Dexdomitor: Product Information (Page 4 of 7)

ADVERSE REACTIONS

Canine sedation/analgesia field study

In the field study safety analysis, 106 dogs received dexmedetomidine and 107 received medetomidine. Dogs ranged from 16 weeks to 16 years of age, representing 49 breeds. The following table shows the number of dogs displaying each clinical observation (some dogs experienced more than one adverse reaction).

Table 4: Adverse reactions during the canine sedation/analgesia field study

	DexmedetomidineTotal n= 106	MedetomidineTotal n=107
Ausculted unidentified arrhythmias	19	20
Severe bradycardia requiring treatment	1	1
Apnea requiring treatment	1	0
Slow onset of sedation (exceeding 30 minutes)	1	1
Ineffectiveness (dog standing throughout the study)	3	2
Severe hypothermia requiring treatment	2	0
Prolonged recovery	1	4

The occurrence of ausculted unidentified arrhythmias (some at multiple time points) decreased following the administration of atipamezole.

Canine preanesthesia field study

The preanesthesia field study safety analysis included 192 dogs, between 5 months and 15 years of age, representing 43 breeds enrolled for elective procedures conducted under general anesthesia. The following table shows the number of dogs within a treatment group that showed each clinical sign (dogs may have experienced more than one adverse reaction).

Table 5: Adverse reactions during the canine preanesthesia field study

	Treatment Groups
Induction Anesthetic:	Propofol			Barbiturate
Preanesthetic Dose:	0mcg/m2 n=32	125mcg/m2 n=32	375mcg/m2 n=32	0mcg/m2 n=32	125mcg/m2 n=32	375 mcg/m2 n=32
Emesis	4	7	4	2	3	6
Ventricular premature contractions	0	2	0	4	1	0
Diarrhea	1	0	0	3	1	1
Self trauma	0	2	1	2	1	0
Severe bradycardia	0	0	1	0	0	1
Tachycardia	0	0	0	1	1	0
Urinary incontinence	0	0	0	0	0	1

Other clinical signs observed in dogs treated with dexmedetomidine include decreased respiratory rate and hypothermia.

Feline sedation/analgesia field study

The field study safety analysis included 242 cats (122 received dexmedetomidine; 120 received xylazine), 6 months to 17 years of age, and representing 19 breeds. The following table shows the number of cats reported with an adverse reaction (cats may have experienced more than one adverse reaction).

Table 6: Adverse reactions during the feline field study

	Dexmedetomidinen = 122	Xylazinen = 120
Vomiting	70	82
Urinary incontinence	6	11
Hypersalivation	4	5
Involuntary defecation	4	1
Hypothermia	2	1
Diarrhea	2	0
Arrhythmia	1	2
Corneal ulcer	1	0
Cyanosis	1	0
Dyspnea	1	0

The most frequently observed adverse reaction was vomiting in both fasted and fed cats. Other infrequent clinical signs observed in cats treated with dexmedetomidine included fatigue, anorexia, cystitis, and peripheral vascular disorder.

One incidence of dyspnea was reported, 43 minutes after dexmedetomidine administration during an oral examination/dental procedure. Prior to dexmedetomidine, the cat was free of clinical signs, but had a history of asthma and respiratory infection. The cat responded successfully to treatment.

Feline preanesthesia field study

The field study safety analysis included 184 cats (116 received dexmedetomidine; 68 received saline), 12 weeks to 16 years of age, and representing 11 breeds. The following table shows the number of cats reported with an adverse reaction (cats may have experienced more than one adverse reaction).

Table 7. Adverse reactions during the feline preanesthesia field study

Induction Anesthetic	Ketamine		Propofol
Preanesthetic	Saline n=37	Dexmedetomidine n=64	Saline n=31	Dexmedetomidine n=52
Emesis	2	20	1	12
Pale mucous membranes		11		9
Decreased body temperature		4
Retching		1	1	3
Heart murmur				2
Loose stool		2
Corneal injury	1
Apnea		1
Behavioral change			1
Fluid in endotracheal tube			1

One case of apnea was reported in a cat that received ketamine as the induction agent. This cat required artificial ventilation from the start of the procedure until 30 minutes into recovery when the cat began to breathe on its own. The cat recovered without further problems.