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Dexmedetomidine) Frequently asked questions regarding alpha-2 agonist DEXDOMITOR® (dexmedetomidine) Q: How should I monitor a patient that has received DEXDOMITOR for sedation or as a premedication? A: The monitoring of vital signs is critical for any patient under sedation or anesthesia. It is important to monitor heart rate, blood pressure, palpable pulse quality, and respiratory rate and volume. Because a2 agonists cause peripheral vasoconstriction, the use of pulse oximetry may not adequately reflect the true status of the patient. Q: What can I expect to see in a patient under DEXDOMITOR sedation? A: The patient may have pale pink or grayish mucous membranes because of peripheral vasoconstriction. The sedation induced by DEXDOMITOR causes a decrease in respiratory rate and a lower body temperature. Q: What is considered a low heart rate? A: Because of the wide range of dog sizes and corresponding heart rates, normal heart rates should be based on the dog’s body size. A reduction in heart rate following a2 agonist sedation should be expected. Patient status should be evaluated by the simultaneous measurement of many parameters, including pulse quality, respiratory rate and quality, blood pressure, and heart rate. Q: What is the effect on the respiratory rate? A: DEXDOMITOR does not have a direct effect on respiration. Although the respiratory rate may decrease as a result of sedation, ventilatory volume generally increases, and overall ventilation (gas exchange) remains stable. Q: I am concerned about hypothermia. A: Hypothermia can occur in a patient following administration of any anesthetic or sedative drug. It is important that body temperature be maintained in all patients undergoing anesthesia or sedation, including those that receive an a2 agonist. Q: How do I optimize the effects of DEXDOMITOR? A: Several factors can influence the effects of DEXDOMITOR when administered to a patient. A patient that is stressed may have high levels of circulating catecholamines, which can interfere with the activity of DEXDOMITOR. If possible, the patient should be kept calm before injection, and allowed to rest in a quiet, non-stressful environment for at least 15 minutes after injection. Q: Is there a preferred area of administration for an IM injection of DEXDOMITOR? A: DEXDOMITOR should preferably be given deeply into a muscle, such as the caudal or cranial thigh or epaxial muscle (muscles along the lumbar spine). Q: What causes the occasional muscle twitching that occurs in DEXDOMITOR-treated patients? A: The muscle twitching observed following DEXDOMITOR administration is not seizure activity and does not require treatment. The exact cause of the twitching is unknown and has been observed following administration of all a2 agonists in a variety of species. Q: Can DEXDOMITOR be used in sight hounds? A: Yes. There have been no studies showing that sight hounds experience prolonged effects due to dexmedetomidine, and the availability of ANTISEDAN enables predictable recoveries if needed. Q: Does DEXDOMITOR have an effect on urine production? A: Yes. The increase in urine production is caused by several factors, including transient hyperglycemia and an inhibition of anti-diuretic hormone (ADH). In cats, this effect may be mistaken for urinary incontinence. It is important that patients be allowed to urinate before being sent home. Important Safety Information Do not use DEXDOMITOR in dogs or cats and ANTISEDAN in dogs 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. DEXDOMITOR should not be administered in the presence of preexisting hypotension, hypoxia, or bradycardia. As with all a2-adrenoceptor agonists, the potential for isolated cases of hypersensitivity, including paradoxical response (excitation), exists with DEXDOMITOR. The use of DEXDOMITOR as a preanesthetic in dogs and cats significantly reduces the amount of induction and maintenance anesthetic requirements. Careful patient monitoring is necessary to avoid anesthetic overdose. Arrhythmias, bradycardia, apnea, emesis, convulsions, hypersalivation may occur with DEXDOMITOR use. Severe dyspnea and respiratory crackles due to acute or delayed pulmonary edema could develop in cats. DEXDOMITOR has not been evaluated for use in breeding, pregnant, or lactating dogs or cats; in dogs younger than 16 weeks of age or in cats younger than 12 weeks of age; in geriatric dogs or cats. Occasional vomiting may occur with ANTISEDAN use. Rarely, a brief state of excitement or apprehensiveness may be seen in ANTISEDAN treated dogs. Other potential side effects of a2-antagonists, such as ANTISEDAN, include hypersalivation, diarrhea, and tremors. For more safety information, refer to the full prescribing information. Table 2: PREANESTHESIA DOSE TABLE: Intramuscular sedation, hypotension, and bradycardia. Seek medical Dexmedetomidine has not been evaluated in dogs NADA 141-267, Approved by FDA. (IM) dosing on the basis of body weight. attention immediately. younger than 16 weeks of age, in cats younger than Users with cardiovascular disease (for example, 12 weeks of age, or in geriatric dogs and cats. Preanesthesia in dogs hypertension or ischemic heart disease) should take Dexmedetomidine has not been evaluated for use in Dog Dexmedetomidine Dexmedetomidine special precautions to avoid any exposure to this breeding, pregnant, or lactating dogs or cats. 2 2 Weight 125 mcg/m IM 375 mcg/m IM product. ADVERSE REACTIONS: (dexmedetomidine hydrochloride) lbs kg mcg/kg DEXDOMITOR mcg/kg DEXDOMITOR Caution should be exercised when handling sedated Canine sedation/analgesia field study: In the mL mL animals. Handling or any other sudden stimuli, including field study safety analysis, 106 dogs received Sterile Injectable Solution – 0.5 mg/mL noise, may cause a defense reaction in an animal that dexmedetomidine and 107 received medetomidine. 4-7 2-3 9.4 0.04 28.1 0.12 appears to be heavily sedated. For intramuscular and intravenous use in dogs and for Dogs ranged from 16 weeks to 16 years of age, 7-9 3-4 8.3 0.05 25.0 0.15 The material safety data sheet (MSDS) contains more representing 49 breeds. The following table shows intramuscular use in cats detailed occupational safety information. To report 9-11 4-5 7.7 0.07 23.0 0.20 the number of dogs displaying each clinical observation CAUTION: Federal law restricts this drug to use by or adverse reactions in users or to obtain a copy of the (some dogs experienced more than one adverse on the order of a licensed veterinarian. 11-22 5-10 6.5 0.10 19.6 0.29 MSDS for this product call 1-800-366-5288. reaction). Note to physician: This product contains an alpha - DESCRIPTION: DEXDOMITOR (dexmedetomidine 22-29 10-13 5.6 0.13 16.8 0.38 2 Table 4: Adverse reactions during the canine sedation/ hydrochloride) is a synthetic alpha -adrenoreceptor adrenergic agonist. 2 29-33 13-15 5.2 0.15 15.7 0.44 analgesia field study agonist with sedative and analgesic properties. The PRECAUTIONS: chemical name is (+)-4-[1-(2,3-dimethylphenyl) ethyl]- 33-44 15-20 4.9 0.17 14.6 0.51 For cats, the concurrent use of DEXDOMITOR prior Dexmedetomidine Medetomidine 1H-imidazole monohydrochloride. It is a white, or almost Total n=106 Total n=107 44-55 20-25 4.5 0.20 13.4 0.60 to or with an anesthetic has not been evaluated. white, crystalline, water soluble substance having a Dexmedetomidine in cats has not been evaluated in Ausculted unidentified 19 20 molecular weight of 236.7. The molecular formula is 55-66 25-30 4.2 0.23 12.6 0.69 the presence of other sedatives. arrhythmias C H N •HCl and the structural formula is: 13 16 2 66-73 30-33 4.0 0.25 12.0 0.75 Dexmedetomidine sedation is not recommended for cats with respiratory disease. Adverse reaction reports Severe bradycardia 1 1 73-81 33-37 3.9 0.27 11.6 0.81 for dexmedetomidine include a cat with severe dyspnea requiring treatment CH CH 81-99 37-45 3.7 0.30 11.0 0.90 and respiratory crackles diagnosed as acute pulmonary Apnea requiring 1 0 3 3 edema. The cat’s health history was not known and treatment 99-110 45-50 3.5 0.33 10.5 0.99 the cat recovered with treatment. Slow onset of sedation 1 1 CH Although not observed in the feline field study with N 3 110- 50-55 3.4 0.35 10.1 1.06 (exceeding 30 minutes) 121 dexmedetomidine, rare cases of delayed pulmonary edema, some resulting in death, have been reported Ineffectiveness (dog 3 2 • HCl 121- 55-60 3.3 0.38 9.8 1.13 standing throughout in cats that received medetomidine (another alpha2- N 132 agonist), usually in conjunction with anesthesia. In the study) H 132- 60-65 3.2 0.40 9.5 1.19 these cases, dyspnea due to the delayed onset of Severe hypothermia 2 0 143 pulmonary edema developed up to three days after requiring treatment medetomidine administration. Each mL of DEXDOMITOR contains 0.5 mg 143- 65-70 3.1 0.42 9.3 1.26 Dexmedetomidine should not be administered in the Prolonged recovery 1 4 dexmedetomidine hydrochloride, 1.6 mg methylparaben 154 presence of preexisting hypotension, hypoxia, or (NF), 0.2 mg propylparaben (NF), 9.0 mg sodium The occurrence of ausculted unidentified arrhythmias 154- 70-80 3.0 0.45 9.0 1.35 bradycardia. Due to the pronounced cardiovascular chloride (USP), and water for injection (USP), q.s. (some at multiple time points) decreased following the 176 effects of dexmedetomidine, only clinically healthy administration of atipamezole. INDICATIONS: DEXDOMITOR is indicated for use dogs and cats should be treated. Animals should be >176 >80 2.9 0.47 8.7 1.42 Canine preanesthesia field study: The preanesthesia as a sedative and analgesic in dogs and cats to frequently monitored for cardiovascular function and field study safety analysis included 192 dogs, between facilitate clinical examinations, clinical procedures, The use of dexmedetomidine as a preanesthetic body temperature during sedation or anesthesia.
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