title: The safety of high-dose buprenorphine administered subcutaneously in cats.
abstract: The safety of a proprietary formulation of buprenorphine hydrochloride administered subcutaneously (SC) to young cats was investigated in a blinded, randomized study. Four cohorts of eight cats aged approximately 4 months were administered saline, 0.24, 0.72 or 1.20 mg/kg/day buprenorphine SC for nine consecutive days, representing 0×, 1×, 3× and 5× of the intended dose. Cats were monitored daily for evidence of clinical reactions, food and water intake and adverse events (AEs). Physical examinations, clinical pathology, vital signs and electrocardiograms (ECGs) were evaluated at protocol-specified time points. Complete necropsy and histopathologic examinations were performed following humane euthanasia. Four buprenorphine-treated cats experienced AEs during the study, two unrelated and two related to study drug administration. The two cats with AEs considered related to drug administration had clinical signs of hyperactivity, difficulty in handling, disorientation, agitation and dilated pupils in one 0.24 mg/kg/day cat and one 0.72 mg/kg/day cat. All of these clinical signs were observed simultaneously. There were no drug-related effects on survival, injection response, injection site inspections, body weight, food or water consumption, bleeding time, urinalysis, respiration rate, heart rate, ECGs, blood pressures, body temperatures, macroscopic examinations or organ weights. Once daily buprenorphine s.c. injections at doses of 0.24, 0.72 and 1.20 mg/kg/day for 9 consecutive days were well tolerated in young domestic cats.
authors.affiliation: Abbott Laboratories, Abbott Park, IL, USA.
authors.forename: M K
authors.initials: MK
authors.lastname: Sramek
authors.affiliation: WIL Research, Ashland, OH, USA.
authors.forename: M C
authors.initials: MC
authors.lastname: Haas
authors.affiliation: WIL Research, Ashland, OH, USA.
authors.forename: G D
authors.initials: GD
authors.lastname: Coleman
authors.affiliation: WIL Research, Ashland, OH, USA.
authors.forename: P R
authors.initials: PR
authors.lastname: Atterson
authors.affiliation: QTest Labs, LLC, Columbus, OH, USA.
authors.forename: R L
authors.initials: RL
authors.lastname: Hamlin
mesh_terms: D000701:Analgesics, Opioid / Q000008:administration & dosage / Q000009:adverse effects*; D000818:Animals; D001522:Behavior, Animal / Q000187:drug effects; D001777:Blood Coagulation / Q000187:drug effects; D002047:Buprenorphine / Q000008:administration & dosage / Q000009:adverse effects*; D002415:Cats; D003221:Confusion / Q000139:chemically induced; D003967:Diarrhea / Q000139:chemically induced / Q000662:veterinary; D004326:Drinking / Q000187:drug effects; D004435:Eating / Q000187:drug effects; D005260:Female; D006948:Hyperkinesis / Q000139:chemically induced; D007279:Injections, Subcutaneous / Q000662:veterinary; D008297:Male
chemical_list: D000701:Analgesics, Opioid; D002047:Buprenorphine