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.
DOSAGE AND ADMINISTRATION:
Carefully consider the potential benefits and risk of Meloxicam and other treatment options before deciding to use Meloxicam. Use the lowest effective dose for the shortest duration consistent with individual response.
Dogs: Meloxicam Injection should be administered initially as a single dose at 0.09 mg/lb (0.2 mg/kg) body weight intravenously (IV) or subcutaneously (SQ), followed, after 24 hours, by meloxicam oral suspension at the daily dose of 0.045 mg/lb (0.1 mg/kg) body weight, either mixed with food or placed directly in the mouth.
EFFECTIVENESS:
Cats: The effectiveness of meloxicam injection was demonstrated in a masked field study involving a total of 138 cats representing various breeds. This study used butorphanol as an active control. Cats received either a single subcutaneous injection of 0.3 mg/kg meloxicam injection or 0.4 mg/kg butorphanol prior to onychectomy, either alone or in conjunction with surgical neutering. All cats were premedicated with acepromazine, induced with propofol and maintained on isoflurane. Pain assessment variables evaluated by veterinarians included additional pain intervention therapy, gait/lameness score, analgesia score, sedation score, general impression score, recovery score, and visual analog scale score. Additionally, a cumulative pain score, which was the summation of the analgesia, sedation, heart rate and respiratory rate scores was evaluated. A palpometer was used to quantify the pain threshold.
A substantial number of cats required additional intervention in the 0-24 hour postsurgical period, with the majority of these interventions taking place within the first hour. Therefore, the percentage of cats in each group that received one or more interventions was designated as the primary assessment variable. Approximately half of the cats in each group received a pain intervention as a result of the first (time 0) post-surgical evaluation, i.e., extubation. At this point, the need to provide a pain intervention was not statistically significant between the two groups (p=0.7215). However, the median number of interventions was one per cat in the meloxicam group and two per cat in the butorphanol group and this difference was statistically significant (p=0.0021). The statistical evaluation supports the conclusion that the meloxicam test article is non-inferior to the butorphanol active control. Forty-eight of the 72 cats in the meloxicam group received one or more interventions (66.7%), and 47 of 66 cats in the butorphanol group received one or more interventions (71.2%). The number of interventions administered to the meloxicam group was less than the butorphanol group at 1, 3, 5, 8, 12, and 24 hours post-surgery.
Cats receiving meloxicam injection showed improvement in the pain assessment variables.
Dogs: The effectiveness of meloxicam 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 meloxicam 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.
STORAGE INFORMATION:
Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) see USP Controlled Room Temperature.
Use contents within 6 months of first puncture.
HOW SUPPLIED:
Meloxicam 5 mg/mL Solution for Injection: 10 mL vial and 20 mL vial
NDC no. 86101-027-41 - 10 mL
NDC no. 86101-027-42 - 20 mL