Plasma pharmacokinetics, pulmonary disposition, and safety of subcutaneous gamithromycin in alpacas.

The study objective was to determine the disposition of gamithromycin in plasma, peripheral blood polymorphonuclear cells (PMNs), pulmonary epithelial lining fluid (PELF), and bronchoalveolar lavage (BAL) cells in alpacas. A single subcutaneous injection of gamithromycin (6.6 mg/kg) was administered to six healthy adult alpacas. At various time points after administration, gamithromycin concentrations were analyzed via LC-MS/MS in plasma, PMNs, PELF, and BAL cells until Day 14 post-injection. Plasma gamithromycin concentrations were measured in all six alpacas; the remaining three body compartments were analyzed in four alpacas. Gamithromycin rapidly concentrated in blood PMNs, BAL cells, and PELF. Shorter Tmax , and lower Cmax, and AUC were observed in plasma than in the other three compartments. Cmax was highest in BAL cells (26001.80 ± 12400.00 ng/ml) and PMNs (2573.00 ± 963.30 ng/ml) compared to PELF (660.80 ± 413.70 ng/ml) and plasma (452.30 ± 196.20 ng/ml). Mean terminal half-lives were 72.60 ± 14.10 h in plasma, 56.60 ± 10.60 h in PELF, 62.80 ± 85.30 h in PMNs, and 93.60 ± 124.80 h in BAL cells. No injection site reactions occurred. One alpaca developed colic but no other adverse reactions were noted. Overall, gamithromycin was highly concentrated in white blood cells and pulmonary fluids/cells. Clinical utilization of gamithromycin in alpacas should be done with caution until further investigation of potential for colic.

Field study of the comparative efficacy of gamithromycin and tulathromycin for the treatment of undifferentiated bovine respiratory disease complex in beef feedlot calves.

OBJECTIVE: To compare the efficacy of gamithromycin with that of tulathromycin for the treatment of undifferentiated bovine respiratory disease complex (BRDC) in feedlot calves. ANIMALS: 1,049 weaned crossbred beef calves. PROCEDURES: At each of 6 feedlots, newly arrived calves with BRDC were administered a single dose of gamithromycin (6.0 mg/kg, SC; n = 523) or tulathromycin (2.5 mg/kg, SC; 526). Case-fatality and BRDC retreatment rates during the first 120 days after treatment, final body weight, and average daily gain (ADG), were compared between treatments. At 2 feedlots, calves were assigned clinical scores for 10 days after treatment to determine recovery rates for each treatment. Bioequivalence limits for gamithromycin and tulathromycin were calculated for outcomes for which there was no significant difference between treatments. RESULTS: Mean BRDC retreatment rate (17.7%) for calves administered gamithromycin was greater than that (9.0%) for calves administered tulathromycin. Mean case-fatality rate, final body weight, ADG, and clinical score 10 days after treatment did not differ significantly between treatments. Limits for mean differences within which gamithromycin was bioequivalent to tulathromycin were ± 2.4% for case-fatality rate, ± 13 kg for final body weight, and ± 0.1 kg/d for ADG. CONCLUSIONS AND CLINICAL RELEVANCE: Calves administered gamithromycin had a higher BRDC retreatment rate than did calves administered tulathromycin; otherwise, the clinical efficacy did not differ between the 2 treatments for the treatment of BRDC in feedlot calves.

Field study of the comparative efficacy of gamithromycin and tulathromycin for the control of undifferentiated bovine respiratory disease complex in beef feedlot calves at high risk of developing respiratory tract disease.

OBJECTIVE: To compare the efficacy of gamithromycin with that of tulathromycin for control of undifferentiated bovine respiratory disease complex (BRDC) in feedlot calves. ANIMALS: 2,529 weaned crossbred beef calves. PROCEDURES: At each of 2 feedlots, calves at risk of developing BRDC were administered a single dose of gamithromycin (6.0 mg/kg, SC; n = 1,263) or tulathromycin (2.5 mg/kg, SC; 1,266) metaphylactically. Health (BRDC morbidity, mortality, case-fatality, and retreatment rates) and performance (average daily gain, dry matter intake, and feed-to-gain ratio) outcomes were compared between treatments via classical hypothesis testing. Bioequivalence limits for gamithromycin and tulathromycin were established for outcomes for which no significant difference between treatments was detected. RESULTS: Mean BRDC morbidity rate (31.0%) for calves administered gamithromycin was greater than that (22.9%) for calves administered tulathromycin; otherwise, health and performance did not differ between treatments. Limits for mean differences within which gamithromycin was considered bioequivalent to tulathromycin were ± 10% for BRDC retreatment rate, ± 3.5% for BRDC mortality rate, ± 16% for case-fatality rate, ± 37 kg for final body weight, ± 0.1 kg/d for average daily gain, ± 0.3 kg/d for dry matter intake, and ± 0.7 for feed-to-gain ratio. CONCLUSIONS AND CLINICAL RELEVANCE: The efficacy of gamithromycin did not differ from that of tulathromycin for all outcomes except morbidity rate; calves administered gamithromycin had a higher BRDC morbidity rate than did calves administered tulathromycin. On the basis of the bioequivalence limits established for this dataset, gamithromycin was considered equivalent to tulathromycin for the control of BRDC.