DEXASED: Product Information (Page 2 of 5)

CONTRAINDICATIONS:

Do not use Dexased™ in dogs or cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, or in conditions of shock, severe debilitation, or stress due to extreme heat, cold or fatigue.

As with all alpha2 -adrenoceptor agonists, the potential for isolated cases of hypersensitivity, including paradoxical response (excitation), exists.

WARNINGS:

Human safety: Not for human use. Keep out of reach of children.

Dexmedetomidine Hydrochloride can be absorbed following direct exposure to skin, eyes, or mouth, and may cause irritation. In case of accidental eye exposure, flush with water for 15 minutes. In case of accidental skin exposure, wash with soap and water. Remove contaminated clothing.

Appropriate precautions should be taken while handling and using filled syringes. Accidental topical (including ocular) exposure, oral exposure, or exposure by injection could cause adverse reactions, including sedation, hypotension, and bradycardia. Seek medical attention immediately.

Users with cardiovascular disease (for example, hypertension or ischemic heart disease) should take special precautions to avoid any exposure to this product.

Caution should be exercised when handling sedated animals. Handling or any other sudden stimuli, including noise, may cause a defense reaction in an animal that appears to be heavily sedated.

The safety data sheet (SDS) contains more detailed occupational safety information. To report adverse reactions in users or to obtain a copy of the SDS for this product call 1-800-932-5676.

Note to physician: This product contains an alpha2 -adrenergic agonist.

Animal safety: Dexmedetomidine should not be administered in the presence of preexisting hypotension, hypoxia, or bradycardia. Due to the pronounced cardiovascular effects of dexmedetomidine, only clinically healthy dogs and cats (ASA classes I and II) should be treated. Animals should be frequently monitored for cardiovascular function and body temperature during sedation or anesthesia. Dexmedetomidine sedation is not recommended for cats with respiratory disease.

The use of dexmedetomidine as a preanesthetic in dogs and cats significantly reduces the amount of induction and maintenance anesthetic requirements. Careful patient monitoring during anesthetic induction and maintenance is necessary to avoid anesthetic overdose.

PRECAUTIONS:

Apnea may occur with dexmedetomidine use. In the event of apnea, additional oxygen should be supplied. Administration of atipamezole to dogs is warranted when apnea is accompanied by bradycardia and cyanotic mucous membranes.

Adverse reaction reports for dexmedetomidine in cats include rare events of severe dyspnea and respiratory crackles diagnosed as acute pulmonary edema. Dyspnea due to the delayed onset of pulmonary edema could develop in rare instances up to three days after dexmedetomidine administration. Some of these acute and delayed pulmonary edema cases have resulted in death although this was not observed in the feline clinical field studies with dexmedetomidine.

In dogs, intramuscular atipamezole may be routinely used to rapidly reverse the effects of dexmedetomidine. Since analgesic as well as sedative effects will be reversed, pain management may need to be addressed.

In cats, atipamezole has not been evaluated as a routine dexmedetomidine reversal agent. In cats, cases of dyspnea following atipamezole administration have been reported.

Dexmedetomidine has not been evaluated in the presence of other preanesthetics in cats. Although not observed in the feline field studies, death has been reported in cats receiving dexmedetomidine in conjunction with ketamine and butorphanol.

Analgesia resulting from preanesthetic dexmedetomidine may not provide adequate pain control during the postoperative or postprocedural period. Additional pain management should be addressed as needed.

Following administration of dexmedetomidine, a decrease in body temperature is likely to occur unless externally maintained. Once established, hypothermia may persist longer than sedation and analgesia. To prevent hypothermia, treated animals should be kept warm and at a constant temperature during the procedure, and until full recovery.

Nervous or excited animals with high levels of endogenous catecholamines may exhibit a reduced pharmacological response to alpha2 -adrenoceptor agonists like dexmedetomidine (ineffectiveness). In agitated animals, the onset of sedative/analgesic effects could be slowed, or the depth and duration of effects could be diminished or nonexistent. Therefore, allow dogs and cats to rest quietly for 10 to 15 minutes after injection. Repeat dosing has not been evaluated.

Administration of anticholinergic agents in dogs or cats at the same time or after dexmedetomidine could lead to adverse cardiovascular effects (secondary tachycardia, prolonged hypertension, and cardiac arrhythmias1’2’3). However, an anticholinergic drug may be administered to dogs at least 10 minutes before dexmedetomidine for the prevention of the dexmedetomidine-induced reduction in heart rate. Therefore, the routine use of anticholinergics simultaneously with, or after dexmedetomidine in dogs or cats, is not recommended (see ANIMAL SAFETY).

Spontaneous muscle contractions (twitching) can be expected in some dogs sedated with dexmedetomidine.

Dexmedetomidine has been evaluated only in fasted dogs; therefore, its effects on fed dogs (for example, the occurrence of vomiting) have not been characterized. In cats, there is a high frequency of vomition whether fed or fasted; therefore, fasting is recommended to reduce stomach contents.

Dexmedetomidine has not been evaluated in dogs younger than 16 weeks of age, in cats younger than 12 weeks of age, or in geriatric dogs and cats.

Dexmedetomidine has not been evaluated for use in breeding, pregnant, or lactating dogs or cats.

ADVERSE REACTIONS:

Canine sedation/anaigesia 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/anaigesia 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
InductionAnesthetic: Propofol Barbiturate
Preanesthetic Dose: 0 mcg/m 2 n=32 125 mcg/m 2 n=32 375 mcg/m 2 n-32 0 mcg/m 2 n=32 125 mcg/m 2 n=32 375 mcg/m 2 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
Urinaryincontinence 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 Salinen=37 Dexmedetomidinen=64 Salinen=31 Dexmedetomidinen=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.

POSP APPROVAL EXPERIENCE: The following adverse events were obtained from post-approval adverse drug events reported for Dexased™ sterile injectable solution from 2007 to 2009. Not all adverse reactions are reported. Some adverse reactions occurred when Dexased™ was used alone for sedation; most occurred when Dexased™ was used in the presence of anesthetics and/or other preanesthetics. It is not always possible to reliably estimate the frequency of an adverse event or to establish a causal relationship to the drug, especially when multiple drugs are administered. The following reported adverse events are listed in decreasing order of frequency:

Dogs: ineffective for sedation, death, bradycardia, cardiac arrest, apnea, convulsions, vomiting, prolonged sedation, elevated temperature, and delayed sedation.

Cats: ineffective for sedation, death, cardiac arrest, vomiting, apnea, prolonged sedation, hypersalivation, hypothermia, bradycardia, cyanotic mucous membranes, sedation too brief, and dyspnea.

To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet, contact Akorn, Inc. at 1-800-932-5676 or www.akorn.com For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

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