, eleven experienced diarrhea/ soft stool, and one experienced inappetance. 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).
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 osteoarthri- tis. 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 evalu- ated 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 statisti- cal 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. How Supplied: Loxicom Oral Suspension 1.5 mg/mL: 10, 32 and 100 mL bottles with small and large dosing syringes. Storage: Store at controlled room temperature 68-77°F (20-25°C). Excursions permitted between 59°F and 86°F (15°C and 30°C). Brief exposure to temperature up to 104°F (40°C) may be tolerated provided the mean kinetic temperature does not exceed 77°F (25°C); however such exposure should be minimized. Made in the UK. Manufactured by: Norbrook Laboratories Limited Newry, BT35 6PU, Co. Down, Northern Ireland
Loxicom ® (meloxicam oral suspension) 1.5 mg/mL Oral Suspension Non-steroidal anti-inflammatory drug for oral use in dogs only 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: Before using Loxicom Oral Suspension, consult the product insert, a summary of which follows. Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Description: Meloxicam is a non-steroidal anti-inflam- matory drug (NSAID) of the oxicam class. Indications: Loxicom 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 Loxicom Oral Suspension. Do not use Loxicom Oral Suspension in cats. Acute renal failure and death have been associ- ated with the use of meloxicam in cats. Warnings: Not for use in humans. Keep this and all medi- cations 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 base- line data is recommended prior to and periodically during administration. To report suspected adverse reactions, to obtain a Safety Data Sheet, or for technical assistance, call Norbrook at 1-866-591-5777.
Loxicom ® is a registered trademark of Norbrook Laboratories Limited I01 August 2018
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