Quellin: Product Information (Page 2 of 4)

ADVERSE REACTIONS:

During investigational studies for the caplet formulation with twice daily administration of 1 mg/lb, no clinically significant adverse reactions were reported. Some clinical signs were observed during field studies (n=297) which were similar for carprofen caplet- and placebo-treated dogs. Incidences of the following were observed in both groups: vomiting (4%), diarrhea (4%), changes in appetite (3%), lethargy (1.4%), behavioral changes (1%), and constipation (0.3%). The product vehicle served as control.

There were no serious adverse events reported during clinical field studies with once daily administration of 2 mg/lb. The following categories of abnormal health observations were reported. The product vehicle served as control.

Percentage of Dogs with Abnormal Health Observations Reported in Clinical Field Study (2 mg/lb once daily)
Observation Carprofen (n = 129) Placebo(n = 132)
Inappetence 1.6 1.5
Vomiting 3.1 3.8
Diarrhea/Soft stool 3.1 4.5
Behavior change 0.8 0.8
Dermatitis 0.8 0.8
PU/PD 0.8
SAP increase 7.8 8.3
ALT increase 5.4 4.5
AST increase 2.3 0.8
BUN increase 3.1 1.5
Bilirubinuria 16.3 12.1
Ketonuria 14.7 9.1

Clinical pathology parameters listed represent reports of increases from pretreatment values; medical judgment is necessary to determine clinical relevance. During investigational studies of surgical pain for the caplet formulation, no clinically significant adverse reactions were reported. The product vehicle served as control.

Percentage of Dogs with Abnormal Health Observations Reported in Surgical Pain Field Studies with Caplets (2 mg/lb once daily)

* A single dog may have experienced more than one occurrence of an event.

Observation* Carprofen (n = 148) Placebo(n = 149)
Vomiting 10.1 13.4
Diarrhea/Soft stool 6.1 6.0
Ocular disease 2.7 0
Inappetence 1.4 0
Dermatitis/Skin lesion 2.0 1.3
Dysrhythmia 0.7 0
Apnea 1.4 0
Oral/Periodontal disease 1.4 0
Pyrexia 0.7 1.3
Urinary tract disease 1.4 1.3
Wound drainage 1.4 0

During investigational studies for the chewable tablet formulation, gastrointestinal signs were observed in some dogs. These signs included vomiting and soft stools.

Post-Approval Experience: Although not all adverse reactions are reported, the following adverse reactions are based on voluntary post-approval adverse drug experience reporting. The categories of adverse reactions are listed in decreasing order of frequency by body system.

Gastrointestinal: Vomiting, diarrhea, constipation, inappetence, melena, hematemesis, gastrointestinal ulceration, gastrointestinal bleeding, pancreatitis.

Hepatic: Inappetence, vomiting, jaundice, acute hepatic toxicity, hepatic enzyme elevation, abnormal liver function test(s), hyperbilirubinemia, bilirubinuria, hypoalbuminemia. Approximately one-fourth of hepatic reports were in Labrador Retrievers.

Neurologic: Ataxia, paresis, paralysis, seizures, vestibular signs, disorientation.

Urinary: Hematuria, polyuria, polydipsia, urinary incontinence, urinary tract infection, azotemia, acute renal failure, tubular abnormalities including acute tubular necrosis, renal tubular acidosis, glucosuria.

Behavioral: Sedation, lethargy, hyperactivity, restlessness, aggressiveness.

Hematologic: Immune-mediated hemolytic anemia, immune-mediated thrombocytopenia, blood loss anemia, epistaxis.

Dermatologic: Pruritus, increased shedding, alopecia, pyotraumatic moist dermatitis (hot spots), necrotizing panniculitis/vasculitis, ventral ecchymosis.

Immunologic or hypersensitivity: Facial swelling, hives, erythema.

In rare situations, death has been associated with some of the adverse reactions listed above.

To report a suspected adverse reaction call Elanco Veterinary Services at 1-800-422-9874.

DOSAGE AND ADMINISTRATION:

Always provide Client Information Sheet with prescription. Carefully consider the potential benefits and risk of quellin and other treatment options before deciding to use quellin. Use the lowest effective dose for the shortest duration consistent with individual response. The recommended dosage for oral administration to dogs is 2 mg/lb of body weight daily. The total daily dose may be administered as 2 mg/lb of body weight once daily or divided and administered as 1 mg/lb twice daily. For the control of postoperative pain, administer approximately 2 hours before the procedure. quellin soft chewable tablets are scored and dosage should be calculated in half-tablet increments. Soft chewable tablets can be halved by holding the tablet on each side of the score line and pressing up in the middle to break the tablet into two pieces. Care should be taken to ensure that the dog consumes the complete dose.

EFFECTIVENESS:

Confirmation of the effectiveness of carprofen for the relief of pain and inflammation associated with osteoarthritis, and for the control of postoperative pain associated with soft tissue and orthopedic surgeries, was demonstrated in 5 placebo-controlled, masked studies examining the anti-inflammatory and analgesic effectiveness of carprofen in various breeds of dogs.

Separate placebo-controlled, masked, multicenter field studies confirmed the anti-inflammatory and analgesic effectiveness of carprofen caplets when dosed at 2 mg/lb once daily or when divided and administered at 1 mg/lb twice daily. In these 2 field studies, dogs diagnosed with osteoarthritis showed statistically significant overall improvement based on lameness evaluations by the veterinarian and owner observations when administered carprofen at labeled doses.

Separate placebo-controlled, masked, multicenter field studies confirmed the effectiveness of carprofen caplets for the control of postoperative pain when dosed at 2 mg/lb once daily in various breeds of dogs. In these studies, dogs presented for ovariohysterectomy, cruciate repair and aural surgeries were administered carprofen preoperatively and for a maximum of 3 days (soft tissue) or 4 days (orthopedic) postoperatively. In general, dogs administered carprofen showed statistically significant reduction in pain scores compared to controls.

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