Dexdomitor: Product Information (Page 3 of 7)

Cats — 0.1

Sedation, Analgesia and Preanesthesia: 40 mcg/kg intramuscularly (IM).

This dose can also be used as a preanesthetic and has been shown to markedly reduce anesthetic requirements in cats. Injectable anesthetic drug requirements for intubation were reduced up to 49%, depending on the choice of induction drug. The concentration of inhalation maintenance anesthetic was reduced between 35% and 44%, depending on the choice of induction drug. The anesthetic dose should always be titrated against the response of the patient.

The following table may be used to determine the correct dexmedetomidine dosage for cats based on body weight.

Table 3: FELINE DOSE TABLE: Intramuscular (IM) dosing on the basis of body weight in cats.

DEXDOMITOR 0.5 mg/mL
Sedation/analgesia and preanesthesia in cats
CatWeight		Dexmedetomidine40 mcg/kg IM
lbs	kg	mcg/kg	mL
2-4	1-2	40	0.1
4.1-7	2.1-3	40	0.2
7.1-9	3.1-4	40	0.3
9.1-13	4.1-6	40	0.4
13.1-15	6.1-7	40	0.5
15.1-18	7.1-8	40	0.6
18.1-22	8.1-10	40	0.7

For higher weight ranges, use DEXDOMITOR’s higher concentration and its associated dosing chart.

It is recommended that dogs and cats be fasted for 12 hours before treatment with DEXDOMITOR. An eye lubricant should be applied to cats to prevent corneal desiccation that may result from a reduction in the blink reflex. Following injection of DEXDOMITOR, the animal should be allowed to rest quietly for 15 minutes; sedation and analgesia occur within 5 to 15 minutes, with peak effects at 30 minutes after dexmedetomidine.

Cats — 0.5

Sedation, Analgesia and Preanesthesia: 40 mcg/kg intramuscularly (IM).

This dose can also be used as a preanesthetic and has been shown to markedly reduce anesthetic requirements in cats. Injectable anesthetic drug requirements for intubation were reduced up to 49%, depending on the choice of induction drug. The concentration of inhalation maintenance anesthetic was reduced between 35% and 44%, depending on the choice of induction drug. The anesthetic dose should always be titrated against the response of the patient.

The following table may be used to determine the correct dexmedetomidine dosage for cats based on body weight.

Table 3: FELINE DOSE TABLE: Intramuscular (IM) dosing on the basis of body weight in cats.

DEXDOMITOR 0.5 mg/mL
Sedation/analgesia and preanesthesia in cats
CatWeight		Dexmedetomidine40 mcg/kg IM
lbs	kg	mcg/kg	mL
2-4	1-2	40	0.1
4.1-7	2.1-3	40	0.2
7.1-9	3.1-4	40	0.3
9.1-13	4.1-6	40	0.4
13.1-15	6.1-7	40	0.5
15.1-18	7.1-8	40	0.6
18.1-22	8.1-10	40	0.7

It is recommended that dogs and cats be fasted for 12 hours before treatment with DEXDOMITOR. An eye lubricant should be applied to cats to prevent corneal desiccation that may result from a reduction in the blink reflex. Following injection of DEXDOMITOR, the animal should be allowed to rest quietly for 15 minutes; sedation and analgesia occur within 5 to 15 minutes, with peak effects at 30 minutes after dexmedetomidine.

CONTRAINDICATIONS

Do not use DEXDOMITOR 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.
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 ANTISEDAN (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 ANTISEDAN (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, ANTISEDAN (atipamezole) has not been evaluated as a routine dexmedetomidine reversal agent. In cats, cases of dyspnea following ANTISEDAN (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.